Sartocon Slice Self Contained Unit

Pre-sterelized diposable unit suitable for for use in laboratory and cGMP environments
Specifications Materials of Construction Membrane Polyethersulfone PVDF Polypropylene Silicone Polypropylene Gaskets Spacer Sealing compound Plates with connector

Crossflow Filtration

Pore Size|Retention Rate PESU ultrafiltration cassettes are available in the following nominal molecular weight cut-offs: 10 kD, 30 kD. Available Sizes Sartorius Stedim Biotech Sartocon Slice SCU are availabe in 1, 2 or 3 stack format. Available Filterholder Sainless Steel Holder available. Filtration Area Filter area SCU 0.1 m2, 0,2m2, 0,3m2 Operating Parameters Feed pressure, Pin 58 psi |4 bar maximum 114 < 15 ml/min

Description Sartocon Slice SCU The Sartocon Slice SCU is a 0,1m2 to 0.3 m2 pre-sterilized disposable unit suitable for use in laboratory and cGMP environments. The module may be used in any SARTOFLOW system using a Sartocon Slice type holder. The SCU is available in a variety of MWCO's. The Polyethersulfone Membrane The polyethersulfone membrane (PESU) is a membrane polymer that is well established in the biotechnological and pharmaceutical industries. The PESU membrane is a stable polymer that features a broad pH and temperature range. Polysulfone membranes are designed for use in the biotechnical and pharmaceutical industries.

Product Profile The Sartocon Slice SCU is ideally suited for use with the new SARTOFLOW Alpha Plus single use system. Feature Benefits

available in 3 fifferent flexibility and linear filtration area scale up High flow rates pre-sterilized and preflushed with WFI Silicone sealing compound TC 25 1" Clamp Economical filtration runs Ready to use No glue quick connection to existing equipment

Operating temperature 50C maximum pH stability Air diffusion rates at Pin = 15 psi |1 bar for 1 and 2 stack units

Preconditioning Pre-flushed to a low level of contaminants and gamma irradiated with 25 kGray. Regulatory Compliance All materials have passed the USP Biological Test. All materials are BSE and TSE free. The filtrate meets or exceeds the currently valid USP and EP for sterile Water for Injection, with respect to extractable substances, oxidizable substances and Bacteria Endotoxins. Quality Control Each Sartocon Slice SCU is individually assigned a serial number, integrity tested and certified. It complies with cGMP requirements for non-fiber-releasing filters and is filed under the Drug Master File Number DMF 5967 by the Food and Drug Administration, Washington, DC. Validation information is available upon request. For further assistance, please contact your local Sartorius Stedim Biotech Technical Service or our Goettingen- based Applications Department in Germany. Technical References: Validation Guide Publication No.: SPC5708 Directions for Use Publication No.: SPC6039

Average Water Flux Permeate flow rate Pfeed = 1,5 bar 22 psi, Pret = closed Cut off 10 kD 30kD PESU 0.1m2 l/h 30 60 PESU 0.2m2 l/h 60 120 PESU 0.3m2 l/h NA NA

Protein Markers (PESU Ultrafilter) [NMWCO]; = not measured Substance Vitamin B12 Approx. Mol. Wt. 1,200 1 kD 5 kD 8 kD [%] [%] [%] >70 50 80 99 10 kD PESUmax 30 kD 50 kD 100 kD 300 kD [%] kD [%] [%] [%] [%] [%] >95 >99.9 60 90 >95 >99 <80 > 98 <70 >95

Cytocrome C 12,400 Albumin -Globulin Dextran 67,000 169,000 2,000,000

Order Information Available Sartocon SCU Types and Order Numbers Cut off 10 kD 30kD PESU 0.1m2 3D1463901EFFSG 3D1465901EFFSG PESU 0.2m2 3D1463921EFFSG 3D1465921EFFSG PESU 0.3m2 3D1463931EFFSG 3D1465931EFFSG

Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen, Germany Phone +49.551.308.0 Fax +49.551.308.3289 www.sartorius-stedim.com USA Toll-Free +1.800.368.7178 UK +44.1372.737159 France +33.442.845600 Italy +39.055.63.40.41 Spain +34.91.3586102 Japan +81.3.3740.5407
Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH WG Publication No.: SPC2066-e09041 Order No.: 85034-537-82 Ver. 05 | 2009