Especificaciones Sanitarias

Cleaning and Sanitization Guideline No.
1
EQUIPMENT & PIPING DESIGN CRITERIA
Table of Contents
1.0 CHAPTER OVERVIEW 9
1.1. OBJECTIVE ......................................................................................................................................... 9

1.2. SCOPE ................................................................................................................................................. 9
1.3. RELATED C&S GUIDELINES ........................................................................................................... 10
1.4. RELATED QUALITY PROGRAMS ..................................................................................................... 11
1.4.1. CPM CONTROL POINT MONITORING ................................................................................ 11
1.4.2. MICROSUSCEPTIBILITY INDEX (MSI).................................................................................. 11
1.5. KEY TERMINOLOGY ........................................................................................................................ 12
2.0 STORAGE AND MIXING TANKS 13
2.1. PRODUCT CONTACT SURFACE ........................................................................................................ 13

2.1.1. MATERIALS OF CONSTRUCTION........................................................................................... 13
2.1.1.1. Stainless Steel............................................................................................................. 13
2.1.1.2. FRP............................................................................................................................. 14
2.1.2. SURFACE FINISH................................................................................................................... 15
2.1.3. WELDS ................................................................................................................................. 17
2.1.4. CORNER DETAILS ................................................................................................................. 18
2.2. TANK CONFIGURATION ................................................................................................................... 18
2.2.1. TOP HEAD TYPES ................................................................................................................. 19
2.2.1.1. Closed Tops................................................................................................................ 19
2.2.1.2. Open and Removable Tops ........................................................................................ 20
2.2.2. BOTTOM HEAD TYPES ......................................................................................................... 21
2.3. MANWAY .......................................................................................................................................... 22
2.3.1. LOCATION ............................................................................................................................ 22
2.3.2. TYPES ................................................................................................................................... 23
2.4. AGITATORS....................................................................................................................................... 27
2.4.1. SHAFTS ................................................................................................................................. 27
2.4.2. IMPELLERS ........................................................................................................................... 27
2.4.2.1. Axial Flow Type......................................................................................................... 27
2.4.2.2. Scraping Blade Type .................................................................................................. 28
2.4.2.3. Radial Flow Type ....................................................................................................... 29
2.4.3. SEALS ................................................................................................................................... 29
2.4.3.1. Lubricants................................................................................................................... 30
2.4.3.2. Mounting .................................................................................................................... 30
2.5. BAFFLES ........................................................................................................................................... 31
2.5.1. LOCATION AND SHADOWING ............................................................................................... 32
2.5.2. CONFIGURATION .................................................................................................................. 32
2.5.3. INSTALLATION DETAILS ...................................................................................................... 32
2.6. VENTS ............................................................................................................................................... 33
2.6.1. OVERFLOW AND BREATHER VENTS .................................................................................... 33
Equipment and Piping Design Criteria
1
2.6.2. NOZZLE SIZING FOR C&S .................................................................................................... 33
2.6.3. SAFETY RELIEF VENTS ........................................................................................................ 33
2.6.3.1. Rupture Disks............................................................................................................. 33
2.6.3.2. Pressure Safety Valves ............................................................................................... 34
2.6.3.3. Vent Filters................................................................................................................. 34
2.7. TANK INLETS .................................................................................................................................... 35
2.7.1. DIP/DIVERT TUBES .............................................................................................................. 35
2.7.2. VALVE LOCATION; DEAD LEGS ............................................................................................ 36
2.7.3. TANK MANIFOLDS ............................................................................................................... 37
2.8. TANK OUTLETS ................................................................................................................................ 38
2.8.1. DRAINABILITY CRITERIA AND DRAIN RATES ...................................................................... 38
2.8.2. VORTEX BREAKERS .............................................................................................................. 39
2.8.3. VALVES ................................................................................................................................ 40
2.8.3.1. Selection and Specification Criteria ........................................................................... 40
2.8.3.2. Dead legs .................................................................................................................... 41
2.9. MISCELLANEOUS NOZZLES............................................................................................................. 42
2.9.1. INSTRUMENTS ...................................................................................................................... 42
2.9.2. SPRAY DEVICES ................................................................................................................... 43
2.9.3. SAMPLE VALVES .................................................................................................................. 43
2.9.4. SIGHT AND LIGHT GLASSES ................................................................................................. 44
2.10. IQ/OQ DESIGN REQUIREMENTS...................................................................................................... 45
3.0 PUMPS 46
3.1. GENERAL SANITARY REQUIREMENTS............................................................................................ 46

3.2. MATERIALS OF CONSTRUCTION ..................................................................................................... 46
3.3. SANITARY CENTRIFUGAL PUMPS .................................................................................................... 46
3.4. SANITARY ROTARY LOBE PD PUMPS ............................................................................................. 47
3.5. SANITARY PROGRESSIVE CAVITY PUMPS ...................................................................................... 48
3.6. CIP BYPASS DESIGNS FOR PD PUMPS ............................................................................................. 49
4.0 PROCESS PIPING 51

4.2.2. SURFACE FINISH................................................................................................................... 51
4.3. ELASTOMERS.................................................................................................................................... 51
4.4. JOINTS............................................................................................................................................... 52
4.4.1. WELDS ................................................................................................................................. 52
4.4.1.1. Welder Qualifications................................................................................................. 52
4.4.1.2. Welder Program Qualification ................................................................................... 52
4.4.1.3. Weld Criteria .............................................................................................................. 53
4.4.2. SANITARY CLAMPS .............................................................................................................. 54
4.4.3. GASKETS .............................................................................................................................. 54
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4.4.4. QUICK-CONNECTS ............................................................................................................... 55
4.4.5. BEVEL SEAT FITTINGS ......................................................................................................... 55
4.4.6. COMPRESSION FITTINGS ...................................................................................................... 56
4.5. INSTALLATION ................................................................................................................................. 56
4.5.1. DEAD LEGS .......................................................................................................................... 56
4.5.2. TEE ORIENTATION ............................................................................................................... 56
4.5.3. PIPE SLOPE ........................................................................................................................... 57
4.5.4. PIPE SUPPORTS ..................................................................................................................... 58
4.6. U BEND TRANSFER PANELS .............................................................................................................. 58
4.7. PIGGING TERMINAL DESIGN FOR CLEANABILITY .......................................................................... 59
4.7.1. SELECTION CRITERIA ........................................................................................................... 60
4.7.2. PROPELLANTS ...................................................................................................................... 63
4.7.3. INSTALLATION DETAILS ...................................................................................................... 63
4.8. PIPING SPECIALTIES ........................................................................................................................ 64
4.8.1. FLEX HOSES ......................................................................................................................... 64
4.8.2. STATIC MIXERS .................................................................................................................... 66
5.0 INSTRUMENTATION 67

5.2.2. SURFACE FINISH................................................................................................................... 67
5.3. SELECTION CRITERIA...................................................................................................................... 67
5.3.1. FLOW .................................................................................................................................... 67
5.3.2. TEMPERATURE ..................................................................................................................... 69
5.3.3. PRESSURE ............................................................................................................................. 69
5.3.4. PH & ORP............................................................................................................................ 70
5.3.5. LEVEL................................................................................................................................... 71
5.3.6. CONDUCTIVITY .................................................................................................................... 71
5.4. IQ/OQ DESIGN REQUIREMENTS..................................................................................................... 72
6.0 VALVES 72

6.2.2. SURFACE FINISH................................................................................................................... 73
6.3.1. BALL .................................................................................................................................... 73
6.3.2. DIAPHRAGM ......................................................................................................................... 74
6.3.3. COMPRESSION ...................................................................................................................... 75
6.3.4. MIXPROOF ............................................................................................................................ 76
6.3.5. PLUG .................................................................................................................................... 76
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6.3.6. BUTTERFLY (WAFER) ........................................................................................................... 76
6.3.7. NEEDLE ................................................................................................................................ 77
6.3.8. CHECK .................................................................................................................................. 77
6.3.9. SAMPLE ................................................................................................................................ 77
7.0 SPECIALTY EQUIPMENT 78
7.1. FILTERS ............................................................................................................................................ 78

7.1.1. PUROLATOR ......................................................................................................................... 78
7.1.2. OTHERS ................................................................................................................................ 78
7.2. HEAT EXCHANGERS......................................................................................................................... 78
7.3. HOMOGENIZERS............................................................................................................................... 79
7.4. POST ADDITION (PA) SKIDS ............................................................................................................ 80
8.0 FILLING EQUIPMENT 81
8.1. FILLING EQUIPMENT OVERVIEW ................................................................................................... 81

8.1.1. HEAD TANKS........................................................................................................................ 81
8.1.2. PIPING .................................................................................................................................. 82
8.1.3. NOZZLES .............................................................................................................................. 82
8.1.4. CRITERIA FOR CLEANING CHANGEOVER TIMES .................................................................. 83
8.2. TIME-GRAVITY & TIME-PRESSURE FILLERS ................................................................................ 83
8.2.1. C&S APPROACH .................................................................................................................. 84
8.3. MAGNETIC FLOW METER FILLERS ................................................................................................ 84
8.3.1. C&S APPROACH .................................................................................................................. 85
8.4. WEIGHT FILLERS ............................................................................................................................. 85
8.4.1. C&S APPROACH .................................................................................................................. 86
8.5. PISTON FILLERS ............................................................................................................................... 86
8.5.1. C&S APPROACH .................................................................................................................. 87
8.6. AIR SENSING FILLERS ..................................................................................................................... 87
8.6.1. C&S APPROACH .................................................................................................................. 88
8.7. PRESSURE OVERFLOW FILLERS ..................................................................................................... 88
8.7.1. C&S APPROACH .................................................................................................................. 89
9.0 CLEANING EQUIPMENT 90
9.1. OVERVIEW CIP AND COP............................................................................................................ 90

9.2. SPRAY DEVICES................................................................................................................................ 91
9.2.1. TYPES ................................................................................................................................... 91
9.2.1.1. Static Spray Devices................................................................................................... 91
9.2.1.2. Rotating Spray Devices .............................................................................................. 92
9.2.1.3. Gear Driven ................................................................................................................ 92
9.2.2. SELECTION CRITERIA ........................................................................................................... 94
9.2.2.1. Vessel Configuration.................................................................................................. 94
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9.2.2.2. Type of surface to be cleaned..................................................................................... 95
9.2.2.3. Sanitary Requirements ............................................................................................... 95
9.2.2.4. Available Nozzles ...................................................................................................... 95
9.2.2.5. Shadowing.................................................................................................................. 95
9.2.2.6. Cleaning time ............................................................................................................. 96
9.2.2.7. Reason for cleaning .................................................................................................... 96
9.2.2.8. Soil ............................................................................................................................. 96
9.2.2.9. Budget ........................................................................................................................ 97
9.2.3. SPRAY DEVICE LOCATIONS ................................................................................................. 97
9.2.3.1. Top ............................................................................................................................. 97
9.2.3.2. Sidewall...................................................................................................................... 97
9.2.4. COVERAGE CRITERIA (FLOW/ SURFACE AREA) .................................................................... 98
9.2.5. SPRAY COVERAGE TESTING PROTOCOL FOR TANK VENDORS .............................................. 98
9.2.5.1. Purpose ....................................................................................................................... 98
9.2.5.2. Materials..................................................................................................................... 98
9.2.5.3. Equipment .................................................................................................................. 99
9.2.5.4. Application ................................................................................................................. 99
9.2.5.5. Spray Coverage Procedure ......................................................................................... 99
9.2.5.6. Inspection ................................................................................................................... 99
9.2.5.7. Retesting................................................................................................................... 100
9.2.5.8. Acceptance ............................................................................................................... 100
9.2.6. FLOW VERIFICATION.......................................................................................................... 100
9.3. CIP SKIDS....................................................................................................................................... 101
9.3.1. OVERVIEW WHAT IS A CIP SYSTEM/SKID?..................................................................... 101
9.3.2. GUIDELINE COMPONENT SPECIFICATIONS ......................................................................... 102
9.3.2.1. Heat Exchanger ........................................................................................................ 103
9.3.2.2. Tanks ........................................................................................................................ 103
9.3.2.3. Supply Pump ............................................................................................................ 103
9.3.2.4. Return System .......................................................................................................... 103
9.3.2.5. Chemical Injection ................................................................................................... 104
9.3.2.6. Controls and Instrumentation ................................................................................... 105
9.3.3. CIP SKID SELECTION CRITERIA .......................................................................................... 106
9.3.3.1. Nature of the Soil ..................................................................................................... 106
9.3.3.2. Equipment Being Cleaned........................................................................................ 107
9.3.3.3. Process and Production Issues.................................................................................. 107
9.3.3.4. Utilities: Available vs Required ............................................................................... 108
9.3.3.5. Chemicals Used for Cleaning................................................................................... 109
9.3.3.6. Level of Automation ................................................................................................ 109
9.3.3.7. Validation Issues ...................................................................................................... 110
9.3.4. CIP SKID SELECTION CRITERIA .......................................................................................... 110
9.3.4.1. Toothpaste ................................................................................................................ 110
9.3.4.2. Fabric Softeners........................................................................................................ 111
9.3.4.3. Personal Care Products (Creams and Shampoos) .................................................... 111
9.3.4.4. Detergent Liquids ..................................................................................................... 111
9.3.5. PROTOTYPE CLEANING REGIMENS .................................................................................... 112
9.4. COP UNITS ..................................................................................................................................... 112

