Pall Solutions
for the
BioPharmaceutical
Industry
Contents and Introduction
Global Expertise
Experience
ii
Contents
Introduction Page Direct Flow Liquid Filtration Page Filter Housings Page
Introduction ii Mini Kleenpak Sterilizing-grade 77 Junior B series Filter Housings 145
Table of Contents iii Capsule Filters Sealkleen™ Filter Housings 147
Usage Instructions iv Kleenpak Capsules with 79 Pall Advanta™ Junior Filter Housings 149
Supor® EKV Membrane Assemblies
Pall Advanta Junior F Liquid 151
Supor EKV Sterilizing-grade 81 Filter Housings
Applications Filter Cartridges
Pall Advanta ALT Liquid Filter Housings 153
Biotechnology and Cell Culture 2 Supor EBV Sterilizing-grade 83
Flow Diagram Filter Cartridges Pall Advanta In-Line Liquid and Gas 155
Filter Housings
Blood Products and Fractionation 4 Kleenpak Capsules with 85
Flow Diagram Fluorodyne® II Membrane Assemblies Pall Advanta Jacketed Housings 157
API - Active Pharmaceutical Ingredients 6 Fluorodyne II Hydrophilic PVDF 87 Pall Advanta AGT Gas Filter Housings 159
Flow Diagram Filter Cartridges Pall Advanta AVL Liquid and Gas 161
Formulation and Filling 8 Kleenpak Capsules with 89 Filter Housings
Flow Diagram Ultipor N66 Membrane Assemblies Pall Advanta ALT4 Multi-round Housings 163
Water Purification 10 Sealkleen Membrane Filter Cartridges 91 Veladisc™ Depth Filter Module Housings 165
Flow Diagram
Ultipor N66 Sterilizing-grade 93 Pall Advanta Electrical Trace Heater 167
Filter Cartridges
MDS Junior Style Industrial Housings 168
Direct Flow Liquid Filtration Kleenpak Capsules with 95
IOL and IDL Single-round 169
Depth Filter Sheets, Modules, and Capsules Posidyne® Membrane Assemblies
Industrial Housings
Bio-Series Depth Filter Sheets 15 Posidyne Filter Cartridges 97
PCY Polypropylene Filter Housings 171
P-Series Depth Filter Sheets 17 Novasip™ Liquid Sterilizing-grade 99
Megaplast™ Plastic Filter Housings 173
and Modules Capsule Filters
K-Series Depth Filter Sheets 19 Kleenpak Nova Sterilizing-grade 101
and Virus Removal Capsule Filters Tangential Flow Filtration
T-Series Depth Filter Sheets 21
Novasip DV20 and DV50 103 Tangential Flow Filtration Technology 177
Z-Series Depth Filter Sheets 23
Virus Removal Filter Capsules
E-Series Depth Filter Sheets 25 Ultrafiltration and Microfiltration 179
Ultipor VF Grade DV50 105 TFF Cassette Membranes
Supradisc® Depth Filter Modules 27 Virus Removal Filter Cartridges –
SBF Junior Style Matching Membrane Cassettes to 180
Supradisc II Modules 29
Applications
Supracap™ 60 Depth Filter Capsules 31 Ultipor VF Grade DV20 Virus Removal 107
Filter Cartridges Minimate™ Tangential Flow 181
Supracap 200 Encapsulated 33 Filtration Capsules
Depth Filter Modules Ultipor VF Grade DV50 Virus Removal 109
Filter Cartridges Minimate TFF System 183
Tangential Flow Filtration 185
Direct Flow Liquid Filtration Membrane Cassettes
Membrane and Depth Filter Cartridges, Air and Gas Filtration Tangential Flow Filtration 188
Capsules and Disposable Systems Novasip Capsules with Emflon PFR 113 Membrane Cassette Holders
Disposable Systems 37 Membrane Assemblies Pilot and Process 194
Kleenpak™ Connectors 39 Kleenpak Capsules with Emflon II 115 Development Capabilities
Membrane Assemblies Tangential Flow Filtration Systems 195
Kleenpak Nova Particulate and 41
Prefilter Capsule Filters Kleenpak Capsules with Emflon PFR 117 TFF Polymeric Hollow Fiber Membranes 197
Membrane Assemblies and Ceramic Modules
PreFlow™ Capsule Filters 43
Kleenpak Capsules with HDC II 119 Microza* Membranes 198
Mini Profile® Capsule Filters 45 Gas Filter Assemblies
Kleenpak Capsules with 47 Membralox® Ceramic 203
Emflon PFR Junior-style Filter Cartridges 121 Membrane Products
HDC® II Filter Assemblies
Emflon PFR Sterilizing-grade Filter 123 Pallsep™ Vibrating Membrane 205
HDC II Junior Style Filter Cartridges 49 Cartridges Filtration Technology
Profile II Filter Cartridges 51 Emflon CPFR High-temperature 125 Sheet TFF Membranes 207
Profile II Plus Filter Cartridges 53 Sterilizing-grade Filter Cartridges
Profile Star Filter Cartridges 55 Emflon PFA Filter Cartridges 127
Chromatography
StarClear™ Filter Cartridges 57 Ultipor GF Plus Air and Gas Filters 129
Mustang® Membrane 211
Profile Filter Cartridges with 59 HDC II Gas Filter Cartridges 131
Chromatography Starter Kits
Ultipleat® Construction PallCell Air and Gas Filter Cartridges
®
133
Mustang Coin Unit 215
HDC II Filter Cartridges 61 LG Liquid and Gas Coalescing 135
Mustang Chromatography Capsules 217
Ultipor® GF Plus Filter Cartridges 63 Filter Cartridges
and Cartridges
PreFlow Filter Cartridges 65 Porous Metal Filters for
Resolute** Chromatography Columns 221
Marksman™ Elements with 67 Liquid and Gas Service
Resolute Slurry Packing Systems 223
Nexus A Series Filters Rigimesh® Sintered Metal Mesh 137
Filter Cartridges PK Chromatography Skids 225
Marksman Elements with 69
Poly-Fine® XLD Series Filters PSS Porous Metal Filter Cartridges
®
139
Marksman Elements with 71 PMM® Metal Membrane Filter Cartridges 141
Poly-Fine® II Series Filters
Palltronic® Instruments
Emflon® FM Filter Cartridges 73 Palltronic Flowstar XC 229
Filter Integrity Test Instruments
Ultipor N66 Particulate and 75 * Microza is a trademark of Asahi Kasei Corporation.
Bioreduction Filter Cartridges Palltronic Aquawit XC System 231 iii
** Resolute is a trademark of Euroflow (UK) Ltd.
Palltronic® Instruments Page Pall Technical Services Page Appendices and Index Page
Palltronic Flow Check Device 233 Pre-Inspection Reviews 253 Filter Configurations and Dimensions 272
Palltronic Training Program 234 Filter Integrity Test Equipment 255 O-Rings and Gaskets Reference Guide 274
Drivers for Palltronic Filter Integrity 235 Validation Index 275
Test Instruments Troubleshooting and 257 Trademarks 282
Palltronic Filter Manager 237 Consultancy Services
International Offices 283
iv
Applications
Biotechnology and Cell Culture
Flow Diagram
Aeration
Liquid Gas
Coalescer
Fermenter
2
Biotechnology and Cell Culture
Flow Diagram
Emflon PFR
Sterilizing-grade
Air Filter
Virus Sterilizing-grade
Tangential Flow Filtration Polishing Removal Liquid Filter
Chromatography Filtration
Formulation
and Filling
Cryo-Precipitation Fractionation
Ethanol Filtration
Fractionation
Emflon PFR - Albumin
Sterilizing-grade - Globulin
Vent Filter
Particulate Sterilizing-
Removal grade
Filter Liquid Emflon PFR
Filter Sterilizing Vent
Filter
Anion
Centrifugation Exchanger
Particulate Sterilizing-grade
Removal Liquid Filter Storage Membraplan DG/DGM with
Cryo-Precipitation Cryo-Poor Plasma Filter
- Factor VIII, Fibrinogen - Factor VII, IX, ATIII, C1 Supradur 50P or E-Series
Filter Sheets
Supradisc Bio-Depth
Filter Modules
Supor EKV
Buffer Filter
Immunoaffinity
Chromatography
Virus Fraction I
Inactivation
Particulate Supor EKV
Removal Filter Sterilizing-grade
Liquid Filter
Fraction II + III
precipitates
Immunoglobulin
Supor EKV
Emflon PFR
Buffer Filter Fraction III
Sterilizing Vent
Filter
Purification of
Supor EKV
Storage Contaminant Sterilizing-grade Cryo-Factors Fraction IV
Removal Filter
Formulation Fraction V
and Filling Albumin
4
Blood Products and Fractionation
Flow Diagram
Ethanol Filtration
Particulate Removal Filter
Emflon® FM 73
Purification of Sterilizing-grade Liquid Filter
Immunoglobulin Ethanol Filtration Supor® EKV Filters 77
79
Emflon PFR 81
Sterilizing 101
Vent Filter
Fluorodyne® DFL and DJL Filters 85
87
Particulate Sterilizing-grade
Removal Liquid Filter
99
Filter 101
Virus
Chromatography
Removal Resolute* Chromatography Columns 221
and Systems 225, 261
Mustang® Membrane Chromatography 211
215
Formulation
and Filling 217
Marksman Filters
Activated
Carbon or Catalyst
First
Particulate
Removal
ZHF Automated Systems
Filter
Point-of-Use
Sterilizing-grade
Filter
Activated
Carbon Modules
6
API - (Active Pharmaceutical Ingredients)
Flow Diagram
Reactor
Clean
Distillation Solvent
Column
Solvent
Filter
Solvent
Filter
Particulate
Removal
Filter
Centrifugal
Discharge
System
Water
Removal
Liquid – Liquid
Coalescer
Centrifuge
Formulation
and Filling
Dryer
7
Formulation and Filling
Flow Diagram
Bulk Product
Emflon PFR
Sterilizing Vent
Filter
Emflon PFR
Sterilizing Vent
Filter
Formulation
Tank
Particulate Sterilizing-grade
Removal Liquid Filter Intermediate
Filter Tank
Water
Liquid Filters
Particulate Removal Filters Disposable Systems
PreFlow™ Filters 43, 65 Kleenpak™ Connector 39
Sterilizing-grade Liquid Filters Disposable Systems 37
Supor® EKV Filters 77
79
Integrity Test Instruments
81
101 Palltronic® Flowstar XC instrument 229
Fluorodyne DFL and DJL Filters
®
85 Palltronic AquaWIT XC system 231
87
99 Automated Systems
101
Automated Systems 261
8
Formulation and Filling
Flow Diagram
Filling
Particulate Sterilizing-grade
Removal Liquid Filter
Filter
9
Water Purification
Flow Diagram
Ultipleat Profile
Pure Water Storage
Ultipleat High-flow Particulate Water Tank
Particulate Removal Filter Sterilizing-grade
Removal Filter Vent Filter
Municipal
Water
Point-of-Use
Marksman Sterilizing-grade
Particulate Carbon Particulate
Removal Filter Removal Filter Liquid Filter
Removal 0.1 µm and Distillation
Bag Filter 0.2 µm
Sterilizing-grade
Water for Injection
Filters
10
Water Purification
Flow Diagram
Liquid Filters
Metal Filters
Rigimesh® Sintered Metal Mesh Filter 137
Particulate Removal Filters
High Flow Ultipleat®
Profile® Coreless
Gas and Storage Tank/ Sterilizing-grade Marksman™ Bag Filter 67
Compressed Air Fermenter Vent Filter 69
Vent Filter 71
Profile® Star Filters 55
Carbon Removal Filters
Autoclave/
Freeze Dryer
Steam Sterilizing-grade Liquid Filters
Supor® EKV Filters 77
79
81
101
Pharmaceutical Production Formulation Fluorodyne® DFL and DJL Filters 85
Process and Filling
87
99
101
Water for
Injection
Profile Star Rigimesh Fluorodyne DLF
Particulate Stainless Steel Liquid Filter
Removal Particulate Sterilizing-grade
Filter Removal
Filter
Pure Water
11
12
Direct Flow Liquid Filtration
Depth Filter
Sheets, Modules, and Capsules
Depth Filter Sheets, Modules and Capsules
Pall offers a complete line of cellulosic depth In addition to the full line of depth filter sheets,
filter sheets, modules and capsules for use in Pall also offers a complete line of Supradisc
the pharmaceutical industry. A broad array of and Supradisc II (SD II) depth filter modules.
depth filter grades, from coarse filtration The Supradisc modules are designed around
through fine prefiltration, is available to ensure a rigid polypropylene core to ensure the
maximum efficiency for every process. Pall’s integrity of the filter modules throughout their
depth filter sheets are available in a wide use. The SD II modules offer the advantages
range of sizes for use in process development of an extremely rigid and durable design with
to large-scale manufacturing. patented clip construction and reverse-flow
capabilities. The depth filter modules offer
Depth filter sheets provide an economical and decreased setup and operation while
efficient means of coarse filtration, clarification, increasing the safety of the process.
and prefiltration for a wide variety of
pharmaceutical and biological fluids. In Supradisc modules are also available in an
addition to the mechanical depth filtration encapsulated Supracap format for single-use
mechanisms, Pall’s depth filter sheets possess processing minimizing cleaning and cleaning
either a slight positive charge or a high validation
positive charge that further enhances their
filtration capacity. This inherent Positive Zeta The Supracap 60 Depth Filter Capsules offer
Potential helps to remove negatively-charged ease of use in a disposable device for scale-
contaminants from the fluid stream. up testing and process optimization.
14
Bio-Series Depth Filter Sheets
Exceptional Purity and Low Protein Binding
450
Pall (formerly SeitzSchenk) was specially
0.4 16
400
developed for the strict requirements of the
0.35 14
biotechnological and pharmaceutical
Al/Ni – Ions in ppb
350
Fe – Ions in ppm
0 0
BIO depth filter sheets are available with 2
Bio Depth Filter Non-Pall Non-Pall three different retention rates.
Ion Reduced Standard 0
Product Bio 10 Bio 20 Bio 40
Highly purified natural and modified
Extractables in the first rinse fraction (5 L/m2) ∆p = 1 bar (14.5 psi) with water at 20 °C (68 °F).
■ Aluminum ■ Iron Ions ■ Nickel
celluloses are used in manufacture. These
celluloses are completely free from
1200
inorganic materials like kieselguhr, perlite,
Permeability L/m2/min at 1 bar (14.5 psi) 1100
or glass fibers. The distinguishing feature of
1000
the BIO depth filters is the low release of 900
extractables. BIO depth filters release 800
essentially less extractable metal ions, such 700
15
Bio-Series Depth Filter Sheets
Technical Specifications
Characterization
The tests are carried out according to the methods of the Technical
and Analytical Work Group within the European Depth Filtration
Association or in accordance with in-house test methods.
Technical Data
Sheet Weight per Area Thickness Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
(g/m2) (mm) (%) (mg/m2)
Ca Fe Al
Sterile Prefiltration BIO 20 Cell harvest, clarifying filtration of TFF permeate, clarifying filtration of centrifugation
supernatant, filtration of biopharmaceuticals, filtration of therapeutic proteins, of
vaccines, diagnostics and blood products, plasma fractionation (fine filtration),
filtration of nutrients, protection of chromatography columns and membrane
processes, protection of sterile filter membranes.
Fine Clarifying Filtration BIO 40 Fine filtration of pharmaceuticals and biopharmaceuticals, plasma fractionation (fine
filtration, protein separation), filtration of antibiotics, filtration of
vaccines, separation of adsorbents, filter media, and extraction residues.
16
P–Series Depth Filter Sheets and Modules
Optimized for Low Endotoxins and Low Extractables
-P
-P
P
P
P
S-
50
0
M
0
80
1
10
25
70
90
20
EK
EK
KS
A
K
K
K
PR
A
PR
SU
SU
17
P–Series Depth Filter Sheets and Modules
Technical Specifications
Typical Values for Ions after Flushing with 50 L/m2 WFI(1) Technical Data
Ca Mg Fe Cu Al Ni Code Retention Ash Content Endotoxin
0.5 ppm < 0.1 ppm < 0.1 ppm < 0.1 ppm < 50 ppb < 10 ppb Rate (µm) (%) Level(3)
(1)
The tests are carried out according the methods of the Technical and Analytical Work PEKS 0.1 – 0.3 58 < 0.02 EU/mL
Group within the European Depth Filter Association or in accordance with in-house
tests methods. PEKM 0.2 – 0.4 48 < 0.02 EU/mL
PEK1 0.25 – 0.45 47 < 0.02 EU/mL
Operating Conditions(2) P050 0.5 – 0.85 46 < 0.02 EU/mL
Maximum Operating 80 °C (176 °F) P100 1.5 – 3.5 45 < 0.02 EU/mL
Temperature
P080 1.5 – 4.0 49 < 0.02 EU/mL
Maximum Operating 2.4 bard (35 psid) P200 2.8 – 6.0 43 < 0.02 EU/mL
Pressure
P250 4.0 – 9.0 44 < 0.02 EU/mL
(2)
With compatible fluids, which do not soften, swell or adversely affect the products or
their material of construction. P700 6.0 – 15.0 45 < 0.02 EU/mL
P900 10.0 – 22.0 45 < 0.02 EU/mL
Plastic Parts of Construction of Supradisc Modules (3)
After Flushing with 50 L/m2 WFI.
Supradisc Components Polypropylene
O-rings Silicone elastomer The FDA (Food and Drug Administration) in the USA has registered
Supradisc modules under DMF (Drug Master File) No. 14325.
Sterilization With regard to total extractables P-grade depth filter sheets and
Steam in place 125 °C (257 °F), for 30 minutes at 0.3 bard (4.3 psid) Supradisc modules meet the specifications according to FDA
maximum. guideline CFR part177.2260 e, f, g, h, I, j, k, l, volume 21 chapter 1,
applicable for depth filters with resins. The Quality Management
Nominal Dimensions – Supradisc Modules System of Pall has been certified according to DIN EN ISO 9001 by
Nominal Total Length Double O-ring Execution:
TÜV Cert (Certification Office TÜV Rheinland, Sicherheit und
332 mm (13.1 in.) Umweltschutz GmbH). With regard to food law conformity the
manufacture of depth filter sheets is also subject to ongoing analysis
Flat Gasket Execution:
272 mm (10.7 in.) by the German ISEGA Forschungs-und Untersuchungsgesellschaft
mbH, Aschaffenburg.
Nominal Diameter 284 mm (11.2 in.)
410 mm (16.1 in.)
Technical Service
Flat Sheets
For best possible results and maximum reliability we recommend a
Available in all common sizes test run under real-life conditions.
Code Filter Code Filter Code Gasket Code Filter Code Gasket Code Plastic Parts
Spacing Type Option Area Material
00 Standard PEKS EKS-P S Double 205 0.5 m2(4) (5.9 ft2) S Silicone P Polypropylene
O-ring elastomer
30 Increased PEKM EKM-P 209 1.0 m (10.7 ft )
2 2
P250 K 250 P
P700 K 700 P
P900 K 900 P
18
K–Series Depth Filter Sheets
Bioburden Reduction and Fluid Clarification
Reduction
(1)
Test organisms: Brevundimonas diminuta.
(2)
Test organisms: Serratia marcescens.
1800 25
1700
1600
1400 20
1275
Permeability (L/m2/min)
1200
Retention rates (µm)
15
1000 925
800 785
10
600 510
400
213 5
200 146 185
93 113
29 41 68
0
0
EKS EK1 EK KS50 KS80 K100 K150 K200 K250 K300 K700 K800 K900 EKS EK1 EK KS50 KS80 K100 K150 K200 K250 K300 K700 K800 K900
19
K–Series Depth Filter Sheets
Technical Specifications
Technical Data
Sheet Weight per Area Thickness Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
(g/m2) (mm) (%) (mg/m2)
Ca Fe Al
EKS 1400 3.7 58 1800 15 150
EK1 1400 3.7 51 1600 15 140
EK 1350 3.7 46 1400 10 120
KS50 1350 3.7 46 1400 10 120
KS80 1350 3.7 46 1200 15 120
K100 1350 3.7 46 1400 15 120
K150 1350 3.9 46 1300 15 120
K200 1350 3.9 46 1200 15 110
K250 1300 4.0 46 1000 15 70
K300 1300 4.2 46 900 15 50
K700 1300 4.1 46 900 15 50
K800 1300 4.1 46 900 15 45
K900 1300 4.3 46 900 25 40
Heavy metals < 50 ppm (according to the Recommendation XXXVI/1 BgVV-German Federal Institute for Health Protection of Consumers and Veterinary Medicine).
Sheet
EKS Vaccines, pharmaceuticals and BioPharmaceuticals, phytopharmaceuticals (sterile filtration), plasma fractionation, serum, aqueous cosmetics
(clarifying and fine filtration)
EK 1 Aqueous cosmetics (clarifying and fine filtration), pharmaceuticals and BioPharmaceuticals, plasma fractionation
KS 80 Antibiotics (clarifying filtration), vaccines, infusion solutions, plant extracts (clarifying filtration), plasma fractionation
K 100 Clarifying filtration
K 150 Pharmaceuticals and BioPharmaceuticals (clarifying filtration), serum (pre-filtration)
K 200 Vaccines (prefiltration), phytopharmaceuticals (clarifying filtration)
K 250
K 300 Antibiotics (clarifying filtration), cosmetics (clarifying filtration)
K 700 Antibiotics (clarifying filtration), serum (prefiltration), cell harvest
K 800 Vaccines (prefiltration), cell harvest
K 900 Infusion solutions (prefiltration), cosmetics (particle filtration), cell harvest
20
T–Series Depth Filter Sheets
High Output with Long Filtration Cycles
80 30000
70 25000
25000
60
20000
Permeability (L/m2/min)
50
Retention rates (µm)
40 15000
12750
30 10200 10200
10000
20 7285
5000 3400
10 1700
213 465 565
0 0
T 120 T500 T750 T950 T1000 T1500 T2100 T2600 T3500 T5500 T 120 T500 T750 T950 T1000 T1500 T2100 T2600 T3500 T5500
21
T–Series Depth Filter Sheets
Technical Specifications
Characterization
The tests are carried out according to the methods of the Technical
and Analytical Work Group within the European Depth Filtration
Association or in accordance with in-house test methods.
Technical Data
Sheet Weight per Area Thickness Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
(g/m2) (mm) (%) (mg/m2)
Ca Fe Al
T 120 900 2.8 43 1250 20 75
T 500 850 2.7 38 1000 15 45
T 750 850 2.7 40 770 15 45
T 950 850 2.8 40 600 13 25
T 1000 950 3.6 35 570 15 30
T 1500 850 3.7 33 500 12 25
T 2100 700 3.3 15 350 11 20
T 2600 700 2.9 <1 300 1 5
T 3500 880 4.6 15 450 15 30
T 5500 750 4.5 <1 300 1 5
Heavy metals < 50 ppm (according to the Recommendation XXXVI/1 BgVV-German Federal Institute for Health Protection of Consumers and Veterinary Medicine). The figures quoted in the
diagrams and tables should be regarded as guidelines.
T 950 General prefiltration The Depth Filters conform to the Recommendation XXXVI/1 BgVV
T 1000 (German Federal Institute for Health Protection of Consumers and
T 1500
Veterinary Medicine) and meet the requirements of the Lebensmittel -
T 2100
und Bedarfsgegenständegesetz – LMBG – (Foodstuff and other
T 2600 Pharmaceuticals and Commodities Act), in particular §§ 5, 30 and 31.
T 3500 BioPharmaceuticals (solid/liquid
T 5500 separation)
Serum (prefiltration), vaccines
(prefiltration)
22
Z–Series Depth Filter Sheets
Positive Zeta Potential for Adsorptive Removal from Aqueous Suspensions
10 400
9 350
350
8
300
7
Permeability (L/m2/min)
Retention rates (µm)
250
6
5 200
4 150
3
100 80
2 65
50
1
0
0 Z 200 Z 400 Z 2000
Z 200 Z 400 Z 2000
23
Z–Series Depth Filter Sheets
Technical Specifications
Characterization
The tests are performed in accordance with the methods of the
Technical and Analytical Work Group within the European Depth
Filtration Association or in accordance with in-house test methods.
Technical Data
Sheet Weight per Area Thickness Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
(g/m2) (mm) (%) (mg/m2)
Ca Fe Al
Z 200 1360 3.8 46 2450 35 125
Z 400 1320 3.8 46 2050 45 135
Z 2000 1220 3.9 45 1400 30 80
Heavy metals < 50 ppm (according to the Recommendation XXXVI/1 BgVV-German Federal Institute for Health Protection of Consumers and Veterinary Medicine). The figures quoted in the
diagrams and tables should be regarded as guidelines.
24
E-Series Depth Filter Sheets
Filter Paper with Depth Filter Properties for Solid and Liquid Separation or Clarifying Filtration
Advantages
• Safe operation due to high wet strength
• High mechanical stability (filtration at
high operating pressure is possible)
• Easy removal of protein cakes due to
the very smooth, low adhesive surface
• Higher clarity and retention due to the
depth filter properties
• High dirt-holding capacity
25
E-Series Depth Filter Sheets
Technical Specifications
Technical Support
Fast and reliable technical support is essential. Our Scientific and
Laboratory Services (SLS) teams are at your disposal for technical
service on site, or if you have further questions.
26
Supradisc Depth Filter Modules
™
27
Supradisc Depth Filter Modules
Technical Specifications
Table 1
Sheet Depth Filter Weight per Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
Type Area (g/m2) (%) (mg/m2)
Ca Fe Al
B010 BIO 10 1400 <1 0.28 ppm(1) < 0.05 ppm(1) < 5 ppb(1)
B020 BIO 20 1400 <1 0.17 ppm(1) < 0.05 ppm(1) < 5 ppb(1)
B040 BIO 40 1200 <1 0.48 ppm (1)
< 0.05 ppm (1)
< 5 ppb(1)
XEK1 EK 1 1400 51 1600 15 140
XEK0 EK 1350 46 1400 10 120
X050 KS 50 1350 46 1400 10 120
X080 KS 80 1350 46 1200 15 120
X100 K 100 1350 46 1400 15 120
X150 K 150 1350 46 1300 15 120
X200 K 200 1350 46 1200 15 110
X250 K 250 1300 46 1000 15 70
X300 K 300 1300 46 900 15 50
X700 K 700 1300 46 900 15 50
X900 K 900 1300 46 900 25 40
C100 K 100 IR 1400 51 200 20 75
C250 K 250 IR 1250 46 150 15 50
C800 K 800 IR 1250 46 120 10 30
C900 K 900 IR 1200 46 120 10 30
T950 T 950 850 40 600 13 25
T100 T 1000 950 35 570 15 30
T150 T 1500 850 33 500 12 25
T210 T 2100 700 15 350 11 20
T260 T 2600 700 <1 300 1 5
T350 T 3500 880 15 450 15 30
T550 T 5500 750 <1 300 1 5
(1)
Soluble after 50 L/m2 flushing with WFI.
Code Filter Code Filter Code Gasket Code Filter Code Gasket Code Plastic Parts
Spacing Type Option Area Material
00 Standard See Above Table 1 S Double 203 0.3 m2 (3.2 ft2) S Silicone P Polypropylene
O-ring elastomer
01 High 205 0.5 m (5.9 ft )
2 2
A Polyamide(2)
Temperature C Flat Other Gaskets available on
Gasket 209 1.0 m2 (10.7 ft2) request
(2)
High Temperature only.
30 Increased
cell 216 1.8 m (19.3 ft )
2 2
Optional:
Nominal Dimensions and Weights
Viton* 1 A, EPDM
Diameter 284 mm (11.2 in.)
Gaskets Standard:
Buna N Height (Standard) Flat Gasket:
Approx. 272 mm (11 in.)
Optional:
Silicone, PTFE, Viton A, EPDM O-ring:
Approx. 332 mm (13 in.)
* Viton is a registered trademark of DuPont Dow (non-FDA materials).
Dry Weight 5 – 6 kg (11 – 13 lbs)
depending on filter media
Maximum Differential Pressure
Filter Area 1.8 m2 (19.4 ft2)
Forward Flow 3.5 bard (50 psid) @ 90 °C (195 °F )
Reverse Flow 0.45 bard (6 psid)
Ordering Information
Code Filter Media Code Adapter Code Sealing Materials Code Filter Area Code Molded Parts
200 S Double O-ring S Silicone 232 1.8 m2 (19.4 ft2) P Polypropylene
(White; MVQ)
C Flat gasket
V Viton A
E EPDM
P Buna N
T PTFE
F FEP Encapsulated
Silicone
30
Supracap™ 60 Depth Filter Capsules
Capsules for Process Development and Scale-up Studies
31
Supracap 60 Depth Filter Capsules
Technical Specifications
Ordering Information
Code Type of Sheet Retention Range Ash Content Endotoxin Level(4)
(SC060*) (µm) (%)
P-series: Produced under specific manufacturing and control procedure for low endotoxin content.
Well balanced composition including cellulose fibers as well as kieselguhr and perlites
PEKS EKS-P 0.1 – 0.3 58 < 0.02 EU/mL
PEKM EKM-P 0.2 – 0.4 48 < 0.02 EU/mL
PEK1 SUPRA EK 1 P 0.25 – 0.45 47 < 0.02 EU/mL
P050 KS 50 P 0.5 – 0.85 46 < 0.02 EU/mL
P100 K 100 P 1.5 – 3.5 45 < 0.02 EU/mL
P080 SUPRA 80 P 1.5 – 4.0 49 < 0.02 EU/mL
P200 K 200 P 2.8 – 6.0 43 < 0.02 EU/mL
P250 K 250 P 4–9 44 < 0.02 EU/mL
P700 K 700 P 6 – 15 45 < 0.02 EU/mL
P900 K 900 P 10 – 22 45 < 0.02 EU/mL
Supradur: Depth filter sheets with perlites up to 40 % w/w of selected polyolefin microfibers
D50P Supradur 50 P 0.6 – 3.8 23 < 0.02 EU/ml
BIO Series: Depth filter sheets with highly purified and modified cellulose with very low extractables and low protein adsorption
B010 BIO 10 0.1 – 0.3 <1 < 0.02 EU/mL
B020 BIO 20 0.5 – 1.0 <1 < 0.02 EU/mL
B040 BIO 40 6 – 18 <1 < 0.02 EU/mL
Activated Carbon containing depth filter sheet for decolourization of blood products, glucose solution and antibiotics
XAK5 AKS 5 Methylene blue adsorption <1 < 0.02 EU/mL
> 170 g/m2
(4)
After flushing with 50 L/m2 WFI.
32
Supracap ™ 200 Encapsulated Depth Filter Modules
First Encapsulated Single-use Depth Filter Module for Process-scale Applications
Applications
• Filtration of fermenter broth
• Serum filtration
• Blood plasma filtration Supracap 200 modules in a Pall
• Removal of mammalian cells prior to Advanta Supracap 200 housing
downstream processing
• Filtration of toxic products
• Removal of filter aids
• Removal of catalysts
33
• Removal of activated carbon
Supracap ™ 200 Encapsulated Depth Filter Modules
Technical Specifications
C S P
Code Module Code Inter Disc Code Filter Code Filter Area Code Gasket
Type Spacing Media Material
2 Supradisc II 00 Standard See above table 209(2) 1.0 m2 (10 ft2) S Silicone elastomer
3 Supradisc I 30 Increased cell 214(3) 1.6 m2 (17.2 ft2) F FEP coated silicone
distance(1)
216(2) 1.8 m2 (19.4 ft2)
(1)
Supradisc I design only.
232(4) 1.8 m2 (19.4 ft2)
(2)
Supradisc I design only.
(3)
AKS 5/6 in Supradisc I design only.
(4)
Supradisc II design only.
34
Direct Flow Liquid Filtration
Membrane and Depth Filter Cartridges,
Capsules, and Disposable Systems
Membrane and Depth Filter
Cartridges, Capsules, and Disposable Systems
® ® TM
Pall offers a wide range of filter media and • Profile , HDC II, and Marksman
filter configurations to serve your liquid polypropylene filters
filtration needs. ®
• Emflon FM PTFE filters for solvent
Membranes have been developed to meet polishing
specific application requirements. Pall provides
the broadest array of membranes, including: Pall filters for liquid service are available in a
variety of cartridge configurations that can be
®
• Supor PES (polyethersulfone) used in filter housings. In addition, Pall liquid
sterilizing-grade 0.2 µm filters, which are filters are available in disposable capsule filter
ideal for applications that require broad formats of all sizes with surface areas from
pH compatibility. 0.02 m2 (31 in.2) to to 4.8 m2 (50 ft2). These
®
capsules can be used in disposable systems*.
• Low-binding Fluorodyne II
DBL (0.45 µm) One of Pall’s most convenient products, the
TM
DFL (0.2 µm sterilizing-grade) Kleenpak connector can be used to make
DJL (0.1 µm sterilizing-grade), which aseptic connections in any process
have a PVDF (polyvinylidenedifluoride) environment. These connectors can be
membrane and provide excellent flow incorporated in disposable filter assemblies.
rates
Note: It is important to maintain the integrity
®
• Ultipor N66 filters, which provide of 0.2 µm and 0.1 µm sterilizing grade filters
excellent wettability and are available in and virus filters. Pall recommends
bioburden reduction, prefiltration, and integrity-testing of all sterilizing-grade filters
sterilizing grades prior to steaming, after steaming, and after the
filtration process to ensure that the integrity of
• Ultipor VF Grade DV 20 and DV50 for the filter has been maintained.
virus removal applications (50 and
20 nm) Contact Pall for recommended procedures
and integrity test parameters.
Pall also offers process-optimized prefilters, to
protect sterilizing-grade filters, as well as for * Capsules supplied with sanitary flanges are Tri-Clamp
clarification and bioburden reduction including; compatible. Tri-Clamp is a trademark of Alfa-Laval, Inc.
®
• PreFlow and Ultipor GF resin-bonded
glass fiber filters
36
Disposable Systems
Improving Choice, Flexibility, and Operational Costs for System Designs
Managing the issues of cleaning and Disposable filters can be offered with a
cleaning validation is one of the major wide range of filter media for:
challenges facing the BioPharmaceutical
• Prefiltration and clarification
industry. This has resulted in the use of
disposable equipment being the preferred • Sterilization
option wherever possible. Using disposable • Virus removal
equipment offers many benefits.
They are made from a range of materials
such as:
Features and Benefits
• PES (polyethersulfone)
• Reduced assembly costs
• PVDF (polyvinylidenedifluoride)
• Reduced cleaning costs
• Nylon 66
• Reduced cleaning validation
• PTFE (polytetrafluoroethylene)
• Reduced costs for capital equipment –
capsule filters have a typical installation • Polypropylene
cost that is 80% lower than a similar • Resin-bonded glass fiber
sized stainless steel housing system
• Cellulose-based depth media
• Reduced risk of lost production time
In addition to single-use capsule filters for
due to simpler procedures
direct flow clarification, sterilization and viral
In applications where hazardous materials clearance, Pall provides single-use
are being processed, such as cytotoxic chromatography and tangential flow (TFF)
drugs, disposable equipment can play an products.
important additional role in helping protect
operators. Hazardous liquids can be Scaling Up and Scaling Down
contained during processing with minimal
risk of operator exposure. Pall is well-equipped to support processes
as they are scaled up. Different size
capsules for each specific Pall filter grade
Choice and Flexibility
contain identical filter materials. This
Pall supplies a wide range of disposable feature ensures that scale-up and
filter assemblies and disposable filtration scale-down studies yield relevant
sets, such as capsule filters with information and minimum requalification for
customized tubing systems attached. Pall various batch sizes.
also supports the use of filters attached to
The availability of a variety of capsules for
disposable bag-based processing
small scale operations is beneficial,
systems. Disposable capsule filters of all
particularly for new product developments.
sizes with surface areas from a few cm2 to
Capital investment can be a concern since
as much as 4.8 m2 (50 ft2) are available and
not all new BioPharmaceutical products
can be used in disposable systems. Filters
become commercialized. Single-use
join together in series for protection of the
capsules and systems make it possible to
final filter or in parallel for increased area,
produce new products during the early
making it possible to have unlimited
development stages, without a large
filtration area in disposable systems.
capital investment. Capital deferment and
Flexibility of system design facilitates risk avoidance makes it easy to produce
changes in product to process tests batches for early clinical trials and
development. toxicity studies without capital equipment.
37
Disposable Systems
Technical Specifications
38
Kleenpak™ Connectors
For Simple Sterile Connections between Components
The single use, Kleenpak™ Connector allows for the simple dry
connection of two separate pre-sterilized fluid pathways, while
maintaining the sterile integrity of both. The connector consists
of a male and a female connector, each covered by a vented
peel away strip that protects the port and maintains the sterility
of the sterile fluid pathway.
Ordering Information
Part Number Description Quantity
ACD02S6 Male plus Female Connector with 13 mm (1⁄2 in.) hose barb 1
ACD02F6 Female Connector with 13 mm (1⁄2 in.) hose barb 25 per box, double-bagged
ACD02M6 Male Connector with 13 mm (1⁄2 in.) hose barb 25 per box, double-bagged
40
Kleenpak Nova Particulate and Prefilter Capsule Filters
TM
Improving Choice, Flexibility and Operating Costs for the Prefiltration and Clarification of Liquids
The issues of effective cleaning and Kleenpak Nova capsules are used in a
cleaning validation result in disposable wide range of critical applications including
equipment being the preferred option. the filtration of BioPharmaceuticals,
For many processes, disposable filters can biologicals, diagnostic reagents, serum,
help eliminate cleaning problems, tissue culture media, and culture media
especially where biological products are to components.
be filtered. In applications where hazardous
materials are being filtered, such as Kleenpak Nova Filters Reduce
cytotoxic drugs, capsule filters can play an Operating Costs
important role in helping protect operators.
Kleenpak Nova filters have a typical
Kleenpak Nova capsule filters are installation cost that is 80% lower than a
designed to provide choice, similar sized stainless steel housing
cost-effectiveness and flexibility, while system. Therefore, they offer an extremely
ensuring ease of use for the operator. cost-effective alternative to housing and
cartridge systems. Kleenpak Nova filters
Designed to Provide Choice and can also provide further cost savings:
Flexibility
• No housing maintenance —
Kleenpak Nova capsule filters are available Lower maintenance costs
with either in-line or T-style configurations.
• No housing cleaning or cleaning
The T-style configuration is ideal for
validation —
manipulating multiple filters in series or
Lower labor costs
parallel configuration.
• Filter is pre-assembled —
Kleenpak Nova capsule filters incorporate
Lower labor costs
either a 10 in. (254 mm), 20 in. (508 mm)
or 30 in. (762 mm) length standard Pall • Filter can be provided pre-sterilized —
cartridge filters which have traditionally Lower energy costs
been installed in stainless steel housings.
In applications where a particular filter is
already specified, the user can switch from
a stainless steel housing to a fully
disposable assembly with minimal
requalification. This means the extensive
range of cartridges currently available from
Pall for clarification, bioburden reduction
and prefiltration can easily be provided as
a capsule filter. These include:
• PreFlow™ Filters
• Ultipor® GF Plus Filters
• Profile® Filters
Kleenpak Nova capsules are especially
suited to pilot- and process-scale
applications. They can be autoclaved or
sterilized by gamma-irradiation and can be
supplied as part of pre-sterilized
processing systems such as a
filter/tubing/bag set. 41
Kleenpak Nova Particulate and Prefilter Capsule Filters
Technical Specifications
Ordering Information
NP – In-Line
NT – T-style
Code Filter Size Code Filter Type Code Filter Grade Code Connection Options Code Sterilization
6 AB1 10 in. Pre-filter Grades P Pharmaceutical 1 1 – 11⁄2 in. sanitary flange inlet Status
(254 mm) UUA 0.2 µm rated with Certificate and outlet G Non-sterilized
7 AB2 20 in. UUAP PreFlow filter of Test and Full 9 25 mm (1 in.) single-barb S Pre-sterilized
(508 mm) UB 0.45 µm rated Traceability hose barb inlet and outlet
8 AB3 30 in. UBP PreFlow filter Omit Pharmaceutical 19 1 – 11⁄2 in. sanitary flange inlet
(762 mm) U010Z 1.0 µm rated and 25 mm (1 in.) single-barb
U010ZP Ultipor GF Plus filter hose barb outlet
U2-20Z 2.0 µm rated Options for In-line Only
U2-20ZP Ultipor GF Plus filter 6 13 mm (1⁄2 in.) single-barb
A015P 1.5 µm rated hose barb inlet and outlet
Profile Star filter 16 1 – 11⁄2 in. sanitary flange inlet
Code Vent and Drain
A030P 3.0 µm rated and 13 mm (1⁄2 in.) single-barb
hose barb outlet – Stäubli(1) vent and
Profile Star filter
stepped hose barb
A050P 5.0 µm rated Options for T-style Only
drain
Profile Star filter 1H 1 – 11⁄2 in. sanitary flange inlet
A Stäubli(1) vent and
UY045P 4.5 µm rated and outlet, with 13 mm (1⁄2 in.)
drain
Profile filter with sanitary port on inlet
Ultipleat® construction 1H9 1 – 11⁄2 in. sanitary flange inlet (1)
Stäubli is a trademark of
and 25 mm (1 in.) single-barb Stäubli AG.
42 Note: Partial list of part numbers.
hose barb outlet, with 13 mm
Contact Pall for specific part numbers.
(1⁄2 in.) sanitary port on inlet
PreFlow™ Capsule Filters
Scalable Prefilters with PreFlow UUA and UB Media
43
PreFlow Capsule Filters
Technical Specifications
(1)
In compatible fluids which do not soften, swell or adversely affect the filter or its
materials of construction.
0 0
0 2 4 6 8
Typical Extractables in Water at 20 °C (68 °F)
after 4 hours Extraction Flow Rate (L/min)
Autoclave Sterilization(2)
3 x 1-hour cycles at 125 °C (257 °F) Nominal Filtration Area
(2)
Warning: This product must not be sterilized in situ by passing steam through under 0.1 m2 (1.0 ft2)
pressure.
Nominal Dimensions
Length 124 mm (4.9 in.)
Maximum Diameter 72 mm (2.8 in.)
Connections 10 mm (3⁄8 in.) hose barb
Ordering Information
Part Number Absolute Removal Rating
DFA3001UUAC 0.2 µm
DFA3001UBC 0.45 µm
44
Mini Profile Capsule Filters
®
Pall Mini Profile Capsule Filters have been • Excellent gel removal
designed for small volume production and
• Higher flows and throughputs
scale-up evaluation. These scalable
capsule filters are available in two media • Easy to use self-venting format
types to complement and extend the range • Pharmaceutical P optimized grades
of depth filters available in the Pall with Certificate of Test provides batch
UpScaleSM Program. traceability
They can be used for a wide range of • Low extractables and low
applications including clarification of protein-binding
biological products.
• Manufactured under clean conditions in
Pall Profile II filters are all-polypropylene a controlled environment
depth filter elements, featuring tapered
• Rating range from 0.5 µm to 5 µm
pores that narrow to an inner (downstream)
absolute-rated section. This thick depth
structure provides high-capacity for larger Pall’s UpScaleSM Program
solids and gels as well as for fine particles. From drug discovery and basic research,
Profile Star filter cartridges feature through process development and
high-area star-shaped pleat construction. production, Pall Corporation is the single
The patented design combines the source for all of your filtration and
advantages of depth filters with the high separation needs. Our UpScale program
flow rates of high-area pleated filters. provides you with the scalable filtration
products and the support you need to
Features and Benefits bring new products to market faster.
45
Mini Profile Capsule Filters
®
Technical Specifications
0 0
0 1 2 3 4 5
Nominal Filtration Area
Flow Rate (L/min)
Profile II 46 cm2 (7.1 in2) (3)
Typical initial clean media ∆P; water at 20 °C (68 °F) viscosity 1cP.
Profile Star 90 cm2 (14.5 in2) For assistance in sizing, contact your local Pall representative.
Temperature Maximum 85 mm
Differential Pressure (3.35 in.)
76.5 mm
Maximum Accumulated Autoclave Time (3.07 in.)
Ordering Information(2)
Part Number Medium Removal Rating
BYA015P6 Profile Star 1.5 µm
BYA030P6 Profile Star 3 µm
BYA050P6 Profile Star 5 µm
BYY005P6 Profile II 0.5 µm
BYY010P6 Profile II 1 µm
(2)
This is a guide to the part number structure only.
For availability of specific options, please contact Pall or your local Pall distributor.
46
Kleenpak™ Capsules with HDC II Filter Assemblies
®
High Dirt Retention Polypropylene Liquid Filters in the most Convenient Form
Pall Kleenpak filters combine the widest • A total absence of glues, binder resins
available range of filter media and specially and surfactants results in very low filter
designed self-contained assemblies extractables and extremely clean filtrate
to satisfy the very highest standards of
• All filter materials of construction have
filtration security and user convenience.
met the specifications for USP Class VI
biological tests for plastics at 121 °C
HDC II Filter Medium and meet FDA requirements for food
At the heart of every Kleenpak filter with contact use 21 CFR parts 170-199
HDC II media is a high-performance
pleated cartridge with polypropylene filter Quality and Bio-Safety
medium. The HDC II medium is produced
Biological Tests
by a proprietary technique, varying the fiber
diameter continuously to provide a • Meets USP Biological Reactivity,
pore-size distribution from coarse In Vivo, for Class VI-121 °C plastics
(upstream) to fine (downstream) while Effluent Quality Tests*
maintaining constant void-volume • Meets Cleanliness per USP Particulates
throughout the depth of the filter medium. in Injectables
• The varied fiber diameter means • Non-Fiber-Releasing
extraordinary contaminant-holding
capacity, maximum flow rate, and low • Non-Pyrogenic per USP Bacterial
costs per liter of filtered fluid Endotoxins (< 0.25 EU/mL)
• The fixed pore structure means that • Meets Total Organic Carbon and Water
contaminants will not unload under Conductivity per USP Purified Water,
variations in flow or pressure differential, pH per USP Sterile Purified Water
and fibers will not migrate or become * Per lot sample soak or rinse-up flush aliquots.
dislodged to contaminate process fluids
Convenience to Suit All Needs
Clean and Robust Design The self-contained design of each
The Kleenpak filter uses well-proven Kleenpak filter means that operator
proprietary Pall techniques for filter intervention and exposure during filter
construction and heat sealing. installation and change-out are minimized.
• The highest possible security against • Integrally molded inlet and outlet
filter bypass is ensured, even under connections
conditions of pulsed flow ◆ Maximum convenience and security
• High-strength design allows multiple • Vent and drain connections with seal
autoclave cycles for extended use and protected threads and precision molded
maximum filter economy valves
• Polypropylene outer shell is designed to ◆ Exceptionally simple and reliable
provide long-term assurance of operation
pressure and temperature ratings
• Available in three standard sizes.
• Internal hold-up volume and dead
◆ Flexibility in batch size or flow rate
space is minimized for maximum
requirements
product recovery
47
Kleenpak Capsules with HDC II Filter Assemblies
Technical Specifications
5
02 06
02
2J 1J 25 30
3J0
1J
KA KA KA
KA
60
2J0
Effective Size Code KA
Filter Area KA1 KA2 KA3 20
0.25
J012, J025 0.06 m2 (0.6 ft2) 0.1 m2 (1.0 ft2) 0.2 m2 (2.0 ft2) J060
KA3
J045 0.06 m2 (0.6 ft2) 0.11 m2 (1.2 ft2) 0.22 m2 (2.3 ft2)
10
J060 0.03 m2 (0.3 ft2) 0.05 m2 (0.5 ft2) 0.10 m2 (1.0 ft2)
J100 0.03 m2 (0.3 ft2) 0.07 m2 (0.7 ft2) 0.13 m2 (1.4 ft2)
0 0
0 0.2 0.4 0.6 0.8 1.0
Removal Ratings (Liquids)(1) Flow Rate (Gal/min)
(2)
Typical initial clean ∆P, water at 20 °C (68 °F). Values shown are for 38 mm
J100 J060 J045 J025 J012
(11⁄2 in.) sanitary flange connections. Values with other connections are
10 µm 6 µm 4.5 µm 2.5 µm 1.2 µm available on request. For assistance in filter sizing, contact your local Pall
representative.
(1)
> 99.98% by modified OSU-F2 Beta test.
Operating Conditions(2)
Connections (Inlet and Outlet) Maximum Operating 5.2 barg (75 psig) at 40 °C (104 °F)
Pressure and Temperature
KA1 and KA2 Styles 38 mm (11⁄2 in.) sanitary flange
6 – 13 mm (1⁄4 – 1⁄2 in.) stepped hose barb Maximum Differential 4.1 bard (60 psid) at 40 °C (104 °F)
Pressure and Temperature
KA3 38 mm (1 ⁄2 in.) sanitary flange
1
(2)
Using compatible liquids. Maximum 3.5 barg (50 psig) in air and gas service.
14 mm (9⁄16 in.) stepped hose barb
Steam Autoclaving
Cumulative Autoclave Time(3) 50 hours at 140 °C
(3)
Laboratory tests (1-hour cycles) establish multi-cycle resistance. Filters should be
qualified in actual use.
Warning: Kleenpak filters must not be steamed in situ by passing steam through under
pressure.
Ordering Information
K A P
49
HDC II Junior Style Filter Cartridges
Technical Specifications
Operational Limits Typical Liquid Flow Rates for SLK7002 and MCY4463 Styles
500
Operating 50 °C (122 °F) 80 °C (176 °F)
J006 J012 7
Temperature (Maximum)
J025
Maximum Differential 5.5 bard (80 psid) 4.1 bard (60 psid) 400 6
Pressure
J400 1
J045 0.14 m2 (1.6 ft2) 0.25 m2 (2.7 ft2)
0 0
J060 0.07 m2 (0.8 ft2) 0.15 m2 (1.7 ft2) 0 10 20 30 40 50 60
J100 0.09 m (1.0 ft )
2 2
0.19 m (2.1 ft )
2 2
Flow Rate (L/min)
Ordering Information
Sealkleen Style
Single open-ended 57 mm (2.25 in.) diameter element (excluding flange). Incorporates a patented sealing arrangement that eliminates any chance of fluid bypass via
the seal, from the upstream side of the filter element to the downstream side. The housing elastomeric O-ring is placed on a special flange, which is an integral part
of the element outlet end cap.
SLK
Code Nominal Length HDC II Filter Grade Removal Rating Code Filter Grade
7001 2.5 in. (66 mm) J006 0.6 µm(1) P Pharmaceutical
7002 5.2 in. (133 mm) J012 1.2 µm Omit Other
J025 2.5 µm
J045 4.5 µm
J060 6.0 µm
J100 10.0 µm
J200 20.0 µm
J400 40.0 µm
Junior Style (MCY)
Single open-ended 57 mm (2.25 in.) diameter element with single external O-ring seal contained in the outlet end cap.
Cartridge nominal length of 133 mm (5.25 in.).
MCY
Code Nominal Length HDC II Filter Grade Removal Rating Code Filter Grade Code O-ring
Option
4463 5.2 in. (133 mm) J006 (1)
0.6 µm (1)
P Pharmaceutical* H4 Silicone
J012 1.2 µm
Other O-ring options on request.
J025 2.5 µm
Omit General Use
J045 4.5 µm
* Pall pharmaceutical-grade
J060 6.0 µm filters are designed for use in
conformance with CGMP in
J100 10.0 µm Manufacturing, Processing,
Packing or Holding of Drugs
J200 20.0 µm (21CFR210) and CGMP for
J400 40.0 µm finished Pharmaceuticals
(21CFR211.72) including
(1)
Extrapolated value. batch release certificate and
50 full traceability.
Profile II Filter Cartridges
®
51
Profile II Filter Cartridges
Technical Specifications
AB Style: AB Y
Code Nominal Length Code Removal Code Removal Code Cartridge Code Filter Code O-ring
Rating(5) Rating(5) Style Grade Option
1 10 in. (254 mm)
003 0.3 µm 150 15 µm 7 Double 226 P Pharmaceutical* H4 Silicone
2 20 in. (508 mm)
O-ring J Ethylene
005 0.5 µm 200 20 µm Omit General Use
3 30 in. (762 mm) with bayonet Propylene
010 1 µm 300 30 µm lock and * Pall pharmaceutical-grade
4 40 in. (1016 mm) fin end filters are designed for use in Other materials available on
020 2 µm 400 40 µm conformance with CGMP in request.
Manufacturing, Processing,
030 3 µm 700 – Packing or Holding of Drugs
(21CFR210) and CGMP for
050 5 µm 900 – finished Pharmaceuticals
(21CFR211.72) including
100 10 µm 1200 –
batch release certificate and
(5)
The removal rating is the value in microns at full traceability.
which the modified OSU-F2 test gives a Beta
value of ≥ 5000.
52
Profile Star Filter Cartridges
®
Absolute-rated Pleated Depth Filters combining Long Service Life and High Flow-rates
55
Profile Star Filter Cartridges
Technical Specifications
5
A01
as standard
A01
50
30
A0
A0
Differential Pressure (mbar)
80
Ordering Information
MCY 1000 Style Double open-ended 70 mm (2.75 in.) diameter element with gaskets on both ends. Sealing is assured by using a tie rod and seal nut.
MCY 1000
Code Nominal Code Removal Code Filter Code Gasket Cartridge Sealing
Length Rating(2) Grade Option Arrangements
1 10 in. A010 1.0 µm(3) P Pharmaceutical* H4 Silicone MCY1000 AB Style
(254 mm) A015 1.5 µm(3) Omit General Use J Ethylene propylene Style (Other materials are
2 20 in. available on request)
A030 3 µm * Pall pharmaceutical-grade filters Other materials available on request.
(508 mm) 70 mm 70 mm 70 mm
A050 5 µm are designed for use in
3 30 in. conformance with CGMP in diameter diameter diameter
(762 mm) A100 10 µm Manufacturing, Processing,
A150 15 µm Packing or Holding of Drugs
4 40 in. (21CFR210) and CGMP for
(1016 mm) A200 20 µm finished Pharmaceuticals
(21CFR211.72) including batch
A400 40 µm
release certificate and full Flat gasket Code 7 Code 3
A700 70 µm traceability.
Double O-ring seal
A900 90 µm
AB Style Single open-ended element with double O-rings at one end.
AB
Code Nominal Code Removal Code Cartridge Code Filter Code Gasket
Length Rating(2) Style Grade Option
1 10 in. A010 1.0 µm(3) 3 Double 222 O-ring P Pharmaceutical* H4 Silicone
(254 mm) A015 1.5 µm(3) with flat end Omit General Use J Ethylene propylene
2 20 in. 70 mm (2.75 in.)
A030 3 µm diameter * Pall pharmaceutical-grade filters Other materials available on request.
(508 mm)
A050 5 µm are designed for use in
3 30 in. 7 Double 226 O-ring conformance with CGMP in
(762 mm) A100 10 µm with bayonet lock Manufacturing, Processing,
A150 15 µm and fin end. Packing or Holding of Drugs
4 40 in. 70 mm (2.75 in.) (21CFR210) and CGMP for finished
(1016 mm) A200 20 µm diameter Pharmaceuticals (21CFR211.72)
including batch release certificate
(2)
Absolute rating in this A400 40 µm
and full traceability.
publication means the A700 70 µm
value in microns at which
the modified OSU-F2 test A900 90 µm
gives a Beta value of
56 > 5000.
(3)
Extrapolated value.
Starclear™ Filter Cartridges
The Only Composite Pleated Depth Filters with Positive Zeta Potential
57
Starclear Filter Cartridges
Technical Specifications
Ordering Information
AB HAZ
Code Nominal Length Code Cartridge Style Code Filter Grade Code Seal Material
05(7) 5 in. (127 mm) 7 Double 226 O-ring with P Code outside US H4 Silicone
bayonet lock and
1 10 in. (254 mm) Omit Code in US only J Ethylene propylene
fin end
Supplied with Certificate of Test and Full
2 20 in. (508 mm)
2(8) Double 226 O-ring with Traceability
3 30 in. (762 mm) bayonet lock and flat end
4 40 in. (1016 mm) (8)
Available in cartridge type AB05 only.
Other cartridges available on request.
(7)
Available with cartridge option code 2 only.
58
Profile Filter Cartridges with Ultipleat Construction
® ®
Depth
Filter
59
Profile Filter Cartridges with Ultipleat Construction
Technical Specifications
µm
Pressure (60 psi) (49 psi) (29 psi) (15 psi) µm
140 4.5
0
2.
2
Operating 30 °C 50 °C 70 °C 80 °C
Temperatures (86 °F) (122 °F) (158 °F) (176 °F) 120
80
Steam-sterilization
1
60 m
Up to 140 °C (284 °F) for AB style filter elements 6.0 µ
40 10 µm 20 µm
40 µm
20
70 µm 100 µm
0 0
0 25 50 75 100
Flow Rate (L/min) – 10 in. (254 mm) nominal length cartridge
(2)
Typical initial clean media ∆P 10 in. (254 mm) element, water at 20 °C (68 °F),
viscosity 1 cP. For assistance with filter assembly, sizing and housing
selection, contact your local Pall representative.
Ordering Information
PUY Style Double open ended 63mm (2.5in) diameter cartridge with gaskets both end. Cartridge sealed with tie rod and seal nut.
AB Style: AB UY 7
Code Nominal Code Removal Cartridge Style Code Filter Code Seal Options
Length Rating(3) Grade
1 10 in. (254 mm) 020 2.0 µm Double 226 O-ring P Pharmaceutical* J Ethylene
(extrapolated value) with bayonet lock propylene
2 20 in. (508 mm) Omit General Use
and fin end (Standard)
045 4.5 µm
3 30 in. (762 mm) * Pall pharmaceutical-grade filters H4 Silicone
060 6.0 µm are designed for use in
4 40 in. (1016 mm)
conformance with CGMP in H13 Buna-N
100 10 µm Manufacturing, Processing,
Packing or Holding of Drugs
200 20 µm (21CFR210) and CGMP for
400 40 µm finished Pharmaceuticals
(21CFR211.72) including batch
700 70 µm release certificate and full
traceability.
1000 100 µm
(3)
Absolute rating in this publication
means the value in microns at which
the modified OSU-F2 Test gives a Beta
Value of ≥ 5000 (> 99.98% removal
efficiency).
60
HDC II Filter Cartridges
®
61
HDC II Filter Cartridges
Technical Specifications
45
00
60
J02
Core, Cage and End Caps Polypropylene J1
J0
J0
50
P Grade Code 7 Adapters Polypropylene with encapsulated
stainless steel ring 0.6
Nominal Dimensions
0 0
Lengths 10 in. (254 mm), 20 in. (508 mm), 0 3 6 9 12 15 18
30 in. (762 mm), 40 in. (1016 mm) Flow Rate per 10 in. (254 mm) Filter (Gal/min)
Diameter 70 mm (2.75 in.)
Flow Rate (L/min)
0 10 20 30 40 50 60
Operating Conditions 8
AB1J006
Maximum Differential 5.5 bard (80 psid) to 50 °C (122 °F) 500
Pressure and Temperature(4) 4.1 bard (60 psid) to 80 °C (176 °F)
(4)
Using compatible fluids. 6
Differential Pressure (psid)
400
2
100
0 0
2 4 6 8 10 12 14 16
Flow Rate per 10 in. (254 mm) Filter (Gal/min)
(6)
Typical initial media ∆P 10 in. (254 mm) element; water at 20 °C (68 °F);
viscosity 1 cP. For assistance in filter assembly sizing and housing selection,
contact your local Pall representative.
Ordering Information
AB 7
Code Nominal Code Removal Nominal Filter Cartridge Code Filter Code Gasket
Length Rating Area(7) Style Grade Option
1 10 in. J006 0.6 µm 0.63 m2 (6.7 ft2) Double 226 O-ring P Pharmaceutical* H4 Silicone
(254 mm) with bayonet lock
J012 1.2 µm 0.70 m2 (7.5 ft2) Omit General Use Other materials available on
and fin end(8)
2 20 in. request.
J025 2.5 µm 0.88 m2 (9.5 ft2) * Pall pharmaceutical-grade filters
(508 mm) (8)
Other adapter codes are designed for use in
J045 4.5 µm 0.88 m (9.5 ft )
2 2 available. conformance with CGMP in
3 30 in. Manufacturing, Processing,
(762 mm) J060 6 µm 0.42 m2 (4.5 ft2) Packing or Holding of Drugs
(21CFR210) and CGMP for
4 40 in. J100 10 µm 0.55 m2 (6.0 ft2) finished Pharmaceuticals
(1016 mm) (21CFR211.72) including batch
J200 20 µm 0.55 m2 (6.0 ft2)
release certificate and full
J400 40 µm 0.38 m2 (4.0 ft2) traceability.
62
Ultipor GF Plus Filter Cartridges
®
63
Ultipor GF Plus Filter Cartridges
Technical Specifications
Z
10Z
Support and Drainage Polyester
Z
0Z
-20
30
-4
U0
U6
U0
U2
Core, Cage and End Caps Polypropylene
O-Ring Silicone(1) 15
0Z
Removal Ratings (Liquid)(2) U10 10
U400Z 5
Endotoxin Removal Efficiency(3)
U010Z (1 µm) 99.998%
U2-20Z, U030Z 99.97% 0 0
0 1 2 3 4 5 6
(3)
Efficiency in deionized water with up to 55 – 70 mg E. coli 055-B5 endotoxin per
Flow Rate per 10 in. (254 mm) Filter (Gal/min)
10 in. (254 mm) modular element.
(5)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20°C (68°F);
viscosity 1 cP. For assistance in filter assembly, sizing and housing
Latex Bead Removal Efficiency(4) selection, contact your local Pall representative.
Ordering Information
AB Z 7
Code Nominal Code Removal Filter Cartridge Code Filter Code Gasket
Length Rating Area(8) Style(10) Grade Option
1 10 in. U010 1 µm 0.50 m2 (5.4 ft2) Double 226 O-ring P Code outside US H4 Silicone
(254 mm) with bayonet lock
U2-20 (9)
2 µm 0.65 m2 (7.0 ft2) Omit Code in US only Other materials available on
and fin end
2 20 in. request.
U030 3 µm 0.56 m2 (6.0 ft2) Supplied with Certificate of Test and
(508 mm) (10)
Other adapter codes Full Traceability
U6-40(9) 6 µm 0.56 m2 (6.0 ft2) available.
3 30 in.
(762 mm) U100 10 µm 0.49 m2 (5.3 ft2)
64
PreFlow™ Filter Cartridges
Effective Protection for 0.2 µm and 0.1 µm Filters in Biological Fluids
65
PreFlow Filter Cartridges
Technical Specifications
0.5
Nominal Filter Area per 10 in. (254 mm) Element
Grade UUA 0.57 m2 (6.2 ft2) 0 0
0 10 20 30 40 50 60 70
Grade UB 0.65 m (7.0 ft )
2 2
Flow Rate (L/min)
(1)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20°C (68°F);
viscosity 1 cP. For assistance in filter assembly, sizing and housing
Nominal Dimensions selection, contact your local Pall representative.
Lengths 10 in. (254 mm), 20 in. (508 mm),
30 in. (726 mm), 40 in. (1016 mm)
Operating Conditions
Diameter 70 mm (2.75 in.)
Maximum Operating 5.0 bard (72 psid) to 25 °C (77 °F)
Pressure and Temperature(2)
Extractables
(2)
Using compatible fluids. Compatible fluids are fluids which do not soften, swell, attack
Grade UUA Typically < 100 mg per 10 in. or adversely affect the filter or materials of construction
(254 mm) element
Grade UB Typically < 150 mg per 10 in. Steam and Autoclaving Sterilization(3)
(254 mm) element
Recommended Exposure 3 x 1-hour @ 125 °C (257 °F)
(3)
Laboratory tests establish resistance. Filters should be qualified in actual use.
Contact Pall for recommended procedures.
Ordering Information
AB 7
Code Nominal Length Code Removal Cartridge Code Filter Grade Code Gasket
Rating Style(4) Option
1 10 in. (254 mm) UUA 0.2 µm Double 226 O-ring P Code outside US H4 Silicone
with bayonet lock Other materials available
2 20 in. (508 mm) UB 0.45 µm Omit Code in US only
and fin end on request
3 30 in. (762 mm) Supplied with Certificate of Test and
(4)
Alternate AB adapter codes Full Traceability
4 40 in. (1016 mm) available
Note: Contact Pall for assistance with
part numbers.
66
Marksman™ Elements with Nexis A Series Filters
®
67
Marksman Elements with Nexis A Series Filters
Technical Specifications
Size 2:
Up to 0.31 m2 (3.3 ft2)
Flow Capacity
Size Maximum Recommended(2)
1 114 L/min (30 gal/min) 95 L/min (25 gal/min)
2 227 L/min (60 gal/min) 189 L/min (50 gal/min)
(2)
For maximum filter life.
Performance Specifications
Maximum Forward To 2.9 bard (42 psid) @ 20 °C (68 °F)
Differential Pressure To 1.8 bard (26 psid) @ 54 °C (130 °F)
To 1.0 bard (15 psid) @ 79 °C (175 °F)
Note: Stainless steel flange required for temperatures in excess of 43 °C (110 °F).
NXAM
Code Length Code Filter Code Nominal Code Gasket Code End Code Flange and
Grades Length Materials Configurations Gasket Styles
Blank Standard 3 3 µm 1 Size 1 Blank NF version PF Plastic self- A FSI side entry,
Bag N Buna N adjusting Flange Rosedale,
S Short 5 5 µm
Strainrite, Krystal,
2 Size 2 E EPDM SF Stainless steel Pall
10 10 µm
Bag (peroxide self-adjusting
20 20 µm flange (required B GAF
cured)
for temperatures C FSI over the top,
40 40 µm
V Viton A > 43 °C [110 °F]) Hayward over
70 70 µm the top
NF No flange (For
use with reusable
SS flange)
68
Marksman™ Elements with Poly-Fine XLD Series Filters
®
• Directly fits into bag housings with no * Viton is a registered trademark of DuPont Dow
(non-FDA materials).
hardware changes
• In-to-out flow traps contaminant inside
the element
• Quick, easy changeouts
• All-polypropylene construction
• Short length option to accommodate
shorter baskets
69
Marksman Elements with Poly-Fine XLD Series Filters
Technical Specifications
Materials of Construction Liquid Retention Ratings (µm) (by ASTM F-795 Test)
Filter Media Polypropylene Cartridge 90% > 99.9%
Hardware Polypropylene Designation Efficiency Efficiency
Filter Grades 1.5, 3, 4.5, 10, 20, 30, 40, 70, 90 µm 30 0.006 0.003 0.180 0.090
(> 99.9% Retention Rating 40 0.006 0.003 0.150 0.080
by ASTM F-795 Test)
70 0.006 0.003 0.026 0.013
Maximum Differential Polypropylene Cage:
Pressure To 5.1 bard (75 psid) @ 20 °C (68 °F) 90 0.006 0.003 0.026 0.013
To 2.4 bard (35 psid) @ 54 °C (130 °F)
Note: For mbar values, multiply psid by 69
Stainless Steel Cage:
To 1.7 bard (25 psid) @ 80 °C (175 °F)
Code Length Code Filter Code Nominal Code Support Code Gasket
Grades Length Cage Materials
Blank Standard 1.5 1.5 µm 1 Size 1 Bag U Poly- Blank For NF version
propylene
S Short 3 3 µm 2 Size 2 Bag N Buna N
S Stainless E EPDM (peroxide
4.5 4.5 µm
Steel cured)
10 10 µm
V Viton A
20 20 µm
40 40 µm
70 70 µm
Code End Configurations Code Flange and Gasket Styles
90 90 µm
PF Plastic self-adjusting flange A Rosedale, Strainrite,
SF Stainless steel self-adjusting Krystal, Pall
flange (required for B GAF, FSI side entry
temperatures > 43 °C (110 °F) C FSI over the top,
NF No flange (For use with Hayward over the top
70 reusable SS flange)
Marksman™ Elements with Poly-Fine II Series Filters
®
71
Marksman Elements with Poly-Fine II Series Filters
Technical Specifications
Materials of Construction Liquid Retention Ratings (µm) (by ASTM F-795 Test)
Filter Media Polypropylene Cartridge 90% > 99.9 %
Hardware Polypropylene Designation Efficiency Efficiency
1 227 L/min (60 gal/min) 189 L/min (50 gal/min) 3 0.0130 0.0070 0.660 0.330
2 454 L/min (120 gal/min) 379 L/min (100 gal/min) 5 0.0070 0.0040 0.430 0.220
(1)
For maximum filter life. 10 0.0040 0.0020 0.260 0.130
20 0.0020 0.0010 0.230 0.120
Performance Specifications
40 0.0010 0.0005 0.070 0.035
Filter Grades 1, 3, 5, 10, 20, 40, 70, 90, 150 µm 70 0.0008 0.0004 0.030 0.015
(> 99.9% Retention Rating
by ASTM F-795 Test) 90 0.0008 0.0004 0.015 0.008
Maximum Forward 5.1 bard (75 psid) @ 20 °C (68 °F) 150 0.0006 0.0003 0.010 0.005
Differential Pressure 2.4 bard (35 psid) @ 54 °C (130 °F) Note: For mbar values, multiply psid by 69
PTFM
Code Length Code Filter Code Nominal Code Gasket Code End Configurations
Grades Length Materials
72
Emflon FM Filter Cartridges
®
73
Emflon FM Filter Cartridges
Technical Specifications
Operating Parameters
250 3.5
Maximum Differential 4.1 bard (60 psid) @ 23 °C (74 °F)
∆P)
Pressure (∆ 2.1 bard (31 psid) @ 60 °C (140 °F)
Ordering Information (Part number denotes one filter, minimum order quantity 12)
AB Style: A FM P
Code Cage Option Code Nominal Length Code Cartridge Style Code Seal Option
B Polypropylene cage 1 10 in. (254 mm) 47 Single 226 O-ring with bayonet H15(3) FEP/Silicone
lock and fin end
BA No cage 2 20 in. (508 mm) (Fits in all code 7 housings) H2(4) PTFE
3 30 in. (762 mm)
(3)
AB style only.
7 Double 226 O-ring with bayonet (4)
MCY1000 style only.
4 40 in. (1016 mm) lock and fin end
74
Ultipor N66 Particulate and Bioreduction Filter Cartridges
®
75
Ultipor N66 Particulate and Bioreduction Filter Cartridges
Technical Specifications
Operating Conditions(3) Aqueous Extractables (NVR) per 10 in. (254 mm) Element(6)
Maximum Differential 5.5 bard (80 psid) to 50 °C (122 °F) Typically < 15 – 20 mg
Pressure and Temperature 4.1 bard (60 psid) to 80 °C (176 °F) (6)
In water at 20 – 25 °C (68 – 77 °F) after autoclaving.
2.1 bard (30 psid) to 125 °C (257 °F)
(3)
Using compatible liquids.
Ordering Information
AB
Code Nominal Code Removal Nominal Forward Flow(8) Code Filter Code Gasket
Length Rating Filter Area(7) mL/min at Grade Option
(mbar) psi
1 10 in. NA7 0.2 µm 0.84 m2 (9.0 ft2) 85 at 2260 (30) P Pharmaceutical* H4 Silicone
(254 mm) Other materials available
NX7 0.45 µm 0.46 m2 (5.0 ft2) 10 at 1720 (25) Omit General Use
on request.
2 20 in. NL7 0.45 µm 0.79 m2 (8.5 ft2) 15 at 1720 (25) * Pall pharmaceutical-grade filters
(508 mm) are designed for use in
NB7 0.45 µm 0.84 m (9.0 ft )
2 2
85 at 1240 (18) conformance with CGMP in
3 30 in. Manufacturing, Processing,
(762 mm) NB7W 0.45 µm 0.86 m2 (9.2 ft2) 50 at 1240 (18) Packing or Holding of Drugs
(21CFR210) and CGMP for
4 40 in. NK7W 0.65 µm 0.84 m2 (9.0 ft2) 25 at 1100 (16) finished Pharmaceuticals
(1016 mm) (7)
Per 10 in. (254 mm) cartridge. (21CFR211.72) including batch
(8)
Forward Flow allowable limit for one 10 in. (254 mm) cartridge at given test release certificate and full
pressure, water wet, air test gas. Please contact Pall for method details and test traceability.
parameters.
76
Mini Kleenpak™ Sterilizing-grade Capsule Filters
Ideal for Scale-up and Scale-down
77
Mini Kleenpak Sterilizing-grade Capsule Filters
Technical Specifications
Autoclave 3 x 30-minute cycles @ 140 °C (284 °F) Fluorodyne II DFL 225 mL/min/100 mbar (155 mL/min/psi)
Gamma-irradiation Maximum Dosage: 50 kGy Fluorodyne II DJL 100 mL/min/100 mbar (69 mL/min/psi)
(4)
For fluids at 1 cP viscosity @ 20 °C (68 °F). For other viscosities, divide flow rate by
(3)
Warning: Pre-sterilized units should not be re-irradiated or autoclaved. This product viscosity in centipoise. For assistance, contact your local Pall representative.
may not be sterilized by in situ steaming.
Ordering Information
KA02 P
Code Filter Type Code Inlet and Outlet Code Additional Options
EKV 0.2 µm rated Supor 2(5)
6 – 13 mm ( ⁄4 – ⁄2 in.)
1 1
G Non-sterilized version
stepped hose barb
EBV 0.2 µm rated Supor S Pre-sterilized version
DFL 0.2 µm rated
(5)
Bell on outlet is removable for in-line use.
Fluorodyne II
78
Kleenpak™ Capsules with Supor® EKV Membrane Assemblies
Optimized for Filtration of Buffers and Biological Fluids
High Quality Standards * Per lot sample soak or rinse-up flush aliquots.
79
Kleenpak Capsules with Supor EKV Membrane Assemblies
Technical Specifications
End Cap, Core and Cage Polypropylene Length including 174 mm (6.8 in.)
Sanitary Connector
Sterilization
Autoclave 5 x 60-minute cycles
@ 125 °C (257 °F)
Ordering Information
KA EKV
Code Size and Area Code Filter Grade Code Inlet and Outlet Code Sterilization
Connections Grade
80
Supor EKV Sterilizing-grade Filter Cartridges
®
81
Supor EKV Sterilizing-grade Filter Cartridges
Technical Specifications
Nominal Dimensions
Typical Effective Filtration Area(5)
Lengths 10 in. (254 mm), 20 in. (508 mm), 0.6 m2 (6.5 ft2) per 10 in. (254 mm) module
30 in. (762 mm), 40 in. (1016 mm)
0.26 m2 (2.8 ft2) per 5 in. (125 mm) module
Diameter 70 mm (2.75 in.)
(5)
5 in. (125 mm) filters are standard pleated.
Ordering Information
AB
Code Nominal Code Removal Code Cartridge Style Code Filter Grade Code O-ring
Length Rating Material
05 5 in. (125 mm) EKV 0.2 µm 2 Double 226 O-ring P Pharmaceutical* H4 Silicone elastomer
sterilizing-grade bayonet lock, Other materials available
1 10 in. (254 mm) * Pall pharmaceutical-grade filters are
without fin designed for use in conformance on request.
2 20 in. (508 mm) with CGMP in Manufacturing,
7 Double 226 O-ring Processing, Packing or Holding of
3 30 in. (762 mm) bayonet lock Drugs (21CFR210) and CGMP for
4 40 in. (1016 mm) and fin end finished Pharmaceuticals
(21CFR211.72) including batch
release certificate and full
traceability.
82
Supor EBV Sterilizing-grade Filter Cartridges
®
High Quality Standards * Per lot sample soak or rinse-up flush aliquots.
83
Supor EBV Sterilizing-grade Filter Cartridges
Technical Specifications
Operating Parameters(1)
100
Maximum Operating Pressure 5.5 bar (80 psi) @ 50 °C (122 °F)
(Forward Direction) 3.0 bar (43.5 psi) @ 80 °C (176 °F) 1
50
Maximum Operating Pressure 2.0 bar (29 psi) @ 50 °C (122 °F)
(Reverse Direction)
0 0
(1)
In compatible fluids which do not soften, swell, or adversely affect the filter or its 0 5 10 15 20 25 30
materials of construction.
Flow Rate (L/min)
(3)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20 °C
Sterilization(2) (68 °F); viscosity 1 cP. For assistance in filter assembly sizing and
housing selection, contact your local Pall representative.
Autoclave 5 x 60-minutes cycles at 125 °C
In situ Steam 5 x 30-minutes cycles at 142 °C (287 °F)
Typical Extractables(4) per 10 in. (254 mm) Module
(2)
Maximum differential pressure during steam-sterilization is 1 bar (14.5 psi). < 25 mg in water at 20 °C (68 °F) after 4 hours extraction
(4)
Tested on elements without pre-flushing,
Nominal Dimensions
Nominal Filtration Area per 10 in. (254 mm) Module
Lengths 10 in. (254 mm), 20 in. (508 mm),
30 in. (762 mm), 40 in. (1016 mm) 0.66 m2 (7.1 ft2)
Diameter 70 mm (2.75 in.)
Integrity Test Values for 10 in. (254 mm) Filter at 20 °C (68 °F)
Maximum Allowable Water wet ≤ 23 mL/min
Forward Flow (Air Test Gas) at 2760 mbar (40 psi)
Contact Pall for multi-element integrity test values and recommended test procedures.
Ordering Information
AB 7
Code Nominal Code Removal Cartridge Code Filter Grade Code O-ring
Length Rating Style Material
1 10 in. (254 mm) EBV 0.2 µm Double 226 O-ring P Pharmaceutical* H4 Silicone elastomer
sterilizing-grade bayonet lock Other materials available
2 20 in. (508 mm) * Pall pharmaceutical-grade filters are
and fin end designed for use in conformance with on request.
3 30 in. (762 mm) CGMP in Manufacturing, Processing,
Packing or Holding of Drugs (21CFR210)
4 40 in. (1016 mm) and CGMP for finished Pharmaceuticals
(21CFR211.72) including batch release
certificate and full traceability.
84
Kleenpak™ Capsules with Fluorodyne II Membrane Assemblies
®
85
Kleenpak Capsules with Fluorodyne II Membrane Assemblies
Technical Specifications
Effective 0.04 m 2
0.08 m 2
0.15 m 2
0.34 m2 Aqueous Extractables (NVR)(6)
Filter Area (0.4 ft2) (0.8 ft2) (1.5 ft2) (3.4 ft2)
KA1 and KA2 1 mg
Sterilization (7)
Laboratory tests (1-hour cycles) establish multi-cycle.
Gamma-irradiation Maximum Dosage (G grade): 50 kGy Warning: Kleenpak filters must not be steam-sterilized in situ by passing steam through
under pressure.
Nominal Dimensions
Size Code KA1 KA2 KA3 KA4
Maximum Diameter of Bowl (including Valves) 94 mm (3.7 in) 94 mm (3.7 in) 109 mm (4.2 in.) 109 mm (4.2 in.)
Length (including Sanitary Connection [Code 1]) 117 mm (4.6 in.) 158 mm (6.2 in.) 174 mm (6.8 in.) 286 mm (11.2 in.)
Length (including Hose Barb Connection [Code 6]) 158 mm (6.2 in.) 199 mm (7.8 in.) 210 mm (8.2 in.) 325 mm(12.7 in.)
Ordering Information
KA P
Code Size and Area Code Removal Ratings Code Inlet and Outlet Connections Code Options
1 DBL 0.45 µm 1 38 mm (11⁄2 in.) sanitary flange Blank Autoclave service
2 See above DFL 0.2 µm sterilizing-grade 6 14 mm (9⁄16 in.) hose barb G Unsterilized,
dimensions Gamma-irradiatable
3 table DJL 0.1 µm sterilizing-grade
S Pre-sterilized
4
86
Fluorodyne II Hydrophilic PVDF Filter Cartridges
®
(1)
Except ketones and amides.
87
Fluorodyne II Hydrophilic PVDF Filter Cartridges
Technical Specifications
Diameter 70 mm (2.75 in.) Hot Water Sanitization To 90 °C (194 °F) at 0.5 bard (7 psid)
Nominal Filter Area per 10 in. (254 mm) Element Forward Flow(7)
DBL 13 mL/min at 1240 mbar (18 psi)
Size Code DBL DFL DJL
DFL 12 mL/min at 2760 mbar (40 psi)
Effective 0.55 m2 0.51 m2 0.51 m2
Filter Area (6 ft2) (5.5 ft2) (5.5 ft2) DJL 29 mL/min at 4475 mbar (65 psi)
(7)
Forward Flow allowable limit per 10 in. (254 mm) cartridge at given test pressure, water
wet, air test gas.
Operating Conditions(5)
Maximum Differential 5.3 bard (77 psid) to 50 °C (122 °F)
Pressure and Temperature 3.4 bard (49 psid) to 90 °C (194 °F)
(5)
Using compatible fluids.
AB
Code Nominal Code Removal Code Cartridge Code Filter Grade Code Gasket
Length Rating Style Option
• Sanitary vent and drain valves with • Meets Total Organic Carbon and Water
non-twist hose barbs Conductivity per USP Purified Water;
pH per Sterile Purified Water
• Low hold-up volumes (< 1 mL)
Autoclave Resistance
• Gamma-irradiatable, autoclavable, and
• Lot samples multi-cycle autoclave
pre-sterilized versions available for
challenged
maximum flexibility
* Per lot sample or rinse-flush aliquots.
• Autoclavable versions can be
repeatedly autoclaved
• Manufactured for use in conformance
with cGMP
• ISO 9000 certified Quality system
• Pharmaceutical P optimized
• Certificate of test provided
89
Kleenpak Capsules with Ultipor N66 Membrane Assemblies
Technical Specifications
G and S Grades: 15
Operating Conditions(3)
Maximum Pressure and 5.2 barg (75 psig) to 40 °C (104 °F) Note: Contact Pall for specific part number availability.
S and G grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3 with
Temperature with inlet and outlet options 1 and 6.
Autoclavable grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3
Maximum Operating 4.1 bard (60 psid) at 40 °C (104 °F)
and KA4 with with inlet and outlet options 1 and 6.
Differential Pressure
(3)
Using compatible liquids. Recommended maximum 3.5 barg (50 psig) in continuous air
and gas service. KA*NT filters may be forward flow tested at 5171 mbar (75 psig) at
ambient temperature.
Ordering Information
KA P
Code Size and Area Code Removal Ratings Code Inlet and Outlet Connections Code Options
flange
90
Option P8 available in KA2, autoclave service.
Sealkleen™ Membrane Filter Cartridges
Sterilizing and Microbial Grade Junior Style Filters
91
Sealkleen Membrane Filter Cartridges
Technical Specifications
2
Configuration
100
Single open-ended cartridge 1
(3)
Using compatible fluids. Fluorodyne II:
30 hours at 125 °C (257 °F)
10 hours at 140 °C (284 °F)
(5)
Laboratory tests (1-hour cycles) establish multi-cycle resistance. Filters should be
qualified in actual use. Contact Pall for recommended procedures.
Ordering Information
SLK
Code Nominal Code Removal Nominal Filter Code Filter Forward Flow integrity Test Parameters
Length Rating Area(6) Grade
7001 2.5 in. NNXZ 1.2/0.45 µm 0.17 m2 (1.8 ft2) P Pharmaceutical* Part Number FF Test FF Limit
(64 min) Pressure* Value
NB 0.45 µm 0.30 m2 (3.2 ft2) Omit General Use
mbar (psi) (mL/min)
7002 5.2 in. NL 0.45 µm 0.29 m2 (3.1 ft2)
(133 mm) * Pall pharmaceutical-grade filters SLK7001NRP 2760 (40) 2.3
NX 0.45 µm 0.17 m2 (1.8 ft2) are designed for use in
SLK7001NFP 2760 (40) 3.5
Note: NA 0.45 µm 0.30 m2 (3.2 ft2) conformance with CGMP in
Manufacturing, Processing, SLK7001DFLP 2760 (40) 2
Ultipor N66 = NB, NL, NF 0.2 µm 0.27 m2 (2.9 ft2)
NX, NA, Packing or Holding of Drugs SLK7001NTP 5175 (75) 3.6
NF, NR, NR 0.2 µm 0.17 m2 (1.8 ft2) (21CFR210) and CGMP for
finished Pharmaceuticals
SLK7002NRP 2760 (40) 4.6
NT NFZ 0.2 µm 0.27 m2 (2.9 ft2)
Posidyne = NNXZ, (21CFR211.72) including batch SLK7002NFP 2760 (40) 7
NT 0.1 µm 0.25 m2 (2.7 ft2) release certificate and full
NFZ, SLK7002DFLP 2760 (40) 4
NTZ NTZ 0.1 µm 0.25 m2 (2.7 ft2) traceability.
SLK7002NTP 5175 (75) 5.9
Fluorodyne II = DFL DFL 0.2 µm 0.19 m2 (2.0 ft2)
* Please contact Pall for method details and test
parameters.
92
Ultipor N66 Sterilizing-grade Filter Cartridges
®
93
Ultipor N66 Sterilizing-grade Filter Cartridges
Technical Specifications
Ordering Information
AB
Code Nominal Code(7) Removal Nominal Forward Flow(9) Code Filter Code Gasket
Length Rating Filter mL/min at Grade Option
Area(8) mbar (psi)
05 5 in. NF 0.2 µm 0.79 m2 (8.5 ft2) 12 at 2760 (40) P Pharmaceutical* H4 Silicone
(127 mm)
NR 0.2 µm 0.46 m2 (5.0 ft2) 8 at 2760 (40) Omit General Use Other materials available
1 10 in. on request.
NT 0.1 µm 0.79 m2 (8.5 ft2) 14 at 5175 (75) * Pall pharmaceutical-grade filters
(254 mm) are designed for use in
ND 0.4 µm 0.81 m2 (8.7 ft2) 25 at 3440 (50) conformance with CGMP in
2 20 in. Manufacturing, Processing,
(508 mm)
(7)
Code 7 adapter is standard (except 05 length is Code 2 with flat cap). Packing or Holding of Drugs
(8)
Per 10 in. (254 mm) element. (21CFR210) and CGMP for
3 30 in.
(9)
Forward Flow allowable limit for one 10 in. (254 mm) cartridge at given test finished Pharmaceuticals
pressure, water wet, air test gas. Please contact Pall for method details and test (21CFR211.72) including batch
(762 mm) parameters. release certificate and full
4 40 in. traceability.
(1016 mm)
94
Kleenpak™ Capsules with Posidyne Membrane Assemblies
®
95
Kleenpak Capsules with Posidyne Membrane Assemblies
Technical Specifications
6
Microbial Removal Ratings
4
NFZ 0.2 µm, sterilizing-grade(1) 250
KA3NFZ
NTZ 0.1 µm, sterilizing-grade (2)
2
(1)
Assembly lot samples retain > 107 cfu/cm2 of Brevundimonas diminuta per mod.
ASTM F838-83 and FDA guidelines. 0 0
(2)
Also retains > 107 cfu/cm2 Acholeplasma laidlawii mycoplasma. 0 0.25 0.5 0.75 1
Flow Rate (Gal/min)
(4)
Typical initial clean ∆P, water at 20 °C (68 °F), 1 cP. KA4NFZP ∆P flow is
Nominal Filter Areas
37 mbard/L per min (2.1 psid/gpm). Pressure drops at other flows are
directly proportional to flow. Values shown for 38 mm (11⁄2 in.) sanitary flange
Size Code KA1 KA2 KA3 KA4
connections. Values with other connections are available on request. For
assistance, contact your local Pall representative.
Effective 0.05 m2 0.1 m2 0.2 m2 0.5 m2
Filter Area (0.53 ft2) (1 ft2) (2.1 ft2) (5.3 ft2)
Warning: Kleenpak filters must not be steam-sterilized in situ by passing steam through
under pressure.
Operating Conditions(3)
Sterilization
Maximum Pressure and 5.2 barg (75 psig) to 40 °C (104 °F)
Temperature Gamma-irradiation Maximum Dosage (G Grade): 35 kGy
Ordering Information
KA P
Code Size and Area Code Removal Ratings Code Inlet and Outlet Connections Code Options
1 NFZ 0.2 µm sterilizing-grade 1 38 mm (11⁄2 in.) sanitary flange Blank Autoclave service
2 See above NTZ 0.1 µm sterilizing-grade 2 6 – 13 mm (1⁄4 – 1⁄2 in.) G Unsterilized,
dimensions hose barb Gamma-irradiatable
3 table
6 14 mm (9⁄16 in.) hose barb S Pre-sterilized
4
96
Posidyne Filter Cartridges
®
Positive Zeta Potential for Enhanced Retention of Fine Particles in Large-scale Processes
Features and Benefits * Per lot sample soak or rinse-up flush aliquots.
97
Posidyne Filter Cartridges
Technical Specifications
Z
NF
Z
Supports, Drainage and Polyester 250
, NT
NI
,
End Caps AZ
NB
NDZ
Core and Cage Polypropylene
3 XZ 200
Ordering Information
AB 7
Code Nominal Code Removal Filter Forward Flow Code Filter Code Gasket
Length Rating Area(7) mL/min at Grade Option
mbar (psi)(8)
1 10 in. NNXZ 1.2/0.45 µm 0.82 m2 (8.8 ft2) 22 at 1240 (18) P Pharmaceutical* H4 Silicone
(254 mm) NLZ 0.45 µm 0.82 m2 (8.8 ft2) 15 at 1725 (25) Omit General Use Other materials available
2 20 in. on request.
NAZ 0.2 µm 0.85 m2 (9.0 ft2) 85 at 2060 (30) * Pall pharmaceutical-grade filters
(508 mm)
NBAZ 0.45/0.2 µm 0.82 m2 (8.8 ft2) 20 at 2060 (30) are designed for use in
3 30 in. conformance with CGMP in
(762 mm) NFZ 0.2 µm 0.78 m2 (8.5 ft2) 12 at 2760 (40) Manufacturing, Processing,
NIZ 0.1 µm 0.85 m2 (9.0 ft2) 50 at 3440 (50) Packing or Holding of Drugs
4 40 in. (21CFR210) and CGMP for
(1016 mm) NTZ 0.1 µm 0.70 m2 (7.5 ft2) 14 at 5175 (75) finished Pharmaceuticals
(21CFR211.72) including batch
NDZ 0.04 µm 0.81 m2 (8.7 ft2) 25 at 3440 (50)
release certificate and full
(7)
Filter areas are per 10 in. (254 mm) element. All dimensions are nominal. traceability.
98 (8)
Forward Flow allowable limit for one 10 in. (254 mm) cartridges at given test
pressure, water wet, air test gas. Please contact Pall for method details and test
parameters
Novasip™ Liquid Sterilizing-grade Capsule Filters
The Clear Choice for Steaming-In-Place
Comprehensive Validation
Documentation
Novasip filters have been extensively
tested to ensure consistent and reliable
performance under a range of process
conditions.
Installation and operating instructions
including information on steam-sterilization
are available from Pall.
99
Novasip Liquid Sterilizing-grade Capsule Filters
Technical Specifications
FP1
1
1
LP
P1
LP
(PVDF) DF
NF
DJ
C05N
C3
C3
C3
12
Support and Drainage Polyester Polypropylene
750
C P
Code Nominal Filter Area Code Filter Medium Code Connection Options Code Vent, Drain and Valve
05(5) 0.056 m2 (0.60 ft2) NF 0.2 µm sterilizing-grade 1 26 – 38 mm (1 – 11⁄2 in.) Blank Vent: Quick connect and
Ultipor N66 sanitary clamp disconnect coupling
(compatible with Stäubli*
3 0.22 m2 (2.37 ft2) NF 0.2 µm sterilizing-grade fitting)
Ultipor N66 Valve drain: Hose barb for
3 0.15 m2 (1.62 ft2) DFL 0.2 µm sterilizing-grade 4 – 6 mm (1⁄8 – 1⁄4 in.)
Fluorodyne II i.d. tube, with valve
3 0.15 m2 (1.62 ft2) DJL 0.1 µm sterilizing-grade A Vent and drain: Quick
Fluorodyne II connect and disconnect
coupling (Stäubli*
(5)
NF Media only. compatible) with valve
100
Kleenpak™ Nova Sterilizing-grade and Virus Removal Capsule Filters
Improving Choice, Flexibility and Operation Costs for the Sterile Filtration of Liquids
The issues of effective cleaning and Kleenpak Nova capsules are especially
cleaning validation result in disposable suited to pilot- and process-scale
equipment being the preferred option for applications. They can be autoclaved or
many processes. Disposable filters can sterilized by Gamma-irradiation and can be
help eliminate cleaning problems, supplied as part of pre-sterilized
especially where biological products are to processing systems such as a
be filtered. In applications where hazardous filter/tubing/bag set.
materials are being filtered, such as
Kleenpak Nova capsules are used in a
cytotoxic drugs, capsule filters can play an
wide range of critical applications including
important role in helping protect operators.
the sterilization of BioPharmaceuticals,
Kleenpak Nova capsule filters are biologicals, diagnostic reagents, serum,
designed to provide choice, cost tissue culture media, and culture-media
effectiveness and flexibility, while ensuring components.
ease of use for the operator.
Kleenpak Nova Filters Reduce
Designed to Provide Choice and Operating Costs
Flexibility
Kleenpak Nova filters have a typical
Kleenpak Nova capsule filters are available installation cost that is 80% lower than a
with either in-line or T-style configurations. similar sized stainless steel housing
The T-style configuration is ideal for system. Therefore, they offer an extremely
manipulating multiple filters in series or in cost-effective alternative to housing and
parallel configuration. cartridge systems. Kleenpak Nova filters
can also provide additional cost savings:
Kleenpak Nova Capsule filters incorporate
either a 10 in. (254 mm), 20 in. (508 mm) • No housing maintenance —
or 30 in. (762 mm) length standard Pall Lower maintenance costs
cartridge filter which have traditionally been
• No housing cleaning or cleaning
installed in stainless steel housings. In
validation —
applications where a particular filter is
Lower labor costs
already specified, the user can switch from
a stainless steel housing to a fully • Filter is pre-assembled —
disposable assembly with minimal Lower labor costs
requalification. This means the extensive • Filter can be provided pre-sterilized —
range of sterilizing-grade and virus filters Lower energy costs
currently available from Pall can easily be
provided as a capsule filter, including:
• Low binding, high-flow Fluorodyne II
PVDF filters
• Ultipor N66 and positively-charged
Posidyne nylon 66 filters
• Supor polyethersulfone filters
• Ultipor VF DV20 and DV50 virus
removal filters
101
Kleenpak Nova Sterilizing-grade and Virus Removal Capsule Filters
Technical Specifications
Ordering Information
NP – In-line
NT – T-Style P
Code Filter Size Code Filter Type Code Connection Options Code Sterilization
6 AB1 10 in. (254 mm) Sterilizing State 1 25 – 38 mm (1 – 11⁄2 in.) State
7 AB2 20 in. (508 mm) DFL 0.2 µm rated Fluorodyne II filter sanitary flange inlet and outlet G Non-sterilized
8 AB3 30 in. (762 mm) DJL 0.1 µm rated Fluorodyne II filter 9 25 mm (1 in.) single-barb
hose barb inlet and outlet S Pre-sterilized
NF 0.2 µm rated Ultipor N66 filter
NT 0.1 µm rated Ultipor N66 filter 19 25 – 38 mm (1 – 11⁄2 in.) sanitary
flange inlet and 25 mm (1 in.)
NFZ 0.2 µm rated Posidyne filter
single-barb hose barb outlet
NTZ 0.1 µm rated Posidyne filter
Options for In-line Only
EKV 0.2 µm rated Supor filter
6 13 mm (1⁄2 in.) single-barb
92D 0.2 µm rated Suporlife(4) filter hose barb inlet and outlet
(3)
Note: Empty Kleenpak Nova
Virus Filters 16 25 – 38 mm (1 – 11⁄2 in.) sanitary
Capsule Housings for water at 20 °C LUDV50(4) Ultipor VF grade DV50 virus filter flange inlet and 13 mm (1⁄2 in.) Code Vent and Drain
(68 °F), 1 cP. For other liquids, LDV20(4) Ultipor VF grade DV20 virus filter single-barb hose barb outlet – Stäubli* vent and
multiply pressure times the viscosity
in centipoise. For complete Options for T-style Only stepped hose barb
(4)
L included in part number for in-line (NP) filters;
assembly, including AB-Style filter omitted for T-style filters (NT) 1H 25 – 38 mm (1 – 11⁄2 in.) sanitary drain
cartridge, add housing, and flange inlet and outlet, with
cartridge media pressure-drop A Stäubli* vent and
13 mm (1⁄2 in.) sanitary port on
values. Contact Pall for assistance. drain
inlet
Note: Partial list of part numbers. 1H9 25 – 38 mm (1 – 11⁄2 in.) sanitary * Stäubli is trademark of Stäubli
Contact Pall for specific flange inlet and 11⁄2 in. AG.
recommendations single-barb hose barb outlet,
with 13 mm (1⁄2 in.) sanitary port
102 on inlet
Novasip™ DV20 and DV50 Virus Removal Filter Capsules
Steam-In-Place Capsules for Virus Filtration
• Robust size exclusion mechanism * Per lot samples soak or rinse-up flush aliquots.