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9.4.1. OVERVIEW WHAT IS A COP SYSTEM/SKID ..................................................................... 112
9.4.2. GUIDELINE COMPONENT SPECIFICATIONS ......................................................................... 113
9.4.3. SELECTION CRITERIA ......................................................................................................... 113
9.4.3.1. Nature of the Soil ..................................................................................................... 113
9.4.3.2. Equipment Being Cleaned........................................................................................ 114
9.4.3.3. Process and Production Issues.................................................................................. 114
9.4.3.4. Utilities: Available vs Required ............................................................................... 115
9.4.3.5. Chemicals Used for Cleaning................................................................................... 115
9.4.3.6. Level of Automation ................................................................................................ 116
9.4.3.7. Validation Issues ...................................................................................................... 116
9.4.4. STORAGE RACKS ................................................................................................................ 116
10.0 CIP PIPING SYSTEMS 118
10.1. OVERVIEW GENERAL DESIGN CRITERIA FOR CIP PIPING ..................................................... 118
10.2. TANK CIRCUITS ............................................................................................................................. 118
10.3. LINE CIRCUITS ............................................................................................................................... 119
10.4. COMBINATION CIRCUITS .............................................................................................................. 120
10.5. RELATIVE CIP UNIT LOCATION CRITERIA................................................................................... 120
10.6. RETURN OPTIONS ........................................................................................................................... 121
10.6.1. RETURN PUMPS .................................................................................................................. 121
10.6.2. EDUCTOR RETURNS............................................................................................................ 122
10.6.3. GRAVITY RETURNS ............................................................................................................ 122
10.6.4. OVERPRESSURE .................................................................................................................. 123
10.6.5. COMBINED RETURN SYSTEMS ........................................................................................... 124
10.7. CHEMICALS FOR CLEANING ......................................................................................................... 124
10.7.1. TYPES ................................................................................................................................. 125
10.7.1.1. Alkalines................................................................................................................... 125
10.7.1.2. Acids......................................................................................................................... 125
10.7.1.3. Enzymatics ............................................................................................................... 125
10.7.1.4. Emulsions ................................................................................................................. 125
10.7.1.5. Solvents .................................................................................................................... 125
10.7.2. DOSING ............................................................................................................................... 126
10.7.3. SAFETY AND HANDLING .................................................................................................... 126
10.7.4. MONITORING FOR RESIDUAL LEVELS ................................................................................ 126
11.0 SANITIZATION SYSTEMS 126
11.1. OVERVIEW...................................................................................................................................... 126

11.1.1. DEFINITION OF SANITIZATION, STERILIZATION ................................................................. 126
11.1.2. CLEANING VS. SANITIZATION ............................................................................................ 127
11.2. STEAM ............................................................................................................................................. 127
11.2.1. PIPING SPECIFICATION ....................................................................................................... 127
11.2.2. PRESSURE VS. ATMOSPHERIC STEAMING .......................................................................... 128
11.2.3. AIR REMOVAL..................................................................................................................... 129
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11.2.4. MECHANICAL SEALS .......................................................................................................... 129
11.2.5. CONDENSATE REMOVAL .................................................................................................... 129
11.2.6. TRAPS ................................................................................................................................. 129
11.2.6.1. Drip Traps ................................................................................................................ 131
11.2.6.2. SIP condensate traps................................................................................................. 131
11.2.7. VALVES .............................................................................................................................. 131
11.2.8. STEAM FLOW CONTROL ...................................................................................................... 132
11.2.9. QUALITY, PURITY, CHEMICAL TREATMENT ...................................................................... 132
11.3. HOT WATER ................................................................................................................................... 132
11.3.1. PIPING SPECIFICATION ....................................................................................................... 132
11.3.2. TIME/ TEMPERATURE MONITORING.................................................................................... 133
11.3.3. SUPPLY SYSTEM, QUALITY REQUIREMENTS ....................................................................... 133
11.4. CHEMICALS FOR SANITIZATION ................................................................................................... 134
11.4.1. TYPES ................................................................................................................................. 135
11.4.1.1. Hypochlorites ........................................................................................................... 135
11.4.1.2. Quaternary Ammonium Compounds ....................................................................... 135
11.4.1.3. Acid Sanitizers ......................................................................................................... 136
11.4.1.4. Ozone ....................................................................................................................... 137
11.4.1.5. Alcohols ................................................................................................................... 137
11.4.2. DOSING ............................................................................................................................... 137
11.4.3. SAFETY AND HANDLING .................................................................................................... 137
11.4.4. MONITORING FOR RESIDUAL LEVELS ................................................................................ 137
12.0 COMPRESSED AIR SYSTEMS 139
12.1. PROCESS AIR CRITERIA ................................................................................................................ 139

12.2. PIPING ............................................................................................................................................. 139
12.3. COMPONENTS ................................................................................................................................. 139
13.0 PROCESS ROOMS AND OPERATING AREAS 141
13.1. OVERVIEW...................................................................................................................................... 141

13.2. OPEN PROCESSES DOS AND DONTS .......................................................................................... 141
13.3. ROOM FINISHES ............................................................................................................................. 141
13.3.1. FLOORS ............................................................................................................................... 141
13.3.2. WALLS ................................................................................................................................ 142
13.3.3. CEILING .............................................................................................................................. 142
13.3.4. WALL GUARDS ................................................................................................................... 143
13.3.5. DOORS ................................................................................................................................ 143
13.3.6. LIGHT FIXTURES................................................................................................................. 143
13.4. ACCESS ........................................................................................................................................... 143
13.5. VENTILATION ................................................................................................................................. 143
13.6. FACILITY FLOWS ........................................................................................................................... 144
13.6.1. MATERIAL .......................................................................................................................... 144
13.6.2. EQUIPMENT ........................................................................................................................ 144
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13.6.3. PERSONNEL ........................................................................................................................ 145
13.6.4. TRASH ................................................................................................................................ 145
14.0 APPENDIX 146
14.1. COMPONENT SPECIFICATION SHEETS FOR C&S......................................................................... 146

14.1.1. PROCESS TANKS ................................................................................................................. 146
14.1.2. PROCESS PUMPS ................................................................................................................. 146
14.1.3. SPECIALTY EQUIPMENT...................................................................................................... 146
14.1.4. PROCESS VALVES ............................................................................................................... 146
14.1.5. INSTRUMENTATION ............................................................................................................ 146
14.1.6. CIP EQUIPMENT ................................................................................................................. 146
14.1.7. COP EQUIPMENT................................................................................................................ 146
14.1.8. TRANSFER PANELS ............................................................................................................. 146
14.2. LIST OF TABLES ............................................................................................................................. 146
14.3. LIST OF FIGURES ............................................................................................................................ 152

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1.0 CHAPTER OVERVIEW

1.1. OBJECTIVE
The Objective of this Guideline is to provide a technical reference of the Colgate-

Palmolive (CP) related Industrys Best Practices in equipment and piping design for
Cleaning and Sanitization as adopted by CP and applied to our manufacturing
philosophies. The document is centered around good sanitary design, which focuses on
unique characteristics of equipment, piping, and components that ensure effective
cleaning and sanitization.
Operations, Quality, Engineering, and Maintenance personnel will use this Guideline to
design, specify, and procure equipment, components, and facilities where system
cleanability and microbial control is to be considered. The Guideline will be applicable
for new installations as well as existing facilities in need of system renovations or
improvements.
This document is not intended to be a process design guideline, but applies to cleaning
and sanitization aspects of design to be considered with other CP process design
guidelines. C&S Guideline #1, along with the other C&S Guidelines, will assist in the
implementation of the following CP Quality Standards.
QS# Title
020 Product Design

021 Technology Transfer
022 Process Control
023 Microbiological Control
030 Corrective and Preventative Action
031 Change Control
040 Water and Utility Systems
041 Facilities
043 Equipment
1.2. SCOPE
This Guideline includes:
Fundamental design criteria to help ensure cleanability of the various types of process
equipment used in CP manufacturing sites throughout the world.
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Descriptions of design and installation techniques for process piping systems and
components in cleanable systems.
Design and specification information for various types of cleaning and sanitization
equipment that could be used for CP process systems.
Sanitary piping system design strategies and details.
Facility considerations for the proper design and maintenance of production areas in
order to maintain proper quality control.
Design criteria for compressed air, steam, water, and other utilities that come into
contact with the product.
Since it is to be used as a design supplement to other CP documents, this Guideline does

not include complete design specifications, SOPs, or criteria for process design other than
sanitary considerations.
1.3. RELATED C&S GUIDELINES
C&S Guideline #2 Principles and Practices
This document serves as a Cleaning and Sanitization fundamentals course: general

theory, history and definitions of manual cleaning, COP, CIP and SIP; cleaning
mechanisms, spray ball types and uses; cleaning and sanitizing agents; discussion of
various CIP/SIP system configurations and philosophies.
C&S Guideline #3 Plant Assessment
This document is primarily intended for plant operations staff as a tool to assess
cleaning and sanitization aspects of production systems in comparison to Guidelines 1
& 2. These assessments will help plants to identify potential hot spots in system
design and installation, which could affect microbial and quality control.
C&S Guideline #4 Protocol for C&S Aspects of New Product Development
This document defines C&S related aspects of R&D formula development and
implementation.
C&S Guideline #5 Guideline for C&S Plant Implementation
This document outlines organizational and resource requirements for successful

implementation and maintenance of plant C&S programs.

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C&S Guideline #6 Validation
This document provides an overview of general Validation principles and CPs

Validation program. The document outlines requirements for documenting master
plans, C&S SOPs and protocols; establishing acceptance criteria; training; change
control.
1.4. RELATED QUALITY PROGRAMS
1.4.1. CPM CONTROL POINT MONITORING
CPM is a preventive system that identifies and monitors specific microbial contamination
within a production process that can adversely affect the safety and quality of a particular
product.
The purpose of the CPM is to improve understanding of how process and procedures
impact microbial contamination risk, by shifting the focus to in-process preventive
actions rather than end-product testing.
Therefore, the plant C&S assessment as per these Guidelines compliments CPM
implementation by uncovering potential equipment and procedures micro hot spots that
may need correction and monitoring.
Plants must prepare to implement CPM in line with C&S assessment findings. Global
Microbiology Group in Piscataway may be contacted to facilitate CPM implementation.
1.4.2. MICROSUSCEPTIBILITY INDEX (MSI)
The Micro Susceptibility Index (MSI) is a data-based driven tool used to assess micro
risk. The MSI was created by David Preston (Salford Plant) and is a calculated parameter
based on initial micro test results performance divided by the total number of samples
analyzed. It reflects the overall formula robustness and the plant/process micro-integrity
robustness for that given formulation as an index number.
The MSI allows one to identify those formulas or plant processes that pose the highest
microbial risk as determined by the index number. Data is generated monthly (also 12
month rolling data), organized and presented in such a fashion as to rate formulas, lines
and their rate of change in managing that micro risk, thus allowing concentration and
focus of resources to best manage that risk. This information can be presented to
management and be used to accomplish needed change in either formulation or plant
processes.

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1.5. KEY TERMINOLOGY
Bioburden: A general term used to describe the microbiological loading or activity in a

system. This term can cover a wide range of microbiological limits and categories, and
can be represented in terms of total microbial count, colony forming units (cfu), etc.
CCA: Clean Compressed Air
CIP (Clean In Place): An automated or semi-automated method of cleaning process

equipment without disassembling or moving the equipment and its components.
COP (Clean Out of Place): cleaning equipment or components out of their production
location in a in a manual, semiautomatic or automatic manner.
SIP: Sanitize In Place
CIPS/R: CIP Supply and Return (piping)
GMP: Good Manufacturing Practice, a term adopted by the US Food and Drug
Administration (FDA)
Micro Sensitivity: The degree a products quality characteristics are affected by

microbial contamination
Sanitization: The reduction of microbial contamination to a specified level
Sterilization: The complete elimination of microbial contamination
Soil: Residual product on a surface which is being cleaned.
EHEDG: European Hygienic Equipment Design Group Guidelines
Profilometer: An instrument used to measure surface roughness
Visually Clean: When examined visually, under well-lit and close inspection, a surface
appears to be free of residual product and extraneous matter that adulterates,
contaminates, or pollutes
Sanitary Design: Design that is accessible and allows easy disassembly for cleaning and
sanitization. Surfaces and corners are smooth to minimize contamination.