Housing Shell Polyetherimide 3.2 mL/min at 5860 mbar (85 psi) for CLM05DV20P1G
O-rings (1)
Silicone 0.3 L/min @ 2 bar (29 psi) for CL3DV50P1G
(1)
Other polymers available.
Sterilization
Nominal Dimensions Autoclavable and Steamable in situ for 3 x 1-hour cycles at up to
CLM05DV20 C3DV50 125 °C (257 °F) (non-irradiated product only). Gamma-irradiatable(2).
(2)
Contact Pall for recommended procedures.
Length 84 mm (3.3 in.) 157 mm (6.18 in.)
Diameter 123 mm (4.8 in.) 123 mm (4.8 in.)
Effluent Quality Tests (P Tests)
Nominal Filter Area 0.07 m2 (0.75 ft2) 0.4 m2 (4 ft2)
Meets Cleanliness per USP Particulates in Injectables.
Operating Conditions
Recommended Operating 1 – 2 bard (15 – 29 psid)
Pressure
Ordering Information
Part Number Media Type Rating
CLM05DV20P1G Hydrophilic PVDF For viruses ≥ 20 nm
CL3DV50P1G Hydrophilic PVDF For viruses ≥ 50 nm
Note: For suggested qualification protocols, test/validation discs, sizing and sterilizing
recommendations, multi-element forward flow values or other information, please contact
Pall or your local Pall representative.
104
Ultipor VF Grade DV50 Virus Filter Cartridges – SBF Junior Style
®
105
Ultipor VF Grade DV50 Virus Filter Cartridges – SBF Junior Style
Technical Specifications
Nominal Dimensions
Length 62 mm (2.4 in.)
Diameter 43 mm (1.7 in.)
Configuration
Single open-ended cartridge
Sanitary style plug adapter
Double 116 O-ring
Ordering Information(6)
Part Number Media Type Removal Rating
SBF1DV50PH4 Hydrophilic PVDF TR ≥ 106 for viruses
≥ 50 nm
(6)
H4 suffix = Silicone O-rings (standard). Ethylene Propylene and Fluoropolymer
Elastomer O-rings available. See Appendix for alternate O-ring polymer codes. P in part
number indicates optimized and qualified for pharmaceutical use including 100%
integrity test and Certificate of Test.
Note: For suggested qualification protocols, test and validation discs, sizing and
sterilizing recommendations, SBF style cartridges with 0.2 µm or other grade, please
contact Pall.
106
Ultipor VF Grade DV20 Virus Removal Filter Cartridges
®
107
Ultipor VF Grade DV20 Virus Removal Filter Cartridges
Technical Specifications
AB 7
Code Nominal Code Rating Filter Type Code Filter Code Gasket
Length Grade Option
1 10 in. DV20 ≥ 3 log TR for viruses > 20 nm Ultipor VF P Pharmaceutical* H4 Silicone
(254 mm)
UDV50 ≥ 6 log TR for viruses > 50 nm Ultipor VF Omit General Use Other materials available
2 20 in. on request.
DVD Sub 0.1 µm virus prefilter Ultipor VF * Pall pharmaceutical-grade filters
(508 mm) are designed for use in
DJL 0.1 µm (+ 0.2 µm prefilter layer) Fluorodyne II conformance with CGMP in
3 30 in. Manufacturing, Processing,
(762 mm) DFL 0.2 µm (double-layer) Fluorodyne II Packing or Holding of Drugs
(21CFR210) and CGMP for
4 40 in. DBL 0.45 µm (+ 0.65 µm prefilter layer) Fluorodyne II finished Pharmaceuticals
(1016 mm) (21CFR211.72) including batch
release certificate and full
traceability.
108
Ultipor VF Grade DV50 Virus Removal Filter Cartridges
®
109
Ultipor VF Grade DV50 Virus Removal Filter Cartridges
Technical Specifications
AB 7
110
Air and Gas Filtration
Air and Gas Filtration
Pall air and gas filters have been developed Coalescing filters protect downstream
from a successful range of products that are equipment and processes from compressor
widely used in the pharmaceutical and wear products, lubrication oil, water or other
biotechnology industries. liquid droplets, corrosion products, and other
particulate contaminants, while reducing
Emflon filters have been designed and maintenance costs.
liquid-validated for use as sterilizing filters for
® ®
air, gas, and vent service in critical ambient Rigimesh sintered metal mesh, PSS sintered
®
and high-temperature applications in metal powder and PMM metal membrane
BioPharmaceutical and bioprocess industries filter cartridges can be used for both gas and
such as product or hot WFI tank vents, liquid service. Metal filters are also used for
autoclaves, freeze dryers, and high-flow steam filtration.
applications such as fermenter inlet and
exhaust air. Note: It is important to maintain the integrity
of 0.2 µm sterilizing-grade filters. Pall
Pall capsule filters combine process and recommends integrity testing of all
Junior-size cartridge technology with the latest sterilizing-grade filters prior to steaming, after
polymers in an all-plastic filter assembly that steaming, and after the filtration process to
offers the benefits of a disposable capsule for ensure that the integrity of the filter has been
air, gas and vent filtration. Pall capsule filters maintained. Contact Pall for recommended
can be autoclaved, even steamed-in-place or procedures and Integrity test parameters.
gamma-irradiated, to provide a reliable, cost-
effective alternative to stainless steel housings.
112
Novasip™ Capsule with Emflon PFR Membrane Assemblies
®
113
Novasip Capsule with Emflon PFR Membrane Assemblies
Technical Specifications
de
e
nl
od
)i ) in
mo
m
Endcaps Polypropylene sig psig 1.5
nt
100
nt
p
(29
Ve
9
Ve
(2 rg
Core and Cage Polypropylene rg ba
= C3PFRP1 = C2PFRP1
Operating Conditions(3) (4)
Typical initial clean ∆P, air at 20 °C (68 °F).
Maximum Operating 6.5 barg (94 psig) at 40 °C (104 °F) Contact your local Pall representative for assistance.
Pressure
Ordering Information
C P F R P 1
Code Nominal Filter Area Code Connection Code Vent, Drain and Valves
2 0.17 m2 (1.8 ft2) 1 25 – 38 mm (1 – 11⁄2 in.) Blank Vent: Quick connect and
Sanitary flange fittings disconnect coupling (compatible
3 0.23 m2 (2.5 ft2) with Stäubli* fitting) with valve
Drain: Hose barb for 4 – 6 mm
(1⁄8 – 1⁄4 in.) i.d. tube, with valve
114
Kleenpak™ Capsules with Emflon II Membrane Assemblies
®
Custom-made Sets
We are happy to work with end-users to
provide custom-designed processing
systems which will integrate one or more of
our capsule ranges.
115
Kleenpak Capsules with Emflon II Membrane Assemblies
Technical Specifications
Maximum Operating 4.1 barg (60 psig) 5.2 barg (78 psig) Autoclave Sterilization
Pressure at 38 °C (100 °F) at 38 °C (100 °F) Gamma-irradiated Filters One 30-minute cycle at 125 °C
Maximum Differential 2.1 bard (30 psid) _ Non Gamma-irradiated Filters 3 x 1 hour cycles at 125 °C
Pressure at 80 °C (176 °F)
Warning: Kleenpak filters must not be in situ steam-sterilized by passing steam through
(1)
In air/nitrogen gas service or other compatible fluids, which do not soften, swell, or under pressure. The figures are maximum allowable figures determined by testing under
adversely affect the filter or its materials of construction. controlled laboratory conditions to the total number of hours indicated. Actual operating
conditions may affect the filters long-term response to sterilization. Filters should be
qualified for each process application.
Ordering Information
KA V002P
116
Kleenpak™ Capsules with Emflon PFR Membrane Assemblies
®
117
Kleenpak Capsules with Emflon PFR Membrane Assemblies
Technical Specifications
Operating Conditions(1) 0 0
0 20 40 60 80 100
Maximum Operating 40 °C (104 °F)
Temperature Flow Rate (Nm3/h)
Ordering Information
KA PFRP
118
Kleenpak™ Capsules with HDC II Gas Filter Assemblies
®
High-capacity Polypropylene Air and Gas Filters in the Most Convenient Form
119
Kleenpak Capsules with HDC II Gas Filter Assemblies
Technical Specifications
Materials of Construction Typical Air Flow Rates (at 2 barg [30 psig] Inlet Pressure)(3)
Flow Rate (scfm)
Medium Polypropylene
0 5 10 15
Support, Drainage, Core, Polypropylene 250
KA1 KA1 KA2 KA2
Cage, End Caps and Shell
Vent and Drain Valve O-ring Ethylene Propylene (EPDM) 3
200
= J025P = J045P
Nominal Filter Areas
(3)
Typical initial clean ∆P, air at 20 °C (68 °F). Values shown are for 38 mm
Effective Size Code (11⁄2 in.) sanitary flange connections. Values with other connections are
Filter Area KA1 KA2 KA3 available on request. For gases other than air or nitrogen, contact your
local Pall representative.
J012, J025 0.06 m2 (0.6 ft2) 0.1 m2 (1.0 ft2) 0.2 m2 (2.0 ft2)
Connections (Inlet and Outlet)
J045 0.06 m2 (0.6 ft2) 0.11 m2 (1.2 ft2) 0.22 m2 (2.3 ft2)
KA1 and KA2 Styles 38 mm (11⁄2 in.) sanitary flange
J060 0.03 m2 (0.3 ft2) 0.05 m2 (0.5 ft2) 0.10 m2 (1.0 ft2) 6 – 13 mm (1⁄4 – 1⁄2 in.) hose barb
J100 0.03 m2 (0.3 ft2) 0.07 m2 (0.7 ft2) 0.13 m2 (1.4 ft2) KA3 Style 38 mm (11⁄2 in.) sanitary flange
14 mm (9⁄16 in.) hose barb
Nominal Dimensions
Operating Conditions (Gases)(4)
Size Code KA1 KA2 KA3
Maximum Diameter of 94 mm 94 mm 109 mm Maximum Operating 3.5 barg (50 psig) to 40 °C (104 °F)
Bowl (Including Valves) (3.7 in.) (3.7 in.) (4.2 in.) Pressure and Temperature
Nominal Length (Including 117 mm 158 mm 174 mm Maximum Differential 3.5 bard (50 psid) at 40 °C (104 °F)
1 in. Tri-Clover Connection) (4.6 in.) (6.2 in.) (6.8 in.) Pressure and Temperature
Warning: Kleenpak filters must not be steam sterilized in situ by passing steam through
under pressure.
Ordering Information
KA J
Code Nominal Code Removal Rating Code Filter Grade Code Connection This is a guide to the
part number structure
Length in Liquids* Type and possible options
only. For availability of
1 012 1.2 µm P Pharmaceutical** 1 38 mm (11⁄2 in.)
See above specific options, please
sanitary flange contact Pall.
2 dimensions 025 2.5 µm Omit General Use
table 2 6 – 13 mm
3 045 4.5 µm **Pall pharmaceutical-grade filters are
(1⁄4 – 1⁄2 in.)
designed for use in conformance
060 6.0 µm with CGMP in Manufacturing, stepped hose barb
100 10 µm Processing, Packing or Holding of
Drugs (21CFR210) and CGMP for 6 14 mm (9⁄16 in.)
* Due to the enhanced particle finished Pharmaceuticals hose barb
removal efficiencies in gases, the (21CFR211.72) including batch
approximate ratings for gas service release certificate and full
can be calculated by dividing the traceability.
120 liquid rating in µm by between 5 and
10.
Emflon PFR Junior Style Filter Cartridges
®
High-flow, Hydrophobic Filters for Small-scale Sterile Gas and Vent Applications
121
Emflon PFR Junior Style Filter Cartridges
Technical Specifications
Materials of Construction Differential Pressure at 50 Nm3/h (30 ft3/min) Air Flow and
Membrane Hydrophobic PTFE 2 barg (29 psig) Inlet Pressure(2)
End Cap, Core and Cage Polypropylene MCY1110PFRPH4 500 mbard (7.25 psid)
MCY3330PFRPH4
MCY2230PFRPH4 50 hours Nominal Filter Area
MCY4463PFRPH4 Part Number Surface Area
MCY2230PFRPH4(1)
MCY3330PFRPH4(1)
MCY4440PFRPH4(1)
MCY4463PFRPH4(1)
SBF1PFRPH4
SLK7001PFRP
SLK7002PFRP
(1)
H4 suffix refers to silicone O-ring.
122
Emflon PFR Sterilizing-grade Filter Cartridges
®
• Inherently hydrophobic
• Oxidation resistant hardware
• High-flow and low pressure drop
• 100% bacteria retentive in liquids
• 100% virus retentive in gases
• Melt-sealed construction
• Enhanced steaming resistance
• 100% Forward Flow tested
• Water intrusion testable
• Individually serialized
• Manufactured for use in conformance
with cGMP
• FDA-listed materials per 21 CFR
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized
• Certificate of Test provided
• Validation Guide available
123
Emflon PFR Sterilizing-grade Filter Cartridges
Technical Specifications
150
2.0
Removal Ratings
Air and Gases < 0.003 µm, particulate (2)
100 1.5
Liquids 0.2 µm, sterilizing(3)
1.0
(2)
By NaCl CNC particle analysis. Also retains 100% of Brevundimonas diminuta bacteria,
bacteriophage and virus aerosols. 50
(3)
Lot samples of assemblies retain > 107 cfu/cm2 of Brevundimonas diminuta in liquid per 0.5
mod. ASTM F838-83 and FDA guidelines.
0 0
0 80 160 240 320
Nominal Dimensions
Flow Rate (Nm3/h)
Lengths 127 mm (5 in.), 10 in. (254 mm),
= Vent = 2.1 barg = 4.1 barg
20 in. (508 mm), 30 in. (762 mm),
(30 psig) inlet (60 psig) inlet
40 in. (1016 mm)
(5)
Typical initial clean medium ∆P per 254 mm (10 in.) element, air at 20 °C
Diameter 2.75 in. (70 mm) (68 °F). For multi-element cartridges, divide pressure drop by number of
254 mm (10 in.) elements. Non-linear cartridge turbulence factors are
incorporated into housing pressure drop values. For complete assembly
Nominal Filter Area pressure drop, add filter cartridge medium value to housing value at
specified flow rate. For gases other than air or nitrogen, contact your local
0.8 m2 (8.6 ft2) per 10 in. (254 mm) element Pall representative.
0.4 m2 (4.1 ft2) per 5 in. (127 mm) element
Typical Continuous Air Service Life(4) 0.3 bard (4.3 psid) at 142 °C (287 °F)
Typical Vent Service Life 0.5 bard (7.3 psid) at 125 °C (257 °F)
6 months to 80 °C (176 °F) 0.2 bard (3.0 psid) at 142 °C (287 °F)
(4)
In air/N2 service or other compatible gases.
For continuous air flow above 60 °C (140 °F), Emflon CPFR filters are recommended. Integrity Test Values for one 10 in. (254 mm) Cartridge(6)
Emflon PFR can be operated at higher temperatures for shorter time periods.
Forward Flow (Air/Test/Gas) 60:40 IPA: Water wet (v:v)
15 mL/min at 1035 mbar (15 psi)
Aqueous Extractables (20 °C [68 °F])
Water Intrusion 0.33 mL/min at 2485 mbar (36 psi)
< 5 mg per 10 in. (254 mm) element after 1-hour steam at 125 °C (257 °F) (6)
Contact Pall for multi-element values. AB05PFR value is 7.8 mL/min at 2485 mbar
(36 psi).
Ordering Information
AB PFR V
Code Nominal Length Code Cartridge Style Code Filter Grade Optimization Code O-ring Material
05 5 in. (127 mm) 2(7) Double 226 O-ring with P Pharmaceutical* Oxidation-resistant H4 Silicone
bayonet lock and flat end polypropylene
1 10 in. (254 mm) Omit General Use Other materials available.
hardware
7 Double 226 O-ring with
2 20 in. (508 mm) * Pall pharmaceutical-grade
bayonet lock and fin end
filters are designed for use in
3 30 in. (762 mm) conformance with CGMP in
(7)
AB05 cartridges only.
4 40 in. (1016 mm) Manufacturing, Processing,
Packing or Holding of Drugs
(21CFR210) and CGMP for
This is a guide to the part number structure and possible options only.
finished Pharmaceuticals
For availability of specific options, please contact Pall.
(21CFR211.72) including
batch release certificate and
124 full traceability.
Emflon CPFR High-temperature Sterilizing-grade Filter Cartridges
®
Materials of Construction Typical Air Flow at 20 °C (68 °F) and 2 barg (30 psig) Inlet
Pressure(2)
Membrane Double-layer proprietary hydrophobic
PTFE Flow Rate (scfm)
0 50 100 150 200 250
Drainage Layers Specially developed, resin impregnated 300
polyaramid non-woven material 4.0
End Cap, Core and Cage Pigmented polypropylene 250
3.5
Adapter Pigmented polypropylene with
(2)
Typical initial clean medium ∆p per 254 mm (10 in.) element, air at 20 °C
3.4 bard at 90 °C (50 psid at 194 °F)
(68 °F). For multipleat cartridges, divide pressure drop by number of 254 mm
(10 in.) elements. Contact Pall for assistance in sizing.
Maximum Operating Temperature (In Compatible Gases)
120 °C (248 °F) Typical Service Life in Continuous Flowing Air Service(3)
1 year at 100 °C (212 °F)
Maximum Forward Steaming Conditions 6 months at 110 °C (230 °F)
1 bard at 125 °C (15 psid at 257 °F) 2 months at 120 °C (248 °F)
0.3 bard at 142 °C (4.3 psid at 288 °F) (3)
For continuous air flow above 60 °C (140 °F), in air/N2 service or other compatible
gases, Emflon CPFR filters are recommended. Emflon CPFR can be operated at
higher temperatures for longer time periods.
Maximum Reverse Steaming Conditions
0.5 bard at 125 °C (7.3 psid at 257 °F) Typical Cumulative Steam Life(4)
0.2 bard at 142 °C (3.0 psid at 288 °F) 100 hours (1-hour cycles) at 140 °C (284 °F)
(4)
The steam life and service life data were determined by testing under controlled
Integrity Test Values(1) laboratory conditions up to the time indicated. Actual operating conditions may affect
the filter’s long-term resistance to steam sterilization and hot air service. Filters should
Forward Flow Test With 60/40 IPA/Water wet (v:v) be qualified for each process application.
and air as test gas
14 mL/min at 1040 mbar (15 psi)
Water Intrusion Test 0.3 mL/min at 2500 mbar (36 psi)
(1)
Values are for one 10 in. (254 mm) filter at 20 °C (68 °F). Please contact Pall for
multi-element integrity test values.
Ordering Information
AB CPFR V
Code Nominal Length Code Cartridge Style Code Filter Grade Optimization Code O-ring Material
05 5 in. (127 mm) 2(5) Double 226 O-ring with P Pharmaceutical* Oxidation resistant H4 Silicone
bayonet lock and flat end polypropylene
1 10 in. (254 mm) * Pall pharmaceutical-grade Other materials available.
hardware
7 Double 226 O-ring with filters are designed for use in
2 20 in. (508 mm) conformance with CGMP in
bayonet lock and fin end
Manufacturing, Processing,
3 30 in. (762 mm) Packing or Holding of Drugs
(5)
AB05 cartridges only.
(21CFR210) and CGMP for
finished Pharmaceuticals
(21CFR211.72) including
This is a guide to the part number structure and possible options only.
batch release certificate and
For availability of specific options, please contact Pall.
full traceability.
126
Emflon PFA Filter Cartridges
®
Emflon PFA filters are a further addition Optimized pleating configuration and
to the successful Emflon filter range. membrane support, together with a wide
The filters contain a proprietary bore cartridge core and adapter, ensure
pleated hydrophobic PTFE membrane that this high-flow performance can be
and are designed for the removal of exploited to the fullest.
micro-organisms and particles from air
and gases. Typical Applications
Emflon PFA filters: • Large-scale fermenter air
• Offer exceptionally high-flow rates to
• Intermediate product vessel venting
ensure low installation and operating
costs • Autoclave vacuum break
127
Emflon PFA Filter Cartridges
Technical Specifications
60 AB2
Nominal Filter Area 1
40 AB3
AB1PFA7PV 0.8 m (8.6 ft )
2 2
20 AB2
0
Maximum Differential Pressure(1) AB3
Temperature Maximum Differential Pressure
Forward Direction
0 50 100 150 200 250 300 350 400
Steam up to 125 °C (257 °F) 0.3 bar (4.3 psi) Air Flow Rate
(1)
Validated using 1-hour cycles.
= Nm3/h = ft3/min
Ordering Information
AB PFA V
Code Nominal Length Code Cartridge Style Code Filter Grade Optimization Code O-ring Material
05 5 in. (127 mm) 2(4) Double 226 O-ring with P Pharmaceutical* Oxidation resistant H4 Silicone
bayonet lock and flat end polypropylene
1 10 in. (254 mm) Omit General Use hardware
7 Double 226 O-ring with
2 20 in. (508 mm) * Pall pharmaceutical-grade
bayonet lock and fin end
filters are designed for use in
3 30 in. (762 mm) conformance with CGMP in
(4)
AB05 cartridges only.
Manufacturing, Processing,
Packing or Holding of Drugs
(21CFR210) and CGMP for
This is a guide to the part number structure and possible options only.
finished Pharmaceuticals
For availability of specific options, please contact Pall.
(21CFR211.72) including
batch release certificate and
full traceability.
128
Ultipor GF Plus Air and Gas Filters
®
High Capacity, Long Life Filters for Air and Gas Service
129
Ultipor GF Plus Air and Gas Filters
Technical Specifications
Steam Sterilization
Up to 140 °C (284 °F)
AB
MCY100
Code Nominal Filter Removal Nominal Cartridge Code Filter Code O-ring
Length Medium Rating in Liquids* Filter Area(6) Style Grade Option
1 10 in. (254 mm) U010Z 1 µm 0.50 m2 (5.3 ft2) Double 226 O-ring P Code outside US** H4 Silicone
with bayonet
2 20 in. (508 mm) U2-20Z 2 µm 0.65 m (6.9 ft )
2 2
Omit Code in US only H13 Nitrile
lock and fin end
3 30 in. (762 mm) U6-40Z 6 µm 0.55 m2 (5.9 ft2) Other materials available
**Supplied with Certificate of Test
on request.
and Full Traceability.
4 40 in. (1016 mm) U200Z 20 µm 0.49 m2 (5.2 ft2)
* Due to the enhanced particle removal efficiencies in gases, the approximate ratings for gas
service can be calculated by dividing the liquid rating in µm by between 5 and 10.
SLK
MCY4440
MCY4463
130
HDC II Gas Filter Cartridges
®
131
HDC II Gas Filter Cartridges
Technical Specifications
Retention Ratings
Liquids Gas Flow Rates per 10 in. (254 mm) Cartridge(2)
Code Absolute Retention (90%) Efficiency(3) Nominal Filter For Air
Rating for 0.3 µm Aerosols Area(4) m3/h
∆P = 10 mbar
(0.15 psi)(4)
J006 0.6 µm(3) < 1.0 µm(3) 99.9998 % 0.62 m2 (6.67 ft2) 4.0
J012 1.2 µm < 1.0 µm(3) 99.996 % 0.69 m2 (7.43 ft2) 10.0
J025 2.5 µm < 1.0 µm(3) 99.75 % 0.86 m2 (9.26 ft2) 14.0
J045 4.5 µm 1.2 µm 99.95 % 0.86 m2 (9.26 ft2) 17.0
J060 6.0 µm 3.0 µm 99 % 0.40 m2 (4.31 ft2) 24.0
J100 10.0 µm 5.4 µm 93 % 0.52 m2 (5.6 ft2) 39.0
J200 20.0 µm 10.0 µm – 0.53 m2 (5.7 ft2) –
J400 40.0 µm 22.0 µm – 0.37 m2 (3.98 ft2) –
J700 70.0 µm 35.0 µm – 0.37 m2 (3.98 ft2) –
(2)
For fluids of 1 cP viscosity. As a general guide for viscosities multiply pressure drop by viscosity in cP. For cartridges of 508, 762 and 1016 mm nominal length, divide differential
pressure by 2, 3, and 4 respectively.
(3)
Based on mineral oil test.
(4)
For 10 in. (254 mm) nominal length cartridge
(5)
Extrapolated value.
Ordering Information(5)
MCY 1000 style Double open-ended 70 mm (2.75 in.) diameter element with gaskets on both ends. Sealing is assured by using a tie rod and seal nut.
MCY 100
Code Nominal Length Code(4) Removal Rating(5) in Liquids* Code Gasket Options Cartridge Sealing Arrangements
1 10 in. (254 mm) J006 0.6 µm H13 Nitrile 1000 style AB style
2 20 in. (508 mm) J012 1.2 µm J Ethylene
3 30 in. (762 mm) J025 2.5 µm propylene
4 40 in. (1016 mm) J045 4.5 µm Other materials available on request.
(5)
For availability of specific options, J060 6.0 µm Flat Code 7 Code 3
contact Pall J100 10.0 µm Gasket Double O-ring seal
(6)
Absolute rating means the value in
microns at which the OSU-F2 test J200 20.0 µm
gives a beta value of > 5000. J400 40.0 µm
* Due to the enhanced particle removal
efficiencies in gases, the approximate J700 70.0 µm
ratings for gas service can be
calculated by dividing the liquid rating
in µm by between 5 and 10.
AB style Single open-ended 70 mm (2.75 in.) diameter element with double O-ring at one end
AB
Code Nominal Code Removal Rating Code Cartridge Code Filter Code O-ring
Length in Liquids* Style Grade Option
1 10 in. (254 mm) J006 0.6 µm 3 Double 222 O-ring P Pharmaceutical* H4 Silicone
2 20 in. (508 mm) J012 1.2 µm with flat end J Ethylene
Omit General Use
3 30 in. (762 mm) J025 2.5 µm 7 Double 226 O-ring propylene
with bayonet * Pall pharmaceutical-grade filters
4 40 in. (1016 mm) J045 4.5 µm lock and fin end are designed for use in Other materials available on
conformance with CGMP in request.
J060 6.0 µm
Manufacturing, Processing,
J100 10.0 µm Packing or Holding of Drugs
(21CFR210) and CGMP for
J200 20.0 µm finished Pharmaceuticals
J400 40.0 µm (21CFR211.72) including batch
release certificate and full
132 J700 70.0 µm traceability.
Pallcell Air and Gas Filter Cartridges
®
Pallcell filter cartridges for air and gas Features and Benefits
service feature a binder-free pure cellulose
• Absolute (liquid) rated for reliability
filter medium which is pleated with
all-polypropylene hardware into either • Fixed pore structure for consistent
single open-ended (SOE) modular AB style effluent quality
cartridges designed for sanitary-style filter • Low pressure drop
housings, or economical double
open-ended (DOE) modular cartridges • High-capacity for long-life
designed for industrial DOE style housings. • Non-fiber-releasing
Pallcell filters are recommended for
• Resin-free melt-sealed construction
clarification of air and gas feeds and as an
economical prefilter for high-flow • Broad chemical compatibility
fermentation air-sterilizing membrane • Low extractables
cartridges.
• Choice of AB (SOE) sanitary or (DOE)
cartridge styles
• ISO 9000 Certified Quality System
• Manufactured for use in conformance
with cGMP
• FDA-listed materials per 21 CFR
133
Pallcell Air and Gas Filter Cartridges
Technical Specifications
5
0.07
Seals(1)
AB Code 7 Style(3) Single open-end, Double 226 O-ring = 3.4 barg = 6.9 barg
adapter with bayonet lock and (50 psig) inlet (100 psig) inlet
finned end (4)
Typical initial clean medium ∆P per 10 in. (254 mm) element, air at 20 °C
Uni Cap Cartridge Double open-end, male and female (68 °F). For multi-element cartridges, divide pressure drop by number of
end caps and flat gasket seal 10 in. (254 mm) elements. Non-linear cartridge turbulence factors are
incorporated into housing pressure drop values. For complete assembly
(3)
Alternate adapter codes available. pressure drop, add filter cartridge medium value to housing value at
specified flow rate. For gases other than air or nitrogen, contact your
local Pall representative.
Nominal Filter Area per 10 in. (254 mm) Element
Operating Conditions
0.44 m2 (4.7 ft2)
Maximum Differential 5.5 bard (80 psid) at 50 °C (122 °F)
Pressure and Temperature(5)
Nominal Dimensions
AB Style 4.1 bard (60 psid) at 80 °C (176 °F)
Lengths 10 in. (254 mm), 20 in. (508 mm),
30 in. (762 mm), 40 in. (1016 mm) DOE Style 3.1 bard (45 psid) at 82 °C (180 °F)
(5)
In air/N2 service or other compatible gases.
Diameters AB Style:
70 mm (2.75 in.)
DOE Style:
64 mm (2.5 in.)
Ordering Information
AB
PUY
134
LG Liquid and Gas Coalescing Filter Cartridges
Removal of Oil and Water Droplets in Critical Gas Service
135
LG Liquid and Gas Coalescing Filter Cartridges
Technical Specifications
Ordering Information(5)
Part Nominal Length Nominal Configuration, Operating Service
Number Filter Area Adapter and Seal Design Pressure
CC05LGH13 5 in. (127 mm) 0.08 m2 (0.84 ft2) SOE, Internal O-ring Low/High > 17.2 barg (250 psig)
CC1LGA7H13 10 in. (254 mm) 0.26 m2 (2.8 ft2) SOE, Piston O-ring Low > 17.2 barg (250 psig)
CC3LGA7H13 30 in. (762 mm) 0.88 m2 (9.5 ft2) SOE, Piston O-ring Low > 17.2 barg (250 psig)
CC3LGB7H13 30 in. (762 mm) 0.80 m2 (8.6 ft2) SOE, Piston O-ring Low/High > 17.2 barg (250 psig)
CC3LG02H13 30 in. (762 mm) 0.88 m2 (9.5 ft2) DOE, Gasket seals Low/High > 17.2 barg (250 psig)
CS604LGH13 40 in. (1016 mm) 2.60 m2 (28 ft2) SOE, Piston O-ring Low/High > 17.2 barg (250 psig)
(5)
CC05LGH13 replaces PFS4463ZMH13; CC3LGB7H13 is recommended in amine/ammonia gas service. H13 suffix indicates Buna-N O-ring material (standard).
See Appendix for alternate polymers and codes.
Note: For sizing coalescer assemblies or other information, please contact your local Pall representative.
136
Rigimesh Sintered Metal Mesh Filter Cartridges
®
137
Rigimesh Sintered Metal Mesh Filter Cartridges
Technical Specifications
0 0
Nominal Dimensions 0 10 20 30 40
Flow Rate (gpm)
Diameters 64 mm (2.5 in.)
Flow Rate (L/min)
0 25 50 75 100 125 150
Operating Conditions 0.008
RM
RR 5
Maximum Differential Pressure and Temperature(4)
0.002
1
Recommended Maximum Flow Densities(5)
Grade Aqueous Air 0 0
L/min (gal/min) Nm3/hr (acfm) 0 10 20 30 40
Ordering Information
MBS100
Code Nominal Length Filter Area Code Liquid Ratings(7) Gas Ratings(7) Code Gasket Options
1 10 in. (254 mm) 0.9 m (1.0 ft )
2 2
RA 450 µm 350 µm H13 Buna-N gaskets (Standard)
2 20 in. (508 mm) 0.19 m2 (2.0 ft2) RT 225 µm 175 µm H Viton*
3 30 in. (762 mm) 0.28 m2 (3.0 ft2) RS 105 µm 85 µm J Ethylene Propylene
4 40 in. (1016 mm) 0.37 m2 (4.0 ft2) RR 70 µm 55 µm J7 Ethylene Propylene (Steam Service)
RM 45 µm 25 µm Other materials available on request.
* Viton is a registered trademark of DuPont Dow
RJ 25 µm 18 µm (non-FDA materials).
RK 18 µm 13 µm
RZ(8) 15 µm 2 µm
(7)
Liquids: > 99.98% by mod. OSU-F2 test.
Gases: 100% for hard spherical particles.
(8)
Supramesh® (Sintered powdered metal and mesh composite
medium).
138
PSS Porous Metal Filter Cartridges
®
Pall PSS porous metal filter cartridges are Features and Benefits
made from fine stainless steel powders
• All-stainless steel construction
sintered to form rugged high voids and
fixed pore filters with high-temperature, • Controlled and fixed pore size
pressure, and solvent resistance. P Series • PH grade for clean steam
cartridges begin as flat porous sheets
which are shaped and welded into • Up to 2x life of competitive filters
cylindrical elements. S Series cartridges • High pressure and corrosion resistant
are produced in cylindrical form with higher
• Withstands high reverse-flows
voids and narrower pore size distributions
for greater flows at comparable ratings. • High-temperature capabilities
Double open-ended (DOE) style cartridges • Repeatedly cleanable
are standard. They are recommended for
steam service and well suited for liquid or • No soluble polymeric extractables
gas applications including solvents, • No unloading or shedding
chemical intermediates, heat transfer and
• Absolute rated for reliable performance
cryogenic fluids, polymers,
pharmaceuticals, and high-temperature • ISO 9000 Certified Quality System
gases. Single open-ended (SOE) AB • Manufactured for use in conformance
sanitary and threaded styles are also with cGMP
available.
• FDA-listed materials per 21 CFR
139
PSS Porous Metal Filter Cartridges
Technical Specifications
0 5 10 15 20 25 30
End Caps Type 316 stainless steel (1) 3.2
P05 P09 PH
200
Gasket Buna-N (Standard)(2)
Configuration(3) 1.6
100
Double open-ended (DOE), flat gasket seals
(3)
Single open-ended AB sanitary and threaded styles available. PF
0.8 50
Operating Conditions 0 8 16 24 32
3.6
S050 S100
Maximum Differential Pressure(4) 240
Forward and Reverse 3.4 bard (50 psid) to 232 °C (450 °F)
Ordering Information
MBS100
Code Nominal Length Filter Area Code Liquid Ratings(7) Gas Ratings(7) Code Gasket Options
1 10 in. (254 mm) 0.05 m (0.5 ft )
2 2
PD 55 µm 20 µm H13 Buna-N gaskets (Standard)
PE 35 µm 11 µm
2 20 in. (508 mm) 0.09 m2 (1.0 ft2) H Viton*
PF 20 µm 2.8 µm
3 30 in. (762 mm) 0.14 m2 (1.5 ft2) J Ethylene Propylene
PH 13 µm 1.3 µm
J7 Ethylene Propylene (Steam Service)
P09 9 µm 0.8 µm
Other materials available on request.
P05 5 µm 0.4 µm * Viton is a registered trademark of DuPont Dow
S35 35 µm 11 µm (non-FDA materials).
S200 20 µm 2.8 µm
S100 10 µm 0.8 µm
S050 5 µm 0.4 µm
140 (7)
Liquids: > 99.98% by mod. OSU-F2 test.
Gases: 100% for hard spherical particles.
PMM Metal Membrane Filter Cartridges
®
141
PMM Metal Membrane Filter Cartridges
Technical Specifications
0 3 6 9 12 15
End Caps Type 304 stainless steel (1) 0.54
M020 M050 M100 35
Gasket Buna-N (standard)(2) M150
(1)
Other grades and alloys available. 30
(2)
Other polymers available. 0.405
Configuration(3)
20
Double open-ended (DOE), flat gasket seals 0.27
(3)
Single open-ended AB sanitary and threaded styles available. 15
M200
Operating Conditions 0 0
0 1 2 3 4
Maximum Differential Pressure and Temperature(4)
Flow Rate (gpm)
Forward Flow Direction 8.6 bard (125 psid) to 232 °C (450 °F) (6)
Typical initial clean medium ∆P per 10 in. (254 mm) element, water at
Reverse Flow Direction 0.7 bard (10 psid) to 232 °C (450 °F) 20 °C (68 °F), 1 cp. For assistance in sizing and housing selection, contact
your local Pall representative.
(4)
Minimum collapse differential pressure. Limit with Buna-N gaskets: 121 °C (250 °F).
Other gasket materials to 232 °C (450 °F). For Reinforced for 3.4 bard (50 psid)
Reverse Flow option, temperatures to 316 °C (600 °F), or in other alloys to 677 °C
(1250 °F), contact your local Pall distributor.
Ordering Information
MBS100
Code Nominal Length Filter Area Code Liquid Ratings(7) Gas Ratings(7) Code Gasket Options
1 10 in. (254 mm) 0.14 m (1.5 ft )
2 2
M200 20 µm 55 µm H13 Buna-N gaskets (Standard)
2 20 in. (508 mm) 0.28 m2 (3.0 ft2) M150 15 µm 25 µm H Viton*
3 30 in. (762 mm) 0.42 m2 (4.5 ft2) M100 10 µm 18 µm J Ethylene Propylene
4 40 in. (1016 mm) 0.56 m2 (6.0 ft2) M050 5 µm 13 µm J7 Ethylene Propylene (Steam Service)
M020 2 µm 2 µm Other materials available on request.
* Viton is a registered trademark of DuPont Dow
(7)
Liquids: > 99.98% by mod. OSU-F2 test. (non-FDA materials).
Gases: 100% for hard spherical particles.
142
Filter Housings
Filter Housings
TM
Pall has over 35 years of successful • Junior Style and Sealkleen stainless
experience in designing and manufacturing steel filter housings for laboratory use
filter housings for a wide range of applications. and process development
All Pall housings allow optimal product flow at TM
minimal pressure drop to offer users the • Pall Advanta Junior housings for small
advantages of reduced energy costs, safer to medium volume sanitary applications
operation, and the longest possible filter
• Pall Advanta single-round sanitary
service life.
housings with aseptic design and
TM
The Pall Advanta line of sanitary housings is engineered for the filtration of gases and
specially designed for applications in the fluids in today’s manufacturing
pharmaceutical and biotechnology industries. processes
There are no removable tube sheets in these
• Pall Advanta multi-round sanitary
housings, therefore enabling Clean-in-Place
housings for high-flow liquid applications
operation. The housing design is flexible,
providing various inlet and outlet options and TM
• Veladisc filter housings for Supradisc
vent and drain configurations. The number of depth filter modules
welds is minimized to reduce the chances of
residual deposit. The interior and exterior • Junior Style industrial housings for small
surfaces are electro-polished to meet the flow applications
most stringent surface requirements.
• IOL and IDL industrial single cartridge
Pall’s expertise in BioPharmaceutical filtration filter housings
and separation ensures that Advanta
housings meet all GMP requirements. • PCY polypropylene housings for liquid
filtration applications
Supported by the state-of-the-art
TM
manufacturing technology, Pall is the leader in • Megaplast plastic housings that can be
providing the most reliable and technologically utilized safely at high pressures for
advanced filter housings to the industry. In this high-flow rate applications
section, you will find complete product data
for following Pall air/gas and liquid service filter
housings.
144
Junior B series Filter Housings
Small-scale Stainless Steel Housings for High-flow Gas or Liquid Filtration
145
Junior B series Filter Housings
Technical Specifications
Materials of Construction Typical Liquid Flow Rates for Typical Air Flow Rates for
BLS/BTS 7001 Housing* BLS/BTS 7001 Housings*
Housing 316L stainless steel except the
10000 10000
closure ring which is 431 stainless steel
Seal Material Ethylene Propylene
Vessel Closure Closure ring
BLS Housing:
Hose barb 10 10
1 10 100 1 10 100
Design Code Designed and manufactured to Pall Flow Rate (L/min) Flow Rate (Nm3/h)
industrial standards which includes:
a) A minimum design capability of * 1 bar = 14.5 psi, 1 Nm3/h = 0.59 scfm
5 x maximum operating pressure
b) Hydrostatically testing each unit to
at least 1.5 x maximum operating Nominal Dimensions
pressure
BLS7001G23J BLS7001G22J BTS7001G23J
* Stäubli is a registered trademark of Stäubli AG.
Dimension A 121 mm 218 mm 218 mm
(4.76 in.) (8.6 in.) (8.6 in.)
Operating Conditions Dimension B 64 mm 64 mm 64 mm
Maximum Operating -1(1) to 10 barg (2.52 in.) (2.52 in.) (2.52 in.)
Pressure (-14.5(1) to 150 psig) Dimension C 75 mm 75 mm 75 mm
Maximum Operating and 140 °C (284 °F) (2.95 in.) (2.95 in.) (2.95 in.)
Steaming Temperature Dimension D 49 mm 49 mm 49 mm
(1)
Full vacuum. (1.93 in.) (1.93 in.) (1.93 in.)
Use with Steam: This housing may be steam-sterilized and used for steam filtration up Dimension E – 66 mm 66 mm
to a temperature of 140 °C (284 °F). Operating limits for steam service may be (2.60 in.) (2.60 in.)
influenced by filter cartridge specifications. Refer to appropriate literature for Pall filter
cartridges. Weight 1.3 kg 1.3 kg 1.3 kg
(2.87 lbs) (2.87 lbs) (2.87 lbs)
B S7001G J B E
146
Sealkleen™ Filter Housings
Versatile In-line Filter Housings for Small-scale Production
147
Sealkleen Filter Housings
Technical Specifications
External:
Ra ≤ 0.8 µm (≤ 32 µin.) (typical) 150 2.0
Documentation Certificate type 2.3 to EN10204
100
1
Operating Conditions 50
G23L
Maximum Operating -1 to 10 barg
(1)
Temperature
(1)
Full vacuum. Typical Water Flow Rates
Flow (gal/min)
Nominal Dimensions 0 1 2 3 4 5
200
Part Number A(2)
B C
(3)
Weight Volume GNW15 and G10
ZLK702G23LHKH4 202 mm 63.5 mm 135 mm 1.1 kg 0.5 L 2.5
Differential Pressure (mbar)
Overall Height
connections including clamp and
silicone gasket A
ACS0272EU Silicone housing gasket
Ordering Information
Applications
Series AGT ALI ALT AVL
Applications Air and Gas Air and Gas, Air and Gas, Air and Gas,
Liquid Liquid Liquid
Specification
Maximum Operating Pressure -1 to 10 barg (-14.5* to 150** psig)
Materials of Construction
All Product Wetted Parts AISI 316L
V-Clamp AISI 316L, Nitronic 60
Seals Silicone elastomer
Surface Finish All electropolished
Internal: Ra ≤ 0.4 µm (≤ 15 µin.) (typical)
External: Ra ≤ 0.8 µm (≤ 32 µin.) (typical)
High quality sanitary T-style housings for general purpose small-scale Typical Air Flow Rates(4)
gas filtration. Flow Rate (Nm3/h)
0 20 40 60 80 100 120 140 160
Features of this housing range for use in sanitary gas applications are 4.4 300
A B
• A: Vent
high quality electropolished internal surfaces, a design optimized for • B: 1 barg (15 psig)
• C: 2 barg (29 psig)
CIP/SIP requirements, design variants for easy automation, as well as • D: 3 barg (44 psig) C
convenient filter integrity testing with the Water Intrusion Test method
Ordering Information
Code Design Code Inlet and Outlet Code Vent Code Drain
– To European Pressure 05 For 3⁄4 in. sanitary flange D For 1⁄2 in. sanitary flange D For 1⁄2 in. sanitary flange
Equipment Directive to ISO 2852 to ISO 2852 to ISO 2852
D To European Pressure 23 For 1 in. sanitary flange E Butt weld H Sanitary valve with
Equipment Directive with to ISO 2852 13.5 x 1.6 mm to ISO 1127 quick release fitting for
enhanced documentation Stäubli couplings
including 3.1b stamped NW15 Dairy fitting NW15 to H Sanitary valve with
material and certification DIN11851 quick release fitting for K Sanitary valve with
Stäubli* couplings hose barb for 6 mm
B21 Butt weld 21.3 x 1.6 mm (1⁄4 in.) i.D. tubing
to ISO1127 N No vent
E Butt weld 13.5 x
Gasket material silicone, other gasket
(5)
1.6 mm to ISO 1127
materials available on request.
Please contact Pall. N No drain
* Stäubli is a trademark of Stäubli AG.
150
Pall Advanta Junior F Liquid Filter Housings
Technical Specifications
High quality versatile sanitary T-style housings for all small-scale gas Typical Water Flow Rates(3)
filtration.
Typical Water Flow Rate (gpm)
Features of this housing range are high quality electropolished internal 0 5 10 15 20
500 7
surfaces, a design optimized for CIP/SIP requirements, design
variants for easy automation, as well as convenient filter integrity
6
testing. 400
• Cartridge retained by built-in flanges and double O-ring seal Typical Water Flow Rate (L/min)
Nominal Dimensions
Part Number(1) Face to Face Overall(2) Clearance Main Accessories and Spares
Width Height Required Part Number Description
ALT440G05HKH4 151 mm 314 mm 112 mm ACS0598CM Diaphragm valve for 1⁄2 in. sanitary clamp
ALT44GNN15HKH4 (5.9 in.) (12.4 in.) (4.4 in.) compatible connections to ISO 2852
ALT440GA15HKH4 including clamp and silicone gasket
ALT440GB21HKH4
ALT440G23HKH4 ORH4P-150 Silicone housing closure gasket
ACS0718EU Housing valve gasket kit
ALT440G05DDH4 151 mm 227 mm 112 mm
(5.9 in.) (8.9 in.) (4.4 in.) ACS0224DA V Clamp housing closure
(1)
MCY2220 and MCY1110 variants may be possible, refer to Pall. Further spares and accessories available upon request.
(2)
For MCY4440 filters, where smaller filter elements are used, please consult for nominal
length information.
Ordering Information
Code Design Code Inlet and Outlet Code Vent Code Drain
– To sound engineering 05 For 3⁄4 in. sanitary D For 1⁄2 in. Tri-Clamp* D For 1⁄2 in. sanitary
practice clamp to ISO 2852 to ISO 2852 clamp to ISO 2852
D To sound engineering 23 For 1 in. sanitary H Sanitary valve with K Sanitary valve with
practice with enhanced clamp to ISO 2852 quick release fitting for hose barb for 6 mm
documentation including Stäubli* couplings (1⁄4 in.) i.D. tubing
3.1b stamped material A15 Aseptic thread connections
and certification to DIN11864-1 * Gasket material silicone, other gasket
materials available on request.
NW15 Dairy fitting NW15 to Please contact Pall.
DIN11851 * Stäubli is a trademark of Stäubli AG.
151
Pall Advanta Junior F Gas Filter Housings
Technical Specifications
Versatile high quality sanitary T-style housings for all small-scale gas Typical Air Flow Rates(4)
filtration. Flow Rate (Nm3/h)
0 20 40 60 80 100 120 140 160
Features of this housing range for use in sanitary gas applications are 4.4 300
A B
• A: Vent
high quality electropolished internal surfaces, a design optimized for • B: 1 barg (15 psig)
• C: 2 barg (29 psig)
CIP/SIP requirements, design variants for easy automation, as well as • D: 3 barg (44 psig) C
convenient filter integrity testing with the Water Intrusion Test method
Ordering Information
Code Design Code Inlet and Outlet Code Vent Code Drain
– To sound engineering 05 For 3⁄4 in. sanitary flange D For 1⁄2 in. sanitary flange D For 1⁄2 in. sanitary flange
practice to ISO 2852 to ISO 2852 to ISO 2852
D To sound engineering 23 For 1 in. sanitary flange E Butt weld H Sanitary valve with
practice with enhanced to ISO 2852 13.5 x 1.6 mm to ISO 1127 quick release fitting for
documentation including Stäubli couplings
3.1b stamped material A15 Aseptic thread connections H Sanitary valve with
and certification to DIN11864-1 quick release fitting for K Sanitary valve with
Stäubli* couplings hose barb for 6 mm
NW15 Dairy fitting NW15 to (1⁄4 in.) i.D. tubing
DIN11851 N No vent
E Butt weld 13.5 x
B21 Butt weld 21.3 x 1.6 mm * Stäubli is a trademark of Stäubli AG.
1.6 mm to ISO 1127
to ISO1127
N No drain
(5)
Gasket material silicone, other gasket
materials available on request. Please
152 contact Pall.
Pall Advanta™ ALT Liquid Filter Housings
Advanced Sanitary T-Style Filter Housings for Liquid Applications
153
Pall Advanta ALT Liquid Filter Housings
Technical Specifications
External: 150
Ra ≤ 0.8 µm (≤ 32 µin.) (typical) 2
0 0
Nominal Dimensions 0 10 20 30 40 50 60 70 80 90 100
Part Number(2) Face to Face Overall Clearance Flow Rate (L/min)
Width Height Required (3)
The flow and pressure drop characteristics refer to the empty housing only
for water at 20 °C (68 °F). For other liquids multiply pressure drop by relative
ALT105G23CBH4 190 mm 378 mm 160 mm density. To obtain the total pressure drop of a complete filter assembly, the
(7.4 in.) (14.8 in.) (6.2 in.) cartridge pressure drop must be added. Please refer to the relevant filter
cartridge literature or contact Pall.
ALT11G23CBH4 190 mm 514 mm 320 mm
ALT11GNW25CBH4 (7.4 in.) (20.2 in.) (12.5 in.)
Ordering Information
ALT 1 G H4(6)
Code Design Code Cartridge Type Code Inlet and Outlet Code Vent Code Drain
– To European Pressure 05 AB05 code 2 23 1 in. sanitary A Sanitary valve B Sanitary valve with
Equipment Directive flange to ISO 2852 fitting for Stäubli hosebarb
1 AB1 code 7 type couplings
D To European Pressure NW25 Dairy fitting NW 25 D ⁄2 in. sanitary flange
1
2 AB2 code 7
Equipment Directive to DIN 11851 C 111⁄2 in. sanitary flange connection to
with enhanced 3 AB3 code 7 connection to ISO 2852
documentation A25 Aseptic thread ISO 2852 with side
connection N No drain
including 3.1b sanitary valve with
stamped material and NW 25 to quick release fitting (6)
Silicone elastomer seal material.
certification DIN 11864-1 for Stäubli type other materials available upon
request.
95 ISO butt weld couplings
33.7 x 2.0 mm D 11⁄2 in. sanitary flange
to ISO 1127 compatible with
side sanitary valve
with fitting for
Stäubli type
couplings
155
Pall Advanta In-Line Liquid and Gas Filter Housings
Technical Specifications
Operating Conditions
0 0
0 10 20 30 40 50 60 70 80 90 100
Maximum Operating -1(1) to 10 barg
Pressure (-14.5(1) to 150(2) psig) Flow Rate (Nm3/h)
Ordering Information
ALI 1 G H4(4)
Code Design Code Filter Height Code Inlet and Outlet Code Vent Code Drain
– To European Pressure 05 AB05 code 2 23L 1 in. Tri-clamp* A Sanitary valve A Sanitary valve
Equipment Directive fittings to ISO2852 coupling to coupling to Stäubli
1 AB1 code 7 Stäubli** type type RBE.03
D To European Pressure 94 33.7 mm (1.33 in.) RBE.03
2 AB2 code 7
Equipment Directive O.D x 2.0 mm B Sanitary valve with
with enhanced 3 AB3 code 7 (0.079 in.) wall butt D ⁄2 in. sanitary
1
hosetail for 6 mm
documentation weld to ISO 1127 flange connection (1⁄4 in.) ID tubing
including 3.1b to ISO 2852
* Tri-Clamp is a trademark of D ⁄2 in. sanitary flange
1
stamped material and
Alfa-Laval, Inc. ** Stäubli is a trademark of connection to
certification
Stäubli AG. ISO 2852
(4)
Gasket material — silicone, other
gasket materials available on
request. Please contact Pall.
156
Pall Advanta™ Jacketed Housings
T-Style and In-Line Housings with Jacket for Temperature Control
157
Pall Advanta Jacketed Housings
Technical Specifications
Number of Cartridges 1
40
Cartridge Style AB Code 7 0.5
Inlet and Outlet Connections 11⁄2 in Sanitary coupling 30
Jacket:
20
1
⁄2 in. NPT 0.25
ALI:
None
Closure Style Vee-band clamp
Flow Configuration ALT:
Tee
ALI:
In-Line
Operating Conditions
Maximum Operating -1(1) to 10 barg
Pressure (-14.5(1) to 150(2) psig)
Ordering Information
ALT1 J23 H4
ALI1 J23L H4
158
Pall Advanta™ AGT Gas Filter Housings
Advanced T-style Housings for Sanitary Applications
This range of Pall filter housings has been Features and Benefits
specifically designed and engineered for
• Crevice-free internal surface finish of
the filtration of air and gases. The design
≤ 0.4 µm (≤ 15 µin.) Ra is ideal for all
complements the high-flow capacities of
sanitary applications
the Pall Emflon range of sterilizing gas filter
cartridges to ensure reliable and cost • Designed for in-line steaming and
efficient filtration. integrity testing with Water Intrusion and
Forward Flow
These advanced gas filter housings are
from the Pall Advanta range of housings. • Non-rotation valve connections for easy
Manufactured from 316L stainless steel, condensate draining
Pall Advanta housings are engineered to • Optional vent valve with integrated
meet the requirements of the Stäubli* compatible connector for easy
BioPharmaceutical industry. Advanced connection to Palltronic test equipment
manufacturing technologies are used to
construct a robust housing, incorporating a • Low dynamic pressure drop to assist in
high degree of automated orbital welding. energy conservation
ACS0457FA Pressure gauge kit -1 to 10 barg for 11⁄2 in. sanitary clamp connection
to ISO 2852 (includes clamp and gasket)
Contact your Pall representative or local representative for other spares and accessories.
159
Pall Advanta AGT Gas Filter Housings
Technical Specifications
0
Operating Conditions
0 100 200 300 400 500
Maximum Operating -1 to 10 barg
Pressure (-14.5(1) to 150(2) psig) Flow Rate (Nm3/hour)
Vent mode 2 barg inlet 4 barg inlet
Maximum Operating 150 °C (300 °F) (29 psi) (58 psi)
Temperature NW25
(1)
Full vacuum. NW50
(2)
With compatible fluids, which do not soften, swell or adversely affect the materials. (3)
The flow pressure drop characteristics refer to empty housings only for air at
20 °C (68 °F). To obtain the pressure drop of a complete assembly, the cartridge
pressure drop must be added. 1 Nm3/h = 0.59 scfm.
Nominal Dimensions
Part Number Face to Face Width Overall Height Clearance Required Weight Volume
AGT105G94EEH4 240 mm 9.4 in. 345 mm 13.6 in. 180 mm 7.08 in. 2.5 kg 5.5 lbs 1.5 L
AGT11G95EEH4 240 mm 9.4 in. 528 mm 20.7 in. 340 mm 13.3 in. 3.6 kg 7.9 lbs 3.0 L
AGT12G95EEH4 240 mm 9.4 in. 779 mm 30.6 in. 590 mm 23.3 in. 4.4 kg 9.6 lbs 4.6 L
AGT13G95EEH4 240 mm 9.4 in. 1054 mm 41.4 in. 840 mm 33.0 in. 5.3 kg 11.6 lbs 6.2 L
AGT105GNW25ABH4 190 mm 7.4 in. 431 mm 16.9 in. 180 mm 7.08 in. 2.5 kg 5.5 lbs 1.5 L
AGT11GNW50ABH4 190 mm 7.4 in. 591 mm 23.2 in. 340 mm 13.3 in. 3.6 kg 7.9 lbs 3.0 L
AGT12GNW50ABH4 190 mm 7.4 in. 842 mm 33.1 in. 590 mm 23.2 in. 4.4 kg 9.7 lbs 4.6 L
AGT13GNW50ABH4 190 mm 7.4 in. 1117 mm 43.9 in. 840 mm 33.0 in. 5.3 kg 11.6 lbs 6.2 L
AGT105G23ABH4 190 mm 7.4 in. 431 mm 16.9 in. 180 mm 7.08 in. 2.5 kg 5.5 lbs 1.5 L
AGT11G31ABH4 190 mm 7.4 in. 591 mm 23.2 in. 340 mm 13.3 in. 3.6 kg 7.9 lbs 3.0 L
AGT12G31ABH4 190 mm 7.4 in. 842 mm 33.1 in. 590 mm 23.2 in. 4.4 kg 9.7 lbs 4.6 L
AGT13G31ABH4 190 mm 7.4 in. 1117 mm 43.9 in. 840 mm 33.0 in. 5.3 kg 11.6 lbs 6.2 L
AGT105G23CDH4 190 mm 7.4 in. 365 mm 14.3 in. 180 mm 7.08 in. 2.5 kg 5.5 lbs 1.5 L
AGT11G31CDH4 190 mm 7.4 in. 521 mm 20.5 in. 340 mm 13.3 in. 3.6 kg 7.9 lbs 3.0 L
AGT12G31CDH4 190 mm 7.4 in. 776 mm 30.5 in. 590 mm 23.3 in. 4.4 kg 9.7 lbs 4.6 L
AGT13G31CDH4 190 mm 7.4 in. 1051 mm 41.3 in. 840 mm 33.0 in. 5.3 kg 11.6 lbs 6.2 L
Ordering Information
AGT 1 G H4(4)
Code Design Code Cartridge Type Code Inlet and Outlet Code Vent Code Drain
– To European Pressure 05 AB05/AB02 23 1 in. sanitary flange A Sanitary valve with A Sanitary valve with
Equipment Directive Code 2 to ISO 2852 fitting for Stäubli fitting for Stäubli*
D To European Pressure 1 AB1 Code 7 NW25 NW25 to DIN 11851 type couplings couplings
Equipment Directive 2 AB2 Code 7 94 ISO butt weld B Sanitary hose barb B Sanitary hose barb
with enhanced 33.7 x 2.0 mm to valve for 8 mm valve for 8 mm i.D.
documentation 3 AB3 Code 7 i.D. tubing tubing
ISO 1127
including 3.1b C 1 in. sanitary flange D ⁄2 in. sanitary flange
1
Pall Advanta AVL series filter housings are Features and Benefits
L-flow pattern (in the side, out the bottom)
• Convenient L-flow pattern facilitates
sanitary stainless steel housings. They
piping and solves many head-space
accommodate one single open-ended
limitations
Code 7 filter cartridge of 5, 10, 20, or 30
inches (127 mm, 254 mm, 508 mm or • Low-point drain facilitates drainage of
762 mm) nominal length. The Pall Advanta steam-condensate, product or CIP
AVL series housings are used for either gas fluids
or liquid applications, and are designed to • Crevice-free internal surface finish of
meet the stringent requirements of the ≤ 0.4 µm (≤ 15 µin.) Ra is ideal for
BioPharmaceutical industry. These sanitary applications
housings are commonly used for venting
applications because of their convenient • Purpose-design enables inline
flow pattern and low pressure-loss. steaming and integrity testing (by water
intrusion — WIT — and forward flow)
• CE marking shows design-review to
European Pressure Equipment Directive
97/23/EC (housings with volumes
> 2.5 L)
• Every housing supplied with a quality
certificate and manufactured to ATEX
Directive 94/9/EC (Group ll Category 2)
• Variety of connection-styles, vents and
drains offers choice and convenience
161
Pall Advanta AVL Liquid and Gas Filter Housings
Technical Specifications
Ordering Information
AVL 1 G
Code Design Code Cartridge Code Inlet and Code Vent Code Drain Code Seal
Type Outlet Material(5)
– To European 05 AB05 23L For 11⁄2 in. A Quick-connect and A Quick-connect and H4 FDA-
Pressure code 2 sanitary disconnect male disconnect male listed
Equipment 1 AB1 code 7 flange to connector connector Silicone
Directive ISO2852 (compatible with (compatible with
2 AB2 code 7 Stäubli* coupling) Stäubli* coupling) Other elastomer
(5)
The Pall Advanta filter housings have been Features and Benefits
specifically designed and engineered for
• Aseptic design
today’s manufacturing processes. These
advanced housings are manufactured from ◆ Crevice-free electropolished surfaces
316L stainless steel and are engineered to with an internal Ra value of ≤ 0.4 µm
meet the requirements of the (≤ 15 µin.)
BioPharmaceutical industry. ◆ Fully self draining
State-of-the-art manufacturing
technologies are used to construct a ◆ No dead legs
housing ideal for the most critical of • Low hold-up volumes for maximum
applications. product recovery
This multi-round version of the Pall • Quick fit Stäubli-type* connections for
Advanta housing range is designed to easy filter integrity testing
allow up to four filter elements in parallel
• Easy to use low-point sanitary drain
arrangement.
valve
During the design process, critical features
• Range of options to aid use in
were optimized to ensure trouble-free use
automated production systems
and low installation and maintenance
costs. Areas included in this process were: • Options available for use with CIP spray
cleaning device
• Surface finish
• Every housing supplied with a quality
• Suitability for CIP and SIP
certificate and manufactured to ATEX
• Integrity testing Directive 94/9/EC (Group ll Category 2)
• Incorporation into automated • Design variants to ASME and European
production processes Pressure Equipment Directive, CE
marking available
* Stäubli is a trademark of Stäubli AG.
163
Pall Advanta ALT4 Multi-round Housings
Technical Specifications
External: 6
400
Ra ≤ 0.8 µm (≤ 32 µin.) (typical)
Inspection Documentation Certificate type 2.3 to EN10204 300
4
* Nitronic is a registered trademark of Armco, Inc.
200
Operating Conditions 2
100
Maximum Operating -1 to 10 barg
Pressure (-14.5(1) to 150 psig)
0 0
Maximum Operating and 150 °C (300 °F) 0 100 200 300 400 500
Steaming Temperature Flow Rate (L/min)
(1)
Full vacuum.
(2)
The flow and pressure drop characteristics refer to the empty housing only
for water at 20 °C (68 °F). For other liquids multiply pressure drop by relative
density. To obtain the total pressure drop of a complete filter assembly, the
cartridge pressure drop must be added. Please refer to the relevant filter
Nominal Dimensions cartridge literature or contact Pall.
Part Number Width Overall Clearance
(Face to Face) Height Required
ALT41G31ABH4 319 mm 528.5 mm 310 mm Main Accessories and Spares
(12.6 in.) (20.8 in.) (12.2 in.)
Part Number Description
ALT41G31CBH4 319 mm 486.5 mm 310 mm
ALT41G31CDH4 (12.6 in.) (19.2 in.) (12.2 in.) ACS0598CM Diaphragm valve for 1⁄2 in. sanitary flange
compatible connections including clamp
ALT41G31DDH4 319 mm 476.5 mm 310 mm and silicone gasket
(12.6 in.) (18.8 in.) (12.2 in.)
ACS0457FA Pressure gauge kit -1 to 10 barg for
ALT41GNW50ABH4 319 mm 528.5 mm 310 mm 11⁄2 in. sanitary flange connection to
ALT41GA50ABH4 (12.6 in.) (20.8 in.) (12.2 in.) ISO 2852 (includes clamp and gasket)
ALT41G95ABH4 368 mm 528.5 mm 310 mm ORH4P-676 Silicone housing closure gasket
(14.5 in.) (20.8 in.) (12.2 in.)
ACS0602EM Silicone housing valve gasket kit
ALT42G31ABH4 319 mm 777.5 mm 564 mm
(12.6 in.) (30.6 in.) (22.2 in.) LY00381 Valve knob cap
ALT43G31ABH4 319 mm 1025.4 mm 818 mm CC41608CC00 Valve stem
(12.6 in.) (40.4 in.) (32.2 in.)
ACS0364DA V-clamp housing closure
ALTA41G31ABH4 373 mm 526 mm 310 mm
ALTA41G31CBH4 (14.7 in.) (20.7 in.) (12.2 in.) ACS0814AS CIP Spray Device
ALTA41G31CDH4 * Further spares and accessories available upon request.
ALTA41G31DDH4 373 mm 487 mm 310 mm
(14.7 in.) (19.2 in.) (12.2 in.)
Ordering Information
ALT 4 G H4
Code Design Code Cartridge Code Inlet and Outlet Code Vent Code Drain
Type
– To European 05 AB05 code 2 G31 50 mm (2 in.) OD A Sanitary valve with B Sanitary valve with
Pressure Equipment tubing with sanitary quick release fitting for hosebarb for 8 mm
Directive 1 AB1 code 7 flange to ISO 2852 Stäubli* type couplings ID tubing
A To ASME Code 2 AB2 code 7 GNW50 Dairy fitting NW50 C For 11⁄2 in. sanitary flange D For 1⁄2 in. sanitary
D To European to DIN 11851 connection to ISO 2852 flange connection
3 AB3 code 7 with side sanitary valve
Pressure Equipment GA50 Aseptic thread N No drain
Directive with 4 AB4 code 7 connection NW50 with quick release fitting
enhanced to DIN 11864-1 for Stäubli* type couplings Wall thickness as specified in
(3)
ISO1127.
documentation G95 Butt weld D For 1⁄2 in. sanitary flange * Stäubli is a trademark of
including 3.1b 60.3 x 2.3 mm(3) E Butt weld 13.5 x 1.6 mm(3) Stäubli AG.
stamped material
and certification G34 50 mm (2 in.) S For 11⁄2 in. sanitary flange
NB SCH10 connection to ISO 2852
with side connection for
1
⁄2 in. sanitary flange
164 N No vent
Veladisc™ Depth Filter Module Housings
Filter Housings for Supradisc™ Depth Filter Modules
165
Veladisc Depth Filter Module Housings
Technical Specifications
Inlet and Outlet Connections 300 mm (12 in.) Housing: P12-01 768 mm 464 mm 330 mm
11⁄2 in. sanitary flange (30.25 in.) (18.25 in.) (13 in.)
Dome Vent 11⁄2 in. sanitary flange on P12-04 1683 mm 1378 mm 1270 mm
300 mm (12 in.) and 400 mm (16 in.) (66.25 in.) (54.25 in.) (50 in.)
Ordering Information
Code Application Code Nominal Code Number of Code Closing Code Adapter
Module Diameter Modules System Style
P Pharmaceutical 284 300 mm (12 in.) 00 Half Height C V-band clamp 00 Flat gasket
Module 300 mm (12 in.)
410 400 mm (16 in.) 88 Double O-ring
01 1 Module H Rathmann Clamp
closure
02 2 Modules
03 3 Modules Bolt closure
400 mm (16 in.)
04 4 Modules (Standard)
300 mm (12 in.)
(Engineered Option)
166
Pall Advanta™ Electrical Trace Heater
For Enhanced Temperature Control
Materials of Construction
Housing 316L Stainless Steel
Standard Gasket Silicone
O-ring Material
Other Specifications
Number of Elements Around 1
Number of Elements High 1
Cartridge Style 4463
Legs and Support None
Vent 3 mm (1⁄8 in) NPT
Ordering Information Drain 6 mm (1⁄4 in.) NPT
Closure Style Vee band clamp
MDS4463 MFH4
ASME Code No
Code Inlet and Outlet Connections Flow Configuration Tee
N4 6 mm (1⁄4 in.) NPT Replaceable Tube Sheet No
N8 13 mm ( ⁄2 in.) NPT
1
Davitor No
168
IOL and IDL Single-round Industrial Housings
Pall IOL and IDL Single-round Housings IDL Style - Features and Benefits
are constructed of stainless steel and are
• Single cartridge housings accepts
designed for industrial applications (such
Double open-end, RF and MCY 1000
as filtration of fluids in utilities areas).
Style Filters
• Quick opening T-Handle V-Band Clamp • Variety of Inlet and Outlet sizes and
facilitates Filter Change Out O-ring Seal Options Offered
• Wide Choice of Inlet and Outlet sizes • Optional Mounting Brackets available
and O-ring Seal options
Top: IOL Series Filter Housing
Bottom: IDL Series Filter Housing • Passivated for purity.
Ordering Information
IOL G
Code Cartridge Style Code Nominal Cartridge Code Inlet and Outlet Vent and Drain Code Seal Materials
Length
3 Code 3 05 5 in. (127 mm) N12 19 mm (3⁄4 in.) NPT 6 mm (0.25 in.) NPT H Viton A
7 Code 5 1 10 in. (254 mm) N16 25 mm (1 in.) NPT 6 mm (0.25 in.) NPT H1 FEP Encapsulated
8 Code 8 2 20 in. (508 mm) B12 19 mm (3⁄4 in.) BSPT 6 mm (0.25 in.) BSPT Viton A
18 Code 18 3 30 in. (762 mm) B16 25 mm (1 in.) BSPT 6 mm (0.25 in.) BSPT H4 Silicone
IDL G
Code Cartridge Code Nominal Cartridge Code Inlet and Outlet, Code Housing Options Code Seal Materials
Style Length Vent and Drain
D DOE/RF V-band 04 4 in. (102 mm) See above IOL Style table – Blank See above IOL Style table
1 MCY 1001 V-band 1 10 in. (254 mm) C2 Passivated
T DOE/RF 2 20 in. (508 mm) C9 Clean for
Through Bolt 3 30 in. (762 mm) Oxygen Service
170
PCY Polypropylene Filter Housings
171
PCY Polypropylene Filter Housings
Technical Specifications
Nominal Dimensions
Length PCY1 Housing:
440 mm (17.3 in.)
10
PCY2 Housing: 10 50 100
688 mm (27 in.) Flow Rate (L/min) (log scale)
Diameter Both Styles: = RF/RMF and = AB Code 7 and
147 mm (5.7 in.) MCY 1000 styles Code 3 styles
ACS0067AY X Option
ACS0182AY Y Option
Ordering Information
PCY G
Code Cartridge Nominal Code Inlet and Outlet Code Seal Material Code Vent and Drain
Style Length
1001 DOE MCY1000 10 in. (254 mm) 16 25 mm (1 in.) BSPT H13 Nitrile – No tappings
H FDA approved Viton Y Head and bowl tapped
1002 DOE MCY1000 20 in. (508 mm) 19 25 mm (1 in.) BSP
HB General purpose Viton 6 mm (0.25 in.) BSPT
1RF DOE RF/RMF 10 in. (254 mm) (female with plug)
2RF DOE RF/RMF 20 in. (508 mm)
X Head and bowl tapped
13 SOE AB code 3 10 in. (254 mm) 6 mm (0.25 in.) BSP
(female with plug)
23 SOE AB code 3 20 in. (508 mm)
17 SOE AB code 7 10 in. (254 mm)
27 SOE AB code 7 20 in. (508 mm)
172
Megaplast™ Plastic Filter Housings
Pall Megaplast housings are manufactured The housings accommodate either one Pall
from PFA (Perfluoroalkoxy), PVDF AB Code 3 style filter cartridge which
(Polyvinylidenedifluoride) or polypropylene. features a high security double O-ring
This range represents a significant advance sealing mechanism, or the RF style
in filter housing design. The housings are Profile II filter cartridge which employs a
crevice-free and can be used at high knife edge seal, tie-rod and seal nut. PVDF
pressures (with suitable safety measure housings are available in two lengths to
implemented), and their filter cartridges can accommmodate either 10 in. (254 mm) or
be installed and changed quickly and 20 in. (504 mm) nominal length filter
easily. cartridges. PFA and natural polypropylene
housings are designed to use one 10 in.
As a result of computer-aided design and
(254 mm) nominal length filter.
high technology plastic molding
techniques, Megaplast housings can be
used for high flow-rate applications with Features and Benefits
very low corresponding pressure drops. • Three part construction (head, collar
All fluid contact surfaces are molded rather and bowl)
than machined, to provide very smooth • DIN outlet and inlet connections (natural
surfaces with a high level of particulate polypropylene and PVDF housings only)
cleanliness when compared with other
currently available plastic filter housings. • 6 mm (1⁄4 in.) butt weld inlet and outlet
connections (PFA housings only)
Easy to use, Megaplast housings are
constructed from three parts – head, • Threads not wetted by process fluid
bowl,and collar. The screw-threaded • All product wetted surfaces are molded
closure provides a positive and effective (not machined), providing a very
seal, and is not wetted by the fluid being smooth, high quality surface finish
filtered (i.e., no potential contaminant are
• Constructed from PFA, PVDF or natural
traps introduced), and the design avoids
polypropylene
unnecessary stress being placed on the
internal closure O-ring. The coarse collar • AB Code 3 fitting molded into head
thread allows quick one-handed operation, design
without thread galling. • Plug-in element secured in position by
Easy to install, the inlet and outlet bowl
connections are either non-wetted • Mounting bracket is part of the head
international standard DIN, or butt weld. molding (PFA housings), or can be fitted
DIN connections enable the housing to be (PVDF and natural polypropylene
fitted to or removed from pipework housings)
systems without disturbing existing
• Choice of Pall AB Code 3 or RF style
pipework. Megaplast housings also
filter cartridges
incorporate a 6 mm (1⁄4 in.) BSP parallel
female vent and drain port as part of the
bowl, complete with plug and seal. seal
protected non-wetted threads eliminate
potential sources of contamination.
173
Megaplast Plastic Filter Housings
Technical Specifications
PFA Housings:
6 mm (1⁄4 in.) butt weld(1) 10
Head:
1
Polyproylene — supplied blank 1 10 100 1000
PVDF — supplied blank or 6 mm (1⁄4 in.)
Flow Rate (L/min)
BSP parallel female
PFA — 6 mm (1⁄4 in.) BSP parallel female = TAAC = TRX = TAX/TAV
A 18 mm (3⁄4 in.) Flaretek* inlet and outlet connection option is also available.
(1)
Chemical(2):
Not suitable for use above 40 °C (104 °F).
PVDF Water:
(TAVW housing) 10 barg (145 psig) at temperatures up to 40 °C (104 °F). 7.5 barg (108 psig) at temperatures between 40 °C (104 °F)
and 80 °C (176 °F). Not suitable for use above 80 °C (176 °F)
Chemicals:
(TAVC housings) 3.5 barg (50.7 psig) at temperatures up to 40 °C (104 °F). Not suitable for use above 40 °C (104 °F).
PVA Water:
Not applicable
Chemical:
5.6 barg (81 psig) at temperatures up to 30 °C (86 °F) 2.8 barg (40.6 psig) at temperatures between 30 °C (86 °F) and 95 °C (203 °F).
Not suitable for use above 95 °C (203 °F).
(2)
Compatible chemicals are defined as those which do not soften, swell or attack any of the housing components.
Ordering Information
T 01 G
Code Cartridge Code Housing Code Application Code Nominal Code Inlet and
Style Material Cartridge Length Outlet
A AB Code 3 A* PFA C Compatible 1 10 in. (254 mm) 26 Din 25 to
R RF Style V* PVDF chemicals 2 20 in. (508 mm) DIN 8063
W Water part 3 (male)(3)
X Polypropylene
53 6 mm (1⁄4 in.)
* Only available in AB1 code 3. Butt weld(4)
TM
Pall offers the most comprehensive selection Membralox Ceramic Modules
of tangential flow filtration platforms to meet
the increasing diversity of biological and Ceramics are the preferred choice when
biopharmaceutical processes and operating conditions are outside the limits
applications. tolerable by plastics due to extremes of
temperature, or chemical compatibility. In
These platforms are: many high solids applications, such as natural
extracts, the ability to clean ceramics with
Membrane Cassettes and Hardware harsh cleaning agents can give required
Ultrafiltration: Pall membrane cassettes and process cost advantages.
their associated hardware and systems are TM
Pallsep Vibrating Membrane Filters
the preferred choice in applications that
require gentle processing and precise tailoring Pallsep membrane filters are an enabling
of membrane characteristics to the technology for difficult processes where the
application. Predominant use is biotechnology security of a polymeric barrier process is
and biologicals for labile molecules. required, but where feed materials are very
high in complex mixtures of biomolecules and
Microfiltration: Open channel cassettes or viscosities may be elevated. Examples are
cassettes with suspended screens can be direct processing of mycelial fermentation
used in batch applications for the harvesting broths without pretreatment, recovery of cell
of bacterial, mammalian, or insect cells. wall fractions from chemically lysed
Microza Hollow Fiber Modules recombinant bacterial systems used to
produce vaccines.
Ultrafiltration: Hollow fibers are the preferred
choice for larger volume processes with more Plate and Frame Sheet Membranes
robust molecules such as enzymes,and for
clarification of materials where small molecules Bulk processes in the manufacturing of APIs
such as antibiotics are the target. Also the often require extensive membrane areas of
choice for both pure water applications, and predominantly ultrafiltration membrane. Pall
raw water treatment. membranes are available to retrofit most
pre-existing systems.
Microfiltration: Simple flow geometry and
steam sterilizability make hollow fibers an
excellent option for culture techniques such as
perfusion culture.
176
Tangential Flow Filtration Technology
Pall has many years of experience in TFF is utilized to perform various steps on
the design and manufacturing of a wide range of applications in the
state-of-the-art systems. We work closely biopharmaceutical industry. Examples of a
with our clients to evaluate and supply the few typical applications are listed below:
best technical solution for each application
• Concentrate and desalt solutions of
using proven features, designs and
proteins,peptides and oligonucleotides
engineering know-how.
• Purify and recover antibodies or
For TFF applications, systems can be
recombinant proteins from cell culture
designed to automatically perform all
media
phases of a typical process including,
flushing, sanitization, draining, buffer • Vaccine concentration and diafiltration
conditioning, concentration, diafiltration, • Fractionate protein mixtures
product recovery and clean-in-place (CIP)
• Concentration and diafiltration in blood
operations. See “Tangential Flow Filtration
plasma fractionation and purification
Automated Systems” on page 195 for
additional details. • Clarify cell lysates or tissue
homogenates
Applications in TFF • Recover products expressed into the
Tangential Flow Filtration (TFF) is an media from cell culture
efficient method for concentrating, • Continuously perfuse out spent media
desalting, or buffer exchanging solutions of and product from cell culture
biomolecules ranging in volume from
• Recover products from natural extracts
several milliliters to thousands of liters. It
of plants or animal origin
can be used to fractionate large from small
biomolecules,depyrogenate buffer • Depyrogenate water, buffers and media
solutions, harvest cell suspensions, and solutions
clarify fermentation broths and cell lysates. • Prepare samples (concentrate, desalt,
or buffer exchange) prior to or following
column chromatography
177
Ultrafiltration and Microfiltration TFF Cassette Membranes
Pall offers four distinct membrane types • Compatible with acids, bases and a
that provide superior performance and variety of other cleaning agents to
stability to meet the challenges of each optimize for example cleaning
unique TFF application. Membrane Types procedures
include: Omega™, Alpha™, Regen™, and
Alpha Membrane
Supor® TFF membranes. Each membrane
is available in a broad range of cassette Alpha membrane is a PES membrane
types and configurations. modified to minimize the flux depression
caused by antifoam agents (such as
Omega Membrane silicone and polyglycols) that might effect
Omega polyethersulfone (PES) membranes especially membranes with smaller cut offs.
have been specifically modified to minimize Alpha membranes typically clean up
protein binding to the surface and quicker and easier after contact with these
interstitial structure of the membrane. This agents.
polymeric membrane is stable against Features and Benefits
biological and physical degradation due to
• Proprietary membrane chemistry
the unique chemical properties of PES.
reduces non-specific adsorption,
Omega membranes have an anisotropic minimizes membrane fouling and
structure, a thin skin-like top layer with a increases product recovery
highly porous underlying support. The
• Exceptional membrane recovery and
structure of the skin determines the
stability after cleaning which results in a
porosity and permeability characteristics of
longer lifetime of the membrane
the membrane. Anisotropic membranes
have higher water permeability and can
typically be cleaned quicker and easier
than membranes with a uniform,
sub-micron depth structure.
Damage to the skin of anisotropic
membranes is easily detected with an
integrity test. This may not be the case for
membranes with sub-micron porous
underlayers.
178
Ultrafiltration and Microfiltration TFF Cassette Membranes
179
Matching Membrane Cassettes to Applications
Pall offers a broad range of membrane cassettes for TFF to cover the Membrane Area Requirements
growing range of potential applications and process volumes. The process volume and concentration, filtrate flux rate and time
There are four cassette formats for UF and MF applications – requirements must all be considered in order to determine the
Centramate™, Centrasette™, Maximate™ and Maxisette™. membrane area required for a specific process. Specify range of
expected volumes and calculate area based on largest volume.
It is important to consider your specific requirements in order to
select the most appropriate cassette and format for your application. • Filtrate Volume – total filtrate volume collected from concentration
and diafiltration steps. Filtrate volume can be estimated from the
Choosing A Membrane Cassette total process volume, concentration factor and diafiltration
volumes required.
Process Objectives
• Time Requirements – specify the maximum allowable process
It is necessary to clearly define process requirements including the time
following in order to be able to determine the required membrane
molecular weight cut-off (MWCO) and area for a process: • Filtrate Flux Rate (FFR) – the rate of liquid passing through the
membrane e.g. L/m2/h (LMH). Trials are required to determine the
• Is Product in Concentrate or filtrate? actual FFR for a product under a specified set of operating
• Total process volume parameters including transmembrane pressure (TMP), cross flow
flux rate (CFF) and temperature.
• Required concentration factor
To estimate membrane area required for a process, use the following
• Diafiltration requirement
equation;
• Process temperature
Required Membrane Area = filtrate volume ÷ [average filtrate flux rate
• Process time x process time]
You must also evaluate the process fluid characteristics From the Required Membrane Area calculated, a cassette holder with
(concentration, viscosity, impurities, additives, presence of sufficient capacity can be selected.
particulates, etc) and how they may affect the process.
Membrane Molecular Weight Cutoff (MWCO) vs.Molecular Scale-up/Scale-down
weight of sample molecules to be retained/passed
Processes are often developed on a scaled-down system to
As a general rule to maximize product recovery, choose a MWCO conserve sample. It is best to develop a process using a cassette
that is 3 – 6 times smaller than the MW of molecules to be retained. If format that has the same pathlength and channel configuration as the
performing concentration only, a difference of 3 – 4 times is sufficient. full scale system. This allows direct scale-up following a simple rule –
If process includes diafiltration, use 4 – 6 times, favoring the higher increase membrane area and retentate flow rate in direct proportion
factor with increasing number of diafiltration volumes (DV). to increase in sample volume. If this is followed, the TMP,Cross Flow
The same 3 – 6 times rule applies for product passage (transmission). Flux Rate and process time will not change appreciably. If pathlength
In this case, choose a MWCO that is 3 – 6 times larger than the MW is changed, then additional optimization will be required.
of molecules to be passed. The pH and ionic strength of the process
fluid can have a significant affect on transmission of specific
molecules, including low MW species.
Fractionation – separation of large from smaller molecules – can be
achieved by choosing a MWCO that is at least 2 times lower than the
MW of molecules to be retained and 2 times greater than the MW of
molecules to be passed. The higher MW molecules will be
concentrated while the lower MW molecules have to be diafiltered out
to affect a complete separation. There may have to be a compromise
between recovery and complete separation when the difference in
MW is too small.
180
Minimate™ Tangential Flow Filtration Capsules
The easy to use Minimate TFF capsule is • High Product Recovery – Optimized
a valuable tool for any laboratory requiring flow path design coupled with low
tangential flow filtration of small process protein binding Omega membrane
volumes. Sample batch sizes of up to one minimize non-specific binding
liter can be reduced to as low as 5 mL.
• Efficient – Concentration and desalting
Sample concentration and diafiltration processes can be performed on the
(desalting) can take place sequentially same system with minimal user
using the same device and system, saving intervention. Achieve high concentration
time and avoiding product loss associated factors in a single processing step due
with transfer steps. to the low hold-up volume of the device
The Minimate TFF Capsules contain a • Disposable – This economically priced
robust, polyethersulfone, ultrafiltration (UF) device can be dedicated to a single
membrane. The Omega UF membrane batch or process eliminating the time
offers low non-specific adsorption required for cleaning
characteristics resulting in high product
• Confidence – Each pharmaceutical
recovery. The Minimate TFF capsules are
grade Minimate capsule is 100%
available with a wide range of molecular
integrity tested during manufacture to
weight cut-offs. They can be used in a
ensure reliable performance. For critical
variety of biological applications in
applications the user can re-test the
biotechnology, molecular biology, protein
integrity after initial use. A Certificate of
chemistry, microbiology and immunology.
Quality is included with each capsule
Features Applications
• Ready to use – Minimate TFF capsule
• Concentrate and desalt proteins,
includes all fittings and tubing to
peptides, or nucleic acids (DNA, RNA,
simplify installation into filtration setups.
oligonucleotides)
This versatile, self-contained device
works with most laboratory pumps • Recover antibodies or recombinant
proteins from clarified cell culture media
• Cost-effective design – The plastic
construction of the Minimate TFF • Process metal sensitive enzymes and
capsule and chemical compatibility of other biomolecules
the Omega membrane facilitate • Separate (fractionate) large from small
cleaning and reuse biomolecules
• Scalable – The Minimate TFF capsules • Concentrate viruses or gene therapy
have the same path length and similar vectors
materials of construction as larger
• Prepare samples prior to column
Centramate and Centrasette
chromatography
cassettes used in pilot and production
scale. Several Minimate TFF capsules • Concentrate samples after gel filtration
may be connected in parallel for • Depyrogenate water, buffers, and media
increased membrane area Predictable solutions
performance saves time when scaling
up a process.
181
Minimate Tangential Flow Filtration Capsules
Technical Specifications
Ordering Information The Minimate TFF Capsule comes with threaded luer plugs in each of
Part Number Description the four ports. A fitting package with the following components is
OAD65C12 Minimate TFF Capsule included.
with 650 Da Omega membrane
182
Minimate™ TFF System
Streamlining Laboratory-scale Concentration, Desalting, and Buffer Exchange Processes
183
Minimate TFF System
Technical Specifications
All fittings are simple and inexpensive to replace. Three-way valves at Materials of Construction
the reservoir inlet and outlet can be used for sample recovery or spill Reservoir Polysulfone
free addition of rinse and cleaning fluids. Reservoir Cover Polypropylene
• Efficient – Continuous diafiltration for desalting or buffer exchange Reservoir O-ring EP Rubber
can be performed unattended. The diafiltration buffer container is Magnetic Stir Bar PTFE coated
connected to the lid of the feed reservoir. By simply pulling a
Gauge Wetted Parts 316L stainless steel
vacuum on the feed reservoir, new buffer is drawn into the feed
reservoir at the same rate filtrate is generated. The stir plate Gauge Mounting Block Polypropylene
ensures adequate mixing of the buffer addition Luer Fittings Polypropylene and stainless steel
Tubing C-flex* and Pharmed*
• Compact Design – Saves valuable bench space, making the
entire fluid path easily accessible for built-in flexibility Four-way Valves Polycarbonate body, polyethylene core
Drip Tray Urethane
• Process Monitoring – Pressure gauge enables monitoring of feed
* C-Flex is a registered trademark of Consolidated Polymer Technologies, Inc.
pressure to ensure reproducible process parameters for consistent Pharmed is a registered trademark of Saint-Gobain Performance Plastics Corp.
runs
Applications
• Concentrate and desalt proteins, peptides or nucleic acids (DNA,
RNA, oligonucleotides)
• Recover antibodies or recombinant proteins from clarified cell
culture media
• Process metal sensitive enzymes and molecules
• Separate (fractionate) large from small biomolecules
• Concentrate viruses or gene therapy vectors
• Prepare samples prior to column chromatography
• Concentrate samples after gel filtration
• Depyrogenate water, buffers, and media solutions
Ordering Information
Description Part Number Part Number
184
Tangential Flow Filtration Membrane Cassettes
Centramate™, Centrasette™, Maximate™, and Maxisette™ Cassettes
185
Tangential Flow Filtration Membrane Cassettes
Technical Specifications
Maxisette • Alpha
• Supor TFF
The Maxisette format has some distinct benefits that make it
advantageous for large volume processes. Most important is that the • Regen
volumetric flow rate required is 40 % lower compared to cassette Cassette Channel Configurations
formats like the Centrasette. This translates to a smaller pump and
Cassettes are available in fine, medium and suspended screen
piping diameter required for the same membrane area with a
channel formats to best meet the specific requirements of each
corresponding reduction in energy cost. The larger porting in the
application.
Maxisette (almost 50% larger feed and retentate ports than the
Centrasette II Cassette) provides lower resistance to high feed flow Select a cassette channel configuration based on the following
rates which results in lower pressure drops and easier cleaning. criteria:
Storage Agents
Omega, Alpha, Supor TFF and Regen cassettes are shipped wet, in
liquid containing a humectant and bactericidal storage solution. This
solution consists of 15 – 20% glycerin, and 0.05 – 0.1% sodium
azide.
The storage solution must be removed and the cassette flushed well
with water prior to use to prevent product contamination.
Cassettes are also available with circa 0.3N sodium hydroxide as the
storage agent.
Traceability
Each membrane cassette has a unique serial number for full
traceability. Each cassette is supplied with:
• Certificate of quality
• Membrane Cassette Care and Use Procedures
• Material Safety Date Sheet (MSDS) for cassette preservative
• Two platinum cured silicon gaskets
Materials of Construction
Membrane Choice of 4:
Omega, Alpha, Supor TFF or Regen
Encapsulant Polyurethane
Screens Polyester
Spacers Polyolefin/PES
186 Cassettes pass current USP biological safety tests for Class VI plastics at 70 °C.
Tangential Flow Filtration Membrane Cassettes
Technical Specifications and Ordering Information
3. Choose a format code from Table 4 (e.g., C10, C11, or C12). MWCO/Rating 10 kD MWCO/Rating 0.2 µm
Format Centrasette II Format Maximate
Table 1 – Membrane Type Feed Channel Medium Screen Feed Channel Medium
AS Alpha Antifoam-resistant
modified polyethersulfone
187
Tangential Flow Filtration Membrane Cassette Holders
Choosing a Cassette Holder
Designed for optimum performance and Operators must use calibrated torque
product recovery Pall TFF cassette holders wrenches (supplied with the holder) to
are available in a variety of sizes to meet effect required compression of cassettes
every application requirement. This way and gaskets in a manual torque cassette
applications that are developed on a small holder. Auto-torque cassette holders
Centramate Housing with 3-Gauge, 2-Valve Fitting
Kit and Torque Wrench
system using a Centramate or Maximate automatically compensate for cassette
cassette can be easily scaled up, either by compression and temperature reduction.
adding additional cassettes to the holder
They also eliminate variability in technique
or by scaling into a larger cassette format
between operators. Auto-torque cassette
and holder configuration with identical flow
holders are recommended for
path like the Centrasette/Centrastak or
process-scale validated processes.
Maxisette holders.
Sanitary stainless steel holders may be
TFF cassette holders for the medium and
sterilized by steam or autoclaving without
large-scale production environment have a
cassettes installed.
small footprint, yet still are capable of
holding large areas of membrane. All Complete fittings kits consisting of
stainless steel holders are engineered to pressure gauges, valves, filtrate manifold,
precise specifications with a high standard connectors, gaskets and clamps are
internal and external surface finish and are available for most cassette holders.
available with either manual torque (MT) or Ordering a complete fitting kit with the
auto torque (AT) compression systems for cassette holder simplifies installation into a
Holder Fittings Kits system and avoids potential delays in
ease of use.
Complete fittings kits consisting of starting your process due to missing parts.
pressure gauges, valves, filtrate manifold,
connectors, gaskets and clamps are Choosing a Cassette Holder
available for most cassette holders. The following table lists cassette holders with relative area capacities and working volumes. The
Ordering a complete fitting kit with the Minimate TFF Capsule is also included to complete the range of lab scale products.
cassette holder simplifies installation into a Product Membrane Area Working Volumes*
system and avoids potential delays in Lab and Development Scale
starting your process due to missing parts. (Scale-up and Scale-down studies) Starting Final
Minimate TFF 0.005 m2 0.05 ft2 25 – 500 mL 25 mL
Capsule
Centramate LV 0.01 – 0.02 m2 0.1 – 0.2 ft2 25 – 2,000 mL 10 mL
Centramate PE 0.01 – 0.37 m 2
1 – 4 ft2 0.5 – 80 L 150 mL
Centramate 0.01 – 0.46 m2 1 – 5 ft2 0.5 – 100 L 150 mL
Maximate 0.19 – 1.11 m2 2 – 12 ft2 1 – 250 L 350 mL
Pilot Scale (Process Development)
Centrasette LV 0.46 – 2.3 m2 5 – 25 ft2 2.5 – 500 L 400 mL
Centrasette P 0.46 – 2.3 m 2
5 – 25 ft2 2.5 – 500 L 400 mL
Centrasette 5 0.46 – 4.6 m2 5 – 50 ft2 2.5 – 1,000 L 1,000 mL
Process Scale (Production)
Centrastak 100 0.9 – 18.5 m2 10 – 200 ft2 10 – 4,000 4L
Centrastak 200 1.85 – 37.2 m2 20 – 400 ft2 20 – 8,000 10 L
Centrastak 300 2.8 – 55.8 m2 30 – 600 ft2 30 – 12,000 15 L
Centrastak 400 3.7 – 74.0 m 2
40 – 800 ft2 40 – 16,000 20 L
Maxisette 25 2.8 – 27.9 m2 30 – 300 ft2 30 – 6,000 15 L
Maxisette 50 5.6 – 55.8 m2 60 – 600 ft2 60 – 12,000 30 L
Maxisette 100 5.6 – 92.9 m2 60 – 1,000 ft2 60 – 20,000 40 L
(1)
Fewer suspended screen cassettes will fit due to increased thickness. Some holders can fit more membrane area than
can be operated at required cross flow rates due to high pressure drops. Do not use more than the recommended area in
these holders.Manual (MT) and auto-torque (AT) version holders are available for Pilot and Process Scale applications.
(2)
Working Volumes are based on an average filtrate flux rate of about 50 LMH and process time of 5 hours. Starting Range
covers minimum to maximum area installed for screen channel cassettes. Final process volume represents final
concentration volume or minimum working volume for the system. Actual volumes depend on system hold-up volume
and operating parameters. Piping (tubing) lengths and internal diameters significantly affect the final volume.
188
Tangential Flow Filtration Membrane Cassette Holders
190
Tangential Flow Filtration Membrane Cassette Holders
191
Tangential Flow Filtration Membrane Cassette Holders
Technical Specifications
Maximum Operating Pressure 5 bar (75 psi) 6 bar (90 psi) 6 bar (90 psi)
Nominal Dimensions 26 x 25 x 21 cm 30 x 20 x 34 cm 26 x 25 x 27 mm
(Width x Length x Depth) (101⁄4 x 10 x 81⁄2 in.) (12 x 8 x 131⁄2 in.) (101⁄4 x 10 x 103⁄4 in.)
Maximum Operating Pressure 6 bar (90 psi) 5 bar (75 psi) 6 bar (90 psi)
* Extended tie rods available to increase membrane capacity to 5 m (54 ft ) for suspended screen channel cassettes.
2 2
Weight 155 kg (340 lbs) 255 kg (560 lbs) 314 kg (690 lbs) 409 kg (900 lbs)
Maximum Operating 80 °C (175 °F) 80 °C (175 °F) 80 °C (175 °F) 80 °C (175 °F)
Temperature(2, 3)
Maximum Operating 6 bar (90 psi) 6 bar (90 psi) 6 bar (90 psi) 6 bar (90 psi)
Pressure
(1)
Cassette blocks (2 m2 [21.6 ft2] or 2.5 m2 [26.9 ft2]) are recommended. If 0.5 m2 [5.3 ft2] cassettes are used, stabilizer plates must be used between every 5 cassettes (fine/medium screen) or
3 cassettes (suspended screen).
(2)
Maximum operating temperature may be restricted by cassette operating temperature limit.
(3)
Holder may be steamed with compatible cassettes, or without cassettes at up to 142 °C (287.6 °F).
192
Tangential Flow Filtration Membrane Cassette Holders
Technical Specifications and Ordering information
Ordering Information
The following table lists individual cassette holders as well as holders sold in combination with fittings packages. Additional combinations and a
variety of other accessories are available. For complete descriptions and additional offerings, contact your local Pall representative.
Pall offers a range of tangential flow filtration systems from small scale
and process development to full-scale process systems. These
include standard systems such as the Minimate, Centramate Pilot,
and Centrasette 5AT Systems as well as standard and custom
engineered process systems that meet the most stringent control and
validation requirements. Various levels of automation from simple
manual systems to full automation control and data acquisition are
available or can be custom-developed to meet specific requirements.
Contact Pall for further details.
• Scalable design
• Multiple membrane formats
Maxim benchtop TFF System
• Ease of use
for process development and
Microza* Benchtop System
pilot scale applications
Pall Engineering
• Mechanical Design
ASME BPE
Clean In Place (CIP)
Sterilize In Place (SIP)
• Electrical Design
Explosion-proof (XP)design
UL508 Panel fabrication
National Electric Code (NEC) UL
CSA and cUL standards.
Controls
• GAMP-compliant
• PLC /PC based
• SCADA Packages
• DCS
• Standard Package modifications Centrastak Workstation
Project Support
• Process Development
• Project Management
• System Fabrication
• Documentation
Service
• Factory Acceptance Test
• Site Acceptance Test
• Installation Qualification
• Operation Qualification
• Start-up/Commissioning
• Operator Training
Large Process system with automated valves and process control for up to 800 ft2
• Maintenance of membrane.