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2.0 STORAGE AND MIXING TANKS
2.1. PRODUCT CONTACT SURFACE
2.1.1. MATERIALS OF CONSTRUCTION
All materials that come into contact with the product must be non-toxic, mechanically
stable, inert, and resistant to the product and cleaning solutions. Product contact materials
must be 3A approved and/or consistent with European Hygienic Equipment Design
Group (EHEDG) Guidelines for sanitary applications.
2.1.1.1. STAINLESS STEEL
Austenitic stainless steels are the most common materials used at CP for product contact
surfaces. There are several differences between various AISI stainless steel types.
The most common types of stainless steel are:
AISI 304 - commonly found in CPs older facilities; can be susceptible to corrosion when
exposed to chlorides at high temperatures and concentrations; less expensive than 316
SS. 304L slightly reduced corrosion susceptibility and should be used where welding is
required.
Acceptable uses in existing facilities:
Oral Care products not containing SLS

Powder raw materials
Non corrosive PCPs
Non-corrosive HSC products
Structural framing and non-product contact materials
AISI 316 - contains molybdenum, which reduces corrosion when exposed to chlorides
(below 60 C); 316 will also slightly reduce corrosion with certain raw materials, e.g.,
SLS.
316 Acceptable uses in existing facilities:
Oral Care products not containing SLS

Non-corrosive Personal Care products
Non-corrosive HSC products.
Corrosive raw materials

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AISI 316L Best practice for new facilities:
316L (low carbon content) should be used where welding is required. 316L is the
material of choice for all new applications and is best practice for
All liquids
OC products containing SLS
non-liquid PCPs
All metallic materials used in the manufacture of vessels, including plates, sheets,
nozzles, jackets, sheathing, and accessories, should be stainless steel. Furthermore, all
wetted accessories that will be exposed to the internal product contact areas of the vessel
or will contact solutions that will be introduced to the interior of the vessel (e.g., spray
devices, dip tubes, sight glasses, etc.) should meet the material and surface finish
requirements of the interior of the vessel for which they are to be provided.
2.1.1.2. FRP
Fiberglass Reinforced Plastic tanks are sometimes used as storage vessels and process
tanks. This material is acceptable for non-microsusceptible raw materials, such as certain
acids or caustics, non-microsusceptible products such as bleach, but is not appropriate for
product or raw material contact where bioburden is a concern. Although FRP tank
suppliers may claim the surface finish is smooth, the smoothness is never measured or
stated in terms that are comparable to stainless steel finishes or accepted plastics such as
PVDF. Although FRP is indeed used in some food industries, the risks for use by CP is
in the longer term C&S effects of an improperly made tank as opposed the initial
suitability of a well made tank. FRP tanks are susceptible to bubbles just below the
finish layer that can become pits. Improperly made tanks may be subject to blistering
that creates larger pockets for microbial growth. Also, the materials and resins used to
manufacture FRP are more porous and therefore more susceptible to microbial
contamination than other polymers, such as polypropylene. There is an inner layer
applied to these tanks to aid in chemical compatibility, but this liner is extremely thin and
will erode over time and expose the tank to the more porous and rough inner surface. In
general, sanitary fittings and manways are not available for FRP tanks. Generally side
manways are standard on FRP tanks for the primary reason of accessibility to repair these
defects. Existing FRP tanks used on microsusceptible products should be inspected
regularly for any of the above defects and replaced or repaired if defects are found. All
flanges and fittings must be disassembled for manual cleaning in accordance with a
validated SOP.
FRP tanks that are lined with other plastics such as PVC, PP, PVDF are becoming more
widely used and should be considered on the cleaning and sanitization merits of the liner.
FRP construction and fittings issues still apply. Costs of such composites are similar to
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stainless steel and therefore should be considered only when corrosion is a key concern.
Therefore stainless steel is usually a better choice.
2.1.2. SURFACE FINISH
Product contact surfaces should have an interior surface finish of 15-25 -inch (.38-.63
m) Ra. Where micro-susceptibility is a concern or the product is particularly difficult to
clean, the vessel may be electropolished after the mechanical polish has been completed.
All interior welds should be ground smooth and successively polished and
electropolished (where specified) to the same finish as the adjoining surfaces.
Avg deviation
Ra
Mean
Figure 1 - Definition of Ra
Surface finish should be measured by a profilometer (instrument used for measuring
surface variations, see Figure 4 Profilometer), after a successively built-up mechanical
polish is completed, but prior to electropolishing. Table 1 shows a comparison of various
methods of measuring or qualifying the surface characteristics. The current industry
standard is to state the measurement in micro-inch (m) or micron (m same as
micrometer) Ra. The table not only compares units (micro-inch vs. micron or
micrometer), but also compares Ra (Arithmetic Mean) and RMS (Root Mean Square).
Ra and RMS are simply two different methods of calculating the average height of the
peaks and valleys along the measured surface (see Figure 1 for Ra definition). The
standard starting point for most SS sheet stock, 2B mill finish, has a surface finish of
greater than 60 -inch (1.5 m) Ra.

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Table 1 Surface Measurement Comparison
Grit Size RMS RMS Ra Ra
(-inch) (Micron) (-inch) (Micron)
80 80 2 03 71 1 80
120 58 1.47 52 1.32
150 47 1.20 42 1.06
180 34 .86 30 .76
180-240 28 .72 25 .63
240 17 .43 15 .38
320 14 .36 12 .30
When specifying a desired surface finish, the Ra value (or RMS) value should be used in
lieu of Grit. Grit does not guarantee an end result, it only says how to polish a surface and
is dependant on pressure, time, operator subjectivity and the original surface finish. Ra
values are a constant that are measurable and verifiable.
Mechanical polishing should be performed with multiple passes using appropriate

abrasive material. Each polishing pass uses an abrasive with a finer grit than the previous
pass and should be performed at a 90 angle from the previous polishing pass. Each
polishing operation should completely remove the polishing marks from the previous
polishing operation. Surfaces in contact with product shall be free from visible scratches,
burrs, pits, flash, folds, nicks, inclusions, crevices, and other defects. To amplify the
importance of a smooth surface finish, note that bacteria ranges in size from
approximately 60-0.2 microns, virus from 0.1-0.003 microns. Any of these organisms
may find a hiding place in a crack or groove that is not thoroughly cleaned with turbulent
flow (see Section 9.2.4 for discussion on cleaning flow rates).
Figure 2 shows the difference in surface profile for various different polishing
techniques. Buffing may make a surface appear smooth visually, but creates pockets
where impurities can be trapped. Manual buffing should only be performed on non-
product contact surfaces. Mechanical polishing will expose these pockets and should be
used on product contact surfaces. However, mechanical polishing can still leave spikes
in the surface that can trap impurities. Electropolishing will slightly lower the surface Ra
as well as round-off the spike, minimizing areas for surface entrapment.

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Buffing (Scotchbrite) Mechanical Polishing Electropolishing

Figure 2 - Surface Profiles from Various Polishing Techniques
2.1.3. WELDS
Welds exposed within the interior of tanks should be ground smooth and polished to 25
-inch (.63 m) Ra and flush with adjoining surfaces. Surfaces in contact with product
should be free from visible scratches, burrs, pits, flash, folds, nicks, inclusions, crevices,
and other defects as discernible by profilometer inspection. No visible heat tint is
permissible. Backing and purging gases such as argon should be used in the appropriate
purity and flow rate to promote the proper weld penetration, flow, and coloration.
Figure 3 below shows five coupons with examples of various approaches to polishing
welds. The three on the left may be appropriate for exterior surfaces but would not be
suitable for product contact.
*GMAW = Gas Metal Arc Weld (sometimes GTAW - Gas Tungsten Arc Weld)
Figure 3 Sample Weld Finishes

A profilometer, such as the one shown below in Figure 4, is a device for measuring
variations in the surface profile of a given material. Several methods can be used to
establish an instrument reference line from which profile height can be measured. The
simplest approach is to use a skid riding on the surface itself as a reference. Usually the
arm to which the skid is tied pivots a long distance away from the measurement. The skid
assembly and transducer are designed to measure the difference in height between the
skid height and the stylus tip height. The skid rides over imperfections in the surface and

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acts as a mechanical filter of the surface: it smoothes out longer wavelength undulations
in the surface.
Figure 4 Profilometer
This photo represents a laboratory model. Portable units are also
available for use in the field.
2.1.4. CORNER DETAILS
All internal angles 135 or less on product contact surfaces should have a minimum
radius of (6.4 mm). Angles greater than 135 must have a continuous weld that is
polished smooth. Radii for corners where a vessel head meets the vessel sidewall should
not be less than (19.1 mm).
Figure 5 Corner Details

2.2. TANK CONFIGURATION
This section covers vessel design parameters for process vessels that are cleaned and/or
sanitized for product contact. It applies to raw material and WIP storage tanks, mixing
vessels, and head tanks. Although substantial differences exist between vessels used for

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personal care products vs. oral care products, for storage vs. mixing and so on, the
fundamentals of design for good cleaning and sanitization are relatively consistent.
2.2.1. TOP HEAD TYPES
Depending on the use, tanks in the CP facilities may require various types of head
configurations. Only certain head types are appropriate for manual or automated
cleaning. In general the shape of the head should promote for free draining or sheeting of
product and cleaning solutions, allow for spray device ease of alignment with nozzles,
and minimize residual hold-up. Conical top heads, which are often used at CP for large
storage vessels, should have a minimum 30 slope to allow proper sheeting and drainage.
Note that 3A establishes a 3% minimum slope, which may be acceptable depending on
product and cleaning characteristics. However, a 30% slope is desired for CP facilities.
2.2.1.1. CLOSED TOPS
Vessels intended for automated or semi automated cleaning cycles should be provided
with closed top heads. The most common type of head for this application is a Flanged
and Dished head (F&D). The precise type can be specified if the application is clearly
understood (shallow F&D, ASME, 80/10, etc see Figure 6). For example, if headroom
were a concern, then a shallow F&D head would be preferred over an 80/10 head.
However, there are certain economies in tank head fabrication based upon dimensions,
pressure ratings, etc, which can be used to an advantage. Unless there is a particular
reason to the contrary, specify an F&D head and let the tank fabricator choose the most
economical type. Typically, even a shallow F&D head will provide adequate sheeting
and drainage when proper cleaning agents are employed. Flat top tanks, even when
flanged as shown below, are undesirable from a cleaning perspective.

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Unacceptable for CIP
Figure 6 Top Head Types

Examples of various heads used in closed
top vessels, both pressure rated and
atmospheric. From top to bottom:
Flanged Head Flat top with radius or

knuckle for improved cleanability at the
interface to the straight side.
ASME Flanged & Dished (F & D) Along

with a Standard F&D, this is the most
commonly used head for closed vessels and
is very cleanable. The dish radius (DR) is
equal to the outside diameter (OD) of the
vessel.
80/10 Another type of F & D head with a

taller profile. 80/10 means the DR equals
80% of the OD, and the knuckle radius
(KR) equals 10% of the OD.
Elliptical No true dish radius, the dish

depth is equal to 25% of the tank ID.
2.2.1.2. OPEN AND REMOVABLE TOPS
Often times CP will utilize open top vessels for mixing raw materials or other
ingredients, particularly for smaller batch sizes. These tanks are typically cleaned
manually, although there are systems that can be purchased and installed to clean open
top vessels. When removable lids are used, flat tops are typically seen due to cost and
weight. F&D heads weigh substantially more than flat top heads and are therefore often
impractical to be manually removed. When used, flat heads should be flanged as shown
in Figure 6 in order to reduce product and cleaning solution hold-up in corners. Care
should also be given to the gasket type and configuration.

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2.2.2. BOTTOM HEAD TYPES
The same types of heads used in tank tops are also used as tank bottoms, however they
are often mixed and matched. You might find reason to use an ASME dished head
bottom with a flat-flanged top head. The critical issue with the tank bottom head is
drainability. The outlet valve must be at the low point of the tank bottom, and the head
shall be configured to allow the vessel to completely free drain through the outlet.
Dished or conical heads are preferred as they offer better draining. When flat bottom
tanks are used they should be pitched at least per foot to the lower side outlet valve.
Flat bottom tanks with an outlet located in the center are not acceptable. Figure 7 shows
how variations in tank bottom configuration can have an impact on contamination risk.
Although this configuration is

drainable, the design is not
recommended.
Figure 7 - Tank Bottom Configurations

One technique that can be used to further modify a sloped flat bottom tank (see diagram
(d) in Figure 7) is to install a section of stainless steel tube along the bottom of the tank to
enhance drainablity. Although this method can improve drainage for flat bottom tanks,
care must be taken during fabrication so as not to create high spots in the tank bottom as a
result of the welding process. Stainless sheet stock will expand and deform during the
fabrication process, particularly when it is heated for welding. Take steps to ensure the
tank bottom remains sloped to the low point and that the welds for the half-pipe are
polished smooth without pits or cracks. See Figure 8 for half-pipe details.

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HALF-PIPE TANK OUTLET FOR

WELD CONTINUOUS OPTIMAL DRAINAGE
AND POLISH
SMOOTH
SLOPE TO DRAIN
SIDE VIEW DETAIL TANK TOP VIEW
SLOPED FLAT BOTTOM TANK
SS TUBE CUT TO SERVE AS

HALF-PIPE TANK OUTLET
START
HALF-PIPE
@ 25-33% MIN 3% SLOPE
OF TANK ID
TANK SIDE VIEW TANK FRONT VIEW
Figure 8 - Tank Half-Pipe Discharge Details
2.3. MANWAY
Vessels large enough to require personnel entry for maintenance or modification will
require a manway. Also, vessels that are cleaned manually will require a manway for
access to the vessel internals for cleaning and inspection. Of all the nozzles on the top
head, manways create some of the most challenging cleaning problems. Although they
are large in comparison to other nozzles and allow a substantial amount of water into the
neck space during CIP, they are often poorly positioned with respect to spray ball
coverage, creating shadows. Also, many of the commonly used styles are not sanitary in
their design, and simply cannot be cleaned without disassembly.
2.3.1. LOCATION
Manways are typically located on the top head, but can also be found on tank sidewalls
for easier personnel access. From a cleanability standpoint, the top head is the preferred
location as it is typically closer to the spray ball, and its position promotes free draining
much better than a horizontal manway. When locating a manway in the sidewall, the

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collar should be tapered or flared to increase contact from the spray ball and sloped at
least 5 degree drain angle. Position the spray ball below the manway wherever possible.
Unacceptable Acceptable
Figure 9 Manway and Nozzle Positions

2.3.2. TYPES
Some manways simply are not CIP cleanable. They are designed to provide a seal to the
process during operation, but the only way to get them clean is to open the manway and
manually wipe the contact surface. Examples of manways that cannot be adequately
cleaned during a CIP cycle are shown in Figure 10 Atmospheric Manway and Figure
11 Standard ASME Manway. The atmospheric manway only uses one clamp that
provides a looser fit, allowing product or CIP solution to reach beyond the interface of
the O-ring where it cannot be cleaned or rinsed. As a result, these manways must be
manually cleaned. The standard ASME manway provides some inherent improvements
as a result of the pressure rating, such as more uniform clamping and a dished head for
better draining. However, the seal interface is still a trouble spot, as this style gasket will
not be adequately cleaned during CIP.
The sanitary manway shown in Figure 12, which in this case is a K Series design from
Precision Stainless, Inc., has a specially designed grooved gasket to minimize the product
that rolls over to the back side of the O-ring. It has an extra clamp to provide a more
uniform seal around its circumference, and is flared to allow more cleaning solution to
enter the area between the lid and the collar.
Smaller vessels might be designed with a handway, which is typically an 8 or 10

opening similar in design to a manway. Handways are not adequate for manual cleaning

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or visual inspection of the vessel interior. These vessels should be CIP'd with a spray
device or fitted with a removable top head for manual cleaning and inspection.
Figure 13 on the following page shows pictures of some unacceptable combinations of

manway design with cleaning procedures.