• Troubleshooting and Support
Our patented designs provide higher process efficiency, enhanced • Scale-down studies
process control, lower pressure drops, and minimized holdup • Process Audits
volumes to ensure:
• Maximum yield Project Execution
• Cleanability and Recovery To ensure that our entire project team understands your needs, our
• Compact cost-effective systems – more membrane area per Process Engineers will manage your project throughout the entire
square-foot of floor space design, build, and commissioning cycle. Our process engineers will
direct the project team to meet your process requirements on time
• Autotorque device offers consistent pressure for a reliable seal on
every time.
cassettes to ensure batch process repeatability with minimal labor
overhead
Pre-Engineered Systems
Centramate Pilot Maximate Pilot Centrasette 5 SAT Centrastak 100 SAT
Feed Flow Range 7 7 65 120
(L/Min) @ 60 psig
Membrane Area 0.1 –0.5 m2 (1 – 5 ft2) 0.2 – 0.9 m2 (2 – 10 ft2) 0.5 – 7.0 m2 (5 – 75 ft2) 0.9 – 18.6 m2 (10 – 200 ft2)
Membrane Holder Manual Torque Manual Torque Auto Torque Auto Torque
Optional Instrumentation UV, pH, UV, pH, UV, pH, UV, pH,
Conductivity, Integrity, Conductivity, Integrity, Conductivity, Integrity, Conductivity, Integrity,
Auxiliary Pump, Tanks Auxiliary Pump, Tanks
196
TFF Polymeric Hollow Fiber Membranes and Ceramic Modules
For Demanding Duties in Ultrafiltration and Microfiltration
197
Microza Membranes
Technical Specifications
198
Microza Membranes
Polysulfone Membranes – Technical Specifications
Microza SP, SV and VP series hollow fiber ultrafiltration modules have Key Features
a unique double-skinned proprietary polysulfone (PS) membrane with • Combination of high-strength and high-flow due to unique
dense internal layer. Currently available in 3000, 4000, 6000, and membrane construction
10000 molecular weight cut-offs, the modules are used in a range of
• Double-skin provides assurance of removal rating
pharmaceutical applications including pyrogen removal from water,
buffer solutions active ingredients such as antibiotics, and • High-strength fiber allows reverse filtration to assist cleaning in
concentration of protein solutions. SV modules are used for clarifying difficult applications
antibiotic and other broths used for small molecule API production. • Available in a range of sizes from 0.015 m2 (0.16 ft2) to more than
12 m2 (125 ft2)
Materials of Construction • All SP and VP modules may be hot water sanitized: up to 95 °C
(203 °F) – SIP and SLP, or 90 °C (194 °F) – SEP and SAP; and all
Membrane Polysulfone (with silicone coating on
ends in VIP–3017S) may run continuously at 80 °C (176 °F)
Housing Native clear polysulfone (P) or PVC (V) • SP Modules may be autoclaved in single use applications
Potting Material Epoxy resin • VIP 6000 MWCO version steam-sterilizable up to 50 cycles at
Gasket Silicone (P) or butyl rubber (NBR) (V) 125 °C (257 °F) at a differential pressure of 100 mBar
Bacteriostat Glycerin 65%, ethanol 2%, • SV modules are designed for maximized recovery in bulk
water balance fermentation, limited to 50 °C (122 °F)
Connectors and Adapters Contact Pall for wide range of fittings for • Compatible with a wide range of cleaning agents, up to 5000 ppm
these modules
sodium hypochlorite or 4% sodium hydroxide
Connectors and Adapters • Meets the specification for biological tests listed in the current
For available connections, please refer to table on p202.
revision of USP for class VI plastics at 121 °C (249 °F)
• pH range 1 – 14
Part Number(1)
Rating Fiber Nominal Membrane Clean Crossflow Maximum Volume Volume Feed/ Permeate
(MWCO, ID Length(2) Area Water Flux Rate for Pressure Feed Permeate Retentate Connection
Daltons) Lh -1 bar 1ms-1 fluid (barg) at Side(3) Side(3) Connection
velocity 50 °C (mL)
(122 °F)
SEP-0013 3000 0.8 mm 130 0.017 2.5 181 1/1/1 9 9 A2 A1
SEP-1013 3000 0.8 mm 347 0.2 25 724 3/3/2 90 120 B1 B1
SEP-2013 3000 0.8 mm 552 1.0 130 1629 5/3/2 300 500 C4 C3
SEP-3013 3000 0.8 mm 1129 4.7 650 3655 5/3/3 1200 3700 C5 C4
SAP-0013 4000 0.8 mm 130 0.017 3.6 181 1/1/1 9 9 A2 A1
SAP-1013 4000 0.8 mm 347 0.2 36 724 3/3/2 90 120 B1 B1
SAP-3013 4000 0.8 mm 1129 4.7 900 3655 5/3/3 1200 3700 C5 C4
SAV-3013 4000 0.8 mm 1126 5.6 1100 4343 5/3/3 1200 3700 C7 D2
SAV-5013 4000 0.8 mm 1126 12.1 2400 9950 5/3/3 3800 5300 C8 D3
SIP-0013 6000 0.8 mm 130 0.017 4.0 181 1/1/1 9 9 A2 A1
SIP-1013 6000 0.8 mm 347 0.2 40 724 3/3/2 90 120 B1 B1
SIP-1023 6000 0.8 mm 347 0.2 44 724 3/3/2 90 130 B1 B1
SIP-2013 6000 0.8 mm 552 1.0 200 1629 5/3/2 300 500 C4 C3
SIP-3013 6000 0.8 mm 1129 4.7 1000 3655 5/3/3 1200 3700 C5 C4
SIP-3023 6000 0.8 mm 1129 7.2 1700 5610 5/3/3 700 3700 C5 C4
VIP-3017S 6000 0.8 mm 1129 4.7 1000 3655 5/3/3 1200 3700 C5 C4
SLP-0053 10000 1.4 mm 130 0.015 5.7 277 1/1/1 11 9 A2 A1
SLP-1053 10000 1.4 mm 347 0.1 40 776 3/3/2 85 120 B1 B1
SLP-2053 10000 1.4 mm 552 0.6 150 1773 5/3/2 310 500 C4 C3
SLP-3053 10000 1.4 mm 1129 4.5 1500 5819 5/3/3 1850 3700 C5 C4
(1)
Third letter represents housing material: P – Clear native Polysulfone with silicone gasket, V – white PVC with butyl rubber gasket.
(2)
Nominal length is flange to flange, or to ends of connectors on quick-connect modules. Detailed drawings available upon request.
(3)
Guideline module filling volume to allow calculation of minimum system working volumes when added to volumes of attached piping and other components.
Drained residual volumes are considerably less.
(4)
VIP-3017S – Maximum Inlet pressure for steam at 121 °C is 1.1 barg, max TMP 0.1 barg, filtrate pressure 0 (open steaming, no back pressure).
199
Microza Membranes
Polyacrylonitrile Membranes – Technical Specifications
The AP and AV series of Microza hollow fiber ultrafiltration modules Key Features
feature unique double-skinned proprietary polyacrylonitrile (PAN)
• Hydrophilic polyacrylonitrile membrane provides low fouling and
membranes with dense internal layer. Available in 6,000, 13,000,
excellent flux recovery
50,000 and 80,000 molecular weight cut-offs, the modules are used
in a range of pharmaceutical applications especially in purification and • Combination of high-strength and high-capacity due to unique
processing of aqueous enzymes and protein solutions. 80,000 membrane construction
MWCO modules are especially useful for raw water pretreatment to • High-strength fiber allows reverse filtration to assist cleaning in
pharmaceutical water purification plant. difficult applications
• Available in a range of sizes from 0.012 m2 (0.13 ft2) to more than
Materials of Construction 40 m2 (425 ft2)
Membrane Polyacrylonitile • Compatible for continuous operation up to 50 °C (122 °F)
Housing Native clear polysulfone (P) or PVC (V)
• Easily cleanable in most biological applications using minimum
Potting Material Epoxy Resin chemicals or detergents
Gasket Silicone (P) or butyl rubber (NBR) (V)
• Meets the specifications for biological tests listed in the current
Bacteriostat Glycerin 65%, Ethanol 2%,
revision of USP for class VI plastics at 121 °C (249 °F)
water balance
• LGV and LOV modules especially optimized for raw water duty
Part Number(1)
Rating Fiber Nominal Membrane Clean Crossflow Maximum Volume Volume Feed/ Permeate
(MWCO, ID Length(2) Area Water Flux Rate for Pressure Feed Permeate Retentate Connection
Daltons) Lh -1 bar 1ms-1 fluid (barg) at Side(3) Side(3) Connection
velocity 50 °C (mL)
(122 °F)
AIP-0013 6000 0.8 mm 130 0.017 1.0 181 1/1/1 9 9 A2 A1
AIP-1010 6000 0.8 mm 347 0.2 10 724 3/3/2 90 120 B1 B1
AIP-2013 6000 0.8 mm 552 1.0 50 1629 5/3/3 300 500 C4 C3
AIP-3013 6000 0.8 mm 1129 4.7 160 3655 5/3/3 1200 2700 C5 C4
AIV-3010 6000 0.8 mm 1126 4.7 170 3655 3/3/3 1200 2700 C7 D2
AIV-5010 6000 0.8 mm 1126 12.3 700 10134 3/3/3 3800 5300 C8 D3
ACP-0013 13000 0.8 mm 130 0.017 3.4 181 1/1/1 9 9 A2 A1
ACP-0053 13000 1.4 mm 130 0.012 1.9 222 1/1/1 10 9 A2 A1
ACP-1010 13000 0.8 mm 347 0.2 10 724 3/3/2 90 120 B1 B1
ACP-1050 13000 1.4 mm 347 0.12 19 776 3/3/2 90 120 B1 B1
ACP-2013 13000 0.8 mm 552 1.0 160 1629 5/3/3 300 500 C4 C3
ACP-2053 13000 1.4 mm 552 0.6 90 1773 5/3/3 310 500 C4 C3
ACP-3013 13000 0.8 mm 1129 4.7 750 3655 5/3/3 1200 2700 C5 C4
ACP-3053 13000 1.4 mm 1129 3.1 360 3990 5/3/3 1200 2850 C5 C4
ACV-3010 13000 0.8 mm 1126 4.7 830 3655 3/3/3 1200 2700 C7 D2
ACV-3050 13000 1.4 mm 1126 3.1 420 3990 3/3/3 1200 2700 C7 D2
ACV-5010 13000 0.8 mm 1126 12.3 2200 10134 3/3/3 3800 5300 C8 D3
ACV-5050 13000 1.4 mm 1126 7.8 1100 11084 3/3/3 3800 5300 C8 D3
LGV-3010 13000 0.8 mm 1126 7.6 500 3257 3/3/3 – – C7/D2 C7
LGV-5210 13000 0.8 mm 2227 41 4000 8686 3/3/3 – – C8/D3 C8
AHP-0013 50000 0.8 mm 130 0.017 8.3 181 1/1/1 9 9 A2 A1
AHP-1010 50000 0.8 mm 347 0.2 82 724 3/2/2 90 120 B1 B1
AHP-2013 50000 0.8 mm 552 1.0 460 1629 4/2/2 300 500 C4 C3
AHP-3013 50000 0.8 mm 1129 4.7 2250 3655 4/2/2 1200 2700 C5 C4
AHV-3010 50000 0.8 mm 1126 4.7 2500 3655 3/3/3 1200 2700 C7 D2
LOV-3010 80000 0.8 mm 1126 7.6 1500 3257 3/3/3 – – C7/D2 C7
LOV-5210 80000 0.8 mm 2227 41 7000 8686 3/3/3 – – C8/D3 C8
(1)
Third letter represents housing material: P – Clear native Polysulfone with silicone gasket, V – white (gray – LGV, LOV) PVC with butyl rubber gasket
(2)
Nominal length is flange to flange, or to ends of connectors on quick-connect modules. Detailed drawings available upon request.
(3)
Guideline module filling volume to allow calculation of minimum system working volumes when added to volumes of attached piping and other components.
200 Drained residual volumes are considerably less.
Microza Membranes
Polyvinylidenedifluoride Membranes – Technical Specifications
The U series of Microza hollow fiber microfiltration modules feature Key Features
unique proprietary membranes in specially resistant PVDF for
• Low non-specific protein binding for long term flux maintenance in
microfiltration applications. Available in 0.2 µm (UM series) and
cell culture applications
0.65 µm (UJ series) rating, the modules are used in a range of
pharmaceutical applications especially in cell harvesting, perfusion cell • Available different fiber diameters allows optimization to different
culture, viral vector production, and clarification of microbial extracts. particulate or colloidal loadings
• Superior chemical resistance of Microza PVDF ensures
Materials of Construction compatibility in a broad range of processing and cleaning
Membrane Polyvinyldenedifluoride applications
Housing Native clear polysulfone (P) • Highly characterized,optimized void structure ensures reproducible
or filled polysulfone (W) separation efficiency and high throughput
Potting Material Epoxy Resin
• High-strength fiber allows reverse filtration to optimize yield and
Gasket Silicone (P) performance in difficult applications
Bacteriostat Glycerin 65%, Ethanol 2%,
water balance • Available in a range of sizes from 0.02 m2 (0.21 ft2) to 5 m2 (54 ft2)
• U series can operate continuously in processes up to 80 °C
Connectors and Adapters (176 °F) and may be steamed in situ at 125 °C (257 °F) for 20
cycles
For available connections, please refer to table on p202.
• Meets the specification for biological tests listed in the current
revision of USP for Class VI plastics at 121 °C (249 °F)
• pH 2 – 10
Part Number(1)
Rating Fiber Nominal Membrane Clean Crossflow Maximum Volume Volume Feed/ Permeate
(MWCO, ID Length(2) Area Water Flux Rate for Pressure Feed Permeate Retentate Connection
Daltons) Lh -1 bar 1ms-1 fluid (barg) at Side(3) Side(3) Connection
velocity 50 °C (mL)
(122 °F)
UMP-053 0.2 2.6 mm 130 0.015 1.5 287 1/1/1 1/1/1 12 9 A2/A1
UMP-153 0.2 2.6 mm 347 0.08 8 956 3/3/3 3/3/3 90 120 B1/B1
UMP-353 0.2 2.6 mm 1129 2.2 200 5161 3/3/3 3/3/3 1700 2700 C5/C4
UMW-553 0.2 2.6 mm 1172 5.0 500 12424 3/3/3 3/3/3 3800 5400 C6/C5
UMP-0047R 0.2 1.4 mm 314 0.02 19 116 3/3/1.5 2/2/1 23 30 C1/A2
UMP-1047R 0.2 1.4 mm 316 0.09 80 554 3/3/1.5 2/2/1 202 – C2/C1
UMP-1147R 0.2 1.4 mm 546 0.19 180 554 3/3/1.5 2/2/1 360 – C2/C1
UMP-1147M 0.2 1.4 mm 546 0.33 330 953 3/3/1.5 2/2/1 297 – C2/C1
UMP-2147R 0.2 1.4 mm 546 0.77 750 2216 3/3/1.5 2/2/1 – – C4/C2
UMP-3147R 0.2 1.4 mm 630 2.0 2000 – 3/3/1.5 2/2/1 – – C4/C3
UMP-3247R 0.2 1.4 mm 1129 4.0 4000 – 3/3/1.5 2/2/1 – – C4/C3
UJP-0047R 0.65 1.1 mm 314 0.02 24 92 3/3/1.5 2/2/1 23 33 C1/A2
UJP-1047R 0.65 1.1 mm 316 0.10 120 462 3/3/1.5 2/2/1 204 – C2/C1
UJP-1147R 0.65 1.1 mm 546 0.19 230 428 3/3/1.5 2/2/1 370 – C2/C1
UJP-1147M 0.65 1.1 mm 546 0.32 380 708 3/3/1.5 2/2/1 310 – C2/C1
UJP-2147R 0.65 1.1 mm 546 0.73 850 1625 3/3/1.5 2/2/1 – – C4/C2
UJP-3147R 0.65 1.1 mm 630 1.9 2300 – 3/3/1.5 2/2/1 – – C4/C3
UJP-3247R 0.65 1.1 mm 1129 3.8 4600 – 3/3/1.5 2/2/1 – – C4/C3
(1)
Third letter represents housing material: P – Clear native Polysulfone with silicone gasket, V – white (gray – LGV, LOV) PVC with butyl rubber gasket
(2)
Nominal length is flange to flange, or to ends of connectors on quick-connect modules. Detailed drawings available upon request.
(3)
Guideline module filling volume to allow calculation of minimum system working volumes when added to volumes of attached piping and other components.
Drained residual volumes are considerably less.
201
Microza Membranes
Polyolefin Membranes – Technical Specifications
The P series of Microza hollow fiber microfiltration modules feature Key Features
unique proprietary membranes in polyolefin for general microfiltration
• Available different internal fiber diameters provides suitability for
applications. Available in 0.1 µm rating, the modules are used in a
processes with varying particulate or colloidal loading
range of pharmaceutical applications especially in clarification of
microbial cultures for enzyme production, clarification of natural • Broad chemical resistance ensures compatibility in a wide range of
product extracts, and nutraceutical production. processing and cleaning conditions
• Highly characterized,optimized void structure ensures reproducible
Materials of Construction separation efficiency and high throughput
Membrane Polyolefin • High-strength fiber allows reverse filtration to optimize yield and
Housing Native clear polysulfone (P)or PVC (V) performance in difficult applications
Potting Material Epoxy resin • Available in a range of sizes from 0.09 m2 (1 ft2) to over 8 m2
Gasket Silicone (P) (85 ft2)
Bacteriostat Glycerin 65%, ethanol 2%, • P series compatible for continuous operation up to 50 °C (122 °F)
water balance
• Meets the specification for biological tests listed in the current
revision of USP for Class VI plastics at 121 °C (249 °F)
Connectors and Adapters
A – A1 Small hose barb 4.5 mm (3⁄16 in.),
A2 Small hose barb 6 mm (1⁄4 in.)
B – B1 Quick-connect.
To convert feed/retentate to 11⁄2 in. sanitary clamp order
part no. 0450163 (fits in body of module), to 1⁄4 in. sanitary
clamp order part no. 2055675 (fits in body of module),
to 1⁄4 in. hose barb (fits on quick-connect),
order part 2055999 no. (polypropylene), and to 1⁄4 in.
FNPT (fits on quick-connect), order part no. 2089150
(316L stainless steel).
Part Number(1)
Rating Fiber Nominal Membrane Clean Crossflow Maximum Volume Volume Feed/ Permeate
(MWCO, ID Length(2) Area Water Flux Rate for Pressure Feed Permeate Retentate Connection
Daltons) Lh -1 bar 1ms-1 fluid (barg) at Side(3) Side(3) Connection
velocity 50 °C (mL)
(122 °F)
PSP-103 0.1 0.7 mm 347 0.2 25 554 3/2.2/2 90 120 B1 B1
PSP-113 0.1 1.9 mm 347 0.1 7 714 3/2.5/2 110 110 B1 B1
WSP-143 0.1 1.4 mm 347 0.09 13 554 3/2.5/2 90 120 B1 B1
PSP-303 0.1 0.7 mm 1129 6.0 700 3879 5/2.2/3 1200 2700 C5 C4
PSV-303 0.1 0.7 mm 1126 6.0 700 3879 5/2.2/3 1200 2700 C7 D3
PSV-313 0.1 1.9 mm 1126 2.9 240 4900 5/2.5/3 1500 2600 C7 D3
WSP-543 0.1 1.4 mm 1172 8.2 930 11083 4/2.5/4 3800 5300 C7 C6
(1)
Third letter represents housing material: P – Clear native Polysulfone with silicone gasket, V – white (gray – LGV, LOV) PVC with butyl rubber gasket
(2)
Nominal length is flange to flange, or to ends of connectors on quick-connect modules. Detailed drawings available upon request.
(3)
Guideline module filling volume to allow calculation of minimum system working volumes when added to volumes of attached piping and other components.
Drained residual volumes are considerably less.
202
Membralox Ceramic Membrane Products
®
203
Membralox Ceramic Membrane Products
Technical Specifications
• Proprietary built-in gasketing solution to ensure perfect sealing Construction of 316L SS, ceramic, EPDM or FPM
Wetted Materials
• Wide chemical compatibility
• Long service life Membralox HCB Industrial Modules
Part Number 36P2 60P1
Membralox T1-70 Modules Element Type P19-60 P19-40/P37-30
204
Pallsep™ Vibrating Membrane Filtration Technology
The PS10 is an ideal device for process development departments to Electrical Requirement US: 480V 440V, 400V, 60 Hz, 3 phase
demonstrate the feasibility of Pallsep technology for larger scale Europe: 380V, 50 Hz 3 phase
processes. The unit can work with an installed area of between 0.1 Nominal Dimensions Membrane Element:
and 1 m2. This range makes the device suitable for use with the Diameter 610 mm (24 in.)
QuattroFlow pump and several Pall systems. Base Machine, Stack and Pipework:
Height 3338 mm (119 in.)
Width 1600 mm (63 in.)
Operating Conditions Depth 1177 mm (46 in.)
Typical Range Limit Weight Base Machine Only:
1452 kg (3200 lbs)
System Pressure 0.4 – 3 barg 4 barg
(5.8 – 43.5 psi) (58 psi) Assembled Membrane Stack:
544 kg (1200 lbs)
Trans-membrane 0.2 – 1.5 barg 4 barg
Pressure (2.9 – 21.7 psi) (58 psi)
Operating 4 – 50 °C 55 °C
Temperature (39 – 122 °F) (131 °F)
Membrane Housing:
25 kg (55 lbs)
206
Sheet TFF Membranes
For Bulk Pharmaceutical and Bio-Industrial Processes
207
Sheet TFF Membranes
Ordering Information
208
Chromatography
Chromatography
210
Mustang Membrane Chromatography Starter Kits
®
211
Mustang Membrane Chromatography Starter Kits
Technical Specifications
Materials of Construction
Media Mustang membrane of appropriate
chemistry
Housing Polypropylene
Operating Pressures
Typical Differential Pressure < 0.07 bard @ 1 mL/min
(< 1.0 psid @ 1 mL/min)
The following Charts and Graphs Demonstrate the High Resolution and High Dynamic Binding Capacities of
Mustang Membrane Chromatography Units
Mustang S Membrane
25 mm (1 in.) Acrodisc Unit with Mustang S Membrane 25 mm (1 in.) Acrodisc Unit with Mustang S Membrane
Resolution with Cytochrome C and Lysozyme Dynamic Binding with Lysozyme
250 450
Absorbance Lysozyme Elution Peak
Conductivity 400
200
Absorbance 280 mm (11 in.) (in AU)
350
300
Protein (µg/mL)
150
250
200
100
150
Cytochrome C
100
50 52 mg/mL at 0
breakthrough
50
0 0
0 1 2 3 4 5 6 0 5 10 15 20 25
Time (min) Time (min)
The conditions used to generate data for the graph above include buffer: A solution of 0.512 mg/mL Lysozyme was pumped through the Acrodisc unit at
10 mM MES pH 5.5; salt: 1M NaCl in 10 mM MES pH 5.5; gradient: 0 to 1M NaCl in 2.3 mL/min. Breakthrough occurred at 8.0 minutes and was calculated as 52 mg/mL
50 column volume (cv); flow rate: 2.3 mL/min (13 cv/min). using:
(flow rate [2.3 mL/min] X initial protein Lysozyme concentration
[0.512 mg/mL] X time [8.0 min])
membrane bed volume of Mustang S in 25 mm (1 in.) Acrodisc unit (0.18 mL)
212
Mustang Membrane Chromatography Starter Kits
Technical Specifications
Mustang Q Membrane
25 mm (1 in.) Acrodisc Unit with Mustang Q Membrane 25 mm (1 in.) Acrodisc Unit with Mustang Q Membrane
Resolution with BSA and Goat IgC Dynamic Binding with BSA
30 1800
Elution Peak
Absorbance
Conductivity Goat IgG 1600
25
1400
Absorbance (280 mm (11 in.))
BSA
20 1200
1000
15
800
unbound protein
from Goat IgG 600
10
400
5 54 mg/mL at 0
200 breakthrough
0
0 0 5 10 15 20 25
0 1 2 3 4 5 6
Time (min)
Time (min)
The conditions used to generate data for the resolution graph above include buffer: A solution of 0.524 mg/mL BSA was pumped through the Acrodisc unit at 2.3 mL/min.
25 mM Tris pH 8.0; salt: 1M NaCl in 25 mM Tris pH 8.0; gradient: 0 to 0.5M NaCl in Breakthrough occured at 8.1 minutes and was calculated as 54 mg/mL using:
50 column volume (cv); flow rate: 2.3 mL/min (13 cv/min); sample loading: 4% of total
binding capacity. (flow rate [2.3 mL/min] X initial protein BSA concentration
[0.524 mg/mL] X time [8.1 min])
membrane bed volume of Mustang Q in 25 mm (1 in.) Acrodisc unit (0.18 mL)
Mustang E Membrane
Effect of [NaCl] in 25 mM Tris (pH 8) on Endotoxin Dynamic Effect of pH on Endotoxin Dynamic Binding Capacity to
Binding Capacity to Acrodisc Unit with Mustang E Membrane Acrodisc Unit with Mustang E Membrane
1.72E+06
+06 +06
+05 +05
+04 +04
+03 +03
+02 +02
+01 +01
0 0.15 0.5 1 2 5 6 7 8 9
NaCl (M) pH
213
Mustang Membrane Chromatography Starter Kits
Technical Specifications
Ordering Information
Product No. Description Packaging
MSTG25KIT Mustang Starter Kit 4 per package Acrodisc 25 mm (1 in.) with
Mustang Q membrane (MSTG25Q6)
4 per package Acrodisc 25 mm (1 in.) with
Mustang S membrane (MSTG25S6)
2 per package Acrodisc 25 mm (1 in.) with
Mustang E membrane (MSTG25E3)
Complementary Products
Product No. Description Packaging
MSTG25Q6 Acrodisc 25 mm (1 in.) with Mustang Q membrane 10 per package
MSTG25S6 Acrodisc 25 mm (1 in.) with Mustang S membrane 10 per package
MSTG25E3 Acrodisc 25 mm (1 in.) with Mustang E membrane 10 per package
MSTG18H16 Mustang Coin Holder 1 per package
MSTG18Q16 Mustang Q Coin, 0.35 mL bed volume 10 per package
MSTG18S16 Mustang S Coin, 0.35 mL bed volume 10 per package
CLM05MSTGQP1 Mustang Q Capsule, 10 mL bed volume 1 per package
CLM05MSTGSP1 Mustang S Capsule, 10 mL bed volume 1 per package
CLM05MSTGEP1 Mustang E Capsule, 10 mL bed volume 1 per package
CL3MSTGQP1 Mustang Q Capsule, 60 mL bed volume 1 per package
CL3MSTGSP1 Mustang S Capsule, 60 mL bed volume 1 per package
CL3MSTGEP1 Mustang E Capsule, 40 mL bed volume 1 per package
NP6MSTGQP1 Mustang Q Capsule, 260 mL bed volume 1 per package
NP6MSTGSP1 Mustang S Capsule, 260 mL bed volume 1 per package
NP6MSTGEP1 Mustang E Capsule, 160 mL bed volume 1 per package
NP7MSTGQP1 Mustang Q Capsule, 520 mL bed volume 1 per package
NP7MSTGSP1 Mustang S Capsule, 520 mL bed volume 1 per package
NP8MSTGQP1 Mustang Q Capsule, 780 mL bed volume 1 per package
NP8MSTGSP1 Mustang S Capsule, 780 mL bed volume 1 per package
214
Mustang Coin Unit
®
215
Mustang Coin Unit
Technical Specifications
Operating Characteristics(1)
40
Maximum Temperature 38 °C (100 °F)
Maximum Sanitization 1 N NaOH for 30 minutes
Conditions (one cycle only)
20
(1)
With fully compatible fluids that do not soften, swell, or adversely affect the membrane
or its materials of construction.
0
0 30 60 90 120
Size and Capacity
mL
Membrane Bed Volume 0.35 mL DNA breakthrough curves such as the one above, demonstrate the high
Typical Herring Sperm DNA 20 – 25 mg/mL of bed volume dynamic capacity of Mustang Q coin for DNA.
Dynanic Binding Capacity A sonicated solution of herring sperm DNA at a concentration of 129 µg/mL in
Mustang Q 25 mM Tris HCI, pH 8.0 was passed through a coin at a flow rate of
3.5 mL/min, and the A260 absorbance measured downstream.
Typical BSA Binding Capacity 50 – 60 mg/mL of bed volume
Mustang Q
Ordering Information
Part Number Description Membrane Accessible Flow @ 10 psi Typical Coin Pack Size
Volume Capacity
MSTG18S16 Mustang S coins for 0.35 mL > 3.5 mL/min 16 – 18 mg for Lyzozyme 10
method development
MSTG18Q16 Mustang Q coins for 0.35 mL > 3.5 mL/min 7 – 9 mg for DNA 10
method development 17.5 – 21 mg for BSA
MSTG18H16 Mustang Coin Housing 1
216
Mustang Chromatography Capsules and Cartridges
®
217
Mustang Chromatography Capsules
Technical Specifications
For NpxMSTG*P1, x =
6 for a Q or S unit with a bed volume of 260 mL or an E unit with a bed volume of 160 mL
7 for a Q or S unit with a bed volume of 520 mL or an E unit with a bed volume of 320 mL
8 for a Q or S unit with a bed volume of 780 mL or an E unit with a bed volume of 480 mL
*=
Q for a unit with Q (quaternary amine) chemistry membrane
S for a unit with S (sulfonic acid) chemistry membrane
E for a unit with E (polyethyleneimine) chemistry membrane
S Lysozyme 14.3 kD 0.45 – 0.50 g 2.7 – 3.0 g 11.7 – 13.0 g 23.4 – 26.0 g 35.1 – 39.0 g
S Human IgG 160 kD 0.2 g 1.2 g 5.2 g 10.4 g 15.6 g
E Endotoxin Units 4 x 107 1.6 x 108 6.4 x 108 1.28 x 109 1.92 x 109
EU/capsule EU/capsule EU/capsule EU/capsule EU/capsule
218
Mustang Chromatography Cartridges
Technical Specifications
219
Mustang Chromatography Capsules and Cartridges
Ordering Information
220
Resolute* Chromatography Columns
Process Columns for Fast, Contained and Reproducible Operation
DAP Hydraulic linear actuator when column is empty or Flow Packing at optimal linear velocity
Dynamic Axial Packing filled with slurry and has an open flow path with
< 3.0 bar column pressure
/M Option Actuators and integral support and safety devices Access to top and bottom bed supports and seals
Hoist-free Maintenance move and secure Top Adjuster and Column Tube for changeout
(/M option available for either HEP or DAP model)
Resolute 400 400 mm (15.7 in.) 1260 cm2 100 – 300 mm 12.6 – 37.7 L 3 bar (44 psi)
Resolute 800 800 mm (2.6 ft) 5030 cm2 100 – 300 mm 50.3 – 150 L 3 bar (44 psi)
Resolute 1000 1000 mm (3.2 ft) 7850 cm2 100 – 300 mm 79 – 235 L 3 bar (44 psi)
Resolute 1400 1400 mm (4.6 ft) 15390 cm2 100 – 300 mm 154 – 461 L 3 bar (44 psi)
Resolute 1800 1800 mm (5.9 ft) 25450 cm2 100 – 300 mm 255 – 763 L 3 bar (44 psi)
222
Resolute* Slurry Packing Systems
Integrated systems for Scalable Packing and Unpacking of Process Chromatography Columns
Resolute slurry packing systems (SPS) are Compatible with a wide range of
optimized for use with Resolute columns. Chromatographic Media
With the flexibility of 4 systems in the
Increasingly, new types of chromatographic
series, column packing and unpacking can
media with specific packing methods are
be optimized for one or multiple columns
specified for purification processes now in
up to 2000 mm diameter. The Resolute
development. Packing an efficient column
SPS provides simple control of the column
requires a comprehensive understanding of
packing and unpacking process within a
the media characteristics as well as a
cGMP environment. The proven design
packing system with adequate flow
provides scalable packing performance
capacity and flow control. Resolute
for column diameters from 400 mm to
systems deliver excellent performance with
2000 mm with most commonly used
a wide range of media types and column
media types. A range of ancillary
configurations including axial compression
equipment integrates all aspects of the
techniques.
packing and unpacking process.
223
Resolute Slurry Packing Systems
Technical Specifications
Operating Conditions
Model SPS-M1 SPSM2/2E SPS M3
Dimensions 1300 x 875 x 1300 x 875 x 1400 x 875 x
(L x W x H) 1259 mm 1259 mm 1292 mm
(51 x 34 x 49 in.) (51 x 34 x 49 in.) (55 x 34 x 50 in.)
224
PK Chromatography Skids
Improving Choice, Flexibility and Operating Costs for Purification Processes
225
PK Chromatography Skids
Technical Specifications
Flow through Instrumentation Instrumentation flow cell in-line, Design Standards ASME BPE, GAMP
eliminating dead-legs and minimizing CFR 21 Part 11 Compliance Yes
hold-up volume
System Sizes
System PK10 PK25 PK50 PK300
Flow Range (L/H) 10 – 100 25 – 400 50 – 1000 300 – 4000
Piping id 4.6 mm (0.18 in.) 12.5 mm (0.5 in.) 15.7 mm (0.62 in.) 34.8 mm (1.4 in.)
Pipe Connections 6 mm (0.25 in.) 12.5 mm (0.5 in.) 18 mm (0.75 in.) 38 mm (1.5 in.)
Sanitary Clamp Sanitary Clamp Sanitary Clamp Sanitary Clamp
Uncrated Weight 250 kg (550 lbs) 275 kg (606 lbs) 300 kg (660 lbs) –
226
Palltronic® Instruments
Palltronic Instruments
®
228
Palltronic Flowstar XC Filter Integrity Test Instruments
®
See Also:
Palltronic Flow Check Device p. 233
229
Palltronic Training Program p. 234
Palltronic Flowstar XC Filter Integrity Test Instruments
Technical Specifications
Forward Flow ± 3% or ± 0.05 mL/min Vent Hose Connection 8 mm (0.31 in.) Outer Diameter
(whichever is greater)
See Also:
Palltronic Flow Check p. 243
Pall Advanta Gas Housings
Pall Advanta AGT p. 165
Single Round Housings
Pall Advanta AVL p. 167
Single Round Housings
Materials
Other Functions
Stainless Steel – Water Wet DIN 1.4404(1)
Air Clean program, Test Program memory capacity of 500 programs, Test
Stainless Steel – Frame DIN 1.4301(2)
result memory capacity, 10,000 test results and User ID memory capacity
of 250 users Seals EPDM
High-flow:
0.1 – 2,000 mL/min Printer
Bubble Point Test 700 – 6000 mbar (10 – 87 psi) Type Thermal
Printout Lifetime 10 Years
Accuracy Paper Width 112 mm (4.4 in.)
Forward Flow Test +/- 3% or +/- 0.05 mL/min, Paper Roll Diameter 50 mm (1.9 in.)
whichever is the greater
Water Intrusion Test 0.01 mL/min Test Pressure Range 50 – 6000 mbar (0.7 – 87 psi)
Forward Flow Test Measured Flow >10 mL/min:
0.1 mL/min
Ordering Information
Measured Flow <10 mL/min:
0.01 mL/min Standard High-flow
Bubble Point Test 50 mbar (0.72 psi) Part Number AW02XC AW02XCH
(1)
DIN 1.4404 element composition limits are comparable to 316L.
232 (2)
DIN 1.4301 element composition limits are comparable to 304.
Palltronic Flow Check Device
®
Nominal Dimensions
Weight 1.67 kg (3.68 lbs)
Size (H x W x D)(1) 90 x 150 x 180 mm (3 in. x 5 in. x 6 in.)
(1)
L = maximum length including Staübli* connection)
Environmental Conditions
Operating Temperature 20 °C ± 2 °C (68 °F ± 35 °F)
Storage Conditions Room temperature in dry conditions
Pneumatic Specifications
Operating Pressure 2 barg (29 psig)
Maximum Inlet Pressure 3.0 barg @ 40 °C (44 psig @ 104 °F)
Test Gas Clean, dry, compressed air or nitrogen
Flow Range 1 – 10 mL/min
Connections
Inlet Stäubli* nipple RBE03.6150
Outlet Hose Connection:
8 mm (0.25 in.) outer diameter
* Stäubli is a registered trademark of Stäubli AG.
Ordering Information
Part Number FC01
233
Palltronic Training Program
®
234
Drivers for Palltronic Filter Integrity Test Instruments
®
See Also:
Palltronic Flowstar p. 239
235
Aquawit Instruments p. 241
Drivers for Palltronic Filter Integrity Test Instruments
Technical Specifications
Schematic
The schematic below shows signals and data transfer between the
Palltronic test device, PLC and SCADA systems
SCADA
Serial Number
Software Version
Last Calibration Date
Self Test Result
Flowrate or BP Measurement
Result
Driver
Palltronic Device Operation
Test Running
Ordering Information(1)
Part Number Palltronic Device PLC Other Requirements
SDFFS02 Palltronic Flowstar FFS02 Siemens S7-300 RS232 communications module
and XC instruments FFS02 device and S7-400
CDFFSXC Palltronic Flowstar XC OPC Server Any PC package which supports OPC Serial communication port (RS232C)
(1)
This is a guide to the part number structure only. For availability of specific options, please contact Pall or your local Pall representative.
Drivers for other Palltronic models and PLC manufacturer makes and models can be developed on request. Please contact your local Pall company or distributor for further information.
A Palltronic Flowstar FFS02 interface description for remote operation and on-line data logging is available. Pall literature reference USTR2148.
236
Palltronic Filter Manager
®
The Palltronic Filter Manager is an • Hard copy printout with date and time
automated filterability test unit which can displayed helps documentation
be used to test direct flow filters either at requirement
constant pressure or at constant flow. This
• Provides the technological controls to
allows to simulate exactly your processes,
meet the regulatory requirements of
and such a unit can be used for modeling
21 CFR Part 11
of filtration processes either during
scale-up or during scaling down for trouble • Automatic Self Test to check proper
shooting processes or validation test work. functioning of software and internal
components
Palltronic Filter Manager, an instrument
especially designed for laboratory • Extensive validation documentation and
environment is compact, flexible and qualification of hardware and software
splash-proof. The latest touch-screen for compliance with industry and
technology makes the unit extremely user- regulatory requirements
friendly with simple menu-driven data • Designed for easy servicing
input.
Temperature
graphical format Transducer
Collecting
Control Air Supply Vessel
Panel (Unregulated)
Balance
237
Palltronic Filter Manager
Technical Specifications
Ordering Information
Manual Palltronic Filter Manager UM01M
(Test stand and disc holders)
238
Pall Technical Services
Pall Technical Services
With over 50 years of experience in separation Pall’s Total Fluid Management program
technologies, and global reach, Pall provides a provides a full range of products, services and
comprehensive range of technical and support to meet your fluid processing needs.
consultative services: We maintain thirty five well equipped
laboratories worldwide to help solve your
• Validation of filtration processes filtration, separation and purification problems
and provide access to more than four
• Aseptic connector validation
hundred trained Pall scientists and engineers,
• Disposable systems validation as well as links with many specialists in
industry and academia.
• Validation of integrity test equipment
• Training
• Pre-inspection reviews
240
Process-Specific Filter Validation
241
Process-Specific Filter Validation
Technical Specifications
Ordering Information
Test Summary Test Requirements Part Numbers
Compatibility Assessment
To be suitable for use in the manufacture of a pharmaceutical drug product, a – Full process information PTS01CA
filter cartridge must be both chemically and physically resistant to the process – Full product composition
stream and operating conditions. Laboratory tests can be used to establish – Approximately 2000 mL of product
chemical compatibility.
Product Viability Study
Many pharmaceutical products are bactericidal. This test verifies the survival – Full process information PTS01VA (Basic)
capacity of the organism selected for microbial challenge testing, in the whole – Full product composition PTS01VB (Mid)
product or a suitable product simulant, for the process time. – Approximately 200 mL of product PTS01VC (Complex)
Microbial Retention Study
This is to qualify the ability of the filter media to produce sterile filtrate in the – Full process information PTS01BA (Basic)
process. A solution of the product or simulant will be inoculated with the – Full product composition PTS01BB (Mid)
challenge organism at a concentration > 1 x 107 viable organisms/m2 of filter – Approximately 1000 mL of product PTS01BC (Complex)
membrane area. The challenge is carried out on three filter membranes from
different production batches, with at least one being at minimum specification.
Extractables Analysis
Both quantitative and qualitative information on extracted materials must be – Full process information PTS01EA (Generic)
generated. Commonly, extractables cannot be evaluated directly in the actual – Full product composition PTS01EB (Laboratory tests)
product, but a “Model Solvent” approach must be developed. The Pall
Validation Laboratories use a filter cartridge tested with the appropriate
“Model Solvent” to reproduce a worst case situation.
Evaluation of Adsorptive Effects
It is critical that filters are selected to minimize adsorption and loss of product – Full process information PTS01AA
components. Laboratory scale tests can be used to generate adsorption – Full product composition
profiles to help with filter selections and process qualification. – Approximately 1000 mL of product
– Analytical test methods
Generation of Product Wet Integrity Test Parameters
Integrity tests performed on critical filters immediately before and after batch – Full product composition PTS01PA
filtration confirm performance to specification. In order to optimize processing – Approximately 1000 mL of product
it may be more convenient to integrity test the filter cartridge wet with the
product. Pall Validation Services Groups can provide users with the integrity
test data for these specific products.
242
Kleenpak™ Connector Validation
Collection Bag
Female Connector
Tubing
Supply Bag
Clamp
Male Connector
243
Kleenpak Connector Validation
Technical Specifications
Ordering Information
Test Summary Part Numbers
Compatibility Assessment
The Kleenpak connector is considered compatible with a product if exposure under process conditions does not PTS01CG
alter its ability to perform intended functions.
Tests that evaluate the physical integrity of the Kleenpak connector, such as the pressure exposure test can be used to
establish compatibility with specific product or process conditions. During the pressure exposure test, the connector is
exposed to process pressure conditions for a suitable duration at process temperature.
Dimensions are measured to verify conformance to specifications under process conditions.
Soiling Test
The soiling test was developed to evaluate the ability of the Kleenpak connector to produce a sterile fluid path after the
protective peel-away strips of the male and female connectors have been intentionally contaminated with a Geobacillus
stearothermophilius spore suspension. After the deliberate contamination, the connection is made and sterile trypticase
soy broth (TSB) is passed through the connector to a collection container. The container is incubated and analyzed for
contamination. The results of this soiling test are reported in the Validation Guide of the Kleenpak connector.
Process-specific soiling tests can be developed and performed as below:
Fluid specific: standard organism (Geobacillus stearothermophilius), specific product fluid PTS01SA
Organism specific: process specific organism, standard fluid (TSB) PTS01SB
Full process specific: process specific organism and fluid PTS01SC
Extractables Analysis
Extractables analysis can be performed on the Kleenpak connector by choosing suitable model solvents as the PTS01EJ
extracting agent to represent a range of buffers, media and process fluids. Quantitative and qualitative analysis
can be performed. TOC, pH value and conductivity can be determined as well.
Note: To ensure timely and accurate analytical work, Pall laboratories require complete information on product specification and process conditions such as pressure, temperature and
duration before commencing analysis. Each of the validation projects also requires approximately 2000 – 3000 mL of product.
244
Disposable Filtration System Validation
Ordering Information
Test Services Part Numbers
Capsules Microbial Retention PTS01BA (Basic)
PTS01BB (Mid)
PTS01BC (Complex)
PTS01BD (Cartridge challenge studies)
PTS01BE (Process specific bacteria)
PTS01BF (Cytotoxics)
246
Contamination Analysis
247
Contamination Analysis
Further Information
Contaminant Collected
Optical Microscopy
Charges
Wherever possible, we provide a fixed price in advance for the
project. Where this is not possible, we will give an estimate to assist
Scanning Electron Microscopy
with X-ray Emission Spectroscopy you in budgeting and cost control. The final invoice gives details on
items such as labor, and materials.
PTS 04 **
248
Process Development and Optimization
249
Process Development and Optimization
Further Information
Facilities Charges
Pall's Scientific and Laboratory Services (SLS) is represented by thirty Each project is assessed individually. Wherever possible, we provide a
five laboratory facilities at strategic locations world-wide. Many of fixed price in advance. Where this is not possible, we will offer an
these laboratories have their own process wet test area where estimate to assist you in budgeting and cost control.
customer fluids or simulated products can be tested. Equipment can
The final invoice gives details on items such as labor, and materials.
also be rented for trials.
This laboratory network is backed by specific centers of expertise in What’s the Next Step?
downstream processing and has direct access to core R&D centers
where more advanced customer liaison. Contact your local Pall representatives. They will discuss your specific
requirements with you and forward your enquiry to Pall technical
In response to the increasing importance of biotechnology processes specialists.
and products, specialized biologics laboratories have been created in
Portsmouth (UK) and in Florida and New York (USA). Capabilities
include mammalian cell culture and bacterial fermentation with
qualification to handle genetically modified organisms to Class 2,
equipment for optimization of downstream processes including
membrane chromatography, development of disposable systems,
and many aspects of bioanalytical support.
Time is Valuable
Pall recognizes customers’ increasing requirement to reduce the time
to take products to market. Pall has over 50 years of innovation and
development experience with proven solutions, for membrane
purification and separation. Whether it is direct flow filtration,
tangential flow filtration, chromatography or disposable systems, Pall
can deploy a range of scalable and reproducible products for every
application. This is backed with the capability to provide complete
documentation for every test protocol or complete unit operation.
Delegating process development to Pall technologists can
substantially reduce process-development time.
PTS 07 **
250
Training
251
Training
Example Training Courses
PTS 03 **
252
Pre-Inspection Reviews
• Filter selection
• Product certification
• System design
• Operating procedures
• Sterilization procedures
• Integrity testing practice
253
Pre-Inspection Reviews
Technical Data and Filter Selection
Regulatory authorities will expect BioPharmaceutical manufacturers to Operating and Sterilization Procedures
understand the technical specifications of the filters that they use and
Processing limits for critical filters (temperature and pressure, for
to be able to justify that each filter is appropriate for the process.
example) are provided by Pall in its technical documentation. It is
Pall specialists will: necessary to understand how these limits relate to the process in
• Document all the filters you use, by part number and application which the filter is being used. This is important to avoid damage to
the filter and possible adverse effects on the product being
• Assess whether the filters are suitable for the operation in which
processed. This therefore can form part of a regulatory authority
they are being used
audit.
• Ensure you have key technical data and filter qualification reports
Our experts will review the types of filters being used, review the
available in a form ready for audit
processes being operated, and review the documentation supporting
the processes. We will then detail any improvements recommended
Validation Data and, if requested, will help with the rewriting of documents such as
Regulatory authorities expect that the users of sterilizing-grade filters Standard Operating Procedures.
have assessed and confirmed that:
Integrity Testing Procedures
• The filter does not alter the product adversely
• The product does not affect the filter adversely Integrity testing is a mandatory requirement for critical production
filters. Regulatory audits would normally include a review of:
• The process conditions do not affect the filter adversely
• Integrity test method employed
This usually involves a range of process simulation tests involving
techniques such as bacterial retention, extractables analysis, active • Test parameters
ingredient adsorption etc. • Temperature range
We will advise you of the current filter validation requirements as part • Integrity test equipment used
of the review, assess your current documentation, and recommend
• Documentation available to support test instruments
any additional testing.
We review all these areas and can recommend possible
Product Certification improvements.
Where Pall filters are supplied for critical processes they are Charges
supported by a manufacturer's certificate of test. Regulatory
authorities expect this certificate to be checked before the filter is Wherever possible, we provide a fixed price in advance for the
used and referenced in batch documentation. As part of the pre- project. Where this is not possible, we will give an estimate to assist
inspection review, we will ensure the user understands the data you in budgeting and cost control.
supplied and discuss how it should best be used. The final invoice gives details on items such as labor, and materials
254
Filter Integrity Test Equipment Validation
Filter integrity testing can be one of the 2. Alternatively, all OQ tests in the form of
most critical procedures in a filtration a standard system acceptance test
process and may be an essential (SAT) can be performed on your
requirement for batch release of a product. specific instrument. A customized SAT
The increasing requirement for accuracy protocol can also be prepared for you if
and documentation has resulted in a wider required.
use of automated integrity test equipment.