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Cleaning and Sanitization Guideline No. 1
Figure 10 Atmospheric Manway
Acceptable for CIP

w/ considerations
Figure 11 Standard ASME Manway
Flare
Figure 12 Sanitary Manway

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Atmospheric manway on a F&D
head that is CIPd. The manway is
dished but the large diameter the
gasket will retain product. Similar
to the gasket shown in Figure 10.
Acceptable (w/ considerations)

ASME manway on a F&D head that
is CIPd. The manway is more
cleanable than the example above,
but the gasket is still very flat and
will retain product. Note the sight
glass with wiper blade in the center
of the manway requires high
impact or manual cleaning.
Unacceptable
A handway on a tank that is manually
cleaned. In the foreground, half of
the top head is removed for cleaning,
seemingly negating the need for the
handway. Also, the handway is
attached with non-sanitary clamps
and cover.

Atmospheric manway on a tank that
is manually cleaned. This
application is acceptable for manual
cleaning only.
Figure 13 Examples of unacceptable design/procedure combinations

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2.4. AGITATORS
2.4.1. SHAFTS
Shafts should be continuous without couplings and set screws where possible. Where
necessary for flexibility, shaft couplings should be designed to prevent dead spaces and
crevices in the product contact areas. Proper bolt practices (Figure 20) should be used
The shaft should be polished consistent with the surface finish of the interior of the
vessel. Carrier or foot bearings, typically located internal to the vessel on the bottom
head for shaft alignment, are not acceptable for CIP.
2.4.2. IMPELLERS
Impellers should be welded to the shaft wherever possible, with the weld surface polished
consistent with the interior of the tank. Eliminate use of bolts, split shafts, couplings and
threads where possible. When bolts are necessary for flexibility, refer to Figure 20 for
guidelines on acceptable practices. Various impellers used in CP facilities are outlined
below.
2.4.2.1. AXIAL FLOW TYPE
Pitched blade or hydrofoil impellers are used for storage and general compounding
applications, and are relatively easy to clean. Appropriate cleaning chemistry and
agitator rotation is required to clean the bottom of axial flow impellers from spray balls
located above the impeller. Flooding is sometimes used to clean these impellers as well,
but this would not be necessary with properly designed spray device coverage. With
proper flow, the cleaning solutions will roll over the top surface and sheet the bottom
surface while the impeller is spinning. Built chemical detergents with proper surfactants
will also aid in cleaning. This type of cleaning action is limited to marine prop, pitched
blade, or hydrofoil axial flow impellers, and will not work on flat or scraping blade
impellers.
The impeller should be machined or forged stainless steel, not cast. One-piece welded
construction of the impeller is preferred (see Figure 14). Underside cavities in the hub,
mechanical connections, and crevices in the assembled wetted parts should be minimized
in order to facilitate cleaning-in-place.

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Pitched blade axial flow impeller

one-piece construction with welded
connection to shaft
Figure 14 Axial Flow Impeller

2.4.2.2. SCRAPING BLADE TYPE
Certain compounding vessels, such as dental cream mixers, employ a scraping blade
agitator designed for highly viscous materials. These agitators have a complex network
of counter-rotating pitched blades and Teflon scrapers that continuously contact the
interior surface of the vessel. These agitators are difficult to clean, but if properly
designed can be effectively cleaned via automatic CIP equipment utilizing high pressure
spray devices, sometimes supplemented with flooding the vessel. Scraping blade
agitators are typically mounted in the top center of the tank, and are often supported by
complex hydraulics for removal from the vessel.
Figure 15 Scraping Blade Agitator

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2.4.2.3. RADIAL FLOW TYPE
Radial flow impellers come in various configurations, but in general are designed to
promote flow outward within the tank. Because of their design, most of these impeller
types are very difficult to clean using spray devices from above. The example shown in
Figure 16 is often called a Rushton type impeller, and consisted of a flat, solid disk with
straight or pitched blades around the perimeter. Since there is such a large surface area in
the horizontal plane, the bottom of this impeller will not ordinarily get clean with spray
from above. This impeller should either be cleaned from below using a spray device in
the bottom head or sidewall, or by flooding the vessel. Flooding the vessel alone,
however, is not considered an acceptable CIP cycle. This technique should only be used
in conjunction with a CIP cycle using proper spray devices.
Figure 16 - Radial Flow Impeller

2.4.3. SEALS
Agitators and mixers may have shafts that enter the vessel from the top, side, or bottom.
Tanks with agitators entering the side or bottom (below the liquid level), as well as any
tank to be CIPd, must be provided with a sanitary seal. Open tanks or tanks with
removable lids which will be manually cleaned may utilize an agitator without a seal.
Agitator seals for closed vessels should typically be of a dry-running single mechanical
or equivalent pharmaceutical seal design. Sanitary designs for dry running split seals can
also be cleanable, assuming they are located near the vessel (see next paragraph). In
some cases a double mechanical lubricated seal, such as a John Crane type 21, is used for
a more aseptic application. Many seals have devices, such as a carbon catcher, to prevent
seal debris from dropping into the vessel. These are typically difficult to clean from
inside the vessel and therefore should be specified with a seal flush to run cleaning or
rinse solutions through the seal and into the vessel.
Sanitary seals are designed to place the seal surface near the vessel nozzle, as opposed to
standard configurations where the seal is well up into the motor housing, creating a
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substantial dead leg. Seals should be located a maximum of 1.5 times the nozzle
diameters away from the inside of the vessel.
2.4.3.1. LUBRICANTS
Lubricants shall be approved for incidental food contact and comply fully with the
requirements of FDA CFR 178.3570. Examples include food grade mineral oil or castor
oil.
2.4.3.2. MOUNTING
Axial flow agitators at CP are most often vertically mounted from the top. For small
tanks, the mixers can be top-mounted at a 15 angle from vertical. In other cases, the
mixer will be mounted vertically, either from the top or bottom. Either of these cases is
cleanable while rotating using spray balls from the top side. Agitators may utilize a
sanitary clamp for connection to the tank when the nozzle is 4 (102 mm) or smaller.
The preferred connection detail for all nozzle sizes for sanitary applications is an ANSI
pad flange mounted flush to the vessel top head. The flange should be polished smooth
on the interior of the vessel and the bolts should be captive (not extended into the vessel
interior). See Figure 17.
Agitator Shaft
Captive Bolts
ANSI pad flange
welded to tank wall
Seal
Figure 17 - Pad Flange
Clamp-on style agitators for open top vessels should be mounted to minimize the risk of
contaminants from the motor dropping into the vessel (see Figure 18).

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Figure 18 - Agitator Mounts for Open Processing
2.5. BAFFLES
For proper mixing, internal baffles may sometimes be required on the straight sidewall of
the vessel. Material type, welding, and surface finish of the baffles should comply with all
of the material, weld, and polish requirements indicated for vessels.

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2.5.1. LOCATION AND SHADOWING
Baffles should be mounted approximately one (1) inch off the vessel wall and oriented
perpendicular to the vessel wall. The 1 clearance allows for cleaning solutions to get
behind the baffle. Baffles can cause shadowing of spray ball coverage, so care must be
taken to place spray balls so the pattern contacts all surfaces, either by direct contact or
deflections. See Section 9.2 for further discussion on spray ball placement.
Figure 19 Shadowing at Baffles
2.5.2. CONFIGURATION
The baffle tabs should be welded continuously to the vessel wall and comply with all
welding and finish requirements for the vessel. All corners of each baffle (except where
they are attached to the vessel) shall be configured with a minimum " (13 mm) radius,
and all edges shall be rounded and smooth.
2.5.3. INSTALLATION DETAILS
The use of bolts to secure the baffles to the vessel should be avoided whenever possible.
When bolts are required for flexibility, refer to the practices shown in Figure 20 for
proper selection and installation. Whenever screwed fittings are used, mechanical
(manual) cleaning is recommended.

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Product area
Product
Unacceptable Bolts Acceptable Bolts

Figure 20 Bolt Configurations for Product Contact
2.6. VENTS
2.6.1. OVERFLOW AND BREATHER VENTS
Tank overflow or breather vents are typically cleaned from the inside of the vessel with
the spray device. Although the vent is a product contact surface, it is often considered
part of the waste stream in the event of overflow (product passing through this surface
goes to waste, not commercial use) and is perhaps less heavily scrutinized during
cleaning. Consideration should be given to residual in the vent line from product to
product, as this could be a potential source of contamination. The spray device will only
clean 1-2 pipe diameters up into the vent nozzle, so vents on vessels susceptible to high
foaming where product may have entered the vent should be carefully examined. In
these cases the vent pipe should be removed and cleaned manually between product
changeovers.
2.6.2. NOZZLE SIZING FOR C&S
Nozzles in the top head of vessels which are to be cleaned with a static or rotating spray
device should be a minimum of 1 (40 mm) inside diameter to maximize cleaning
solution penetrating into in the nozzle.
2.6.3. SAFETY RELIEF VENTS
2.6.3.1. RUPTURE DISKS
Rupture disks by BS&B, Fike, or Continental Disk are specifically designed for sanitary
applications. The distance from the tank nozzle connection to the inner surface of the
rupture disk is minimal, and will clamp directly on a sanitary clamp ferrule. When using
high-pressure rotary spray devices, check the impact pressure rating of the disk to avoid
rupturing the disk during cleaning. Fittings are also made to use rupture disks in-line as
well as for vessels.

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Figure 21 Sanitary Rupture Disk Housing
2.6.3.2. PRESSURE SAFETY VALVES
There are few truly sanitary pressure safety valves (PSVs), and those available are
reasonably inexpensive. However, where rupture disks are not acceptable because of the
need to reset the device, there are sanitary PSVs available from Tuchenhagen, Cashco,
and others.
2.6.3.3. VENT FILTERS
For processes that are highly susceptible to bioburden or where aseptic conditions are
warranted, tanks should be provided with a sterile vent filter. Many different types of
filters are available for tank venting, but only a few are appropriate for sterile vent
service.
Where sterile venting is required, particulate filters sized at either 0.1, 0.22 or 0.45
micron should be used in a Code 7 style stainless steel housing sized for the maximum
inflow and outflow conditions of the vessel. Code 7 refers to an AB cartridge style for
sanitary applications (Pall or equal), which have double O-ring connections and a locking
tab at the filter outlet to ensure proper alignment. Other AB styles include Code 8, 3, and
2, but Code 7 configurations are the most standard for sanitary applications. Filter
housings can be either in-line or T-style: in-line uses less space, but a T-style is easier to
service. In either case, these filter housings a) create a substantial dead leg in the vent
pipe at the vessel, and b) cannot be cleaned in-place. Vent lines to a filter should have a
close-coupled valve on the vent nozzle of the tank only if it is automatically controlled by
a CIP program with limit switch feedback to confirm that it is closed during CIP. This
minimizes the dead leg as well as protects the membrane. Otherwise, the housing should
be removed during CIP. Membranes used for sterile vent filtration are typically
hydrophobic (not water tolerant) and must be isolated during cleaning.

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Inline Housing T-Style Housing

Figure 22 - Sterile Vent Filters
HEPA (High Efficiency Particulate Air) filters are often used in facility HVAC systems
for clean rooms, etc., but are not considered sterile filters. HEPA filters are more
similar to depth filters, which limit particulate from passing through by creating a very
tortuous path and capturing particles within its filter media. These filters do not have an
absolute cutoff of particle size (e.g., 0.22 micron), so although they may be effective in
reducing overall particulate count, they cannot be relied upon to prevent particles of a
certain size (such as bacteria) from passing consistently. HEPA filters are not suitable
for tank venting, and should not be used as sterile tank vent filters.
2.7. TANK INLETS
2.7.1. DIP/DIVERT TUBES
The inside of dip tubes must be cleaned via the transfer or product pipe. The outside of
the tubes should be cleaned via the spray device (or manually cleaned). Pump-around
loops are often set up around vessels in order to recirculate cleaning solution through a
dip tube during a CIP cycle.
Dip tubes should be welded through the sanitary clamp that connects to the vessel ferrule,
and should terminate outside the vessel at a sanitary tri-clamp style ferrule for process
connection. Smaller diameter (1-2/25-50 mm) dip tubes can be removed and cleaned
out of place. Material, welding, and surface finish on all surfaces that will be exposed to
the interior of the vessel should comply with the material, weld, and polish requirements
indicated above for vessels. Nozzles should be minimum of 1.5 (38mm) diameter, with
a minimum (13mm) gap between the tube and the nozzle for cleaning.
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CIP SUPPLY
Product/ingredient
Dip Tube
Holes for cleaning tank
nozzle at the spray device are
satisfactory (See Figure 28).
Holes should not be drilled
in a product or ingredient dip
tube.
Figure 23 - Dip Tube CIP
2.7.2. VALVE LOCATION; DEAD LEGS
Product inlet valves should be close to the vessel nozzle in order to minimize the dead leg
for cleaning. The location of valves for dip tube lines is not critical, as they will be
cleaned internally via the piping system. The tank side of the inlet valve (without a dip
tube) is typically cleaned from the inside using a spray device, so it should be directly
mounted on the nozzle wherever possible. This valve should be positioned such that the
spray device can properly clean up to the weir or shutoff point from inside the vessel.