Performance Qualification PQ
Use of such equipment must be validated We can also assist in generating
to ensure that it satisfies both process and customized PQ protocols and, if required,
regulatory requirements. perform the tests.
your site.
Operational Qualification OQ
We offer two options.
1. GAMP* guidelines state that the OQ of
standard instruments such as integrity
test units can be divided into two parts.
A completed OQ1 containing extensive
qualification studies on a reference
instrument. A shorter OQ2 protocol on
your specific instrument is then
performed, saving both time and cost.
255
Filter Integrity Test Equipment Validation
Further Information
We have all the necessary equipment to ensure that qualification tests Reports
are performed accurately and reliably. We also supply materials such On completion of the tests, the final reports are reviewed, approved
as filters. This capability means that we can offer a fast, professional and signed by a competent Pall specialist. The full documentation is
and cost-effective service. then submitted to you for approval.
PTS 02 **
256
Troubleshooting and Consultancy Services
257
Troubleshooting and Consultancy Services
Further Information
Facilities In all cases, the report will be reviewed, approved and signed by the
Pall specialist. You may choose to countersign the document as
Laboratories
confirmation of receipt and acceptability of content.
We maintain thirty five laboratories well equipped worldwide to help
Our aim is to ensure not only that your problems are resolved or
solve your filtration, separation, and purification problems
processes improved, but that the investigations are fully documented
People and comply with appropriate manufacturing practices.
We are a network of more than four hundred trained scientists within If required, we will present the basis of the report in a formal meeting
Pall as well as links with many specialists in industry and academia. with you.
Equipment
Our equipment includes scanning electron microscopy, HPLC, mass Charges
spectrometry, TOC analysis, FTIR spectroscopy, GC, filterability kits, The variable nature of troubleshooting and consultancy work means
integrity test units…and many more. that we have to assess projects individually. Wherever possible, we
Databases provide a fixed price in advance. Where this is not possible, we will
We maintain a comprehensive range of internal databases for give an estimate to assist you in budgeting and cost control.
troubleshooting. We also subscribe to external databases to ensure The final invoice gives details on items such as labor, and materials.
the broadest capability and fastest response.
Communications What’s the Next Step?
We operate a Lotus Notes and Intranet system to ensure fast and Contact your local Pall representatives. They will discuss your specific
efficient communications worldwide twenty four hours a day. requirements with you and forward your enquiry to Pall technical
Documentation specialists.
PTS 06 **
258
Systems
Systems
260
Pall Process Engineered Systems
Automated Separation and Purification Systems
The requirements for a new process are Expert Application Knowledge for
seldom the same. Therefore, we begin Our Customers
each enquiry with a project review based
Pall has a large multi-disciplinary team of
on the individual requirements.
engineers and scientists with in-depth
Our product portfolio and technology knowledge of applications and operating
platform is comprehensive and allows us to parameters for separation systems in
always offer the best technical approach biological, BioPharmaceutical and chemical
for each application. We use proven processes. Operating within the PASS (Pall
features, proven designs and proven Advanced separations Systems) group for
packages wherever appropriate. projects and within the SLS (Scientific and
Laboratory Services) and R&D
Short Timescales — Best Results organizations for longer term development
and analysis, they enhance the total
The time-span from drug development to
package for process development and
market introduction is crucial for
advanced solutions.
commercial success. with our extensive
experience and production capabilities, pall
can help to keep this time to a minimum. GMP and GAMP Approach
our project teams focus on your We manage our projects and design our
requirements and directly interlink with your systems in accordance with industry
team over the whole project from guidelines to ensure customer and
specification to commissioning. This regulatory requirements are met.
approach helps to build each system to
The GMP requirements on validation and
your user documentation in the shortest
documentation for automated systems in
possible time.
BioPharmaceutical production are defined
in Annex 15 of the EC Guide to Good
Process Automation for Cost
Manufacturing Practice of Drug Products
Savings
and in other international regulatory
With GMP and documentation guidelines. For the US market, 21 CFR
requirements increasing, process Part 11 further influences the design of
automation is a good investment to electronic recording systems. In addition,
optimize overall production costs: the ISPE Forum has published its
Less operator interference makes comprehensive GAMP Guide to create a
processes run smoothly, validation easier common project design approach for
and with minimum downtime. industry users and
vendors, from a formal user requirement
Pall’s automation solutions are designed for
specification to system commissioning and
process integration and interfacing, in
ongoing maintenance of a validated
compliance with 21 CFR 11, from simple
system. The ASME Bioprocessing and
data logging to full batch records with
European (EHEDG) guidelines are also
electronic signatures.
important reference points for specific
equipment.
261
Pall Process Engineered Systems
Over and above these general guidelines, Pall brings its long-standing
experience in design and manufacture of purification and separation
systems for GMP applications. This unique combination of experience Enquiry or
Tender
in implementation of sanitary design and regulatory requirements
together with process technology know-how provides reassurance of Early Process & Initial System Design In Depth System
Engineering Design & Accurate Budget & Process Design
our ability to meet quality targets. Technical Review Cost Submittal Review
Process
During the whole qualification phase of a new project, Pall is ready Development
and willing to provide support services. we routinely provide a clear
understanding of the scope of responsibilities, develop formal Final System Design
Contract Review
Regular Project
& Fixed Price Review & Update
validation plans and are prepared to assist with all stages of Meeting
Submittal Meetings, Reports
qualification from factory acceptance through to site installation.
When in operation, your Pall system can be monitored continuously
to predefined parameters and all relevant process data logged in a System FAT Delivery & SAT
(Factory Acceptance (Site Acceptance Ongoing Support
comprehensive batch record file to assure the consistency of your Test) Test)
process in accordance with cGMP criteria.
Customer Support
Pall is organized functionally and geographically to give us the closest
link to our customers and fastest response times.
Control Operational
• Installation support
Equipment FS
System FS Check
• Operator training
• After-market service
Mechanical and Operating Control Installation
Electrical Design Interface Design System Design Check • Service contracts
Mechanical and
Electrical Build
Operating
Interface Build
Control System
Programming
263
DGM Plate and Frame Filter Systems
Technical Specifications
Applications
• Plasma fractionation
• Cell harvest
• Clarification of therapeutical proteins, vaccines, diagnostics,
enzymes, and antibiotics
• Removal of activated carbon
• Activated carbon filter
• Removal of filter aids
• Removal of catalysts
Due to the enclosed design of the Membraplan DGM, for the first
time a complete CIP cleaning can be carried out, which — in
combination with manual precleaning-guarantees the reproducibility
of the cleaning method by the FDA Inspection Guide on Cleaning
Validation. The filer plate design was specially developed for strict
requirements on hygiene and cleanliness in the biotechnological and
pharmaceutical industry taking the recommendations and regulations
of FDA, GMP and 3-A into consideration. Closing of the filter pack is
carried out via hydraulic cylinder with mechanical locking.
The pneumatically operated hydraulics are installed on the cross
member and are explosion proof as standard (no electrical
components).
Technical Specifications
Membraplan DGM DG Filter Press DGM Plate and Frame
Size 300 = 300 x 300 mm 600 = 600 x 600 mm
(11.8 x 11.8 in.) (23.6 x 23.6 in.)
400 = 400 x 400 mm 800 = 800 x 800 mm
(1.7 x 15.7 in.) (31.4 x 31.4 in.)
1000 = 1000 x 1000 mm
(39.3 x 39.3 in.)
Chassis Size 30 60
50 100
150
200
Note: Please contact Pall Corporation for additional technical information for sizing and
selection of the correct Membraplan DGM filter press system.
264
ZHF Centrifugal Discharge Filter System
Advantages
• Totally enclosed system for safe
operation
• Short down time by automatic
discharge of filter cake
• Even distribution of filter cake by the
horizontal filter element arrangement
• Easy installation and reduced filter
height due to bottom mounted filter
drives
• Minimal liquid phase loss due to
recovery via scavenge filtration system
• Easy assembly and low maintenance
using wearing sleeves on all dynamic
seal areas
• Seals and bearing can be changed
without removing the filter internals
• Filtration possible with or without use of
filter aids
265
ZHF Centrifugal Discharge Filter System
Technical Specifications
Ordering Information
Filter Type Number of Filter Area of Number of Scavenge Scavenge Total Theoretical
Filter Elements Main Elements Filter Elements Filter Area Filter Area Cake Volume
ZHF-SR 2.5 13 2.2 m2 (23.6 ft2) 2 0.35 m2 (3.76 ft2) 2.55 m2 (27.4 ft2) 70 L
ZHF-SR 5.0 10 4.7 m2 (50.5 ft2) 2 0.94 m2 (10.11 ft2) 5.64 m2 (60.7 ft2) 170 L
ZHF-SR 10 21 9.87 m2 (106.2 ft2) 2 0.94 m2 (10.11 ft2) 10.81 m2 (116.3 ft2) 300 L
ZHF-SR 15 32 15.04 m (161.8 ft )
2 2
2 0.94 m (10.11 ft )
2 2
15.98 m2 (172.0 ft2) 450 L
ZHF-SR 20 28 19.88 m2 ((213.9 ft2) 2 1.42 m2 (15.2 ft2) 21.3 m2 (229.2 ft2) 600 L
ZHF-SR 25 35 24.85 m2 (267.4 ft2) 2 1.42 m2 (15.2 ft2) 26.27 m2 (282.7 ft2) 760 L
ZHF-SR 30 28 30.1 m (323.9 ft )
2 2
3 2.1 m (22.6 ft )
2 2
32.2 m (346.5 ft )
2 2
900 L
ZHF-SR 40 37 39.77 m2 (428.0 ft2) 4 2.8 m2 (30.1 ft2) 42.57 m2 (458.2 ft2) 1200 L
ZHF-SR 50 47 50.52 m2 (543.7 ft2) 4 2.8 m2 (30.1 ft2) 53.32 m2 (573.9 ft2) 1500 L
ZHF-SR 60 55 59.12 m2 (636.6 ft2) 5 3.5 m2 (37.6 ft2) 62.62 m2 (674.0 ft2) 1800 L
ZHF-SR 80 61 64.66 m (695.9 ft )
2 2
6 4.2 m (45.2 ft )
2 2
68.86 m (741.2 ft )
2 2
1900 L
ZHF-SR 90 72 76.32 m2 (821.5 ft2) 6 4.2 m2 (45.2 ft2) 80.52 m2 (866.7 ft2) 2300 L
ZHF-SR 100 81 85.86 m2 (924.2 ft2) 7 6.36 m2 (68.4 ft2) 92.22 m2 (992.6 ft2) 2600 L
ZHF-SR 110 59 97.35 m2 (1047.8 ft2) 6 6.36 m2 (68.4 ft2) 103.71 m2 (1116.3 ft2) 2900 L
ZHF-SR 130 69 113.85 m2 (1225.4 ft2) 6 6.36 m2 (68.4 ft2) 120.21 m2 (1293.9 ft2) 3400 L
ZHF-SR 150 77 123.2 m (1326.1 ft )
2 2
7 7.21 m (77.6 ft )
2 2
130.41 m2 (1403.7 ft2) 3700 L
Note: Maximum usable volume is 2/3 of theoretical volume.
266
PEF Multi Purpose Processor
267
PEF Multi Purpose Processor
Technical Specifications
Technical Specifications
Materials Stainless steel, Hastelloy, Titanium
Pressure Rating Up to 6 bar
(higher pressures upon request)
800 0.48 m2 550 L 120 L 250 mm 5 – 28 9.5 2.9 3260 x 1920 x 3500 mm
(5.17 ft2) (9.84 in.) (128 x 76 x 138 in.)
1000 0.78 m2 850 L 234 L 300 mm 2.5 – 22 15.5 3.4 4160 x 2200 x 3580 mm
(8.40 ft2) (11.8 in.) (164 x 87 x 141 in.)
1250 1.2 m2 1300 L 420 L 350 mm 2 – 15 15.5 6.5 4215 x 2000 x 3700 mm
(12.9 ft2) (13.8 in.) (166 x 79 x 146 in.)
1600 2.0 m2 2300 L 840 L 420 mm 2 – 15 23.0 9.6 4110 x 2500 x 4380 mm
(21.5 ft2) (16.5 in.) (162 x 98 x 172 in.)
2000 3.0 m2 3800 L 1260 L 420 mm 2 – 12 36.0 12.7 4900 x 2820 x 5000 mm
(32.3 ft2) (16.5 in.) (193 x 111 x 197 in.)
268
Water Systems
Full process review and skilled design optimization mean that Pall can Other important features of Pall’s high purity water systems include,
apply UF in its systems with considerable advantages to end-users. according to process requirements, ozone dosing, ultraviolet (UV)
treatment, carbon filters, ion exchange (softeners) and chemical
Benefits include
dosing. Pall’s own cartridge filters are also employed to protect tank
• Excellent protection when used in prefiltration vents, and as highly effective prefiltration or point-of-use guard filters.
• Steam in place options available for pyrogen applications
• Sanitary and cleanable designs where required in final processing
Storage and Distribution
Total system design ensures that water is purified, stored and
Reverse Osmosis distributed with quality maintained to specification all the way. Tank
designs take into account sizing, choice of material and microbiogical
Reverse osmosis (RO) is the finest level of membrane separation in
considerations. Additional components such as heat exchangers,
liquids. The RO membranes used in Pall systems act as an efficient
filters, UV, ozone and point-of-use valves are selected on technical
barrier to all dissolved salts and inorganic molecules as well as most
merit, simplicity, efficiency and cost effective maintenance. Loop
organic compounds (organics typically greater than 100 Daltons in
pressure and flow rates are carefully designed and controlled to meet
molecular weight).
microbiological and safety considerations.
Water passes freely through, while salts are rejected typically from
98% to over 99%. Microbiological Protection
Pall has optimized the pretreatment, design and staging of RO High quality water has to be properly handled and protected from
systems in single or multipass arrangements for stable and low contamination right up to point-of-use.
fouling performance and for extremely high recovery (water
conversion) rates without the use of chemicals. The hydrophobic vent filters in Pall systems provide high sterility
assurance and generous air flow rates with minimum risk of blockage
Benefits include by wetting. Integrity testing of the filters is achieved with minimum
• Compact and modular design fuss and maximum confidence.
• No added chemicals Final water quality at point-of-use is ensured by high flow rate, long
life sterilizing grade filters capable of absolute removal of even the
• Very high rejection rates producing high purity filtrate
smallest organisms which may be encountered in practice.
• Maximum efficiency in throughput
• Recovery rates as high as 95% Pall Advanced Separations Systems
Pall Advanced Separations Systems (PASS) is an independent
Nanofiltration engineering and procurement entity for Pall’s global separations
Pall also uses nanofiltration (NF) water technology with similar but systems business. To successfully deliver high purity water systems
slightly more open membranes than RO. The modules have higher that meet stringent customer requirements we have excellence in:
unit capacity and lower operating pressures for greater economy • Process System Design
where higher passage of monovalent ions and some small organics is
• Documentation
not an important factor.
• Systems Fabrication
These systems are used typically to produce softened process water
and for removal of high levels of common organic compounds found • Project Management
in some waters. PASS will provide the following:
• Installation Support
Other Technologies
• Systems Design
Membrane systems listed above can meet most requirements for
process water, purified water and highly purified water or water for • Document Preparation
injection (WFI) quality. • Validation/Qualification
Some regulations still demand that WFI must be prepared using • Risk Analysis
distillation. Pall systems can be used in parallel or in series with
• Operator Training
distillation and are often employed to take load off existing distillation
installations. Distillation can be incorporated into systems when • Spare Parts
required.
• Service Contracts
• After-Market Service
270
Appendix
Filter Configurations and Dimensions
Adapter Code 7
Diameters of Adapters
Code 2 56.4 mm (2.22 in.)
Ø Code 3 44.2 mm (1.74 in.)
Code 7 56.4 mm (2.22 in.)
Length
Length
SBF1 AVF
Length Length
272
Filter Configurations and Dimensions
(Continued)
Height
Height
Height
Note
In this catalog, any reference to sanitary
flanges for housings or disposable filters
pertains to ferrules designed for use in
connection with mating Tri-Clamp* fittings of
the same dimension, unless otherwise
specified.
* Tri-Clamp is a registered trademark of Alfa Laval, Inc.
273
O-ring and Gasket Reference Guide
Gaskets:
1001 style, 1201 style, Uni Loc
H2 PTFE(3) Gaskets:
1001 style and Uni Loc
H4 Silicone O-rings:
AB codes 7, 8, 2 and 3, Juniors
Gaskets:
1001 style, 1201 style, Uni Loc
Gaskets:
1001 style, 1201 style, Uni Loc
Gaskets:
1001 style, Uni Loc
274
Index
Acids – Capsules
A
Acids – filtration of Auxiliaries and Water Purification 10 Bubble Point Test
Sterilizing-grade Capsules Integrity Test Instruments
Kleenpak™ Capsules with Supor® EKV Palltronic® Aquawit XC System 231
B
Membrane Assemblies 79 Palltronic® Flowstar XC Filter Integrity
Kleenpak™ Nova Sterilizing-grade and Bacterial Challenge Tests Test Instruments 229
Virus Removal Capsule Filters 101 Disposable Filtration System Validation 245 Test Parameters
Novasip™ Liquid Sterilizing-grade Process-Specific Filter Validation 241 Process-Specific Filter Validation 241
Capsule Filters 99 Bacterial Contamination Analysis Buffer Exchange
Sterilizing-grade Cartridges Contamination Analysis 247 Tangential Flow Filtration Membrane Cassettes 185
Fluorodyne® II Hydrophilic PVDF Filter Cartridges 87
Supor® EBV Sterilizing-grade Filter Cartridges 83 Bacterial Removal – air and gas applications Buffer Filtration
Supor® EKV Sterilizing-grade Filter Cartridges 81 Capsules Capsules
Kleenpak™ Capsules with Emflon® II Kleenpak™ Capsules with Supor® EKV
Activated Carbon Removal and Recovery Membrane Assemblies 115 Membrane Assemblies 79
DGM Plate and Frame Filter Systems 263 Kleenpak™ Capsules with Emflon® PFR Kleenpak™ Nova Sterilizing-grade and 101
Rigimesh® Sintered Metal Mesh Membrane Assemblies 117 Virus Removal Capsule Filters
Filter Cartridges 137 Novasip™ Capsules with Emflon® PFR Mini Kleenpak™ Sterilizing-grade
Supracap™ 200 Encapsulated Membrane Assembles 113 Capsule Filters 77
Depth Filter Modules 33 Cartridges Cartridges
Supracap™ 60 Depth Filter Capsules 31 Emflon® CPFR High-temperature Supor® EBV Sterilizing-grade Filter Cartridges 83
Supradisc™ Depth Filter Modules 27 Sterilizing-grade Filter Cartridges 125 Supor® EKV Sterilizing-grade Filter Cartridges 81
Supradisc™ II Modules 29 Emflon® PFR Junior Style Filter Cartridges 121
ZHF Centrifugal Discharge Filter Systems 265 Bulk Chemical for Filtration for APIs
Emflon® PFR Sterilizing-grade Filter Cartridges 123
Emflon® FM Filter Cartridges 73
Activated Carbon Trap Filter Bacterial Removal – liquid applications Marksman™ Elements with Nexis® A
Emflon® FM Filter Cartridges 73 Capsules Series Filters 67
Marksman™ Elements with Nexis® A Kleenpak™ Capsules with Fluorodyne® II Marksman™ Elements with Poly-fine® II
Series Filters 67 Membrane Assemblies 85 Series Filters 71
Marksman™ Elements with Poly-fine® II Kleenpak™ Capsules with Posidyne® Marksman™ Elements with Poly-fine® XLD
Series Filters 71 Membrane Assemblies 95 Series Filters 69
Marksman™ Elements with Poly-fine® XLD Kleenpak™ Capsules with Supor® EKV
Series Filters 69 Membrane Assemblies 79
Profile® Filter Cartridges with Ultipleat® Kleenpak™ Capsules with Ultipor® N66
C
Construction 59 Membrane Assemblies 89 Cake-drying
Profile® Star Filter Cartridges 55 Kleenpak™ Nova Sterilizing-grade and 101 PEF Multi Purpose Processor 267
Activated Carbon – depth filters with Virus Removal Capsule Filters Calibration
Supracap™ 200 Encapsulated Mini Kleenpak™ Sterilizing-grade Capsule Filters 77 Palltronic® Flow Check Device 233
Depth Filter Modules 33 Novasip™ Liquid Sterilizing-grade
Supracap™ 60 Depth Filter Capsules 31 Capsule Filters 99 Capsules – chromotography
Supradisc™ Depth Filter Modules 27 Cartridges Mustang® Chromatography Capsules
Fluorodyne® II Hydrophilic PVDF Filter Cartridges 87 and Cartridges 217 – 220
After-market Service Mustang® Membrane
Posidyne® Filter Cartridges 97
Pall Process Engineered Systems 261 Chromatography Starter Kits 211 – 214
Sealkleen™ Membrane Filter Cartridges 91
Air-Gas Filtration 111 – 142 Supor EBV Sterilizing-grade Filter Cartridges
®
83 Capsules – depth filter
Amine Charged Polymer Supor EKV Sterilizing-grade Filter Cartridges
®
81 Supracap™ 200 Encapsulated
Mustang® Chromatography Capsules Ultipor® N66 Sterilizing-grade Filter Cartridges 93 Depth Filter Modules 33
and Cartridges 217 – 220 Bacterial Retention Studies Supracap™ 60 Depth Filter Capsules 31
Analytical Services Process-Specific Filter Validation 241 Capsules – direct-flow filtration
Contamination Analysis 247 Bacteriophage retention studies Prefilters – air and gas
Disposable Filtration System Validation 245 Process-Specific Filter Validation 241 Kleenpak™ Capsules with HDC® II
Filter Integrity Test Equipment Validation 255 Gas Filter Assemblies 119
Bases – filtration of Prefilters – liquid
Kleenpak™ Connector Validation 243
Sterilizing-grade Capsules Kleenpak™ Capsules with HDC® II
Process Development and Optimization 249
Kleenpak™ Capsules with Supor® EKV Filter Assemblies 47
Process-Specific Filter Validation 241
Membrane Assemblies 79 Kleenpak™ Nova Particulate and Prefilter
Anion Exchange Kleenpak™ Nova Sterilizing-grade and 101 Capsule Filters 41
Mustang® Chromatography Capsules Virus Removal Capsule Filters Mini Profile® Capsule Filters 45
and Cartridges 217 – 220 Kleenpak™ Ultipor® N66 Sterilizing-grade PreFlow™ Capsule Filters 43
Mustang® Membrane Capsule Filters 89 Sterile Filters – air, gas, and vent
Chromatography Starter Kits 211 – 214 Novasip™ Liquid Sterilizing-grade Kleenpak™ Capsules with Emflon II ®
Starclear™ Filter Cartridges 57 Ultipor® GF Plus Air and Gas Filter Cartridges 107
®
Ultipor GF Plus Filter Cartridges 63 Filter Cartridges 129 Ultipor® VF Grade DV50 Virus
Z-Series Depth Filter Sheets 23 Nylon 6,6 Filter Cartridges – SBF Junior Style 105
Kleenpak™ Ultipor® N66 Sterilizing-grade Ultipor® VF Grade DV50 Virus Removal
Engineering Services Capsule Filters 89 Filter Cartridges 109
Process Development and Optimization 249 Novasip™ Liquid Sterilizing-grade Stainless Steel – 304L
Ethanol Filtration Capsule Filters 99 Rigimesh® Sintered Metal Mesh Filter Cartridges 137
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Sealkleen™ Membrane Filter Cartridges 91 Stainless Steel – 316L
Emflon® PFR Junior Style Filter Cartridges 121 Ultipor® N66 Particulate and Bioreduction PMM® Metal Membrane Filter Cartridges 141
Kleenpak™ Capsules with Emflon® PFR Filter Cartridges 75 PSS® Porous Metal Filter Cartridges 139
Membrane Assemblies 117 Ultipor® N66 Sterilizing-grade Filter Cartridges 93 Titania
Nylon – positively charged Membralox® Ceramic Membrane Products 203
Evaluation of Adsorptive Effects
Kleenpak™ Capsules with Posidyne® Zirconia
Process-Specific Filter Validation 241
Membrane Assemblies 95 Membralox Ceramic Membrane Products
®
203
Exhaust Venting Posidyne® Filter Cartridges 97 Filter Selection
See Capsules – gas Polyacrylonitrile Filter Selection 12
See Cartridges – gas Microza Membranes 198 – 202 Pre-Inspection Reviews 253
Extractables Analysis Polyethersulfone – chromatography
Mustang Chromatography Capsules
® Filter System Operation
Disposable Filtration System Validation 245
and Cartridges 217 – 220 Training 251
Kleenpak™ Connector Validation 243
Process-Specific Filter Validation 241 Mustang® Coin Units 215 Filter Validation
Polyethersulfone – filtration Disposable Filtration System Validation 245
Kleenpak™ Capsules with Supor® EKV Filter Integrity Test Equipment Validation 255
F Membrane Assemblies 79 Process-Specific Filter Validation 241
Fermentation Mini Kleenpak™ Sterilizing-grade Training 251
See Cell Culture Capsule Filters 77
Filterability Test Instruments
Sheet TFF Membranes 207
Filter Aid Removal Palltronic® Filter Manager 237
Supor® EBV Sterilizing-grade Filter Cartridges 83
Depth Sheet Filters and Modules 13 – 34 Supor® EKV Sterilizing-grade Filter Cartridges 81 Filtration Principles
DGM Plate and Frame Filter Systems 263 Ultrafiltration and Microfiltration Training 251
Filter Configurations and Dimensions 273 Membranes for Cassettes 178 Filtration System Enhancements
Polyethylene Troubleshooting and Consultancy Services 257
Filter Housings 143
Marksman™ Elements with Nexis® A
Filter Integrity Test Equipment Validation 255 Series Filters 67 Flat Sheet Tangential Flow Filtration
Polyolefin Membranes
Filter Integrity Test Instruments
Microza Membranes 198 – 202 Sheet Tangential Flow Filtration Membranes 207
Flow Measurement
Palltronic® Flow Check Device 233 Polypropylene Flow Measurement
Palltronic® Aquawit XC System 231 HDC II Filter Cartridges
®
61 Palltronic® Flow Check Device 233
Palltronic® Flowstar XC Filter Integrity 229 HDC® II Gas Filter Cartridges 131
Fluorodyne® II Capsules
Test Instruments HDC® II Junior Style Filter Cartridges 49
Kleenpak™ Capsules with Fluorodyne® II
Process Automization Kleenpak™ Capsules with HDC® II
Membrane Assemblies 85
Drivers for Palltronic® Filter Integrity Filter Assemblies 47
Mini Kleenpak™ Sterilizing-grade
Test Instruments 235 Kleenpak™ Capsules with HDC® II
Capsule Filters 77
Remote Control Gas Filter Assemblies 119
Fluorodyne® II Hydrophilic PVDF
Drivers for Palltronic® Filter Integrity Marksman™ Elements with Nexis® A
Filter Cartridges 87
Test Instruments 235 Series Filters 67
Validation Marksman™ Elements with Polyfine® II Formulation and Filling 8
Filter Integrity Test Equipment Validation 255 Series Filters 71 Forward Flow Test
Marksman™ Elements with Polyfine® XLD Palltronic® Aquawit XC System 231
Filter Integrity Test Methodology Series Filters 69
Troubleshooting and Consultancy Services 257 Palltronic® Flowstar XC Filter Integrity
Mini Profile® Capsule Filters 45 Test Instruments 229
Filter Integrity Tests Profile® Filter Cartridges with Ultipleat®
Disposable Filtration System Validation 245 Construction 59 Fractionation
Palltronic® Training Program 234 Profile® II Filter Cartridges 51 Blood Products and Fractionation 4
Pre-Inspection Reviews 253 Profile® II Plus Filter Cartridges 53 Freeze-dryer Vacuum Break Filters
Process-Specific Filter Validation 241 Profile® Star Filter Cartridges 55 Air and Gas Filtration 111 – 142
Training 251 Polypropylene and Polyethylene
Marksman™ Elements with Nexis® A
Filter Media G
Series Filters 67
Activated Carbon
Polypropylene and Positively-charged Gamma-irradiatable
Supracap™ 200 Encapsulated
Glass Fiber Disposable Systems 37
Depth Filter Modules 33
Starclear™ Filter Cartridges 57 Kleenpak™ Capsules with Emflon® II
Supracap™ 60 Depth Filter Capsules 31
Polysulfone Membrane Assemblies 115
Supradisc™ Depth Filter Modules 27
Microza Membranes 198 – 202 Kleenpak™ Capsules with Fluorodyne® II
Alumina
Polytetrafluoroethylene (PTFE) Membrane Assemblies 85
Membralox® Ceramic Membrane Products 203
Emflon® CPFR High-temperature Kleenpak™ Capsules with Posidyne®
Bonded Glass Fiber – positive Zeta
Sterilizing-grade Filter Cartridges 125 Membrane Assemblies 95
Ultipor® GF Plus Filter Cartridges 63
Emflon® PFA Filter Cartridges 127 Kleenpak™ Capsules with Supor® EKV
Cellulose
Emflon® PFR Junior Style Filter Cartridges 121 Membrane Assemblies 79
BioSeries Depth Filter Sheets 15
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Kleenpak™ Connectors 39
E-Series Depth Filter Sheets 25
Emflon® FM Filter Cartridges 73 Kleenpak™ Nova Particulate and Prefilter
K-Series Depth Filter Sheets 19
Kleenpak™ Capsules with Emflon® PFR Capsule Filters 41
Pallcell® Air and Gas Filter Cartridges 133
Membrane Assemblies 117 Kleenpak™ Nova Sterilizing-grade and 101
P-Series Depth Filter Sheets 17
Novasip™ Capsules with Emflon® PFR Virus Removal Capsule Filters
Supracap™ 200 Encapsulated
Membrane Assembles 113 Kleenpak™ Ultipor® N66 Sterilizing-grade
Depth Filter Modules 33
Pallsep™ Vibrating Membrane Capsule Filters 89
277
Filtration Technology 205
Index
Gamma-irradiatable – Low-volume Parenterals
279
Index
Pre-reverse Osmosis Filtration – Tangential Flow Filtration
R
Marksman™ Elements with Poly-fine® XLD Reaction Spare Parts Provision
Series Filters 69 PEF Multi Purpose Processor 267 Pall Process Engineered Systems 261
Press System Regulatory Approval Starclear™ Filter Cartridges 57
DGM Plate and Frame Filter Systems 263 See Validation Steam Service
Pretreatment for Water Regulatory Inspections PMM® Metal Membrane Filter Cartridges 141
Water Systems 269 Pre-Inspection Reviews 253 PSS® Porous Metal Filter Cartridges 139
Prion Removal Regulatory Requirements Rigimesh® Sintered Metal Mesh
Mustang® Chromatography Capsules Training 251 Filter Cartridges 137
and Cartridges 217 – 220 Removal of Activated Carbon Steaming Process Validation
Virus Filters 103 – 110 See Activated Carbon Removal and Recovery Troubleshooting and Consultancy Services 257
P-Series Depth Filter Sheets 17 Removal of Catalysts Steam-in-place Procedures
Process Automation See Catalyst Fines – removal Troubleshooting and Consultancy Services 257
Drivers for Palltronic® Filter Integrity Removal of Filter Aids Sterile Filtration – air, gas, and vent
Test Instruments 235 See Filter Aid Removal Liquid Challenge
Pall Process Engineered Systems 261 Emflon® CPFR High-temperature
Removal of Mammalian Cells Sterilizing-grade Filter Cartridges 125
Process Chromatography 209 – 226 See Cell Culture Emflon® PFR Junior Style Filter Cartridges 121
Process Development and Optimization 249 Resolute Chromatography Columns 221 Kleenpak™ Capsules with Emflon® II
Membrane Assemblies 115
Process Modeling Resolute Slurry Packing Systems 223
Kleenpak™ Capsules with Emflon® PFR
Process Development and Optimization 249 Retention Studies Membrane Assemblies 117
Process Purification Process-Specific Filter Validation 241 Novasip™ Capsules with Emflon® PFR
Chromatography 209 – 226 Reverse Osmosis Membrane Assembles 113
Process Scale-up Water Systems 269 Sterile Filtration – liquid
Troubleshooting and Consultancy Services 257 Rigimesh® Sintered Metal Mesh Fluorodyne® II Hydrophilic PVDF Filter Cartridges 87
Process Simulation Filter Cartridges 137 Kleenpak™ Capsules with Fluorodyne® II
Palltronic® Filter Manager 237 Membrane Assemblies 85
Risk Analysis Kleenpak™ Capsules with Posidyne®
Process System Design Pall Process Engineered Systems 261 Membrane Assemblies 95
Pall Process Engineered Systems 261 Kleenpak™ Capsules with Supor® EKV
Process Troubleshooting S Membrane Assemblies 79
Process Development and Optimization 249 Kleenpak™ Nova Sterilizing-grade and 101
Sampling Virus Removal Capsule Filters
Process-Specific Filter Validation 241 Kleenpak™ Connectors 39 Kleenpak™ Ultipor® N66 Sterilizing-grade
Product Activity after Purification Sanitizing Agents Capsule Filters 89
Troubleshooting and Consultancy Services 257 See Acids – filtration of Mini Kleenpak™ Sterilizing-grade
Product Certification See Bases – filtration of Capsule Filters 77
Pre-Inspection Reviews 253 Novasip™ Liquid Sterilizing-grade
Scale-up
Capsule Filters 99
Product Vessel Venting Troubleshooting and Consultancy Services 257
Posidyne® Filter Cartridges 97
Air and Gas Filtration 111 – 142 Scientific and Laboratory Services Sealkleen™ Membrane Filter Cartridges 91
Product Viability Studies Process Development and Optimization 249 ®
Supor EBV Sterilizing-grade Filter Cartridges 83
Disposable Filtration System Validation 245 Screening
®
Supor EKV Sterilizing-grade Filter Cartridges 81
Process-Specific Filter Validation 241 Mustang® Membrane
®
Ultipor N66 Sterilizing-grade Filter Cartridges 93
Production Temperature Control Chromatography Starter Kits 211 – 214 Sterilization Procedures
Pall Advanta™ Electrical Trace Heaters 167 Palltronic® Filter Manager 237 Pre-Inspection Reviews 253
Profile® Filter Cartridges with Ultipleat® Sealkleen™ Filter Housings 147 Supor® EBV Sterilizing-grade Filter Cartridges 83
Construction 59 Sealkleen™ Membrane Filter Cartridges 91 Supor® EKV Sterilizing-grade Filter Cartridges 81
Profile® II Filter Cartridges 51 Service Contracts Supracap™ 200 Encapsulated
Profile® II Plus Filter Cartridges 53 Pall Process Engineered Systems 261 Depth Filter Modules 33
Profile® Star Filter Cartridges 55 Service Lines – air and gas Supracap™ 60 Depth Filter Capsules 31
Emflon® PFA Filter Cartridges 127
Programmable Logic Controller Supradisc™ Depth Filter Modules 27
Drivers for Palltronic® Filter Integrity Sheet Tangential Flow Filtration Membranes 207
Supradisc™ II Modules 29
Test Instruments 235 Sheets – depth filters
Systems
Project Management BioSeries Depth Filter Sheets 15
Automated Systems
Pall Process Engineered Systems 261 E-Series Depth Filter Sheets 25
Pall Process Engineered Systems 261
K-Series Depth Filter Sheets 19
Protection for Sterile Filter Membranes Centrifugal Discharge Filter Systems
P-Series Depth Filter Sheets 17
See Prefiltration PEF Multi Purpose Processor 267
T-Series Depth Filter Sheets 21
Chromatography
Protein Recovery Z-Series Depth Filter Sheets 23
PK Chromatography Skids 225
Tangential Flow Filtration 175 – 208 Single-use Systems Design
PS Disposable Systems 37 Process Development and Optimization 249
See Filter Media – polysulfone Skids – Chromatography Disposable Systems 37
P-Series Depth Filter Sheets 17 PK Chromatography Skids 225 Fabrication
Pall Process Engineered Systems 261
PSS® Porous Metal Filter Cartridges 139 SLS PEF Multi Purpose Processor 267
PTFE See Scientific and Laboratory Services Plate and Frame Filter Systems
See Filter Media – polytetrafluoroethylene (PTFE) Soiling Tests DGM Plate and Frame Filter Systems 263
Disposable Filtration System Validation 245 Sheet Filters
Purification of Bulk Enzyme Solutions
Kleenpak™ Connector Validation 243 DGM Plate and Frame Filter Systems 263
TFF Polymeric Hollow Fiber Membranes
Tangential Flow Filtration Systems 195
and Ceramic Modules 197 Solvent Filtration for APIs
Validation
PVDF Emflon® FM Filter Cartridges 73
Disposable Filtration System Validation 245
See Filter Media – polyvinylidenedifluoride (PVDF) Marksman™ Elements with Nexis® A
Water Systems 269
Series Filters 67
Pyrogen Removal Marksman™ Elements with Poly-fine® II
See Endotoxin Removal Series Filters 71 T
Marksman™ Elements with Poly-fine® XLD
Tangential Flow Filtration 175 – 208
Q Series Filters 69
Capsules
Profile® Filter Cartridges with Ultipleat®
Qualification Minimate™ Tangential Flow Filtration Capsules 181
Construction 59
See Validation Profile® Star Filter Cartridges 55
280
Index
Tangential Flow Filtration – Z-Series Depth Filter Sheets
Cassettes and Holders TFF Polymeric Hollow Fiber Membranes and Validation Data
Tangential Flow Filtration Membrane Cassettes 185 Ceramic Modules 197 Pre-Inspection Reviews 253
Tangential Flow Filtration T-flow Housings Veladisc™ Module Housings 165
Membrane Cassette Holders 188 See Housings – T-flow
Cell Harvest and Product Separation Virus Concentration
Tissue Culture Media Capsules
Tangential Flow Filtration Membrane Cassettes 185 Kleenpak™ Capsules with Supor® EKV
Ceramic Modules Minimate™ Tangential Flow Filtration Capsules 181
Membrane Assemblies 79 Cassettes
Membralox® Ceramic Membrane Products 203 Kleenpak™ Nova Sterilizing-grade and 101
High Cell Concentration Pall Tangential Flow Filtration Cassettes 185 – 187
Virus Removal Capsule Filters
Pallsep™ Vibrating Membrane Filtration Mini Kleenpak™ Sterilizing-grade Virus Removal
Technology 205 Capsule Filters 77 Capsules
Hollow Fibers PreFlow™ Filter Cartridges 65 Novasip™ DV20 and DV50 Virus Removal
Microza Membranes 198 – 202 Supor® EBV Sterilizing-grade Filter Cartridges 83 Filter Capsules 103
Lab-scale Systems Supor® EKV Sterilizing-grade Filter Cartridges 81 Cartridges
Minimate™ Tangential Flow Filtration System 183 Ultipor® VF Grade DV50 Virus Removal Ultipor® VF Grade DV20 Virus Removal
Tangential Flow Filtration Technology 194 Filter Cartridges 109 Filter Cartridges 107
Large Process Volumes Ultipor® VF Grade DV50
Tangential Flow Filtration Membrane Cassettes 185 Trademarks Virus Filter Cartridges – SBF Junior Style 105
Membranes – ceramic Legal Warranty and Trademarks 282 Ultipor® VF Grade DV50 Virus Removal
Membralox® Ceramic Membrane Products 203 Troubleshooting and Consultancy Services 257 Filter Cartridges 109
Membranes – hollow fiber
Troubleshooting Processes
Microza Membranes 198 – 202
Process Development and Optimization 249 W
Membranes – sheet
Sheet Tangential Flow Filtration Membranes 207 T-Series Depth Filter Sheets 21 Water Droplet Removal
Membranes – vibrating LG Liquid and Gas Coalescing Filter Cartridges 135
Pallsep™ Vibrating Membrane Filtration
U Water for Injection
Technology 205
Ultipor® GF Plus Air and Gas Filter Cartridges 129 Water Systems 269
Mycel Separation
Membralox® Ceramic Membrane Products 203 Ultipor® GF Plus Filter Cartridges 63 Water Intrusion Test
Pilot Scale Palltronic® Aquawit XC System 231
Centramate™ Cassettes and Holders 185 Ultipor® N66 Particulate and Palltronic® Flowstar XC Filter Integrity
Research and Pilot Studies Bioreduction Filter Cartridges 75 Test Instruments 229
Centramate™ Cassettes and Holders 189 – 193 Ultipor® N66 Sterilizing-grade Filter Cartridges 93 Water Purification
Minimate™ Tangential Flow Filtration Capsules 181 Water Systems 269
Ultipor® VF Grade DV20
Systems
Virus Removal Filter Cartridges 107 Water Storage and Distribution
Pilot and Process Development Capabilities 194
Tangential Flow Filtration Systems 195 Ultipor® VF Grade DV50 Water Systems 269
Virus Filter Cartridges – SBF Junior Style 105 Water Systems 269
Training 251 Ultipor® VF Grade DV50 WFI
Tangential Flow Filtration Membrane Virus Removal Filter Cartridges 109 See Water for Injection
Cassette Holders 189 – 193
Tangential Flow Filtration Systems 195 Ultrafiltration WIT
Matching Membrane Cassettes to Applications 180 See Water Intrusion Test
Tanks – sterile venting Membralox® Ceramic Membrane Products 203
Emflon® CPFR High-temperature Minimate™ Tangential Flow Filtration Capsules 181
Sterilizing-grade Filter Cartridges 125 Sheet Tangential Flow Filtration Membranes 207 Z
Emflon® PFR Junior Style Filter Cartridges 121 Tangential Flow Filtration Membrane ZHF Centrifugal Discharge Filter Systems 265
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Cassette Holders 189 – 193
Kleenpak™ Capsules with Emflon® PFR Z-Series Depth Filter Sheets 23
Tangential Flow Filtration Systems 195
Membrane Assemblies 117 TFF Polymeric Hollow Fiber Membranes
Technical Data and Ceramic Modules 197
Pre-Inspection Reviews 253 Water Systems 269
Technical Training and Services Ultrafiltration and Microfiltration
Analysis and Review Membranes for Cassettes 178
Contamination Analysis 247 UpScale™ Products
Pre-Inspection Reviews 253 Disposable Systems 37
Process Development Kleenpak™ Capsules with Emflon® II
Process Development and Optimization 249 Membrane Assemblies 115
Test Instruments Kleenpak™ Capsules with Fluorodyne® II
Palltronic® Training Program 234 Membrane Assemblies 85
Training Kleenpak™ Capsules with Posidyne®
Palltronic® Training Program 234 Membrane Assemblies 95
Troubleshooting Kleenpak™ Capsules with Supor® EKV
Troubleshooting and Consultancy Services 257 Membrane Assemblies 79
Validation Kleenpak™ Ultipor® N66 Sterilizing-grade
Disposable Filtration System Validation 245 Capsule Filters 89
Filter Integrity Test Equipment Validation 255 Mini Kleenpak™ Sterilizing-grade
Kleenpak™ Connector Validation 243 Capsule Filters 77
Process-Specific Filter Validation 241 Mini Profile® Capsule Filters 45
Temperature Control for Hot Water or Steam ®
Mustang Coin Units 215
Pall Advanta™ Jacketed Housings 157 ®
Mustang Membrane
Chromatography Starter Kits 211 – 214
Test Instruments
PreFlow™ Capsule Filters 43
Filter Integrity Test Instruments
Supracap™ 60 Depth Filter Capsules 31
Palltronic® Aquawit XC System 231
Palltronic® Flowstar XC Filter Integrity
Test Instruments 229 V
Filterability Test Instruments
Vaccines
Palltronic® Filter Manager 237
Tangential Flow Filtration Membrane
Process Automization
Cassette Holders 189
Drivers for Palltronic Filter Integrity
®
Tangential Flow Filtration
Test Instruments 235
Membrane Cassettes 185 – 187
Remote Control
Tangential Flow Filtration Systems 195
Drivers for Palltronic® Filter Integrity
Test Instruments 235 Validation
Verification of Flow for Integrity Test Instruments Aseptic Connectors 243
Palltronic Flow Check Device
®
233 Disposable Filtration System Validation 245
Filter Integrity Test Equipment
Palltronic® Instruments 227 – 236 281
Trademarks
282
International Offices
283
International Offices
284
Pall has the most comprehensive
family of scalable separation products.
2200 Northern Boulevard
East Hills, New York 11548-1289 Visit us on the web at www.pall.com/biopharmaceutical
+1 800.717.7255 toll free Pall Corporation has offices and plants throughout the world in locations including:
+1 516.484.5400 phone Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands,
+1 516.801.9548 fax New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, Spain, South Africa,
pharmafilter@pall.com e-mail Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
High area 0.2 µm filter with bioburden and particle removal capability for extended
service life and high flow rates in biologic fluids, cell culture media and buffers
processing times in case of high-volume • Meets pH-shift per USP Sterile Purified
buffers, cell culture media or supernatants. Water
Biological Tests
The amalgamation of new and advanced
design and construction concepts contribute • Meets USP biological reactivity, in vivo,
to significantly higher service life and lower for Class VI 121°C plastics
pressure drops in all kinds of biologic process The quality management system for
applications. manufacturing of Supor UEAV filter cartridges
occurs in an controlled environment and in
In biotech, blood product, vaccine and buffer
conformance with Certified Quality System
applications, these membrane and design
ISO 9001.
benefits mean higher yield, higher process
safety, less time, less handling and less cost. Each filter is 100% integrity tested and fully
traceable by individual marked lot and serial
number.
Supor UEAV Filter Cartridges
Technical Specifications
polyethersulfone membrane
Core Polypropylene
Ordering Information(4)
1 254 mm (10 inch) 2 Double O-ring with bayonet lock and flat end H4 Silicone
2 508 mm (20 inch) 7 Double O-ring with bayonet lock and finned end J EPR
• High density allows operation with higher flow rates and higher biomass loads.
• Outstanding chemical resistance.
(**) Breakthrough capacity at 10% using 5 mg hu IgG/ml in 50 mM sodium acetate buffer, pH 4.7, 150 mM NaCl.
Expanded bed adsorption (EBA) chromatog- cally requires significant feedstock dilution,
raphy is a technology ideally suited for rapid unacceptably increasing process volumes
processing of large volumes of crude biolog- and load times. In addition, these sorbents
ical feedstocks and for the purification of are incompatible with high biomass loads
plasmids, IgG and various recombinant (>10% ww/v); exceeding these levels can
proteins. Rapid, direct capture of target only be achieved by a reduction in operat-
proteins by expanded bed adsorption offers ing flow rates, substantially increasing
considerable operational benefits: process cycle duration.
• Significantly reduces process cycle time by BioSepra® Q and CM HyperZ™ are members
eliminating post-fermentation clarification, of a new family of high-density sorbents
• Improves product quality and yield, from Pall®, specifically designed for high
• Reduces total capture-step costs by 20-40%. productivity expanded bed chromatography
and efficient capture of biomolecules direct-
Existing ion exchange sorbents for EBA have
ly from crude, unclarified feedstocks in a
not been designed for optimal productivity
single pass operation.
in industrial operations. Protein binding typi-
1
PRODUCT NOTE
Higher biomass and flow rate without Figure 1. Structure of HyperZ sorbents.
sacrificing capacity.
The HyperZ™ product range has been
designed to deliver the broadest useful linear
flow range possible of any commercial
expanded bed sorbents. Due to a high
charge density in its hydrogel moiety, the
CM HyperZ™ sorbent has unique protein
™
Conventional Conventional
Bed expansion
Q HyperZ
2
Figure 4. CM HyperZ expansion in the presence of different Figure 6. Efficient separation of a mixture of proteins in
mammalian cell concentrations. packed bed mode using CM HyperZ sorbent.
Bed expansion
A280
No cells, acetate buffer
Time (min)
Linear velocity (cm/h)
Column: 1.1 cm I.D., 8 cm packed bed height. Sample: 1 ml load (15
Column:1 cm I.D., 10 cm settled bed height CM HyperZ sorbent. Sample: mg/ml ovalbumin (A), 3 mg/ml cytochrome c (B) and 5 mg/ml lysozyme
crude high density hybridoma cell culture diluted with equilibration buffer (C)). Conditions: Linear gradient 50 mM acetate, pH 4.5, 0-120 mM NaCl.
(50 mM acetate / 5 mM citrate, 75 mM NaCl, pH 4.7).
Figure 5. Scale-up with Q and CM HyperZ sorbents. Short residence times, high dynamic bind-
ing capacity: Increase throughput.