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Inlet valves should be oriented to
allow maximum coverage from the
spray device. Deflection can be
counted on from rotating spray
devices, not from static spray balls.
Location of valves on a dip tube is

irrelevant to CIP strategy as the inside
of the dip tube should be cleaned via
the CIP supply (Figure 23).
Figure 24 - Inlet Valve CIP
2.7.3. TANK MANIFOLDS
In cases where multiple lines are manifolded together to enter the tank at a single inlet
point, the rules for same general rules as for sanitary piping (see Section 4.0) will apply.
In general, the valves for each ingredient line should be located to minimize the dead leg
at the manifold, and the sequence of the lines on the manifold should be organized to
optimize rinses, e.g., placing the water line the farthest away from the vessel. Also, the
manifold must be pitched towards the tank in order to promote draining. Some ingredient
lines may not be cleaned, depending on the type of material it is carrying. These lines
should be isolated from the cleaning circuit by a physical break prevent and cross
contamination. Also, the isolation valves or interconnection points at the manifold may
need to be disassembled and cleaned manually if the dead legs are to great. Figure 25
shows a tank inlet valve with multiple lines feeding into the same nozzle.

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Locate valves near
manifold to minimize
dead legs; use short Water or flush
outlet tees; pitch line material at the
end of the
manifold
Figure 25 - Tank Inlet Pitched Manifold

2.8. TANK OUTLETS
2.8.1. DRAINABILITY CRITERIA AND DRAIN RATES
Tank outlets should be sized to handle to full flow required for the spray devices (see
Section 9.2.4 for flow rate calculations) in order to prevent flooding of the vessel and a
bathtub ring in the bottom sidewall. For pressure rated vessels, compressed air or gas
overlays can be applied at 2-5 psig to assist in draining the tank. Although the discharge
rate is affected by many factors such as overlay pressure, valve CV, distance to CIPR
pump, etc. can be used to provide a starting point for outlet nozzle sizing relative to CIP
flow rates.
CIP return flow rates should govern outlet sizing in all vessels except for those used for
highly viscous liquids (200,000 300,000 Cps) such as dental creams. These tanks will
inherently have large diameter outlets for process needs. It is important, however, that
adequate flow is achieved in these vessel outlets to achieve turbulent flow. Reference the
Appendix Section 1.11 for tables on turbulent flow in sanitary tubing.

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Table 2 - Tank Discharge Flow Rates
Outlet Nozzle Size Discharge Flow Rate
1 38 mm 15-20 gpm 60-80 lpm
2 50 mm 30-45 gpm 110-170 lpm
3 76 mm 80-100 gpm 300-380 lpm
4 101 mm 180-200 gpm 680-760 lpm
6 152 mm 400-450 gpm 1500-1700 lpm
8 203 mm 650-800 gpm 2400-3000 lpm
2.8.2. VORTEX BREAKERS
Vortex breakers should be used at the tank outlet where cavitations of CIP return pumps
is a concern. Vortex breakers should be centered and located directly over the center of
the bottom outlet port or valve of the vessel. The cross style is more cleanable than the
disk style, and should be used where possible. The device should be constructed of the
same material, finished to the same polish, and match the same weld criteria as the
internal surface of the vessel for which it is installed. The fabrication should consist of a
3 (75 mm) wide, 1/8" (3 mm) flat bar, with each leg of the cross extending a minimum
of 2 (50 mm) beyond the edge of the opening made by the bottom outlet. The vortex
breaker should be continuously welded to the bottom head of the vessel. The corners of
the flat bar not welded to the vessel should be configured with a minimum " (13 mm)
radius, and all edges should be rounded and smooth.
It is possible to retrofit a vortex breaker in an existing tank without welding. In this case,
the cross is designed to fit loosely inside the tank bottom outlet and overlap on the bottom
head as described above. This should be avoided for process vessels, but would be
acceptable for a vessel that sees primarily water or cleaning solutions, such as a
recirculation tank on a CIP skid.

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Disk Style Cross Style
Figure 26 Vortex Breakers
2.8.3. VALVES
Bottom outlet valves should be mounted at the low point of the bottom head to allow
complete draining. The valve body shall be machined or forged, not cast, and should be
flush welded to the tank bottom with sanitary clamp-type connections on all other process
line connections.
2.8.3.1. SELECTION AND SPECIFICATION CRITERIA
The following are samples of typical specifications. Finishes and elastomers for these
valves should be in accordance with relevant sections in the Guideline.
Ball Valve:
Bottom outlet valves shall be of the flush-mounted welded body ball type as
manufactured by PBM or equal, constructed of 316L stainless steel, with PTFE or
stainless filled reinforced PTFE seats and gaskets. Valve outlet shall be in the vertical
position. Cavity fillers and adjustable seals are recommended. Adjustable seals help
maintain seating of upstream seal (as opposed to floating balls) Body cavity fillers reduce
but do not totally eliminate body cavity dead spaces. If the tank will be CIP cleaned, the
cleaning of the valve should be included in the validation procedure. It remains possible
that manual cleaning will be required. Therefore three-piece swing-out construction is
recommended. Piping and utilities at the tank bottom should allow for the swing of the
valve.

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Purge ports are not recommended because cleaning in CP plants is not frequent enough to
compensate for the additional dead space created by the ports. Purge ports are only used
in aseptic operations where cleaning is done after every batch.
If the tank will be electropolished, valves may be purchased with a mechanical polish but
without being electropolished. Manufacturer shall weld the valve bodies to the tanks, re-
polish the weld seams (mechanical polish), and finally electropolish the tank, bottom
outlet valve and sample ports together, to meet the tank surface specification. If the tank
will not be electropolished, the valve may be purchased electropolished
Diaphragm Valve:
Bottom outlet valves shall be of the flush-mounted welded body diaphragm type as
manufactured by ITT or equal, constructed of 316L stainless steel, with EPDM
diaphragm and CIP port. Valve outlet shall be in the horizontal position. Valves shall be
purchased with a mechanical polish but without being electropolished. Manufacturer
shall weld the valve bodies to the tanks, re-polish the weld seams (mechanical polish),
and finally electropolish the tank, bottom outlet valve and sample ports together, to meet
the tank surface specification.
Radial Diaphragm Valve:
Bottom outlet valves shall be of the flush-mounted welded body radial diaphragm type as
manufactured by Asepco or equal, constructed of 316L stainless steel, with EPDM
diaphragm and CIP port. Valve outlet shall be in the horizontal position. Valves shall be
purchased with a mechanical polish but without being electropolished. Manufacturer
shall weld the valve bodies to the tanks, re-polish the weld seams (mechanical polish),
and finally electropolish the tank, bottom outlet valve and sample ports together, to meet
the tank surface specification.
2.8.3.2. DEAD LEGS
Piping downstream of the bottom valve should be designed to minimize dead legs.
Elbows should be used in lieu of tees where possible to minimize product hold-up and
increase cleaning effectiveness.

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Although this dead leg would
meet the 1.5 pipe diameter rule,
the use of a tee instead of a valve
should be avoided wherever
possible due to product loss and
contamination. The blind side of
the tee will not be properly
cleaned, as the flow past the tee
is governed only by available
head in the tank. Notice also that
the valve is downstream of the
Tank discharge Blind side of tee in the piping system, which
valve tee - dead leg creates dead leg for mixing
within the tank.
Figure 27 Dead Leg at Tank Discharge
2.9. MISCELLANEOUS NOZZLES
2.9.1. INSTRUMENTS
Instrument connections are discussed in detail in Section 5.0. Tank nozzles to

accommodate instruments should follow the same general rules as process piping, which
is to minimize dead legs, promote free draining, and eliminate pockets and crevices.
Sanitary clamp connections should be used with short outlet nozzles, minimum size of
1 (38 mm) for clamp-on style instruments. Thermowells should be welded into the
vessels for temperature elements in lieu of direct insertion or threaded fittings. Analytical
instruments such as pH, which require O-ring couplings into the vessel, should be of
sanitary design with the distance from the tank inside wall to the O-ring or sealing
surface kept to a minimum. Spray devices should be positioned to align with the
instrument nozzles where possible.

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2.9.2. SPRAY DEVICES
Nozzles for spray devices should be oversized to provide a (12 mm) minimum
annular space between the drop tube and the nozzle for proper contact of the cleaning
solutions. This would mean that a 1 (25 mm) drop tube would require a minimum
2 (50 mm) nozzle. To aid in cleaning this area, 1/8 (3 mm) holes should be drilled
in the (removable) spray lance as shown in Figure 28 to allow cleaning solution to
spray directly into the annular space above the spray device.
Figure 28 Nozzle Detail for Spray Devices
2.9.3. SAMPLE VALVES
Sample valves shall be of the flush-mounted welded body radial diaphragm type as
manufactured by Asepco or equal. The material of construction and surface finish of the
valve body shall match that of the vessel to which it will be connected, and the
diaphragm material shall be as specified in the data sheet. The body shall be of the two-
piece design held together with a tri-clamp style connection. The vessel side of the valve
body shall be continuously welded to the sidewall of the vessel, and shall comply with
the weld and polish requirements indicated for vessels above and on the corresponding
data sheet. The discharge nozzle of the valve shall be oriented at a 45 angle pointing out
and down. If the vessel is insulated, the insulation and sheathing shall be cut back to
allow for the un-hindered connection of process piping of the same size as the discharge
nozzle, including the clamp.

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Radial Diaphragm
Valve welded
flush here to tank
Sample outlet wall
Figure 29 - Side Mounted Radial Diaphragm Valve for Sample
2.9.4. SIGHT AND LIGHT GLASSES
Sight and light glasses should be constructed of a material that matches the process
vessel. Sanitary units are available which provide a stainless steel frame fused to a
chemical and scratch resistant pre-stressed borosilicate glass viewing window. The
material and surface finish of the stainless portion of each unit shall match that of the
vessel to which it will be installed. Each unit shall mount to the vessel using a sanitary
clamp or pad flange connection and shall provide a flush surface after mounting.
ANSI pad flange used

with a sight glass
Figure 30 Sight Glass

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2.10. IQ/OQ DESIGN REQUIREMENTS
Design requirements that are uniquely required to implement IQ/OQ for vessels include:
Spray ball coverage test beyond the design of spray devices, substantial
coordination through specification and factory acceptance tests is required up front.
See Section 9.2.5.
Access for inspection even if not needed for process, manways, sight glasses, etc.
will be required for visual inspection during cleaning validation
Schedule coordination in order to test certain aspects of the CIP system, certain
items may be required earlier than normal. For example, the agitator must be run to
test the spray coverage, so electrical connection are required, tank nozzles must be
sealed, etc.

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3.0 PUMPS
3.1. GENERAL SANITARY REQUIREMENTS
Pumps for CIP use should be designed either inherently cleanable or easily disassembled
for manual cleaning. Pumps for manual disassembly should have quick opening housings
for access to the impeller and seals. Pumps for CIP are designed to allow complete flow of
cleaning solutions throughout the housing. The rotors are designed to promote turbulent
flow of cleaning solution in front as well as behind the impeller, to minimize (or eliminate)
the potential of seal materials entering the product stream, and to be self draining. When
the pump is a low point in the system, a casing drain should be installed at the bottom of
the impeller housing.
3.2. MATERIALS OF CONSTRUCTION
must be 3A approved and/or consistent with EHEDG Guidelines for sanitary applications.
Typical materials for pump construction should be 316 SS, Teflon, and various carbon and
ceramic materials used in mechanical seals.
3.3. SANITARY CENTRIFUGAL PUMPS
Base mounted sanitary centrifugal pumps should have sanitary type connections with the
pump casing, back plate, impeller, and shaft constructed of 316 stainless steel. Single
mechanical seals shall be carbon and 316 stainless steel. Impeller mounting, stub shaft, and
pin shall be 316 stainless steel. Confirm that seal material is compatible with product,
cleaning and sanitizing solutions. Chromium Oxide (CrO) and Silicon Carbide (SiC) seals
are typically acceptable.

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Figure 31 -
Sanitary
Centrifugal
Pump
3.4. SANITARY ROTARY LOBE PD PUMPS
Where positive displacement pumps are required for process use, rotary lobe pumps are
typically used at CP. Features in sanitary, cleanable PD pumps include 316 SS pump body,
cover, and shafts, single mechanical seals (in lieu of O-rings seals), sanitary clamp
connections, and a housing design that eliminates pockets and dead zones. Although these
pumps are CIPable, they are not fully drainable in the typical mounting position (Figure
34). If full drainability is required, then the pump should be installed with the inlet and
outlet in a vertical position (Figure 32). Some horizontally mounted pumps can be modified
with a low point drain at the bottom of the impeller housing, but this should be coordinated
through the pump manufacturer as the heat of welding can affect the lobe tolerances.
When the pump cannot be vertically mounted, the housing and impeller should be cleaned
manually.