Bed Expansion
3
PRODUCT NOTE
With Q HyperZ™ (data not shown), residence Figure 8. HyperZ sorbent dynamic capacity.
times of 2-5 min. are also sufficient to reach CM HyperZ Q HyperZ
the operation capacity of the sorbent.
to 19 mS/cm).
With Q HyperZ™, average capacities of 80
mg/ml of BSA are obtained in a Tris pH 8.6 % breakthrough % breakthrough
buffer at 300 cm/h. 1 cm I.D. EBA column, 11 cm settled bed height. Linear velocity:
300 cm/h (2X bed expansion). Equilibration buffer:
- CM HyperZ: 50 mM acetate / 5 mM citrate, 150 mM NaCl, pH
CM HyperZ™: An IgG Capture tool, 4.5. Sample: 5 mg/ml hu IgG.
- Q HyperZ: 50 mM Tris-HCl, pH 8.6. Sample : 5 mg/ml BSA.
with minimal feedstock dilution.
With conventional cation exchange sorbents,
Figure 9. Direct capture of hu IgG in the presence of salt
significant feedstock dilution (2-5 fold) with
using CM HyperZ sorbent.
water or low-salt buffer is required to
achieve reasonable protein binding capacity.
Q HyperZ™ : A new tool for anion Increased sorbent life time due to out-
exchange EBA. standing chemical resistance.
Expanded bed anion exchange adsorption The HyperZ™ product range is designed for
has been used to purify natural and recom- use in expanded bed operations where
binant proteins and enzymes from various maximal sorbent fouling can occur. Q and
sources, including E.coli fermentation, CM HyperZ™ sorbents have been engi-
unclarified crude yeast homogenates, plas- neered to withstand very harsh clean-in-
ma and milk from transgenic animals. The place treatments. Long term storage data of
broad use of EBA anion exchange has been CM HyperZ™ are shown in Figure 10.
limited by the fact that animal cells as well Other experiments (data not shown) have
as cell debris of yeast homogenates or DNA demonstrated that continuous storage of
tend to be adsorbed by Q or DEAE function- HyperZ™ in hot solutions of NaOH (1 M at
al groups, resulting in fouling and decrease 55°C) for several days does not impact sor-
of sorbent capacity. Recent work (EBA 2002 bent performance. Agents such as 20%
meeting) suggests that special care given to ethanol, 30% isopropanol or mixtures (20%
cell disruption methods could improve the ethanol/1 M NaOH) or acidic mixtures can
results. also be used for regeneration and cleaning.
4
Figure 10. CM HyperZ sorbent long-term stability to NaOH. • Application 2. Purification of recombinant
endostatin on CM HyperZ™ after method
optimization on CM ProteinChip® Arrays.
DBC hu IgG (mg/ml)
Applications. Figure 11. Capture of endostatin from P. pastoris fermentation broth on CM HyperZ
sorbent and fraction analysis using the ProteinChip® technology.
Typical applications for CM and
Q HyperZ™ sorbents include :
- Direct capture of IgG and IgG
fragments from a variety of
A280
feedstocks.
- Purification of intracellular and
extracellular enzymes.
- Purification of recombinant
proteins from E. coli or yeast fer-
mentation. RC-MS analysis on NP20
ProteinChip® arrays
- Recombinant proteins from
transgenic milk or plant extracts.
- Potential alternative to packed
bed ion exchange sorbents.
5
PRODUCT NOTE
were analyzed (lower part of figure) by Figure 12. Purification of mu IgG1 from hybridoma
SELDI-TOF-MS (Surface Enhanced Laser serum-free medium supernatant on CM HyperZ sorbent.
Desorption-Ionization, combined to Time-
of-Flight Mass Spectrometry), using the
ProteinChip® reader. CM HyperZ™ demon-
A280nm
Conductivity (mS/cm)
strated a fast and efficient capture of the
protein, with a 10X concentration factor in
one step.
™
BIOSEPRA Q & CM HYPERZ
Figure 13. Effect of linear flow rate on dynamic binding capacity of CM HyperZ sorbent in presence of 20% biomass.
C/C0
Cytochrome C (mg/ml)
1 cm I.D. column, 20 cm bed height. Sample: Unclarified yeast lysate. 20% (wet weight) biomass. Cytochrome C represents only 1-2% of
total protein present in sample. Binding: 10 mM Tris-HCl, pH 7.5. Elution: 60 mM NaCl, 50 cm/h in packed bed. > 90% recovery of
bound cytochrome C in all studies. Typical elution volumes: 1.3-1.5 CV. Concentrations of lysates are expressed as the frozen wet weight of
original undisrupted cells, relative to the suspension volume (ww/v). Cytochrome c was quantified by spectrophotometric assay.
6
• Application 5. Purification of a lipase from reduction of the ionic strength below 6 mS/cm.
Y. lipolytica on Q HyperZ™. Elution was peformed by use of an NaCl linear
Courtesy of Prof. R.M. Willemot, INSA Toulouse, France. gradient from 0 to 1 M in one hour. Flow rate was
Figure 14 shows direct capture of a recombinant 300 cm/h. Collected fractions analyzed both by
lipase from a crude clarified fermentation broth of SDS-PAGE and RC-MS (Ciphergen Biosystems)
Yarrowia lipolytica. Adsortion of the enzyme was indicate that lipase (# 36kDa) was efficiently cap-
performed at pH 9.0 with diluted sample for tured on Q HyperZ™ sorbent.
Figure 14. Capture of lipase from Y. lipolytica fermentation broth on Q HyperZ sorbent.
Lipase
Load
FT
Regeneration Lipase
Wash
Elution
20000 40000 60000 80000
0 40 80 120 160
Time (min) MM Load FT W EL
0.7 ml Q HyperZ packed bed column; Equilibration: 50 mM Tris-HCl , pH 9.0 ; Sample (2 ml) is diluted 3 times; Linear flow rate 300 cm/h; Elution in
50 mM Tris-HCl, 1 M NaCl, pH 9.0 at 150 cm/h; Regeneration: 1 M NaOH.
Ordering Information
7
PRODUCT NOTE
8
PRODUCT NOTE
1
PRODUCT NOTE
Cleaning pH 1-14
Volumes changes due to pH and ionic strength Non compressible
Pressure resistance 20 grade: F grade:
200 bar (3,000 psi) >70 bar (1,000 psi)
* Sample: 5 mg/ml BSA in 50 mM Tris-HCl buffer, pH 8.6.
** Sample: 5 mg/ml lysozyme in 50 mM sodium acetate , pH 4.5.
*** Sample: 5 mg/ml hu IgG in 50 mM sodium acetate, 100 mM NaCl, pH 4.7.
• Efficient harvest from dilute feedstock. TABLE 2. Examples of Volumetric Flow vs.
Using Ceramic HYPERD ion exchange sor- Linear Flow Rate.
bents, higher dynamic binding capacity is Flow rate (ml/min)
obtained with dilute feedstock than with Col. Ø 100 cm/h 300 cm/h 500 cm/h
concentrated feedstock (see Figure 6). This 9 cm 110 320 533
behavior – contrary to that observed with
18 cm 420 1,270 2,120
traditional sorbents – illustrates that these
novel materials operate by a mechanism 30 cm 1,180 3,530 5,880
30 2.0
purification scheme. 1.6
20
®
1.2
• Recover product from feedstock of 0.8
moderate ionic strength. 10
0.4
The extraordinarily high ligand density pres-
0 100 200 300 400 500 600
ent within the hydrogel of the CM Ceramic
Flow rate (cm/h)
HYPERD F ion exchange sorbent allows for
effective binding even when product is Column: 9 cm ID x 16 cm; Buffer: 50 mM Tris-HCl, 0.5 M NaCl,
pH 8.6.
present in feedstock of moderate ionic
strength. For example, monoclonal anti-
body has been harvested from feedstock of at pressures up to 70 bar. Since the bead
19 mS conductivity – equivalent to does not deform under fluid flow, the sor-
180 mM salt. Thus, in many applications bent provides linear pressure/flow behavior,
feedstock can be applied without prelimi- and has characteristics well suited to opera-
nary diafiltration or dilution. tion using low-pressure columns and equip-
ment (see Figure 2 and Table 2). For
• Absolute dimensional stability, excellent example, in a pilot-scale column (9 cm ID x
pressure/flow characteristics, easy to 16 cm) operated at 500 cm/h, operating
pack. pressure generated by the sorbent is less
Ceramic HYPERD ion exchangers form very than 2 bar. Equally important, column pack-
stable beds. They do not swell or shrink in ing is accomplished quickly and easily
response to changes in pH, ionic strength owing to the dense nature of the Ceramic
or flow rate. Indeed, the sorbents are stable HYPERD beads.
2
TABLE 3. Lot-to-lot Consistency of Q Ceramic HYPERD F Sorbents.
Lot No. 1 2 3 4 5 6 7 8 9 10 11
Ionizable groups (µeq/ml) 375 329 314 317 322 342 349 349 329 318 338
Dynamic binding capacity for BSA
(mg/ml), 10% breakthrough:
- at 200 cm/h 105 102 97 118 94 103 102 104 97 115 107
- at 600 cm/h 109 93 89 111 89 92 91 89 89 109 96
• Robust, safe and documented for vali- Figure 3. Structure of Ceramic HYPERD Ion Exchange
dation. Sorbents.
Ceramic HYPERD sorbents are manufactured
in BIOSEPRA S.A. ISO 9001 registered manu-
facturing facility. Extensive experience on
batch-to-batch reproducibility (see Table 3)
guarantees the reliable performance and
supply you need for your process. The sor-
bents can be treated with NaOH for effi-
cient cleaning and sanitization.
Ceramic HYPERD sorbents are used in a num-
ber of registered products, as well as in
many clinical and preclinical trials, in
columns larger than 500 liters. All grades of
BIOSEPRA ion exchange Ceramic HYPERD have
Drug Master Files (DMF) :
- Q/S Ceramic HYPERD 20, F: DMF No. 13241 Ceramic backbone Gold-labeled albumin
- DEAE Ceramic HYPERD F: DMF No. 13242 High rigidity
Derivatized hydrogel
- CM Ceramic HYPERD F: DMF No. 11856 High capacity
and for numerous chromatography sorbents,
and provides full documentation to support
regulatory validation. Figure 3. A cross section through the bead
Ceramic HyperD is supplied in 1 M NaCl shows binding of gold-labeled albumin.
containing 20% ethanol / 1.2 mM EDTA. It Notice that the hydrogel completely fills the
is available in a range of package sizes. pores within the ceramic shell, and that
Custom packaging to meet specific manu- gold-labeled albumin – visible as dense
facturing requirements is available on request. black dots – is distributed homogeneously
throughout the hydrogel.
The enhanced diffusion concept. The hydrogel carries an extraordinarily high
concentration of ion-exchange functional
Traditional macroporous ion exchangers groups : 150-400 µeq/ml. The average dis-
operate on the basis of classical pore diffu- tance between charged sites on the hydro-
sion. Pore diffusion is characterized by rap- gel is ~20 Å. Thus, a protein molecule with-
idly decreasing binding capacity with in the gel is simultaneously in contact with
increased flow rate. In contrast, the unique a large number of ion exchange sites. It
structure of Ceramic HYPERD supports a remains in contact with a similar number of
more rapid mechanism of mass transfer, sites no matter where it moves within the
known as enhanced diffusion. Rapid mass three-dimensional structure of the hydrogel.
transfer overcomes classical flow rate As a result, the protein is energetically
dependence. Since product is bound unconstrained and may migrate freely.
throughout the gel-filled pore – not merely Protein diffuses rapidly within the hydrogel
at the interior surface of the pore – total to give a homogeneous distribution, facili-
binding capacity is enhanced. tating uptake of additional material from
Binding of protein within the hydrogel is solution. Under binding conditions, strong
illustrated by the electron micrograph in attractive electrostatic forces between the
3
PRODUCT NOTE
Figure 4. Dynamic Binding Capacity vs. Flow rate on highly substituted hydrogel and the protein
Q Ceramic HYPERD F. drive entry of protein into the gel.
The productivity-enhancing operational
100
characteristics that this novel structure and
Dynamic Binding Capacity
(mg/ml) mechanism provides are illustrated below.
75
25
dynamic binding capacity at high linear
velocity. As shown in Figure 4, there is only
0 100 200 300 400 500 600 700
a modest decline in DBC for BSA as linear
velocity is increased from 50 cm/h to more
Linear velocity (cm/h)
than 650 cm/h. This behavior is further
Column: 6.6 cm ID x 16 cm; BSA (5 mg/ml) in 50 mM Tris-HCl, demonstrated by data in Table 1, compar-
pH 8.6; Dynamic binding capacity at 10% breakthrough.
ing DBC values determined at 200 and
600 cm/h.
For a broad-based measure of productivity,
Figure 5. Binding Capacity vs. Residence Time of Q many process-developers prefer to examine
Ceramic HYPERD F. the influence of residence time on DBC.
This approach allows assessment of sorbent
characteristics without reference to details
Dynamic Binding Capacity
(mg/ml)
for BSA (0.5 mg/ml) in 50 mM Tris-HCl, pH 8.6. reducing bed volume requirements, buffer
volume requirements may also be reduced.
High flow velocity, short residence time,
reduced bed volume, reduced buffer vol-
Figure 6. Binding Capacity of S Ceramic HYPERD F vs. ume – all of these factors support high pro-
Sample Concentration. ductivity and enhanced process economics.
100
Simplify the process by eliminating
Dynamic Binding Capacity
(mg/ml)
50
With traditional macroporous sorbents,
10 mg/ml dynamic binding capacity declines if protein
concentration in the feedstock is reduced.
In contrast, Ceramic HYPERD sorbents pro-
vide higher binding capacity with dilute
0 1,000 2,000 3,000
feedstock. This unique behavior is a func-
tion of enhanced diffusion, and arises
Linear velocity (cm/h) because the absolute rate of uptake into the
Column: 0.2 cm ID x 15 cm; Sample: Hu IgG in 50 mM acetate,
sorbent is independent of protein concen-
pH 4.6. tration in the feedstock.
4
This useful behavior is illustrated in Figure 6. Figure 7. One-step Capture of Mouse IgG1 from CCS
Over a broad range of linear velocity values, on CM Ceramic HYPERD F.
higher DBC is observed for feedstock con-
IgG1
taining 0.5 mg hu IgG/ml than for that con-
NaOH
taining 10 mg hu IgG/ml. With Ceramic
Elution
HYPERD used for product capture, it is possi-
O.D.
ble to reduce or eliminate the need for pre-
liminary concentration of feedstock. Indeed,
a column of Ceramic HYPERD can serve as a U.V.
5
PRODUCT NOTE
shown in Table 3. The data are part of the - Direct capture of biomolecules from a
Regulatory Support File for Q Ceramic variety of feedstocks.
HYPERD F. - Polypeptides, IgG, albumin purification.
- Large-scale purifications.
- Purification of monoclonal antibodies from
Figure 8. Purification of Hexokinase and 3-phospho-
ascites or cell culture.
glycerate-Phosphokinase on Q Ceramic HYPERD 20.
- Plasmid purification.
0.27
- Process polishing steps.
- Rapid high resolution purification (20µm
O.D.
3-Phosphoglycerate-Phosphokinase
0.23 grade).
0.19
• Direct one-step Capture of an IgG1
0.16
from diluted cell culture supernatant
(CCS) on CM Ceramic HYPERD F.
0.12 CM Ceramic HYPERD F can be applied for a
0.08
direct, one-step capture of monoclonal anti-
Hexokinase
body from cell culture supernatant (see
0.04 Figure 7).
Figure 9. Two-step Purification of IgG1 from Ascites Fluid on MEP HYPERCEL followed by DEAE Ceramic HYPERD F.
IgG1 IgG1
(purity 80%) (purity 98%) adsorbed
O.D.
WASH
WASH
impurities
1 2 3
Time (min)
Capture on MEP HYPERCEL Polishing on DEAE Ceramic HYPERD F
MEP HYPERCEL column: First wash with 50 mM Tris-HCl buffer, pH 8, second wash with 25 mM sodium caprylate in same buffer
(arrow 1), followed by a water wash (arrow 2), to remove albumin. Elution with 50 mM sodium acetate, pH 4.0. The IgG1 enriched
fraction is added with Tris base up to pH 8.8 and ionic strength of 7.4 mS/cm, and injected onto the DEAE Ceramic HYPERD F column.
Wash with same buffer to collect the antibody. DEAE Ceramic HYPERD column: 0.6 cm ID x 10 cm; Equilibration: 50 mM Tris-HCl,
pH 8.8; Linear velocity: 160 cm/h. IgG do not bind, adsorbed impurities are eluted by 1 M NaCl (arrow 3).
6
• Polishing step on DEAE Ceramic HYPERD
F after monoclonal antibody capture on • More Regulatory Support information.
MEP HYPERCEL. Regulatory Support Files are updated
DEAE Ceramic HYPERD F has been used in a periodically. Please contact your local represen-
two-step process for a polishing step to tative.
purify a mouse IgG1 from ascites fluid (see
Figure 9). The first step is a capture of the • Information from Regulatory Support
IgG1 on a MEP HYPERCEL column (Hydro- Files.
phobic Charge Induction Chromatography - Long term storage data,
– HCIC –), which results in a good initial - Material Safety Data Sheets,
capture of the IgG1 (93%). - Lot-to-lot consistency information,
A purity of 98% for the IgG1 is achieved in - Detailed Quality Control procedures,
two steps. - Chemical stability in various media,
- Cleaning in place (CIP) studies,
- Extractives and leachables quantification.
1. Duval, M., et al., Job Life Sciences 316 (1993) 1463. Product Cat. No. Size
2. Boschetti, E., et al., J. Biochem. Biophys. Meth. 32
(1996) 15. Q Ceramic HYPERD 20 20040-051 5 ml
3. Coffman, J.L., Boschetti, E., Bioseparation & Biopro- 20040-044 25 ml
cessing, Wiley-VCH Verlag Press, Vol. 1 (1998) 157. 20040-036 100 ml
4. Necina, R., Amatschek, K., Jungbauer, A., Biotech- 20040-028 500 ml
nology and Bioengineering Vol. 60/6 (1998) 689. 20040-010 1L
5. Hanser, E., Mollerup, I., J. Chromatogr. A827 (1998),
259. S Ceramic HYPERD 20 20038-055 5 ml
6. Hahn, R., et al., J. Chromatogr. A795 (1998) 277. 20038-048 25 ml
7. Moure, F., Rendueles, M., Diaz, M., ECCE2 (Second 20038-030 100 ml
European Congres of Chemical Engineering) (1999) 20038-022 500 ml
Montpellier. 20038-014 1L
8. Fernandez, A., et al., J. Chrom. A 746 (1996) 169.
9. Boschetti, E. & Jungbauer, A., Separation Science & Q Ceramic HYPERD F 20066-098 5 ml
20066-031 25 ml
Technology, Academic Press Vol. 2 (2000) 535.
20066-023 100 ml
10. Riedel, K.-U., et al., Eur. J. Biochem. 231 (1995) 742.
20066-015 1L
11. Jouanneau, Y., et al., Eur. J. Biochem. 267 (2000) 780.
20066-064 5L
12. Sookkheo, B., et al., Protein Expression and
20066-056 10 L
Purification 20 (2000) 142.
13. Couriol, C., et al., Chromatographia 52/7-8 (2000) S Ceramic HYPERD F 20062-089 5 ml
465. 20062-030 25 ml
20062-022 100 ml
20062-014 1L
20062-048 5L
20062-055 10 L
7
PRODUCT NOTE
8
PRODUCT NOTE
BioSepra DEAE, CM, SP Figure 1: Chemical structure of available ionizable groups of Trisacryl ion exchangers.
BioSepra Trisacryl
Trisacryl® M, LS sor-
bents are high capacity
DEAE Trisacryl® M, LS CM Trisacryl® M, LS SP Trisacryl® M, LS
ion exchange sorbents
dedicated to a broad
CH OH
range of applications at CH OH 2 CH OH
2 2
CH OH 2 CH CH OH
2 CH OH
2
ion exchangers are CH 2
CH – CH CH – CH
2
CH 2
2 3 2 3 CH3
CH--COOH
spherical semi-rigid CH – CONH – (CH ) – N – (CH ) – N
2 2 2 2 CH – CONH – C – CH – SO H
2 3
– CH CH OH
microbeads of acrylic CH – CH
2 CH – CH
3 2 3
2
CH3
– CH CH – CONH – C – CH OH – CH
copolymers. The CH OH 2
2 2
CH OH
2
CH CH OH
2
strongly bound ion CH – CONH C – CH OH 2
2
CH – CONH – C – CH OH
2
CH – COOH
exchange groups which CH 2
CH OH 2
CH
CH OH
2
2
CH – CH CH
are an integral part of 2 3 3
®
CH – CH
2 3 CH3
are found within its CH 2
three dimensional
structure (See Figure 1).
Each Trisacryl® polymer
sub-unit possesses
hydrophilic groups which ensure biocompatibility support groups and thus modify the available num-
and prevent non-specific adsorption. Trisacryl® ion ber of groups for protein adsorption. The adsorption
exchangers are macroporous. Their open structure capacity is particularly affected by the ionic strength
provides several advantages such as a rapid diffusion and the pH of the buffer, which in turn modifies the
of macromolecules due to the high mass transfer, the net charge of the protein. Usually, an increase of
easy access to ionizable groups and the absence of ionic strength will result in a capacity decrease for a
molecular sieving. given protein. The adsorption capacity and flow rate
are indicative features in the performance of an ion
Capacity exchange support since they determine the produc-
The protein adsorption capacity of Trisacryl sorbents
® tivity level of the support. These two factors are both
is affected by general rules for the ion exchange taken in consideration when discussing productivity,
mechanism. The capacity depends on a number of since a flow rate increase often results in a capacity
factors, including buffer pH and ionic strength, the decrease. The adsorption capacity remains high as
nature of the counter-ion, and the characteristics of the flow rate increases. This phenomenon is attrib-
the protein such as molecular weight and isoelectric uted to the macroporous nature of the support,
point. Variations in pH modify the ionization of the which provides a greater availability of the protein to
ionizable groups.
1
PRODUCT NOTE
tion and regeneration may be Chemical stability Stable to all solvents commonly used in liquid
chromatography (6 M guanidine hypochloride, 8 M urea)
BioSepra Trisacryl
solutions. Additionally, the matrix is resistant to low ionic strength buffer (0.01-0.05 M), e.g. acetate
denaturing agents commonly used in biochemistry for CM and SP Trisacryl® and Tris-HCl for DEAE
®
(8 M urea, 6 M guanidine hypochloride and other Trisacryl®. Recommended pH ranges are as follows:
chaotropic agents) and to non-ionic detergents such - pH 2-6 for SP Trisacryl®
as triton X-100, octylglucoside, and Tween 80. - pH 4-6 for CM Trisacryl®
Trisacryl® ion exchangers are acid-resistant, they can - pH 7-9 for DEAE Trisacryl®
be used with inorganic acids (i.e. 1 M HCl), as well
■ Inject the sample, starting with 2 mg of protein for
as organic acids, e.g. for the separation of peptides.
1 ml of sorbent.
These sorbents are resistant to highly acidic solutions ■ Wash the column with at least 1 cv of the same
– contrary to polysaccharide-based supports – to
buffer and collect the non-adsorbed protein fraction.
highly alkaline solutions – contrary to most synthetic
■ Generate an ionic strength gradient with 0 to 1 M
supports – and to enzymatic attack due to their syn-
thetic origin. NaCI in the same low ionic strength buffer. The gra-
All these properties are particularly important in dient slope should range from 5 to 10 mM/cm.
large scale applications since they permit efficient These experiments will allow optimization of the elu-
sanitization and depyrogenation of the sorbent. tion conditions and selection of pH and ionic strength
for stepwise elutions.
Thermal Stability
Trisacryl® sorbents tolerate high thermal variations
Choice of the Counter-lons
from -20°C to +121°C (the sorbents may be auto- Salt elution gradients are usually performed by an
claved during 20 min) without modification of their increase of the NaCI concentration. In this case, the
properties. elution depends on the competition with Na+ for the
cation exchangers (CM and SP Trisacryl®), and Cl-
Biological Stability for the anion exchangers (DEAE Trisacryl®). However,
other counter-ions can be used, giving different sep-
Trisacryl® is a totally synthetic sorbent and is therefore
aration profiles, as shown on Figure 2.
completely resistant to enzymatic and microbial
degradation.
2
Figure 2. Separation on DEAE Trisacryl M of a mixture of cytochrome c (A), human hemoglobin Figure 3. Separation of oligomers of 5'(d)-TMP
(B), ovalbumin (C) and β-lactoglobulin (D) according to the counter-ion. on DEAE Trisacryl M.
NaCl [E]
A B
Conc.
DI
[E] b [E] 0.5
b d
a TRI
Conc.
Conc.
a d 0.5 c 0.5 0.4
c
TETRA 0.3
PENTA 0.2
0.1
Conc.
a b 0.5 0.5
c d c 0.2 M NaCl, pH 5.3; Elution gradient: NaCl from
d 0.2 to 0.5 M; Flow rate: 30 cm/h.
0 50 100 Vr 0 50 100 Vr
E = concentration in Eq./L; Vr = retention volume; Column dimensions: 1.6 cm I.D. x 10 cm; Buffers: Tris-PO4---
(A), Tris-SO4-- (B),Tris-Cl - (C), Tris-CH3COO - (D), pH 8.6; Gradient slope: 10 mE/cm; Flow rate: 32.5 cm/h .
The affinity order of different counter- 5. Calculate the column cross-sectional References
ions is as follows: area and diameter.
1. Lebart, M.C., et al., J. of Biol. Chem. Vol. 268, No. 8
■ For cation exchangers: (1993) 5642.
Ca++ > Mg++ > Na+ > NH4+ > K+ Applications 2. Tousch, D., et al., Biochrom. 5 (1990) 30.
3. Séné, C., et al., ChimicaOggi (03/1990), 15.
■ For anion exchangers: Trisacryl® ion exchangers have proven 4. Corthier, G., et al., J. Immunol. Meth. 66 (1984) 75.
to be very efficient on the laboratory 5. Girot, P., Boschetti, E., J. Chrom. 213 (1981) 389.
Citrate > PO4- - - > SO4- - > Br - > Cl - 6. Veau, B., et al., Biochim. Biophys. Acta 1428 (1999)
level due to their excellent resolution,
> CH3COO - 39.
and also on industrial scale due to their
high productivity performance.
Scaling Up a Process
DEAE, CM, and SP Trisacryl® sorbents
The choice of the equipment size and are commonly used for the fractionation
operating parameters for a pilot- or pro- of proteins from various origins and at Ordering Information
duction-scale chromatography step is different scales. DEAE Trisacryl® is cur-
not an easy task. To help determine the rently used in 500 L columns for the Product Cat. No. Size
sorbent volume requirements for a production of insulin.
given process, BioSepra’s basic guide- DEAE Trisacryl M 25079-013 300 ml
lines are as follows: An example of separation obtained on
25079-054 1L
different Trisacryl® ion exchangers is 25079-039 10 L
1. Determine, by experiments, the opti-
shown in Figure 3. CM Trisacryl M 26708-016 300 ml
mal dynamic capacity and linear velocity.
26708-032 1L
2. Determine, by experiments, the opti- Validation 26708-024 10 L
mal column height. SP Trisacryl M 25910-019 300 ml
Drug Master Files are available for dif-
25910-027 1L
3. Based on the linear velocity and the ferent types of Trisacryl® ion exchangers: 25910-035 10 L
column height, determine the duration - DMF No. 7830 for DEAE Trisacryl® DEAE Trisacryl LS 26710-012 1L
of one cycle, and the number of cycles - DMF No. 8039 for SP Trisacryl®. 26710-020 10 L
to be run per day.
Trisacryl® ion exchangers are currently CM Trisacryl LS 20030-011 1L
4. Knowing the number of cycles per used by pharmaceutical companies for
20030-037 10 L
day, calculate the volume of sorbent the production of injectables. SP Trisacryl LS 26711-010 1L
needed. 26711-028 10 L
3
PRODUCT NOTE
4
PRODUCT NOTE
HO
CH2
high degree of rigidity to support O
high flow rates, and an organic dex- O
tran component that provides (CH2)2 OH
O
hydrophilicity and biocompatible R--N--R
+
functional groups.
The resulting interpenetrated poly-
mer network has several advantages O
HO
CH2 SP
such as good chemical stability and
O
bed stability in both aqueous and O
organic solvents. The sorbent does SO3 OH
not shrink or swell with pH or ionic O
strength, and withstands pressure
generated even when exceeding 600
cm/h. The unique network also elimi- The porous silica matrix is coated with a continuous layer of ionizable dextran
nates non-specific sorption of proteins. to yield high exchange capacity and improved stability.
1
PRODUCT NOTE
Chemical composition and structure. Figure 2. Pressure vs. Flow Rate curve generated with a DEAE
Spherodex LS column.
Spherodex sorbents are rigid spherical ion
®
Pressure (bar)
and ionizable dextran. The particle size ranges from
100 and 300 µm. The derivatized dextran is uni- 2
L/h
The dextran polymer carries the classical ionizable 50 150 250
BIOSEPRA Spherodex
cm/h
groups tightly anchored onto the polymer: 100 200 300
Flow rate
- DEAE (diethylaminoethyl).
Column: 30 cm I.D. x 78 cm containing 55 L of sorbent; Eluent:
- SP (sulfate). 1 M sodium chloride; Throughput at 1 bar: 2.3 cv/h.
Additionally, the entire structure is stabilized by
chemical cross-linking of the polysaccharide via pro-
prietary patented technology.
Mechanical stability.
Porosity. Spherodex® ion exchangers are non-compressible
The structure of the Spherodex network is macrop-
®
and may be submitted to pressures over 50 bar.
orous, as a result of a specific silica polymerization Pressure thus presents an easy method for increasing
technology. This open structure offers the following the linear column flow rate (Figure 2). This excellent
advantages: mechanical stability offers additional advantages:
■ Absence of molecular sieving phenomena. ■ No variation of the column volume as the ionic
■ Rapid diffusion of macromolecules into the beads strength, pH, or flow rates values are changed.
(high mass transfer). ■ Greater flexibility in selecting the working flow
®
2
Applications. Separation of a protein mixture on SP Spherodex®.
Spherodex LS sorbents have proven to be very efficient in
®
The strong anionic character of this sorbent permits the
the laboratory as well as in production scale fractionation of separation of a mixture of three well-known proteins.
proteins. DEAE Spherodex® has been used for many years at Impurities are found in the flowthrough (they do not inter-
production scale in the fractionation of human plasma pro- act with the sorbent). The three other sample proteins
teins and placenta extracts. It has been used at column scale adsorbed to the column are eluted using a linear sodium
of 1,500 L in the purification of albumin. It was also suc- chloride gradient in the starting buffer (Figure 4).
cessfully used in production scale for the purification of IgG
and transferrin from human plasma.
Figure 4. Separation of a mixture of (a) β-lactoglobulin, (b) Ovalbumin,
In other fields of protein fractionation, Spherodex® ion (c) Cytochrome c, and (i) impurity on an SP Spherodex column.
exchangers were described as being very efficient when used
as such or when chemically modified. DEAE Spherodex® has
Conc.
been used for the separation of gangliosides and lipid-like c
molecules. It was also used as a matrix for affinity chro- [NaCl]
matography at laboratory scale as well as at large scale for
1
the separation of tetanus toxin after immobilization of gan-
glioside GM-1 on partially modified DEAE Spherodex® and b
for the isolation of antitetanus toxin antibodies.
a
2
Liters/h
1
3
4
5 Ordering Information
3
PRODUCT NOTE
4
PRODUCT NOTE
Introduction Figure 1. Structure (left) and internal porous structure (right) of QMA Spherosil.
+
N CH3
specifically designed for biochemi-
BioSepra Spherosil
CH3
cal use. The polymer provides
Silica
ionic and slightly hydrophobic
properties to the sorbent. This
unique mix mode chromatogra-
phy allows the purification of pro-
Polymer layer
teins difficult to isolate on classical
sorbents.
QMA Spherosil M, LS ion exchan-
gers are available in dry form. Table 1. Main Properties of QMA Spherosil sorbents.
QMA Spherosil® are rigid beads Nature of ionizable group . . . . . . . . . . . . . . . . . . . . . . Quaternary amine
based on porous silica. The parti- Average ionized groups (µeq/g) . . . . . . . . . . . . . . . . . . 300
cle size ranges between 100 and pk of ionizable group . . . . . . . . . . . . . . . . . . . . . . . . . 11
Working pH range . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
300 µm for LS grade (M grade,
Stability to detergents and denaturing agents . . . . . . . . Excellent
with particle size of 40-100 µm is Heat stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Good
available on request). The silanols Microbial stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . Excellent
covering the pore surface are Volume changes due to pH and ionic strength . . . . . . . None
linked to functionalized polymers Capacity for BSA (µeq/g) (2) . . . . . . . . . . . . . . . . . . . . . 30
(this occurs by covalent binding).
(1) For globular macromolecules. (2) Determined in 0.025 M phosphate buffer, pH 6.
The polymer provides the ionic
and slightly hydrophobic proper-
ties to the sorbent. QMA is a qua- require the modification of parameters typically selected in hydrophilic
ternary amine (see structure in ion exchange. The ability to manipulate two physical properties during
Figure 1). Silica allows for the chromatography makes possible the purification of proteins which have
combination of high rigidity and been previously difficult or impossible to isolate on classical gels.
high porosity, whereas the role of
the cationic polymer is to adsorb Porosity
the protein to be purified.
The sorbent structure is macroporous, due to the specific technology of
Regardless of whether the gel is
silicate polymerization used (Figure 1). It offers following advantages:
polyanionic or polycationic, it
- Absence of molecular sieving phenomenon,
additionally demonstrates some
- Rapid diffusion of molecules inside the network (high mass transfer).
hydrophobic character. This allows
adsorption and elution, but may
1
PRODUCT NOTE
Thermal stability 7
Applications
Since they are based on silica and 5
300
2
Other applications in fluidized beds Beyond the described applications, The following examples are illustrative
have been reported. Fluidized beds there is a great potential both on the of some of the numerous applications
constitute an excellent means for the laboratory and industrial level. of Spherosil®.
separation of specific proteins from
turbid solutions.
Example I. Separation of sweet whey Example II. Continuous adsorption For continuous sorption operation, a
proteins on QMA Spherosil®. of bovine serum albumin in fluidized counter-current fluid bed column
Courtesy of S. Stefanos & J. Wietzerbin, Mary bed columns of QMA Spherosil® LS. (100x3 cm) is equipped with a num-
Ann Liebert Inc. Publications, NY. Courtesy of Dr. J.P. Van der Wiel, Delft ber of perforated plates to suppress sil-
University of Technology, The Netherlands. ica beads mixing. The QMA Spherosil®
a b LS sorbent used here is transported
downward by temporarily reversing
O.D. 280 nm
O.D. 280 nm
β-lactoglobulin 6
2 the liquid flow as detailed in Figure 7.
9
Figure 8 shows that the pH has an
10
3
effect on the continuous adsorption
1
process. At pH 6, the adsorption phe-
α-lactalbumin nomenon is quicker and makes the
continuous separation of albumin pos-
sible, even from unfiltered cloudy solu-
5
7
tion. This represents a significant
8 advantage over packed bed chro-
4 matography.
Time Time
Figure 7. Experimental set-up for fluidized bed
continuous adsorption.
Figure 6. HPLC analysis of sweet whey proteins 1: column; 2: sorbent loading vessel; 3: sorbent
separated on QMA Spherosil® LS sorbent. container; 4: sorbent collector; 5: pulsation unit;
(a) Chromatographic profile before separation. 6: sorbent inlet; 7: sorbent outlet; 8: liquid inlet;
(b) Protein profile after separation. 9: liquid outlet; 10: sorbent transport water.
Column: TSK-G-3000 SW; Buffer: 0,05 M phos-
phate, pH 7.5 containing 0.15 M sodium chloride;
Flow rate 1 ml/min.
N
References
mg
C (g/L) a ( (
m2 S
b
This example shows a simple and effi- 1. Grandgeorge, N., Tayot, J.L., Proceedings
cient method for the separation of 1.5 1.5 "Colloque technologie sur la purification des
pH 6
protéines", Paris (1984) 303.
α-lactalbumin and β-lactoglobulin pH 7
2. Tayot, J.L., et al., Proceeding IABS Congress,
from crude sweet whey: Melbourne (1986).
1 1
- Equilibrate a column (6 mm I.D.) 3. Van der Wiel, Engineering Foundation confer-
ence, Uppsala, May 1986.
containing 5 g of QMA Spherosil® in a
4. Cueille, G., Tayot, J.L., Proceeding Biotech'85,
solution of 0.05% sodium chloride 0.5 0.5 Geneva (1986).
(about 0.01 M). 5. Veron, J.L., et al., Biotechnology of Blood
Proteins 227 (1993) 183.
- Inject 120 ml of sweet whey (80 g/L)
into the column.
1 5 9 Tray No. 1 5 9 Tray No.
- Wash the column with 0.05 M NaCI,
elute with 0.1 M HCI. This should be Figure 8. Continuous adsorption of bovine serum
performed at a flow rate of 80 ml/h. albumin on QMA Spherosil® LS in counter-current
column. Ordering Information
- Reequilibrate the column with 0.05 M Buffer: 1 mM Tris-HCI, pH 8 or 7; Liquid flow:
NaCI. 49.8 ml/min; Sorbent flow: 1.54 ml/min. Product Cat. No.
(a) Steady-state concentration profile at different
HPLC analysis shows that the HCI elut-
pH. (b) Amount of protein adsorbed per plate. QMA Spherosil M ®
26165
ed fraction includes mainly α-lactalbu-
QMA Spherosil® LS 26099
min and β-lactoglobulin.
3
PRODUCT NOTE
4
PRODUCT NOTE
HA Ultrogel®
Hydroxyapatite Chromatography Sorbent
• Effective purification mechanism in a variety of processes
• High porosity
• Easy cleaning
• Used in large scale step
perature.
10 40 80 100 ml
HA Ultrogel porosity is comparable to an
agarose gel, with an exclusion limit for globular Column: 1.6 x 6.5 cm; Sample: 1 mg of protein mixture
proteins of 5,000,000 daltons. This macroporos- composed of ribonuclease (MW 14,700) and PHA-ELs
(Erythroagglutinating and lymphostimulating Phyto-
ity avoids any moleculear sieving effect during hemagglutinin) (MW 128,000) from Phaseolus vulgaris, in
the separation (see figure 1). 1 ml of 5 mM potassium phophate, pH 6.8; Elution gradi-
ent: 5 mM to 500 mM potassium phosphate, pH 6.8;
The sorbent is shipped in 1 M NaCl containing
Flow rate: 14.4 cm/h.
20% ethanol and is available in a range of pack-
age sizes. Special packaging to meet specific
manufacturing requirements is available on
request.
1
PRODUCT NOTE
Stability Applications
The recommended flow rates to be used with Hydroxyapatite adsorption chromatography
HA Ultrogel sorbent depend on the column can be used in a variety of applications, includ-
geometry and on the separation phase (cap- ing the separation of proteins, peptides and
ture, elution or washing steps). At process scale, nucleic acids,from pilot to production scale (see
typical flow rates from 30 to 200 cm/h are cur- figures 2, 3, 4).
rently applied with multi-liter column sizes. For proteins, the most well-known application
Hydroxyapatite crystals are naturally resistant to of hydroxyapatite is the separation of basic pro-
most chemical agents, except solutions with a teins (cytochrome c, lysozyme, etc.) and phos-
pH less than 4 and complexing agents. phoproteins. HA Ultrogel sorbent can be used
®
BIOSEPRA HA ULTROGEL
Hydroxyapatite is dissolved by acidic solutions, for the separation of human serum proteins
while EDTA, citrate and other complexing and plant proteins such as lectins, glycopro-
agents decrease the adsorption capacity of the teins, glycosidases, phospholipidases, sulfohy-
resin. Complexing agents may be used in drolases, sphingomyelinases, transferases, treha-
extreme cases, e.g. when the desorption of cer- lases and kinases.
tain compounds irreversibly bound to the As a phosphate-containing sorbent, HA Ultrogel
matrix is required. can be used for the separation of phosphate-
HA Ultrogel sorbent is resistant to denaturing dependent proteins and enzymes as well as
agents: it can be treated with 8 M urea, 6 M DNA-dependent enzymes.
guanidine-HCl, 1% SDS and chaotropic agents HA Ultrogel sorbent provides an efficient tool
such as 3 M KSCN. for IgG purification in a one step chromato-
The agarose moiety of HA Ultrogel sorbent is graphic purification by separation with phos-
chemically stabilized by cross-linking with phate buffer. This approach is very mild (neutral
epichlorohydrin in a strong alkaline medium. pH, physiological conditions) compared to tra-
HA Ultrogel sorbent is stable in alkaline condi- ditional elution in acidic solutions, and pre-
®
tions, and can be regularly treated with 0.1 to serves the biological activity of the antibody.
1M sodium hydroxide for regeneration and HA Ultrogel has been used for the separation
depyrogenation. The chromatographic behav- of:
ior of the sorbent was not significantly modified
- Synthetic polypeptides (acidic polypeptides
of after 5 weeks of incubation in 1M NaOH,
such as poly-L-glutamate, poly-L-aspartate).
pH 13.
- Basic polypeptides such as poly-L-lysine, poly-
HA Ultrogel sorbent should not be treated with
L-ornithine.
solutions at pH <4 due to the nature of the
- Neutral polypeptides such as poly-L-proline.
hydroxyapatite crystals.
It can be used for the separation of various
HA Ultrogel sorbent is stable a high tempera-
types of nucleic acids, including transfer RNA
ture (up to 121°C). It can be sterilized by auto-
and low molecular weight glyoxylated deriva-
claving without undergoing any changes to its
tives of DNA, with reproducibility, stability and
chromatographic properties. However, the
reliability (see figure 2 and 3).
operation should be performed in buffered con-
ditions at pH 7 to avoid the presence of phos-
phate which may precipitate.
HA Ultrogel sorbent should never be frozen.
2
Figure 2. Separation of glycohydrolases from a crude enzyme Figure 4. Separation of trypsin and chymotrypsin from a porcine
extract of buckwheat. pancreatic enzyme extract.
A282 nm
PO---
4 [M]
Spec. Ac.
%T (282 nm)
0.8
70 tr.
0.15
ch.
20 200
0.5
90
10 100 0.05
1 2 3 4 5
0.2
e 30 60 ml
a b c d
Column: 1.6 x 5 cm; Sample: 30 mg protein in 1 ml of 5 mM phosphate
100 200 300 ml
buffer, pH 6.8; Gradient: 5 to 200 mM sodium phosphate, pH 6.8; Flow
Column: 2 x 6 cm; Sample: 40 mg of lyophilized extract in 1 ml of rate: 10 cm/h; Temperature: 10°C; Histogram with broken line: trypsin
1 mM phosphate buffer, pH 6.8; Discontinuous elution gradient of phos- activity; Histogram with solid line: chymotrypsin activity.
phate buffer; Flow rate: 7.1 cm/h; Temperature: 4°C. Peak a: proteins Spec. Ac.: specific activity in U/mg. tr: trypsin, ch: chymostrypsin.
with no glycohydrolase activity; peak b: β-glucosidase. Trypsin activity was primarily found in the peak eluted by 50 mM phos-
Courtesy of R. Rourbouze & F. Percheron, Biochemistry Lab., Faculty of phate where the chymotrypsin was eluted by 100 mM phosphate. The
Pharmacy, Paris. final yield was approximately 50%.
3
PRODUCT NOTE
4
PRODUCT NOTE
Trisacryl® GF05 sorbent is composed of a Figure 1: Chemical structure of Trisacryl GF05 sorbents.
highly hydrophilic copolymer designed
BioSepra Trisacryl GF05
grade) for fractionation at high flow Table 1. Main properties of Trisacryl GF05 sorbents.
with low pressure, designed for industri-
Particle size .......................................... M grade: 40 - 80 µm
al scale. LS grade: 80 -160 µm
■ Ready and easy to use.
Exclusion limit ....................................... 3,000 dt*
■ High flow rates.
Linear fractionation range ........................ 200 -2,500 dt
■ Non biodegradable.
Resolution power ................................... 2,500 plates/m
■ Highly stable in acidic media. Desalting capacity .................................. 33 % gel volume
These characteristics allow Trisacryl® Pressure resistance .................................. up to 3 bar (44 psi)
®
GF05 sorbents to perform chromato- Stability to detergents and dissociating agents .. Excellent
graphic separations quickly and with Thermal stability ..................................... Up to 121°C
great selectivity under medium pressure, pH stability ........................................... 1 - 11
sterile conditions, and in the absence
* Calculated on the basis of a standard experimental curve.
of any non-specific interactions with
the matrix.
porosity.
copolymer formed by the copolymeriza-
tion of N-acryloyl-2-amino-2-hydrox- The exclusion limit of Trisacryl® GF05 (determined using oligonu-
ymethyl-1,3-propanediol, and a hydrox- cleotides) is 3,000 dt.
ylated acrylic bifunctional monomer. Close control over the polymerization reaction guarantees not
See chemical structure in Figure 1. only a regular porosity inside each bead, but also excellent repro-
The molecule features a high degree of ducibility from lot to lot.
hydrophilicity contributed by a second-
ary amide group, and by the presence
of three primary hydroxymethyl groups
per repeating unit.
1
PRODUCT NOTE
properties.
1.0
2
Applications Figure 4. Steps from an automatic desalting of Fractionation and purification of bio-
human plasma on a Trisacryl GF05 LS column. logical molecules on Trisacryl® GF05.
Desalting on Trisacryl® GF05. Trisacryl® GF05 permits the separation
Trisacryl GF05 is particularly suitable to
®
of a variety of complex mixtures (see
rapid desalting of large solution volumes. Figure 6) such as :
D.Pl.
D.Pl.
D.Pl.
D.Pl.
D.Pl.
D.Pl.
D.Pl.
D.Pl.
D.Pl.
D.Pl.
■ Pressure resistance allows high flow - Polypeptides
rates. - Oligonucleotides
1 2 3 4 5 6 7 8 9 10 Cycles
■ Provides a low dilution factor (about - Oligosaccharides
1.05 - 1.1). Column dimensions: 44 cm I.D. x 40 cm (60 L of gel); - Small proteins
■ Provides large desalting capacity (up
Buffer: 0.05 M Tris-HCl, pH 8.4; Flow rate: 80 L/h; - Polynucleotides
Sample volume: 12.5 L; Desalting time per cycle: 75
- Small water-soluble polymers
to 33% gel volume). min (including equilibration time). Volume/h: 1.3.
Pressure: 0.7 bar (average). D.Pl. = desalting plasma The best resolution is obtained with a
These desalting properties are illustrated fraction. (Courtesy of Mr. J. Saint-Blancard, CTSA
sample volume between 0.5 and 4% of
by the results obtained in the use of Clamart, France).
gel volume.
Trisacryl® GF05 for human plasma frac-
tionation: 17 L of human plasma were
FIgure 6 : Fractionation of peptides obtained
run through a 60 L Trisacryl® GF05 col-
from trypsin hydrolysis of bovine thyroglobulin.
umn (44 cm I.D. x 40 cm) and desalted Determination of the molecular
within 1.5 hour. Linear flow rate was weight of an unknown molecule.
Conc.
35 cm/h, corresponding to a volumetric The measurement of molecular weight
flow rate of 36 L/h. The volume of can be performed by comparing the
desalted plasma was 18 L, correspon- Kav of the studied molecule to the Kav
ding to a dilution factor of 1.059. relative to standard molecular markers
Similar results are illustrated in Figure 4. obtained on Trisacryl® GF05 selectivity
Trisacryl® GF05 can be applied to sever- curve (see Figure 5). In this case, it is
0
al other "desalting" operations such as important to notice that the selectivity 20 40 60 80 ml
removal of small aromatic molecules, curve must be determined using mole- Buffer: 0.1 M KH2PO4, 0.15 M KCl, pH 7.4; Sample:
separation of fluorochromes after pro- cules from the same species as the stud- 1 ml. U.V; Detection: 280 nm; Flow rate: 11.5 cm/h;
tein labelling, elimination of detergents Column: 1.6 x 45 cm; Experiment time: 8 hours.
ied molecule. For example, the stan-
in protein solutions, separations of sug- dard molecules must be performed with
ars, elimination of peptides. known oligosaccharides if the studied
Trisacryl® GF05 has an appreciable time molecule is a sugar. References
advantage over dialysis for desalting.