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Figure 32 - Rotary Lobe Pump - Vertical Position
3.5. SANITARY PROGRESSIVE CAVITY PUMPS
Progressive cavity pumps are often used in high viscosity applications and shear
sensitive. These pumps are also positive displacement pumps, and can be sanitary and
CIPable if properly specified and designed. The impeller is a rotor and stator type design
serves as the motive force to push fluid through the channel. Figure 33 below shows an
example of sanitary rotor.
Figure 33 - Progressive Cavity Rotor

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There are several things to consider when specifying a progressive cavity pump for CIP
applications.
Do not specify open throat suction hoppers such as often used in food applications.
These sections have a large entrance diameter into the pump housing and therefore
difficult to achieve turbulent flow. Close coupling the pump directly to a tank
discharge that has proper spray devices for CIP, however, is an acceptable practice.
Specify single mechanical seals in lieu of compression seal packing
Stator and rotor elastomers must be compatible with cleaning chemicals and
temperature ranges per recommendations in this Guideline
Progressive cavity pumps are typically low speed pumps, and typical of other PD
pumps require a bypass line to circulate CIP solution around the pump in order to
achieve turbulent velocities in the piping system. This is discussed in more detail in
the next section.
3.6. CIP BYPASS DESIGNS FOR PD PUMPS
PD pumps are often installed with a bypass loop to allow a higher flow for CIP. These
bypass loops, as seen below, can create a dead leg when installed improperly. Valves
should be located adjacent to the tee, preferably on the upstream and downstream side, in
order to minimize the dead leg.
Figure 34 Incorrect Pump Bypass

This configuration creates a deadleg at the tees
Another way to design a bypass loop is shown in Figure 35, in this case for a progressive
cavity pump. Close-coupled compression valves (diaphragm valves would also work
well) are installed to create a bypass around the pump during CIP. During normal
processing, the valves are both in the closed position. In this case, a three-way valve with
a vent open to atmosphere is installed on the inlet side of the bypass. The open port

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provides a method for leak detection should the valve seal fail and cause product to flow
into the bypass line.
Figure 35 - Progressive Cavity Pump Bypass

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4.0 PROCESS PIPING

Austenitic stainless steels are the most common material used at CP for product contact
surfaces. 316L is the material of choice for all new applications. For new applications,
specify type 316L, stainless steel sanitary seamless (1/2 (13mm) and smaller) or weld-
seam (3/4 (19mm) and larger) per ASTM A270, drawn and bright annealed, with
maximum Rockwell B hardness of 90. All tubing shall meet the requirements of ASME
BPE 97 (See Appendix Section 1.3). Sanitary tubing connections should be used in lieu
of threaded fittings, and wherever possible tubing and components should be welded.
Various types of plastic pipe may also be used for sanitary applications; however, there
will be temperature limitations with these materials that should be considered.
Polypropylene (PP) and PVDF are the best choices from a sanitary standpoint (when they
are compatible with the product and temperature range), as they can be fusion butt-
welded to avoid cracks at the joints. PTFE, PVC and CPVC are more porous materials
and are therefore more difficult to clean. Also, socket weld joining systems typically
used with these materials are not acceptable for cleaning applications. All plastic piping
systems should to be continuously supported (full length of horizontal runs) to prevent
sagging and low-point pockets, particularly in heated systems.
Stainless steel should be mechanically polished on 15-25 -inch Ra (240 grit) on the
internal surface. Mechanically polished O.D. Ra of 30 -inch surface finish for non-
insulated exposed tubing. Bright annealed or pickled O.D. for non-exposed or insulated
tubing.
4.3. ELASTOMERS
Elastomers used as seals and gaskets for product contact service shall comply with USP
Class VI requirements (see Appendix Section 1.7) for shedding and off gassing (see
Appendix Section 1.1, Definitions and Abbreviations). Each elastomer should be
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reviewed for product and cleaning solution compatibility. Piping and clamp systems
should be designed to control extrusion onto the product zone, which would cause dead
zones which are difficult to clean. Types of elastomers that may be used include:
Table 3 - Elastomer Compatibility Chart

Material Acid Caustic 2
<40% <20% sodium
phosphoric hydroxide
Methylene Propylene Diene Monomer (EPDM) B B
Nitrile Rubber (Buna-N) D A
Nitrile/Butyl Rubber (NBR) C A
Silicone Rubber C A
Fluoroelastomer (Viton) A B
Teflon A A
Notes: A=No Effect
B=Minor Effect
C=Moderate Effect
D=Sever Effect Not recommended
4.4. JOINTS
4.4.1. WELDS
Welds should be used wherever possible to minimize the number of clamped

connections. In order to ensure consistent welds, the qualifications of the welders should
be carefully controlled.
4.4.1.1. WELDER QUALIFICATIONS
All welders shall be qualified in accordance with applicable code requirements.

Qualification shall be made in accordance with ASME B31.1, B31.9, ASME Boiler and
Pressure Vessel Code, Section IX, Welding and Brazing Qualifications or AWS B3.0 as
applicable to the work being performed.
4.4.1.2. WELDER PROGRAM QUALIFICATION
The welding contractor or fabricator should provide, as a minimum, the following:
1. Welder's qualification documentation for each welder involved in the project. Only
approved welders shall be used, and there are no exceptions.

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2. Written documentation for automatic welding equipment calibration.
3. Owner or Owner's Representative approval for all equipment utilized in the welding
process including welding head, power supplies, facing tools, deburring tools, etc.
4. Three (3) sample welds for each tube size used in project for owner approval prior to
any system welding. The three samples shall consist of the following:
One completed weld.

One tack weld.
One weld using program with last weld time reduced to zero.
All welds performed during the project will be compared to these welds.
Fully automatic orbital welders of appropriate size and type shall be utilized for all welds.
Manual welding is acceptable only when absolutely necessary and shall be performed by
approved welder(s). All manual welds shall be documented. The thickness of the
weldment shall not fall below 90% of the nominal tube wall thickness. Heat sensitive
materials such as gaskets, seals, and seats shall be removed from components prior to
welding to prevent damage. Joining methods shall assure joints are free of gaps, crevices,
rough areas, accumulations of material, or other non-self-cleaning pockets or ridges.
In areas where qualified welders are not available, sanitary clamps and roll-on ferules are
preferred over the use of substandard welders for either automatic or manual production
welds.
4.4.1.3. WELD CRITERIA
Welds should be inspected for the acceptance criteria listed below:
Full penetration over complete internal periphery

No slag or other inclusions (other than spot at tail off of weld)
Suitable finish slope to taper at the end of the weld
Welds are smooth with a minimum internal weld bead
Internal weld bead is not higher than 25% of wall thickness
No cracks, crevices, pits, or pin holes
No evidence of porosity in the weld
No significant discoloration at the weld zone (three samples of progressive
discoloration can be provided for approval and clarification of "significant
discoloration")

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4.4.2. SANITARY CLAMPS
Sanitary clamps are the most common type of joining method next to welding for sanitary
tubing. They are designed to provide a smooth inner surface with no holdup of material
in the pipe. Sanitary clamps still have gaskets that can degrade and leak, so their use
should be minimized. Wherever possible, piping systems and components should be
welded in place. In-line valves and other components are available with features that
allow them to be welded into the line yet still maintain access to replacement parts, such
as gaskets and seals. The use of sanitary clamps should be limited only to areas where
the connection needs to be taken apart for cleaning, maintenance, or process
requirements.
Figure 36 Sanitary Clamps
", " Stainless steel, Type 304, polished, heavy duty, Triclover 13MHHS-3/4-S or
equal
1" to 4" Stainless steel, Type 304, polished, heavy duty, Triclover 13MHHM or equal.
Three-segment clamps also permissible.
4" to 6" Stainless steel, Type 304, bolted, polished, high pressure by Triclover or
equal.
4.4.3. GASKETS
The preferred gasket for sanitary CIP use is a USP Class IV, Rubber Fab, TEFSTEEL,
50% Teflon and 50% passivated 316L SS powder, molded flanged O-ring type for
sanitary clamp fittings. Rated to 400F continuous service. This material will provide the
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longest life in high temperature applications or where cleaning chemicals are frequently
used. Black EPDM gaskets are a lower cost alternative, and are an acceptable alternative
as long as temperature requirements of the material are met.
4.4.4. QUICK-CONNECTS
Most quick-connects (Swagelok, Parker, Camlock, etc.) used to temporarily join flex
hoses to piping systems are not sanitary. They typically have a dead space between the
two mating ends that is not completely cleanable. Quick-connects and temporary
couplings should be manually cleaned between product changeovers. See Figure 37.
Figure 37 - Camlock Connectors
4.4.5. BEVEL SEAT FITTINGS
Bevel seat fittings or dairy style fittings are often used in CP facilities and are
acceptable for 3A or EHEDG applications. These fittings do not have threads exposed to
the process solution, but are a moderately higher risk for contamination than sanitary
clamps with gaskets. Proper mating and alignment is critical for this class of fittings.
Figure 38 - Bevel Seat Fitting

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4.4.6. COMPRESSION FITTINGS
Compression fittings (Swagelok, Parker, Camlock, etc.) used to join small diameter
tubing are not sanitary, and should not be used for joining CIP or product piping.
4.5. INSTALLATION
4.5.1. DEAD LEGS
Dead legs should not be greater than 1.5 branch pipe diameters (as measured from the
inside wall of the main line tube to the nearest shut-off point, such as weir of a diaphragm
valve). Connections for sample valves, pressure gauges, air vents, and bypass and
isolation valves shall be installed to minimize dead legs. Short outlet tees are
commercially available which have a sanitary clamp close coupled to the run of the tee, as
shown on the left in Figure 39.
1D
1D Unacceptable
CP practice
1.5D 6D
Figure 39 - Dead Legs

Preferred (maximum) dead leg on the left
Unacceptable design on the right
4.5.2. TEE ORIENTATION
Dead end tees (valves, instruments, blind caps, etc.) should be oriented approximately 5
above horizontal to optimize drainage while air trapping is minimized. Dead-end tees
should not be installed with the branch line pointing down, as this will create a non-
drainable pocket. Tees may be installed with the branch line facing up only when the dead
leg is less than 1.5D. These tees for pipe runs shall be pitched only as needed to meet the
required pipe slope. See Section 4.5.3.

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Preferred Undesirable
traps air
5-15
Unacceptable
traps product
Figure 40 - Tee Orientation
Improper tee
orientation
Figure 41 Example of Tee Orientation
When instruments have a connection larger than the line size it is attaching to (see left
side of Figure 55), specially designed instrument tees can be used to minimize the dead
leg.
4.5.3. PIPE SLOPE
Piping for systems being cleaned shall be sloped to provide complete system drainability.
Sloping requirements for process depends on product characteristics, such as viscosity.

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Unless process requirements dictate otherwise, piping for CIP should be installed at 1%
slope in the appropriate direction.
4.5.4. PIPE SUPPORTS
Pipe supports for stainless steel tubing and hosing shall be Tri-Clover CF series (or equal)
tube OD hanger with BUNA inserts. Sanitary supports from Behringer Piping Systems
(or equal) that utilize 304 SS hangers and plastic inserts (see Figure 42) may also be
used.
Figure 42
Sanitary Pipe
Support
4.6. U BEND TRANSFER PANELS
Transfer panels are often used in lieu of valves to divert flow between process equipment.
Transfer panels should follow all of the same guidelines for process piping (slope,
drainage, dead legs, etc.). For simple transfers, double or swing elbows can be used to
accomplish the same switching needs without the need for a transfer panel.
Figure 43 U-Bend Transfer Panel

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Figure 43 shows a freestanding transfer panel with U-bend flow diverters. These panels
should be constructed with a 1/4" thick 304 stainless steel faceplate with a minimum 10
gauge 304 stainless steel housing where enclosed back is desired. All welds should be
ground and polished flush with corners rounded and polished
U-bends should be constructed with extended tangent type 90 elbows and machine orbital
welded (or clamped for increased flexibility). Provide extension rod with target at
centerline of U-bend to activate concealed proximity sensor in panel. Front (panel side) of
ferrules should be sanitary clamp, while the back of the ferrule is a weld connection.
Spool pieces shall be welded continuous on both sides to the faceplate. All sanitary piping
shall be fully drainable. Provide end caps and clamps for all sanitary connections.
4.7. PIGGING TERMINAL DESIGN FOR CLEANABILITY
Bullet launchers have been installed as fixed types, which avoid the needs for an isolating
valve and can be loaded when the system is empty. Launchers can also be detachable
which require a full line size isolation ball valve but can be used detached and used in
multiple locations. The type used has important cleaning implications.
A fixed launcher is a dead leg and therefore can only be used with the bullet in place
during processing if cleaning is frequent and if the bullet is isolated from the process with
a shutoff valve. Cleaning must be validated in accordance with Guideline 6, and the
system monitored through CPM.
Although this system will remove the majority of the product in the piping circuit, there
will be some residual. This emphasizes the importance of established acceptance criteria
for residual soil. In some cases the pig may not achieve visually clean result by itself so
when this is a requirement the subsequent rinse steps should be followed to complete
cleaning.
The pigging system consists of cleaning bullets, pigging terminal (bullet launcher and
catcher) and propellant. In order to properly specify these components, the designer
should first establish the following information:
Size and length of pipe

Pipe specification (304, schedule 40, etc.)
Product type
Product viscosity
Product temperature
Cleaning and sanitizing solution type and temperatures

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Propellant
Interior condition of pipe
Valve and fitting specifications
4.7.1. SELECTION CRITERIA
Cleaning bullets should be made of Food Grade material, such as neoprene, and be of a
solid, uni-mold construction. The bullet should be bi-directional, flexible and capable of
traversing radius bends of 1.5 times the pipe diameter. It should provide a tight seal
between the bullet and the pipe for separation of the product and propellant, and be
capable of passing over a standard tee without losing its seal.
Bullet launchers are typically fixed, which avoids the needs for an isolating valve and can
be loaded when the system is empty. Launchers can also be detachable which require a
full line size isolation valve but can be used detached and used in multiple locations.
WIPING DISK
GUIDE DISK
Figure 44- Pigging System Cleaning Bullet
The bullet launcher is not a CIPable component. The detachable devices are preferred
over fixed units as they can easily be removed for COP. When fixed units are used, they
must be flushed through completely after the bullet has been sent, and then the manual
valves, filter housings, and ancillary components disassembled and COPd.

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Figure 45 Fixed Launcher/Receiver
As shown in Figure 45, launchers are typically not CIPable as they have a blind flange
closure, welded couplings for pressure gauge, pressure recorder, propellant inlet, and line
size product discharge.

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F
I
L
T
E
R
pump
Fixed Launchers Detachable Launcher

Figure 46 Bullet Launchers
Bullet catchers are either the fixed type or in-line. Fixed catchers collect the bullet in the
end cap and product in the lower section, which makes for easier removal. These
terminals can also be used as a launcher. In-line catchers stop the bullet with a stopper
rod in the lower catcher section, and then the entire assembly is removed for bullet
removal.
Bullet catchers are also not cleanable via automatic CIP cycles. Either fixed or in-line
catchers must be removed after the pigging process and COPd. Since in-line catchers
are removed to replace the pig, there is little benefit in the fixed-style catchers from a
cleanability perspective.
storage
tank storage
storage
tank
tank
Fixed Catcher In-line Catchers
Figure 47 - Bullet Catchers

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Listed below are some general criteria for the proper selection of terminals for pigging
applications:
For best results, the launchers and receivers should be designed for a specific
bullet type and size.
Pressure gauges:
o Can help verify that the bullet has been launched or received.
o Are helpful in monitoring the bullets travel through the pipe.
o Can alert the operator not to open the system while under pressure.
Pressure relief valves can prevent dangerous over pressurization of the system.
Signal devices indicate passage of the cleaner and can activate other accessories.
Non-intrusive magnetic signals are best for process piping systems. A magnet in
the cleaning device activates the signal.
Pressure and flow control valves are used to regulate travel speed and reduce
pressure fluctuations. Ideal displacement speed is considered 3-5 feet per second
(0.9-1.5 meters per second).
Pressure recorders are used to compare pig runs and indicate changes or problems
in the process piping and control system.
Gauge plugs and probes allow addition or removal of accessory items without
major changes to the piping system.
Valves should be full port for best pig performance.
4.7.2. PROPELLANTS
Compressed air or nitrogen is typically used to propel the cleaning bullet down the piping
system. The compressed gas must have established quality standards per validated
protocol. Typically, the propellant should be filtered at the point of use. See Section
12.0 for compressed air and nitrogen criteria or C&S.
4.7.3. INSTALLATION DETAILS
Figures Figure 48 and Figure 49 below show some examples of how pigging systems are
used with multiple tanks and drums. Again, note that pigging does not clean the line to
a visually clean standard. Regardless of the pigging sequence, a subsequent cleaning
cycle (either manual, CIP or combination of COP/CIP) should be completed.

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tank A tank B
Figure 48- Pigging Details - 2 Tanks
air
tank A tank B
drum
Figure 49 - Pigging Detail - Tanks and Drum

4.8. PIPING SPECIALTIES
4.8.1. FLEX HOSES
Tubing shall be Sani-Tech Sani-Flo FB series (or equal) ferruled, sanitary braided tubing
or Sani-Flex reinforced silicone tubing. Tubing shall be of smooth bore construction and
shall be manufactured for sanitary applications. Tubing shall be capable of operating at
process design temperatures and pressures. Tubing material shall be non-toxic, non-
contaminating, non-porous and non-aging. Tubing fittings shall be 316L stainless steel
and shall be of the sanitary type unless otherwise noted. End connections should be
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attached to the hose in a manner that minimizes the crevices and promotes free draining
in either direction.
Convoluted lining aids in
Smooth bore bending radius and
lining preferred operation but is not suitable
product contact, CIP or COP
Figure 50 - Flex Hoses
Good: Hose ends are

not on the floor
Bad: Hose ends are open

to atmosphere; clamps are
not sanitary design
Figure 51 Flex Hose Stored Out of Use

As shown above, hoses should be stored so that their ends are not lying on the ground and
so that they free drain. Hoses that are dry should be capped while being stored.

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4.8.2. STATIC MIXERS
Static mixers must be of sanitary design (Sani-matic or equal) with welded, polished, and
free draining internals. Sanitary designs should have simple internals (cross style) with
smooth inner surfaces and no dead spots. An example of a static mixer that would not be
considered sanitary is shown in Figure 52 below.
Figure 52 - Non-Sanitary Static Mixers

Design requirements that are uniquely required to implement IQ/OQ for process piping
include:
Sampling If effluent testing is to be used for validation criteria, sample points will
need to be provided after each unit operation or piping section to be cleaned.
Inspection As visual inspection will be a key component of the CP cleaning

validation approach (See GL6), areas within piping systems that are improperly
designed for CIP service (e.g., dead legs, inadequate velocity, pockets) should be able
to be disassembled for visual inspection during validation.

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5.0 INSTRUMENTATION
In general, isolation valves should not be used to isolate the instrument from the process
line for maintenance reasons, as this creates a deadleg.
surfaces. 316L is the material of choice for all new applications in product contact
services.
Stainless steel should be mechanically polished on 15-25 -inch Ra on the internal

surface. Mechanically polished O.D. Ra of 30 -inch surface finish for non-insulated
exposed tubing. Bright annealed or pickled O.D. for non-exposed or insulated tubing is
acceptable.
5.3. SELECTION CRITERIA
5.3.1. FLOW
Coriolis (mass flow) meters by Micro-Motion, Endress & Hauser (or equal) are used for
highly accurate flow measurements. These meters are available in sanitary
configurations, but the U-tube configurations will have some product hold-up. In order
to free drain, they should be installed either in an inverted position (Figure 53) or at
position 5-15 above horizontal, similar to the tee position previously described.
Straight through designs are also available, which provide the ability to fully drain the
line after cleaning. The straight through style is properly installed vertically, with
product flowing from bottom to top.

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Figure 53 - Mass Flow Meters

Magnetic flow meters are also available in designs that are suitable for CIP. Where
accuracy is less critical, sanitary 316 stainless steel turbine or vortex shedding type
meters may be used. However, each of these devices has internal components that may
not be appropriate for cleaning high viscosity fluids. These flow meters are more
appropriate for CIP supply and return lines than for product service.
Turbine meter
Vortex meter
Figure 54 - Flow Meters

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5.3.2. TEMPERATURE
Indicators shall be suitable for sanitary applications and connections shall be made by the
use of sanitary clamp fittings. Indicators shall be provided with polished 316 stainless
steel well assembly and bi-metallic dial thermometer. Indicating range shall be suitable
for the application.
Acceptable
Dead Space
Unacceptable
Figure 55 Temperature Indicator Mounting
RTD elements shall be connected to the process piping by means of a sanitary connection
and installed similar to the conductivity sensor detail, see Figure 58. Sensor element shall
be provided with 316 stainless steel housing and all probe elements in contact with
process fluid shall be polished (25 inch, Ra) 316 stainless steel suitable for high purity,
clean in place sanitary applications. Sensing element shall be 3A approved and/or
consistent with EHEDG Guidelines for sanitary applications.
5.3.3. PRESSURE
Gauges shall be of pharmaceutical grade and shall meet 3A and/or EHEDG sanitary
requirements. Gauges shall be a minimum of 3-1/2" in diameter. All wetted parts shall
be compatible with cleaning solutions. All wetted surfaces shall be electropolished 316
stainless steel. Connections shall be made by the use of sanitary clamp fittings. Pressure
elements should not be isolated from the process line with a shutoff valve for
maintenance or calibration. The diaphragm should be close coupled to the process line to
minimize the deadleg.

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Figure 56 - Pressure Indicator

5.3.4. PH & ORP
pH and ORP (Oxidation Reduction Potential) probes are similar in their C&S
characteristics. They are both typically mounted in a vessel sidewall via an Ingold or
sanitary clamp nozzle. Ingold nozzles require an O-ring at the interface between the
nozzle and the probe. This o-ring minimizes the dead space for solution to clean around
the cavity, however does pose cleaning and sanitization problems when located long
distances from the spray device. The only way to truly clean these nozzles is to have
impingement from a spray device aimed directly at the nozzle itself. These nozzles are
often tilted 5-15% up so as to drain into the process vessel.
Sanitary clamp fittings are also available for C&S applications. These nozzles are
recessed farther away from the tank, but allow a greater gap (much like a dip tube) for
cleaning solution to enter and flush the cavity. Microbial growth is also minimized as
there are no O-rings in this design.

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Ingold nozzle Sanitary Clamp Nozzle

Figure 57 - pH & ORP Tank Connections
5.3.5. LEVEL
Various types of level measurement can be considered sanitary, including capacitance,

float, radar, ultrasonic, and DP. However, each of these styles has particular issues that
must be addressed to ensure that it is being used in the appropriate application.
Capacitance: Cleaning chemicals often have a different capacitance range than process
solutions, so although these probes can be easily cleaned they are often inappropriate for
CIP applications.
Float: Available in SS for sanitary applications, these probes are a simple design and
easy to clean in certain applications, such as purified water or low viscosity solutions.
Not recommended for high viscosity or sticky product solutions.
Radar/ultrasonic: Can be non-intrusive which may be a benefit for some process

applications. Sanitary designs minimize the distance from top-works to the vessel
internal, allowing adequate coverage from internal spray devices. Not recommended for
agitated or foaming products.
DP: pressure differential is a common and reliable method of measuring level, and when
flush mounted sensors are properly located on the tank or piping manifold, they are easily
cleaned with a CIP system.
5.3.6. CONDUCTIVITY
Conductivity/Resistivity sensor housing shall be of PVDF, suitable for end of tee/in-line

installation, and have a titanium electrode. Sensor shall have a sanitary connection with
the preferred mounting configuration as shown in Figure 58.
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Preferred
Unacceptable Minimum Dead leg
installation
Figure 58 - Conductivity Sensor Installation
In some cases, instrumentation will be required (or is desired) in order to complete the
operational qualifications and cleaning validation activities that are not necessarily
required for the process itself. This amplifies the need for a clearly defined validation
program, including established acceptance criteria, selection of analytical methods, and a
well defined sampling plan (Reference Guideline 6 Cleaning Validation). In order to
show that cleaning cycles subsequent to validation are performed in a consistent and
repeatable manner, additional instruments may be appropriate for CIP only. Instruments
that are likely to be used for ongoing cycle monitoring include:
Temperature
Timed step sequences (process controller)
Conductivity
TOC
pH
6.0 VALVES

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surfaces. 316L is the material of choice for all new applications in product contact
services.
Stainless steel should be mechanically polished on 15-25 -inch Ra on the internal

surface, mechanically polished O.D. Ra of 30 -inch surface finish for non-insulated
exposed tubing, bright annealed or pickled O.D. for non-exposed or insulated tubing.
6.3. SELECTION CRITERIA
6.3.1. BALL
Ball valves are frequently used in piping systems at CP plants for raw materials and
finished products. . Full port ball valves must be used on pigged product lines. These
valves have been typically placed in the line with sanitary clamps so they can be removed
for maintenance or replacement. Caution should be applied when specifying ball valves
on new systems, as there are cleanability issues on many styles that are claimed to be
sanitary. The seal and encapsulation elastomers on many valve styles create dead spaces
and pockets that cannot be cleaned simply by running cleaning solution through the pipe.
To clean all surfaces, these valves should be removed and manually cleaned. Facilities
should use Control Point Monitoring (CPM) to target ball valves as a critical point to
check for cleaning and microbial considerations.
Some valve designs such as PBM Igenix Series and Tassalini (Cipriani, Inc. in U.S.)
address some of the cleanability issues by including features such as adjustable seals and
body cavity fillers. Adjustable seals help maintain seating of upstream seal (as opposed
to floating balls). Body cavity fillers reduce but do not totally eliminate body cavity dead
spaces. If these or similar valves that are claimed to be sanitary are used in CIPd
systems, the cleaning of each valve should be included in the validation procedure. It
remains possible that manual cleaning will be required. Therefore three-piece swing-out
construction is recommended. Three-piece valve bodies should be used with weld-end
fittings. These valves can be welded in line yet allow the body to swing out for removal.
This can eliminate clamps and gaskets that are potential sources of leakage and
contamination if not routinely replaced.
Purge ports are not recommended because cleaning in CP plants is not frequent enough to
compensate for the additional dead space created by the ports. Purge ports are only used
in aseptic operations where cleaning is done after every batch.
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6.3.2. DIAPHRAGM
The preferred sanitary valve is the diaphragm valve. These valves should be forged body
diaphragm valves with a 25 -in Ra mechanical polish internal finish, nickel plated or
thermoplastic handwheel and bonnet, and foundry exterior with rising stem. Diaphragm
can be Viton, EPDM, EPDM backed Teflon, or silicone. Valve body shall be 316L
stainless steel with weld or sanitary end connections.
Figure 59 - Diaphragm Shutoff Valve

Standard diaphragm valves may be mounted in horizontal or vertical position. When
mounting them in the horizontal, the valve body must be rotated 5-20 on axis (depends
on the manufacturer) in order for it to drain completely.
Diaphragm valves can be configured in many special fabrications to minimize dead legs
for specific process requirements. Valves can be ported to couple tow valves very near
to each other, or some manufacturers (ITT, Saunders, GEMU) can fabricate special valve
bodies to provide zero dead leg divert configurations.