1. Brown, E., et al., Proc. Int. Symp. Aff. Chromatogr.,
Desalting by gel chromatography is Strasbourg (1979) 37.
presently the only available method for Figure 5. Selectivity curve determined using a 2. BoschettI, E., et al., Sci. Tools 30 (1983) 27.
mixture of 5'-TMP oligomers on Trisacryl GF05. 3. Girot, P., et al., J. Chromatogr. 213 (1981) 389.
removing salts from very labile biologi-
4. Pasero, L., et al., Biochim. Biophys. Acta 869
cal substances. Vo 2 (1986) 147.
3
Specially designed for preparative chro-
1 5. De Caro, A., et al., Biochem. J. 222 (1984) 669.
4
Kav 5
6. Eloy, C., et al., J. Chromatogr. 321 (1985) 235.
matography, Trisacryl® GF05 LS offers 1 6 7. Iberg, N., et al., J. Biol. Chem. 261 (1986) 13542.
increased flow rate, while retaining the .8 8. Viallard, J.L., et al., Clin. Chim. Acta 161 (1986) 1.
properties of Trisacryl® GF05 M. 2 Ve 9. Saint-Blancard, J., et al., Proc. Int. Symp. Aff.
.6 Chromatogr., Veldhoven (1981) 305.
3
Flow rates over 80 cm/h are commonly
4
used for this type of gel in installations .4
5
using columns of 50 to 200 L, with 6 Ordering Information
.2
backpressures less than 1 bar (see Product Cat. No. Size
Figure 4).
3 4 5 6 7 8 9 10 20 MW 103
Trisacryl GF 05 M 25914-060 100 ml
The range of molecular weight exploited ranges 25914-037 1L
between 306 (monomer) and 1836 (hexamer). 25914-045 10 L
Column: 1.6 cm I.D. x 40 cm; Sample volume: 1 ml; Trisacryl GF 05 LS 25916-040 100 ml
Buffer: 0.05 M Tris-HCl, pH 7.4 containing 0.17 M 25916-016 1L
sodium chloride; Linear flow rate: 5 cm/h. The insert 25916-032 10 L
represents the complete chromatogram obtained.
3
PRODUCT NOTE
4
PRODUCT NOTE
Ultrogel AcA ®
BioSepra Ultrogel AcA sorbents from Pall® are a 34 sorbent contains 3% polyacrylamide (Ac)
range of composite sorbents for size exclusion and 4% agarose (A). The particle size is com-
of biological macromolecules. They consist of prised between 60 and 140 µm.
polyacrylamide and agarose gel matrix and pos- In addition to the superior physicochemical
sess good mechanical and chromatographic properties of Ultrogel AcA, this sorbent provides
properties when compared to classical size excellent separation efficiency, demonstrated by
exclusion sorbents. They are suitable for medi- the low HETP (Height Equivalent to a
®
um and large scale applications. The principal Theoretical Plate). The HETP of approximately
characteristics of Ultrogel AcA are a narrow par- 0.15 mm corresponds to over 1,500 theoretical
ticle size distribution and a narrow pore size dis- plates per meter; excepted for Ultrogel AcA 202
tribution. The particles are semi-rigid. the HETP is 0.3 mm (eq. 3,000 plates per
These characteristics combine to provide high meter). There are only moderate HETP varia-
resolution at high flow rates. In addition, tions as a function of flow rate.
Ultrogel sorbents can be simply and rapidly In order to obtain optimum separation of the
packed. Ultrogel AcA sorbents offer a choice sample components, Ultrogel AcA sorbent
between maximum resolution at recommended should be chosen so that the molecular weights
flow rates or rapid separations at higher flow of all sample solutes to be purified fall within its
rates with minimal loss of resolution. Five differ- fractionation range. If the molecular weights
ent types of Ultrogel AcA are available allowing are unknown, the optimum sorbent type can
the fractionation of molecules with molecular be determined on an analytical scale empirically.
weights ranging from 1,000 and 1,200,000.
The sorbents are shipped in 1 M sodium chlo-
The sorbent is mainly dedicated for fractiona-
ride containing 20% ethanol* and are available
tion, purification and molecular weight purifica-
in a range of package sizes. Special packaging
tion.
to meet specific manufacturing requirements is
The concentration of polyacrylamide and available on request.
agarose in the Ultrogel AcA beads vary with the
* Ultrogel AcA 202 is supplied in 1 M sodium chlo-
sorbent designation. For instance, Ultrogel AcA
ride, 20% ethanol and 5 mM EDTA.
1
PRODUCT NOTE
Conc.
b d
erties. They can be used at high flow rate while
Kav
e
c
maintaining a good resolution. 0.6 a
Ultrogel AcA sorbents are chemically stable in
buffer solutions between pH 3 and 10. Any d 20 40 60
0.4
conventional buffer for biochemical separation
purposes can be used. A high concentration of c
denaturing agents such as urea or guanidine
0.2
hydrochloride, or detergents such as SDS,
BIOSEPRA ULTROGEL AcA
b
should be avoided. As with all gel fractionation
sorbent, the disruptive influence of such addi-
tives should be checked in each case. The 1 2 3 4 5 6 7 8
MW (x104)
buffers used should have an ionic strength of at
least 0.05 M to minimize non-specific adsorp- Column: 1.6 x 40 cm; Buffer: 0.05 M Tris-HCl, pH 7.4
containing 0.17 M sodium chloride: sample constituted of
tion or ion exchange effects between the sam-
®
advised. Ultrogel AcA sorbent cannot be auto- Kav with the selectivity curve (see figure 1).
claved, as this may decompose the agarose.
● Desalting
The term is used to describe the separation of
Applications
substances present in a solution into 2 groups :
The main applications of Ultrogel AcA are: one consisting of the macromolecules which
- Fractionation and purification of biological are totally excluded from the sorbent, and the
molecules by size exclusion, other consisting of the low molecular weight
- Determination of molecular weights, components which diffuse into the sorbent net-
- Desalting. work. Ultrogel AcA 202 sorbent is dedicated to
Ultrogel AcA sorbents allow the separation of this application (see figure 2).
components of a complex mixture by size
1. Separation of salts
exclusion. The fractionation range is comprised
between 1,000 and 12,000,000 daltons. Each If the separation of proteins from salts is opti-
type of sorbent has a specific molecular mized, very large volumes may be processed.
weight/fractionation range. The sample volume must theoretically corre-
spond to the difference between the total sor-
● Determination of molecular weights bent volume and the void volume (generally
60% of the sorbent volume). For sorbents tra-
Molecular weights of proteins may be reliably
ditionally used for desalting, the recommend-
determined by choosing an Ultrogel AcA sor-
ed sample volume is only 30% of the sorbent
bent which has the required fractionation
2
Figure 2. Example of desalting using Ultrogel AcA 202. Since it is a mild process, size exclusion desalting is some-
times the only technique which can be employed for the
UV detection
Salt concentration detection
total removal of salts from highly unstable biological macro-
Conc.
B
● Affinity
Ultrogel AcA also provide excellent supports for the prepara-
tion of derivatives for use in affinity chromatography. The
quality of the agarose used in the manufacture of these sor-
bents results in an almost total absence of the non-specific
300 600
adsorption's which are frequently encountered with compet-
Conc.
3
PRODUCT NOTE
4
PRODUCT NOTE
MEP HYPERCEL®
Hydrophobic Charge Induction Chromatography (HCIC) Sorbent
• Specially designed for purification of antibodies.
• Direct sample loading without any adjustment of pH or ionic strength.
• High purity achieved in a single step.
• High IgG capacity, independent of subclass or species.
®
BIOSEPRA MEP HYPERCEL
MEP HYPERCEL is a high capacity, high selec- TABLE 1 : MEP HYPERCEL Main Properties.
tivity sorbent specially designed for the cap-
ture and purification of monoclonal and Particle size 80-100 µm
polyclonal antibodies. Dynamic binding capacity for ≥ 20 mg/ml
MEP HYPERCEL supports efficient capture and hu IgG* (10% breakthrough)
purification of antibodies from a broad Ligand 4-Mercapto-Ethyl-Pyridine
range of sources, such as animal sera, ascites Ligand density 70-125 µmol/ml
fluid and cell culture supernatant. A variety Working pH 3 -12
of cell culture formulations are readily accom- Cleaning pH 3 -14
modated, including protein-free, albumin-
Pressure resistance < 3 bar (44 psi)
supplemented and serum-supplemented
Typical working pressure < 1 bar (14 psi)
media. In contrast to Protein A sorbents, IgG
binding capacity on MEP HYPERCEL is essen-
* Determined using 5 mg/ml human IgG in PBS, flow rate:
tially independent of subclass or species. 60 cm/h.
"Weakly-binding" variants (e.g., murine IgG1)
are well retained.
®
• Sample preparation is reduced to clarifi- - Gentle elution reduces the risk for antibody
cation. aggregation and eliminates the need for
- Feedstock may be applied without adjust- desalting or diafiltration. A simple lower-
ment. Binding occurs at neutral pH, and is ing of the pH to 4, at low ionic strength,
independent of ionic strength. No need to will elute the antibody.
add lyotropic or other salts.
• Chemically stable to base.
- Concentration of dilute samples is not
necessary. Efficient capture is achieved - Easy long term cleaning with 1 M sodium
even with feedstocks as dilute as ~50-100 µg hydroxide gives this material a significant
IgG/ml. advantage over Protein A-based sorbents.
• Rapid and efficient sample processing. MEP HYPERCEL is supplied in 1 M NaCl con-
- Large volumes of sample can be processed taining 20% ethanol and is available in a
rapidly and efficiently. Dynamic binding range of package sizes. Custom packaging
capacities ≥ 30 mg IgG per ml of sorbent to meet specific manufacturing require-
(at 10% breakthrough) are routinely ments is available on request.
achieved.
- High purity in one step. Product purities
of 70-90%, or greater, are typically
achieved.
1
Hydrophobic Charge Induction Figure 1. Adsorption elution mechanism.
Chromatography Mechanism
Hydrophobic Charge Induction Chromato- ADSORPTION HIC
(hydrophobic
graphy (HCIC) is based on the pH-dependent association)
behavior of ionizable, dual-mode ligands.
MEP HYPERCEL carries an antibody-selective
ligand, 4-Mercapto-Ethyl-Pyridine (4-MEP).
DESORPTION
As shown in figure 1, adsorption is based on (ionic repulsion)
mild hydrophobic interaction, and is
achieved without addition of lyotropic or
®
2
During chromatography on Protein A sorbents, elution Preliminary concentration is not required. Indeed, har-
of antibody at pH 3 frequently leads to aggregation and vest and concentration of antibody on MEP HYPERCEL
loss of activity. Elution from MEP HYPERCEL is achieved can be used to replace traditional concentration proce-
under milder conditions. dures. Concentration and initial purification can be
achieved in a single step.
• Capacity and ionic strength
A plot demonstrating the influence of ionic strength on • Capacity for IgG variants
binding capacity is shown in figure 3. Dynamic binding The data in table 2 illustrate that binding capacity for
capacity was determined in the presence of sodium IgG is little influenced by subclass or species. In contrast
chloride, at concentrations ranging from 50 mM to 1 M. with Protein A sorbents, there is no significant difference
Binding capacity is constant over this range. between capacity for murine IgG2a and the IgG1, the
Such behavior is typical at pH values where the ligand later being "weakly bound" by Protein A.
carries little or no charge (e.g., pH 6.5-9.0). The data MEP HYPERCEL is "antibody selective". Nevertheless, its
demonstrate that typical feedstock may be loaded selectivity is sufficiently broad to provide high binding
without adjustment of ionic strength. Neither diafiltra- capacity for a broad range of IgG variants.
tion nor addition of lyotropic salt is required. Viscous
feedstocks such as animal sera or ascites fluids may be
diluted. Purity
Antibodies are eluted using dilute buffer (e.g., 50 mM When antibody is isolated from protein-free cell culture
sodium acetate or sodium citrate, pH 4). supernatant using MEP HYPERCEL, product of >90% puri-
ty (SDS-PAGE) is typically obtained. In the example
• Capacity and antibody concentration shown in table 3, product of 99% purity was recovered
The influence of IgG concentration on dynamic binding
capacity is illustrated in figure 4. Concentration ranges TABLE 2. MEP HYPERCEL Capacities.
from 50 µg/ml to 5 mg/ml. No significant variation in
Binding capacity
capacity is observed. MEP HYPERCEL supports efficient
capture of antibody from highly dilute feedstock. Human polyclonal IgG 32 mg/ml
Murine monoclonal IgG1 (from ascites fluid) 37 mg/ml
Murine monoclonal IgG2a (from cell culture) 34 mg/ml
Figure 3. Influence of pH and ionic strength on the binding
capacity of MEP HYPERCEL.
Figure 4. Influence of human IgG concentration on the binding
A B capacity of MEP HYPERCEL.
DBC at 10% breakthrough
(mg/ml)
35 35
DBC at 10% breakthrough
(mg/ml)
25 25 40
30
15 15
20
5 5
10
4 5 6 7 8 9 10 0 0.2 0.4 0.6 0.8 1
pH NaCl (M) 0 1 2 3 4 5
IgG capacities obtained at 10% breakthrough on MEP HYPERCEL vs. pH (A) and IgG (mg/ml)
ionic strength (B) of the binding buffer. Experimental conditions : Column 1.1 cm
ID x 9 cm ; Sample : IgG (2 mg/ml) ; Flow rate: 90 cm/h. Working buffer : PBS, pH 7 ; Flow rate : 70 cm/h.
3
in a single chromatographic step. Isolation included in schemes for antibody purifica-
from crude feedstock – bovine serum and tion, this approach is convenient and
ascites fluid or CCS supplemented with FBS effective.
– is also illustrated, with purity values rang-
ing from 69 to 83%. When antibody is iso-
Stability and Cleaning
lated from albumin-containing feedstock,
albumin is the principal remaining impurity. The physical and chemical properties of
In such applications, product of 70 to >90% MEP HYPERCEL are well suited to both labora-
purity is generally obtained in including an tory and process scale use. MEP HYPERCEL is
additional washing step with water or sodium compatible with systems routinely used for
caprylate to selectively desorb the albumin. low or medium-pressure process chromato-
If a simple anion exchange procedure is graphy. Sorbent-related backpressure is less
used to bind residual albumin, product of than 0.5 bar in practical application at linear
99% purity can be obtained. Since anion velocities up to 200 cm/h. Pressure/flow
exchange chromatography is frequently curves for columns up to 300 mm I.D. are
shown in figure 5. To assure best capture
efficiency, it is recommended that initial
Figure 5. Backpressure as a function of flow rate. loading studies be conducted at 70 cm/h.
----- ----- ID 90 mm column
MEP HYPERCEL is chemically stable from pH 4
to 14. Sodium hydroxide, 0.5-1.0 M, is
Pressure (bar)
L
• Direct capture from cell culture super-
1 2
natant.
+ Capture of antibody from both protein-free
ml and serum-supplemented (5% fetal bovine
-
serum) cell culture supernatant (CCS) is
B described. In both cases, clarified samples
A280nm
H
were loaded without concentration or
adjustment of composition. The IgG con-
a
b centration in the protein-free CCS was
L
114 µg/ml. Chromatograms are shown in
1 2 figure 6 and results are summarized in
+
ml table 3.
ml In both applications, the column was equili-
Sample A = 300 ml protein-free cell culture supernatant.
brated with 50 mM Tris-buffer, pH 8.0. After
Sample B = 300 ml cell culture supernatant containing 5% fetal loading, the column was washed with the
bovine serum ; Equilibration : 50 mM Tris-HCl, pH 8 ; Elution : same buffer. PBS, pH 7.4 may also be used.
50 mM acetate, pH 4 ; Flow rate : 70 cm/h. In curve B, (a) and (b)
are respectively water and 25 mM sodium caprylate washings ; During chromatography of serum-supple-
SDS-PAGE (reduced conditions) : (1) = crude sample, (2) = purified mented cell culture supernatant, two
IgG. H = Heavy chain ; L = Light chain.
4
additional wash steps (figure 6) were added equilibrated with 25 mM Tris buffer, pH 8.8,
to promote desorption of albumin. containing sodium chloride sufficient to pro-
In both cases, the IgG fraction was eluted vide a conductivity of 10 mS. The IgG
under the influence of 50 mM sodium fraction obtained following HCIC is diluted
acetate, pH 4.0. Product isolated from pro- with two volumes of the same buffer and
tein-free CCS was 99% pure (SDS-PAGE). applied to the column.
Despite the presence of abundant albumin in After loading, elution is continued with the
the feedstock, product isolated from serum- above buffer. Antibody appears as an unre-
supplemented CCS was 69% pure. The lat- tained peak, while albumin is retained. The
ter could be brought to 99% purity by latter is desorbed using 25 mM Tris buffer
®
application of a simple anion exchange pro- containing 0.5-1.0 M sodium chloride, pH 8.8.
BIOSEPRA MEP HYPERCEL
cedure.
• Additional Applications :
• Purification of monoclonal IgG from MEP HYPERCEL has been studied in a broad
ascites fluid. range of applications, including :
IgG was isolated from ascites fluid using the - Isolation of antibodies from sweet-whey
same procedure as described above for use and colostrum.
with serum-supplemented CCS. In order to - Isolation of antibodies from transgenic
reduce viscosity, the sample was diluted plant and animal sources.
with an equal volume of equilibration buffer - Isolation of IgA and selected fusion pro-
prior to loading. The chromatogram appears teins.
in figure 7. Results are summarized in table
3. Isolated product was 83% pure. Purity of
the IgG fraction could be brought to 98% For industrial applications, a validation pack-
using the anion exchange procedure sum- age is available and provides necessary
marized below. information to assist users in development
of validation procedures.
• MEP HYPERCEL followed by Anion
Exchange Chromatography.
Efficient removal of residual albumin present
in the IgG fraction can be accomplished References
using DEAE Ceramic HYPERD. The column is
®
1 2
Ordering Information
+
5
PRODUCT NOTE
6
PRODUCT NOTE
MBI HYPERCEL ™
rate antibodies from cell culture super- direct capture step, or in a sequence, combined to
natant and from other non conven- other standard chromatographic steps (e.g. ion
tional sources such as sweet whey, exchange).
milk from hyper-immunized animals, HCIC (MEP) and mixed mode ligands (MBI) repre-
recombinant expression systems or sent cost-effective alternatives to Protein A-based
from human plasma Cohn fractions sorbents for the capture of antibodies. MEP
(obtained by alcohol precipitation). HyperCel™ binds IgG at neutral pH, and typically
elutes at slightly acidic pH (pH 4.0). MBI adsorbs
Mixed-mode ligand complements antibodies at mildly acidic pH (typically in the pH
Hydrophobic Charge Induction range of 5.0 - 5.5), and IgG is eluted at alkaline pH
Chromatography (MEP HyperCel™). (8.0 - 9.5). While operating at physiological ionic
strength for IgG capture, MBI HyperCel™ gives the
The MBI HyperCel™ ligand is a comple- users more options to explore, according to the pI
ment to the Hydrophobic Charge and pH-sensitivity of their specific antibody. This
Induction Chromatography (HCIC) alkaline elution may preserve the biological activity
sorbent MEP HyperCel™ (refer to our of acidic-sensitive IgGs, or limit aggregation and
Product note LPN PN702-002). MBI precipitation during the purification process.
HyperCel™ can be used alone as a
1
PRODUCT NOTE
MBI HyperCel™ can be used at both Figure 1. Pressure vs. Flow Rate.
laboratory or process-scale : the sor-
psi bar
bent is easy to pack and run, and can 15 1
be operated at low backpressure 12.5 0.8
(<3 bar) in ml to multi-liter packings.
Pressure
10
0.6
See pressure vs flow rate curve in 7.5
0.4
Figure 1. 5
0.2
2.5
0 0
100 200 300 400 500 600 700
Antibody selectivity of MBI HyperCel®
™
albumin.
Column: 15.6 cm x 2.5 cm I.D., 50 mM sodium acetate, 0.14 M NaCl, pH 5.5.
2-mercapto-5-benzimidazole sulfonic
acid (MBI) – see Figure 2 – used as a Figure 2. Structure of the MBI ligand.
ligand for the adsorption of immuno-
globulin G was deduced from an
extensive number of synthetic ligands
described in the literature. From this
review, it appeared that heterocycles
were among those molecules repeat-
edly described for the capture of anti-
bodies. The MBI ligand has a sulfonate
group present on the aromatic ring Figure 3. Effect of binding pH on discrimination between
which is negatively charged over the human IgG and albumin.
recommended adsorption pH range
(5.0 - 5.5). Most of the antibodies are 50
Dynamic binding capacity (mg/ml)
30
ionic effect. The separation between
25 IgG
IgG and human albumin as a function
20
of the adsorption pH is shown in
15
Figure 3.
10
Experimental data based on protein 5
binding capacity as a function of tem- 0
perature and competition using 2 3 4 5 6 7
pH
8
2
concentration of the IgG itself as well as the relative 2. Influence of ionic strength.
isoelectric points of the IgG and feedstream proteic MBI HyperCel™ is suited to direct capture of IgG at
contaminants. physiological ionic strength. The optimal capacity is
MBI HyperCel™ has a dynamic capacity of 20-40 mg/ml typically obtained in the presence of 0.14 M NaCl,
with concentrated hu IgG (standard residence times as shown in Figure 4.
around 5 min and adsorption in 50 mM acetate,
0.14 M NaCl, pH 5.5). Higher capacities may be Figure 5. IgG dynamic binding capacity vs. pH.
observed by increasing the residence time.
80 10
0.14 M NaCl
Conductivity (mS/cm)
30 60
pH 5.0
adjustment (typically in the pH range of 5-6) is 25
recommended (refer to Table II).
20
pH 5.5
15
Table II. Guidelines for adsorption pH optimization
according to feedstream composition and IgG 10
concentration.
5
Type of feedstream Recommended binding pH
Albumin present IgG <250 µg/ml pH 5.0 - pH 5.5 IgG concentration (mg/ml)
optimization
Albumin present IgG ≥250 µg/ml pH ≥ 5.5 0.05, 0.25 and 1 mg/ml hu IgG in 50 mM sodium acetate, 0.14 M NaCl, pH
5.0 or 5.5 containing 0.14 M NaCl.
3
PRODUCT NOTE
50mM bicarbonate
pH9, 0.14 M NaCl
In most cases, 30 to 60 min wash pro-
A280 nm
0.3
0.2
0.1
0 30 60 ml Non reducing
SDS-PAGE
Load: Direct sample load on Protein A Ceramic HyperD® F. Wash: PBS. Elution:
0.1 M acetic acid.
4
Example 2. Purification of monoclonal IgG1 from Example 4. Capture of Mouse monoclonal IgG1
ascites fluid. from a low expression hybridoma cell super-
natant – Influence of adsorption pH.
Figure 8. Mouse Monoclonal IgG1 purification on MBI HyperCel™.
Low expression Mouse IgG1 cell culture supernatant
(150 µg/ml) was loaded on MBI HyperCel™ at two
Non-reducing Reducing
IgG
HC The data shows that the capture of this low IgG1 titre
can be performed on MBI HyperCel™ at both pH 5.0
Load
F0
Table III. Use of MBI HyperCel™ in a three-step FT
sequence as alternative to Protein A for clinical FT
grade IgG purification.
W
Process IgG purity HCP Protein A E
MW (Da) 120000 140000 160000
(%) (ng/mg IgG) (ng/mg IgG)
MBI HyperCel 99.3 3.52 NR Sample: 150 µg/ml IgG1 in cell culture supernatant, protein-free medium;
+ IEX1 + IEX2 40 ml of cell culture supernatant (CCS) are filtered and loaded on an MBI
HyperCel™ column (10 cm x 0.3 cm ID). Equilibration buffer: 50 mM sodium
Protein A sorbent 99.9 < 0.64 < 0.15 acetate, 0.14 M NaCl, pH 5.0 or 5.2. Elution buffer: 50 mM sodium bicarbon-
+ IEX1 + IEX2 ate, 0.14 M NaCl, pH 9.0. Column regeneration and cleaning: 1 M NaOH
(10 CV). Linear flow rate : 150 cm/h; Residence time: 4 min. Analysis per-
Data courtesy of Dr. Philippe Marschal, Novartis Pharma AG. formed on normal phase (NP20) ProteinChip® Arrays.
IEX = Ion Exchange step, HCP = Host Cell Proteins, NR = Non Relevant. F0 = load, FT = flowthrough, W= wash, E= elution.
5
PRODUCT NOTE
Example 5. Purification of polyclon- Figure 10. Purification of polyclonal antibodies from human
al IgG from human plasma Cohn plasma Cohn fraction.
fractions on MBI HyperCel™ and
comparison with a Protein A sorbent A
and MEP HyperCel™. 1.5 MBI HyperCel
A 280 nm
IgG
0.5 50 mM bicarbonate
1 M NaOH
ethanol precipitated fraction, contain- 0.14M NaCl, pH 9.5
6
Example 6. Separation of IgG light and heavy Figure 11B. Purification of a monoclonal humanized IgG1a from
chains. a CHO cell line grown in protein-free medium (stirred reactor
tank). Analysis using RC-SELDI-MS of collected fractions during
Figure 11A shows the chromatographic profile corre- chromatography on MBI HyperCel™on an NP 20 ProteinChip®
sponding to the purification of a humanized mono- Array.
clonal IgG1 expressed in CHO cells which were
pH 7.0 pH 7.5 pH 8.0 pH 8.5 pH 9.0
grown in a protein-free cell culture medium. Figures L FT
11B and 11C show RC-SELDI-MS profiles of the frac- Intact 150000
tions collected along the chromatography: heavy IgG
1600
Absorbance, mAU
1400
Figure 11C. Separation of light and heavy chains from intact
1200
antibody using pH step elution on MBI HyperCel™.
1000
800
pH 7.5 pH 8.5 80
600
pH 7.0 pH 8.0 pH 9.0
Heavy chain
Relative peak intensity
400 70
Light chain
200 Intact IgG
60
0
0 50 100 150 200 50
Elution (ml)
40
10
Ordering Information
7
PRODUCT NOTE
8
PRODUCT NOTE
BioSepra® Protein A Ceramic HyperD® F sor- Table 1: Main Properties of Protein A Ceramic
bent available from Pall® is a high capacity HyperD F sorbent.
.
affinity sorbent designed for process-scale
purification of immunoglobulins G. The sor- Particle size 50 µm (av.)
bent combines ease of use with high bind- Dynamic binding capacity for > 30 mg/ml
ing capacity and excellent scalability. Anti- hu IgG* (10% breakthrough,
100 cm/h)
bodies of greater than 95% purity are isolat-
ed from cell culture supernatant or ascites Ligand Recombinant Protein A
fluid in a single chromatographic step. Immobilized Protein A 4 - 5 mg/ml of sorbent
Dilute feedstock (~100 µg IgG/ml) may be Working pH 2 - 11
applied without preliminary concentration. Cleaning pH 2 - 13
BioSepra Protein A Ceramic HyperD F sor- Volume changes due to pH Non compressible
bent is prepared using a rigid proprietary and ionic strength
ceramic bead. Recombinant Protein A is Pressure resistance 70 bar (1,000 psi)
immobilized to a specially formulated hydro- * Determined using 10 mg/ml hu IgG in PBS, pH 7.4; Elution
gel within the porous ceramic bead. with 0.1 M sodium citrate, pH 2.5. Column: 4.6 ID x 100 mm.
The ceramic bead, the hydrogel, and the
linkage used for the Protein A coupling are
chemically stable over a broad range of con- sorbent facilitates operation at high linear
ditions. Cleaning-in-place and sanitization velocity. Similarly, bed depth may be
procedures using sodium hydroxide may be increased to provide increased residence
employed with only limited loss of binding time and enhanced capture efficiency.
capacity. The unique, multi-point coupling The sorbent is ideal for production scale
®
chemistry provides a sorbent that exhibits purification. The dense ceramic material
very low leakage of recombinant Protein A. settles quickly and packs easily, even in large
The Protein A ligand is of recombinant ori- columns. Equally important, the material
gin and is produced in strict compliance does not shrink or swell in response to
with cGMP requirements. The rec Protein A changes in pH, ionic strength or flow rate.
is purified by standard chromatographic The material is shipped in 1 M NaCl con-
processes and is never in contact with taining 20% ethanol and is available in a
immunoglobulins. range of package sizes. Special packaging to
The rigidity of Protein A Ceramic HyperD F meet specific manufacturing requirements is
available on request.
1
PRODUCT NOTE
hu lgG concentration (mg/ml) Experimental: 2.55 mg/ml hu IgG1; Column: 1.0 x 11.7 cm.
2
• Purity Table 3. Preparative Purification of Monoclonal IgG on Protein A Ceramic HYPERD F.
During studies with various IgG Source Origin IgG Initial IgG Eluted IgG Purity
subclasses and feedstocks, Protein A Subclass conc. (mg/ml) (mg) SDS-PAGE
Ceramic HyperD F sorbent provided Ascites fluid murine IgG1 kappa 6.34 37 > 98%
high purity product, even at high Ascites fluid murine IgG1* 2.26 20 > 98%
column loading. Results are summa- Ascites fluid murine IgG1* 3.86 31 > 98%
rized in table 3. In all cases, the Ascites fluid murine IgG2b** 2.31 6 > 98%
purity was greater than 98% as Ascites fluid murine IgG2a** 2.43 10 > 98%
Ascites fluid murine IgG2a* 2.86 28 > 98%
determined by SDS-PAGE. No albu-
Cell culture supernatant murine IgG1* 0.05 15 > 98%
min was detected in IgG1 isolated
Cell culture supernatant humanized IgG1* 0.20 30 > 98%
from ascites fluid. Isolation of anti-
body from serum-containing cell Column: 6.6 mm ID x 120 mm; Volume: 4 ml, 10-30 mg IgG per run; Loading: 1 M glycine / 2 M NaCl (*), pH
8.9 or PBS (**); Elution: 0.1 M acetic acid.
culture supernatant is illustrated in
figure 4. Analysis by SDS-PAGE is
shown in figure 5. Figure 4. Isolation of IgG1 from serum-con- Figure 5. SDS-PAGE analysis of feedstock (1),
Despite the relatively high selectivi- taining cell culture supernatant on Protein A flowthrough (2), recovered IgG1 (3).
Ceramic HyperD F sorbent.
ty of Protein A, isolation of high 1 2 3
purity product, suitable for thera-
UV
peutic use requires further, ortho-
gonal chromatographic steps.
Cation exchange chromatography
may be conducted using CM or S
Ceramic HyperD F sorbents.
Typically, the cation exchange pro-
cedure is designed to bind IgG
while impurities are selectively des- Time (min)
orbed. Anion exchange chromatog-
The arrow indicates introduction of elution buffer.
raphy on Q or DEAE Ceramic Column: 3 mm ID x 100 mm. Loading and wash: 1 M
HyperD F sorbents may be glycine / 2 M NaCl, pH 8.9. Elution: 100 mM acetate
buffer, pH 4.6. Linear velocity: 300 cm/h. Sample:
employed to bind a variety of rela- 50 ml cell culture supernatant. Figure 6. Pressure vs. number of cycles.
tively acidic impurities while the
antibody passes unretained in the
flowthrough fraction.
Pressure (bar)
3
• Cleaning Figure 7. Tentative schematic structure of immobilized
Protein A on Ceramic HyperD.
Recombinant Protein A, rich in carboxylic
side chains, is coupled to the primary-
amine-containing hydrogel via stable sec-
ondary-amide linkages. The procedure has
been tailored to give optimized multi-point
attachment, as illustrated in figure 7.
This unique multi-point coupling chemistry
confers high chemical stability.
Cleaning with sodium hydroxide from 1 to
100 mM can be performed repeatedly.
Modest decreases in binding capacity can
occur over time depending upon the
concentration of sodium hydroxide and the
total contact time. Alternatively, cleaning
may be conducted using 6 M guanidine
hydrochloride for some/all cleaning cycles.
The arrows represent proteolysis sensitive locations of Protein A
• Ligand leakage between sub-units responsible for Fc binding.
4
Applications References
Optimum binding conditions depend upon
1. Boschetti, E., Jungbauer, A., Separation Science &
the IgG subclass to be purified. In most
BIOSEPRA Protein A Ceramic HYPERD F
physiological conditions. For weakly inter- 3. Eliasson, M., et al., J. Biol. Chem. 263 (1988) 4323.
4. Akerstrom, B., J. Biol. Chem. 261 (1986) 10240.
acting immunoglobulins (e.g. murine IgG1), 5. Watanabe, M., et al., Japan J. Exp. Med. 225 (1981) 51.
efficient binding is accomplished at higher 6. Der Balian, G.P., et al., J. Exp. Med. 152 (1980) 209.
pH (~ 8.5 - 9.0) using a mobile phase aug- 7. Ledbetter, J.A., Immunol. Rev. 47 (1979) 63.
8. Medgyesi, G.A., Fust, G., et al., Immunochemistry 15
mented with glycine and sodium chloride.
(1978) 125.
Elution is normally accomplished at acidic 9. Lindmark, R., Movitz, J., Sjoquist, J., Eur. J. Biochem.
pH (2.5 - 3.0). Milder pH can be used for 74 (1977) 623.
10. Sjoquist, J., Movitz, J., et al., Eur. J. Biochem. 30
weakly adsorbed IgGs such as mouse IgG1. (1972) 190.
Once conditions have been optimized, scale 11. Kronvall, G., Seal, U.S., et al., J. Immunol. 104
(1970), 140.
up is accomplished by increasing the col-
umn diameter while maintaining the opti-
mum bed height and linear velocity.
Detailed recommendations for use can be
found in the Product Insert which is sup-
plied with the product.
Protein A Ceramic HyperD F sorbent is well
suited to isolation and purification of IgG
from ascites fluid, cell culture supernatant,
transgenic milk, and various animal sera.
Other applications include :
- Separation of IgG subclasses (e.g. Protein
A does not interact with human IgG3).
- Separation of Fc fragments from a mixture
of Fc and Fab fragments obtained after
enzymatic hydrolysis.
- Purification of humanized or mouse mono-
clonal antibodies.
- Separation of immune complexes.
- Purification of enzyme conjugates.
- Removal of bovine IgG from hybridoma
®
cell culture.
Ordering Information
5
PRODUCT NOTE
6
PRODUCT NOTE
Heparin HyperD® M
Affinity Chromatography Sorbent
BIOSEPRA Heparin HyperD M
BioSepra® Heparin HyperD® M Figure 1 : Dynamic binding capacity vs. linear velocity.
®
1
PRODUCT NOTE
The main benefits of Heparin HyperD® M Figure 2: Pressure vs. linear flow velocity.
sorbent are:
Pressure
● Rapid packing due to the high density of psi bar
45
BIOSEPRA Heparin HyperD M
3
heparin sorbent which settles in a few minutes.
30 2
● HyperD® sorbent is very rigid and allows
15 1
the use of high flow rates without pres-
sure increase or shrinking or swelling of the
®
Stability. Validation.
The non compressible HyperD matrix can
®
The heparin used for the production of
withstand very high flow rates without any Heparin HyperD® M has a North American
risk of bed collapse. As a result, Heparin origin and is from porcine intestinal
HyperD® M can be used with LPLC, MPLC mucosa. The heparin is produced in compli-
or HPLC systems. An HPLC purification can ance with the applicable requirements of
be performed in less than 10 minutes using the FDA’s Good Laboratory Practices and
a 0.46 I.D. x 5 cm column. Faster purifica- Good Manufacturing Practices regulations.
tion saves user time and preserves the bio-
A validation file can be provided to industri-
logical integrity of the purified proteins. The
al customers to support the regulatory
mechanical properties of Heparin HyperD®
requirements for producing clinical and
M sorbent remain constant across a wide
approved therapeutics.
range of velocities. Minimum pressure drop,
2
Applications. ● Lipoproteins (LDL, VLDL, VLDL apoprotein, HDL)
Heparin is a mucopolysaccharide known for its antico- may form an insoluble complex with heparin in the
agulant and clarifying actions. presence of divalent cations. This property is
exploited in the separation of serum lipoproteins on
Heparin is essentially composed of equimolar quanti-
immobilized heparin (e.g. lipoprotein elimination
ties of glucosamine and glucuronic acid, alternatively
from serum to reduce interference with enzymatic
linked by α-1,4 glycosic bonds.
assays).
A certain number of its hydroxyl groups are esterified
● Growth hormones.
with sulfuric acid, especially those on C-6 of glu-
cosamine. Other groups are also sulfated, including ● Growth factors: FGF, ECGF.
C-3 of glucosamine and C-2 of glucuronic acid. The ● DNA- and RNA-related enzymes as heparin is an
main characteristic of heparin is that it contains a inhibitor of DNA and RNA polymerases, and inter-
large number of amino groups combined with sulfate acts with numerous DNA- and RNA-dependent
groups, the latter being quite labile in acidic medium. enzymes. These properties are used to purify a wide
The molecule contains small quantities of other sugar, variety of enzymes (polymerases, restriction
such as galactose and xylose, and amino acids, e.g. endonucleases,...).
serine, which explains positive ninhydrin reactions. ● Other applications: immobilized heparin has been
As a result of its composition and its biochemical role, used for the purification of various other enzymes
heparin has the property to combine with a number (collagenase, α-L-iduronidase, hyaluronidase and
of proteins, enzymes and in general with polycationic lysozyme), fibronectin, fibronectin fragments and
organic compounds. It is also combined with alka- hormones receptors.
loids, antibiotics, stains and hormones.
There are many fields of applications of Heparin
HyperD® M sorbent which are related to the different
types of interactions of native heparin.These interac-
tions may be specific as with certain coagulation factors Ordering Information
or may be due to a more complex ionic interaction.
Product Cat. No. Size
Seven major groups of proteins can be purified on
Heparin HyperD® M: Heparin HyperD® M 20029-039 25 ml
20029-021 100 ml
● Coagulation factors such as ATIII, Factor IX, Factor 20029-013 1L
VII, Factor XI, Factor XII and XIIa. 20029-054 10 L
● Lipoprotein lipases are enzymes which participate in
lipid metabolism. Forming ionic complexes with
heparin, immobilized heparin provides a suitable
means for their purification. There are numerous
References
reports on the purification of lipoprotein lipases
from serum, mammalian heart, adipose tissue and 1. Lebing, W.R. et al., Vox Sang 67 (1994) 117.
2. Josic, D., Bal, F., Schwinn, H., J. Chromatogr. 632 (1993) 1.
bovine milk. 3. Kisiel, W., Davie, E.W., Biochemistry 14 (1975) 4928.
4. Lindon, J., et al., J. Lab. Clin. Med. 253 (1978) 5946.
5. Augustin, J., Freeze, H., J. Biol., Chem. 253 (1978) 2912.
6. Ashby, P., et al., Biochem. J. 171 (1978) 305.
7. Bengtson, G., Olivecrona, T., J. Biochem. 167 (1977) 109.
8. Pan, Y.T., et al., Arch. Biochem. Biophys. 189 (1978) 231.
9. Huet, J. et al., Meth. Enzymol. 273 Part A, 249.
3
PRODUCT NOTE
4
PRODUCT NOTE
Blue Trisacryl M ®
1
PRODUCT NOTE
Figure 2. Sorption capacity (Calb) and sodium chloride elution On the industrial level, Blue Trisacryl® M is the ideal
molarity (Melu) of human albumin at different pHs. sorbent for human albumin separation in a single
step, for interferon purification and for TPA isolation.
Calb
(mg/ml) [NaCl] Blue Trisacryl® M may be used in any other purifica-
30 2 tion of Cibacron Blue F3GA-affine proteins. Many
other enzymes may be purified on Blue Trisacryl® M,
Melu such as sulfatases, phosphatases, RNA polymerases,
20 mono-oxygenases, and oxydoreductases.
1
®
Calb
BioSepra Blue Trisacryl
10
Application examples
0 Example I. Separation of phytohemagglutinin-
4 5 6 7 8 9 10 11 pH
induced interferon (-IFN) on Blue Trisacryl® M.
Courtesy of S. Stefanos, J. Wietzerbin, published by Mary
Ann Liebert Inc. Publications, NY.
-3
3
–– prot. (mg/ml)
Blue Trisacryl® M can be used for the purification of PB = 0.02 M phosphate buffer, pH 7.2
PBS = phosphate buffer saline
many proteins. Generally speaking, the Cibacron EG = ethylene-glycol mixed with PBS (50:50)
Blue F3GA chromophore interacts with most
enzymes which need NAD as cofactor (kinases,
dehydrogenases, phosphatases). Other proteins with
a non-enzymatic activity can also be separated: Example II. Analytical separation of human plas-
albumins, lipoproteins, growth factors such as matu- ma proteins on Blue Trisacryl® M.
ration promoting factor and heparin-binding growth
%T
factors, clotting factors, interferons (Example I) and (280 nm) [NaCl]
plasma proteins.
IgG Transferrin Albumin 2
The interaction mechanism between Cibacron Blue
F3GA and proteins involves one or more of the fol-
50
lowing:
- Stereospecific recognition of NAD analogs,
1
- Electrostatic and hydrophobic interaction,
- Electron exchange.
Due to its high selectivity and resolution power, Blue
Trisacryl® M may be used on the laboratory level for 0
rapid analytical and preparative separations of 100
1 2 3
numerous proteins (Example II). The separation Hours
speed allows several chromatographic cycles to be
Column: 1.6 cm I.D. x 10 cm; Buffer: 0 05 M Tris-HCI, pH 8 8; Elution
performed in a single day.
performed by a continuous sodium chloride gradient from 0 to 3 M;
Flow rate: 100 cm/h; Separation time: 180 min; Temperature: 20°C.
2
Example III. Automatic separation of Example IV. Purification of phospho- Example V. Purification of MPF
human albumin from plasma on Blue fructokinase-2/fructose-2,6-bisphos- (Maturation-Promoting Factors) on a
Trisacryl® M by step elution chroma- phatase (PFK 2/FBP) on a Blue Blue Trisacryl® M column from a
tography. Trisacryl® M column from an anion hydroxyapatite fraction obtained
exchange chromatography of a using a x.laevis unfertilized egg
%T
spinach extract. extract.
(280 nm) [NaCl] pH (Courtesy of Y. Larondelle, E. Mertens, E. Van Courtesy of P. Nguyen-Gia, M. Bomsel, J.P.
INJECTION 1 INJECTION 2
Schaftingen & H.G. Hers, Université Labrouase, C.L. Gallien & H. Weintraub,
3 Catholique de Louvain, Eur. J. of Biochem.). CNRS, Unité d'Enseignement et de Recherche
Biomédicale des Saints-Pères, Paris, Eur. J. of
9
PFK2 or
Biochem.
2 FBPase2 Protein
(mU/ml) (µg/ml)
8 C
1.5 A (280 nm)
8 A (280 nm)
PFK2 0.16 0.04
1 7
NaCl 6
1 (2 M) 0.12 0.03
6
4
0
0.08 0.02
0.5
B D
E F 2
Elution volume
A 0.04 0.01
0 FBPase 0 A B C
Column: 2.5 cm I.D. x 6 cm; Adsorption buffer: 0 10 20 30 40 50 0 0
Fraction No. 0 10 20 30 40 50
0.05 M Tris-HCl, 0 5 M NaCI, pH 8; Albumin elution Fraction No.
buffer: 2.5 M NaCl in the same buffer; Regeneration
solution: water-ethylene glycol mixture (50:50). 21 mU ot PFK 2/FBP were injected into a 2 cm I.D. x
7 ml (12 mg/ml) of the MPF extract were applied to
—— UV absorbance at 280 nm 0.9 cm Blue Trisacryl M column pre-equilibrated
a 10 ml Blue Trisacryl M column pre-equilibrated
- — - lonic strength ---- pH with 25 mM Tris-acetate buffer, pH 7.8 containing
with 80 mM sodium glycerol-2-phosphate, 20 mM
5 mM magnesium acetate, 5 mM dithiothreitol and
EGTA, 15 m M MgCI2, 1 mM dithiothreitol, ATP and
0.2% Triton X-100. Elution was performed by a sodi-
phenylmethylsulfonylfluoride. The MPF activity was
um chloride gradient up to 2 M. For the determina-
retained and eluted with the same buffer containing
tion of proteins (histograms), six pools (A to F) were
500 mM NaCI.
prepared and concentrated. The purification factor
The horizontal lines show fractions pooled to give
from the previous column was 27.6; The recovery
three sets: Inactive peaks A and B (emerging with
was approximately 44%.
the flowthrough and eluted with extraction buffer
containing 100 mM NaCI), and the active MPF
(peak C) eluted with extraction buffer and 500 mM
NaCI.
Left absorbance axis relates to peak A, right axis to
peaks B and C. Purification factor from the previous
References column was 12. Recovery was 51%.
3
PRODUCT NOTE
4
PRODUCT NOTE
SDR HyperD ®
HYDROPHOBIC POLYMER
from biological fractions is necessary, and OH O
SILICA
OH O
to eliminate solvent and detergent from bio-
logical fluids. OH O
Triton X-100
1
PRODUCT NOTE
Capacity and solvent- 100 cm/h (initial concentration of Triton X-100 and TnBP in
detergent removal effi- bovine plasma are respectively 10 and 5 mg/ml).
ciency. Examples of removal efficiencies from various feedstreams
are summarized in Table II.
The structure of SDR
HyperD® sorbent has been
engineered to optimize the
®
exclusion limit of 10 kDa IgG TnBP 5,000 ppm < 0.4 ppm 99.9%
allows target proteins to be Triton X-100 10,000 ppm < 10 ppm 99.9%
"excluded" from the sor- ATIII TnBP 5,000 ppm < 0.4 ppm 99.9%
bent, and are found unre- Triton X-100 10,000 ppm < 10 ppm 99.9%
tained in the column void
Bovine serum TnBP 5,000 ppm < 0.4 ppm 99.9%
volume.
Triton X-100 10,000 ppm < 10 ppm 95.5%
On the other hand, the high
specific surface area (200 Sample volume: 3.6 CV, Flow rate: 150 cm/h; Column length: 10 cm;
m2/g) of the porous silica Residence time: 4 min.
NOTE: The removal efficiency is also dependent on flow rate and column load-
allows a high capacity for ing: i.e. when using a 10 cm column at 150 cm/h (2 CV load of bovine serum
Triton X-100 and TnBP. The supplemented with Triton X-100 or TnBP), a removal of 95.5% was observed
dynamic binding capacities for Triton X-100; this removal efficiency was decreased to 80% when 8 CV
currently obtained are 60-80 loads were used.
2
Guidelines for binding capacity optimization. Cleaning in place and chemical stability.
As for any sorbent, the dynamic binding capacity
SDR HyperD® sorbent is insoluble in water and in
(DBC) of SDR HyperD® sorbent is sensitive to the lin-
organic solvents. It is also very stable to strong
ear flow rate, to the residence time on the column
denaturating agents and chaotropic agents. The sor-
and to the nature of the sample. Therefore, it is
bent can be treated with 0.01 to 0.1 M hydrochloric
recommended to start trials by loading not more
acid or water-miscible organic solvent. SDR HyperD®
than 5 CV of sample on a column with a minimum
sorbent can also be treated with oxidizing agents
height of 15 cm, and a working flow rate not
such as peracetic acid (1500 ppm in sodium acetate,
exceeding 150 cm/h. Adsorption buffer sample load
pH 5.0), which is a well-known bactericide and spo-
and flow rate can be increased according to per-
ricide.
formance. Note that the rigid nature of SDR
HyperD® sorbent allows to use higher flow rates Recommendations for sanitization are shown in
(i.e. > 600 cm/h) for washing and cleaning, with Table III.
moderate backpressure (< 2 bar).
Method Procedure
Alcohol/acid treatment Wash with at least 3 CV of a solution of 20% (v/v) ethanol containing 1 M acetic acid.
This solution should be injected after removal of dissolved gas at a flow rate of 10-20 cm/h
(1 hour contact time). After treatment, reequilibrate with normal sterile pyrogen-free buffer.
Diethylpyrocarbonate/ Wash with 2 CV of PBS buffer containing 95% ethanol - 5% diethylpyrocarbonate solution.
ethanol treatment Then wash the column with 3 CV of 3 M pyrogen-free sterile NaCI / 1 M acetic acid to
remove pyrogens. Reequilibrate the column in sterile pyrogen-free buffer.
Reference
● Specific sorbent to remove solvent-detergent mixtures from
virus-inactivated biological fluids.
Guerrier, L., et al., J. Chromatogr. B, 664 (1995) 119.
Ordering Information
Product Cat. No. Size
3
PRODUCT NOTE