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1 x 5 divert
valve
1 x 2 divert
valve
Figure 60 - Diaphragm Divert Valves
6.3.3. COMPRESSION
Compression or stem valves are commonly used in the dairy industry and are 3A
approved. However, these lines are consistently sanitized between batches so the
comparison to CP facilities is not appropriate. There is a small holdup volume in this
valve, as it does not completely free drain; and the bevel seat interface can tend to leak
unless a mix proof design is used (see below). For lines that are frequently cleaned and
sanitized (each batch or at least several times per week), these valves could be an
acceptable option for sanitary use.
Figure 61 - Compression (Stem) Valve

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6.3.4. MIXPROOF
Double-seat mixproof or rising stem sanitary valves are common to the food and dairy
industry. They are designed to separate incompatible products or products from CIP
solutions. A mixproof double-seat valve is a self-draining compression valve that allows
two dissimilar fluids to flow through a single body, safely preventing the two liquids
from mixing. These valves are often arranged in a matrix to consolidate product and CIP
lines for product transfer and cleaning. See Figure Figure 62. These valves are not fully
sanitary, therefore they may require CPM and manual cleaning.
Product path
CIP path
Mixproof zone open

to atmosphere
Figure 62 - Mixproof Valve

6.3.5. PLUG
316 stainless steel valve body, TFE coated 316 stainless steel plug, and EPDM O-rings.
Provide with large orifice and straight through flow for minimum pressure drop, suitable
for sanitary operations. Valve shall be quarter turn, suitable for continuous operation
with 260F, 20 psig saturated steam, with throttling and positive shut off capabilities.
Provide with butt weld or sanitary clamp fittings. These valves are not fully sanitary,
therefore they may require CPM and manual cleaning.
6.3.6. BUTTERFLY (WAFER)
This valve is often used for shut-off application in larger line sizes. The internal wafer
should be smooth and polished consistent with the line size specifications, and preferably
electropolished. The seal is the primary source of contamination and should be designed
for minimal holdup, with seal materials compatible with the cleaning solutions. As the
stem is connected on two sides of the valve interior, the valve stem should be located
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horizontally to minimize pooling at the stem interface. These valves are not fully
6.3.7. NEEDLE
Used for flow control in small lines. This valve is not very cleanable. Representative
style would include the Nupro Series 4BMRW (or equal) needle valve, bellows type, 316
stainless steel body and internals, 25 -inch Ra internal polish. These valves are not fully
6.3.8. CHECK
Check valves should be avoided where possible in process lines, as they are difficult to
clean. Representative style would include the Tri-Clover disk type or a ball type check
valve, neither of which is truly sanitary. These valves are not fully sanitary, therefore
they may require CPM and manual cleaning.
6.3.9. SAMPLE
Sanitary diaphragm valves are preferred or sanitary plug valves (ITT or equal), although
some processes may use ball valves if they are used in the process lines. Sample valves
should be located in easily accessible areas and should be connected to process lines with
short outlet tees. Tees for sample valves may be pointed down as they are a low point
and can be used for system draining if needed.
Short outlet tee is

preferred over this
fitting
Sample valve outlet
Figure 63 Sample Valve

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7.0 SPECIALTY EQUIPMENT

7.1. FILTERS
7.1.1. PUROLATOR
Purolator filters are used in the dental cream process and include fine mesh screens and a
motor driven scraper blade. There are two aspects to cleaning these filters, the housing,
and the filter assembly. Filter housings generally have too large a diameter to clean with
the process piping CIP sequence, and therefore must be removed and cleaned either
manually or with a COP system. The filter assembly, as shown in Figure 64, is mounted
on a cart so it, too, can be cleaned out of place, separate from the housing. The remaining
piping segment can be CIPd if a spool piece is installed at the location of the removed
filter housing. Alternatively, the filter head can be left in place and CIPd by capping the
housing connection after removal of the filter and housing.
Figure 64 Purolator Filter (housing not shown)

7.1.2. OTHERS
Other types of process filters generally follow the rules as described for cleaning the
Purolator filter. Housings should be cleaned out of place using a COP system, ultrasonic
cleaner, or a sink with manual cleaning. Most filter elements, other than sintered
stainless steel, are meant to be replaced and not cleaned.
7.2. HEAT EXCHANGERS
Various types of heat exchangers are used for process applications, but all sanitary
designs fall into either the shell-and-tube or tube-in-tube category. Plate and frame heat

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exchangers are not CIPable due to crevices in the frame and a seal design that creates
pockets. They also do not free drain, so the only areas these types of heat exchangers
should be used is perhaps for certain raw materials when sanitization is not a primary
concern. Plate and frame HEXs that can be fully disassembled for manual cleaning may
be used if proper procedures are followed for COP.
Shell-and-tube heat exchangers are available in flow-through and U-tube configurations,

with double tube, single pass, multiple sections, and serpentine configurations. U-tubes
are more common and less expensive to fabricate than flow-through exchangers, as there
is only one headplate to fabricate. Sanitary exchangers for product contact should also be
specified with a double tube sheet. This design eliminates the possibility of
contamination of the tube side with shell side fluid due to a joint failure. If a leak
develops, the tube side or shell side fluid would visibly leak to the outside without
crossing over into the other fluid.
Representative specification would be a double tube sheet, fully drainable with

removable U-tube or flow-through bundle. All parts of unit in contact with CIP solutions
shall be 316L SS; parts not in contact with CIP solutions shall be 304 SS. Tube seal shall
be welded to tubesheet. Unit shall be ASME code stamped. Unit shall possess a
minimum 1-1/2" sanitary fitting connections for water inlet/outlet. Tubeside shall be
polished to 25 inch, Ra. Pressure drop shall be no greater than an 15 psig (1 Bar).
Exchanger shall be provided by YULA, Allegheny Bradford, Feldmeier, ITT, or equal.
Figure 65 - Sanitary U-Tube Heat Exchanger
7.3. HOMOGENIZERS
Some of the newer dental cream processes utilize homogenizers after the mixer in lieu of
Purolator filters. Along with increasing yield and handling larger process flow rates,
homogenizers are more robust and flexible than filters. However, as evidenced by the
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intricacy of the rotor and stator below, the homogenizer is still difficult to clean in place
and should not be presumed to be CIPable upon specification and purchase. CIP cycles
for this equipment should undergo engineering trials and cycle development prior to
cleaning validation. For product changeover cleaning, the head should be disassembled
as shown and cleaned manually or in a COP system.
Figure 66 -
Homogenizer
with rotor and
stator (inset)
7.4. POST ADDITION (PA) SKIDS
Post addition skids are used in various making systems for adding color, fragrance, or
other ingredients. These skids, or fabricated assemblies, consist of many of the
components described in this guide such as tanks, piping, pumps, valves, and
instrumentation. PA skids, however, are by nature designed for dedicated product and are
therefore often overlooked from a cleaning perspective. Nonetheless, these systems
should be designed with cleaning in mind from the beginning, just as any other piece of
process equipment would be.
Rules for dead legs, surface finish, cleaning solution velocity, etc. all apply. If an outside
vendor fabricates these skids, the cleaning requirements and expectations of the system
need to be detailed clearly in the specification. Component specifications should be
included using the information from this Guideline. Ingredient tanks may be used for
dedicated product, but that tank may still need periodic cleaning and sanitizing due to the
micro-susceptibility of the ingredient. Therefore, a spray ball might be appropriate for
the tank even though it is not cleaned between each batch. If a spray ball is specified,
then test and acceptance criteria (such as a riboflavin test) also should be specified
initially (See Section 9.0)

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8.0 FILLING EQUIPMENT

8.1. FILLING EQUIPMENT OVERVIEW
There are many different types of filling machines within the CP facilities throughout the
world. Some have been designed or modified to be automatically cleaned in place by
delivering cleaning solution through the machine product contact areas between batches.
Even so, there are still components of the nozzle area that will not be completely cleaned
in a CIP cycle. Also, this can be achieved for certain types of fillers, but for others it is
virtually impossible to automatically clean the entire filler automatically without
disassembly. The 6 primary types of fillers in the CP facilities, listed in order of the
simplest to the most complex design, are:
1) Time-gravity or time-pressure
2) Magnetic or mass flow meter
3) Weight filler
4) Piston filler
5) Air sensing
6) Pressure overflow
The nozzles, valves, pistons, etc., should be manually cleaned for all six of these
machines. CIP may prove to be effective for the first three machines in the list, however,
these components (head tanks, hoppers, hoses, etc.) must be designed with C&S criteria
as described in pertinent sections of this Guideline. Some combination of CIP and COP
would be the most desirable for these machines. The last two machines on the list are
complex and must be manually cleaned.
8.1.1. HEAD TANKS
Head tanks should be cleaned separately from the filling equipment, following criteria for
tanks in this and other related Guidelines.
Figure 67 - Head Tanks

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8.1.2. PIPING
Piping systems leading up to tanks and filling machines should be cleaned separately
from the filling equipment, following criteria for piping in this and other related
Guidelines. These piping systems are often designed as manifolds that have substantial
dead legs, as seen in Figure 68. In some cases the lines will remain full of product when
not in use n order to minimize waste. In these cases, qualification criteria for the
acceptable hold duration must be in place and documented.
Figure 68 - Filling Line Piping Systems

8.1.3. NOZZLES
Filling nozzles should be manually cleaned. See GL2, Section 4.2 and 4.5 for criteria on
cleaning nozzles and small parts for filling machines.
Figure 69 - Filling Nozzles Being Manually Cleaned

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8.1.4. CRITERIA FOR CLEANING CHANGEOVER TIMES
Modern manufacturing methods emphasize on quick machine changeovers. World-class

manufacturers can changeover a filling machine, no matter its complexity, within 15-30
minutes. By a changeover, it is understood the process of changing over from one SKU to
another. This may involve adapting or changing the machine configuration to accept
other package sizes or changing the product.
From a C&S point of view the first part of the definition needs to be accomplished in
such manner that it does not compromise the quality of the product. For example, if the
changeover process requires the filling machine to have a different nozzle, then the new
nozzle must be perfectly cleaned and sanitized. This means that any parts that are added
to the machine must meet the C&S criteria.
On another hand, the period designated for the changeover is often used for C&S
purposes. In that case, the time designated for changing the machine configuration is not
necessarily equal to the time needed to C&S the machine. The time needed to C&S a
machine depends obviously on the product, the machine type, and the machine size.
Furthermore the procedure needs to be validated. It is not enough to pretend the machine
has been cleaned and sanitized; the procedure needs to be statistically validated. As a
result, changeovers requiring C&S will most likely take longer than the current world
standards mentioned earlier. If possible, identify filling machine spare parts that can be
cleaned and sanitized in advance, and be ready for changeover, in order to minimize
changeover time.
8.2. TIME-GRAVITY & TIME-PRESSURE FILLERS
Time Gravity or Time-Pressure systems are used for liquid products. Both systems are
similar. The only difference is that in time-pressure filling compressed air is added to the
tank, which increases the product fill velocity.
Figure 70 illustrates the operating principles and the major components. The diagram is
not intended to represent a particular machine, rather the operating principles for these
types of fillers. These systems are typically used with in-line fillers. In-line fillers will
have from 1 to 14 nozzles. Valves in the most current machines are ball valves driven
pneumatically. In some other machines the valve will be a simple solenoid actuated
valve. The valve will be of the plunger type. The nozzles and valves are, as in the case of
many other machines, complex and difficult to clean.

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Product in Product in
Compressed air in
Tank Tank
(open to atmosphere)
Valve
(actuated by a timer) Valve
(actuated by a timer)
Nozzle Nozzle
Bottle Bottle
TIME-PRESSURE FILLING
TIME-GRAVITY FILLING
Figure 70 - Time-Gravity & Time-Pressure Fillers
8.2.1. C&S APPROACH
Only machines specifically designed for pharmaceutical products with a water-like

viscosity are designed for CIP-SIP applications. Time-gravity machines will require
manual cleaning of the tank if it is atmospheric, whereas spray ball could be provided on
the closed tank for time-pressure filling equipment. Valves need to be sanitary design.
These machines are often marketed by manufacturers as being CIPable, but upon
examination fall short of the criteria outlined in this Guideline for C&S design practices.
Hoses with barb and clamp-type connections, ball valves, and intricate nozzles all pose
areas that could not be cleaned via an automatic CIP cycle. Careful attention to these and
other critical components during specification could lead to a machine that is well suited
for CIP and SIP, except a few discrete areas. Regardless of the specification, the nozzles
(at a minimum) will need to be removed and cleaned manually on a periodic basis,
perhaps not as frequently as some of the other machine types.
8.3. MAGNETIC FLOW METER FILLERS
Figure 71 shows a magnetic flow meter machine. The flow meter measures the amount
liquid being dispensed to the bottle. Of course, the magnetic flow meter can be
substituted with a mass flow meter.

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Rotary joint
Distributor
Magnetic flow meter

Valve
Nozzle
Bottle
Pump
Figure 71 - Magnetic Flow Meter
8.3.1. C&S APPROACH
In general the machine is very sanitary. Cleaning the machine depends on the fluid
velocity as determined by the pump and the nozzle configuration.
Although this machine is perhaps more suitable for CIP than many of the others, there are
two primary areas of concern:
Nozzle: Again, the nozzle has very intricate components and although the machine may
be designed to flush through the nozzle path during CIP, there are too many areas that
will not get adequate contact from the cleaning solution. Unless these are validated
with a CIP cycle, they should be cleaned manually.
Pump: As shown, the machine has a pump that is followed by solenoid valve (not
shown). When product is not needed at the machine, the valve is closed and product
simply circulates around the pump, creating a dead leg. In some installations the dead leg
can be eliminated and control the product by shutting off the pump, but this approach still
requires further evaluation by the machine manufacturer.
8.4. WEIGHT FILLERS
Figure 72 shows a diagram of a weight filler. The load cell under the bottle measures the
amount of liquid being dispensed to the bottle.

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Product intake
Nozzle positive
shut-off mechanism
Tank
Nozzle
Bottle
Load cell
Figure 72- Weight Filler

8.4.1. C&S APPROACH
In general the machine is considered to be sanitary and the tank is equipped with spray
balls. The nozzle shut off mechanism inside the product tank is not typically a good
sanitary design. Hygienic-conscious weight filler manufacturers are revising this concept
and eliminating the plunger mechanism by replacing it with a magnet. Although new
machines will feature a better design, because of the laminar flow nozzle configuration,
the nozzles still will need to be disassembled for manual cleaning and sanitization.
8.5. PISTON FILLERS
There are innumerable versions of this filling concept. Figure 73 illustrates the operation
and filling principles. The diagram is not intended to illustrate a particular machine.
Piston fillers are best used with viscous products. All toothpaste fillers are piston fillers.
As the piston retracts, it draws product into the cylinder. When the cylinder reaches the
predetermined stroke length, the piston travel direction reverses and the valve rotates
90so that the product is directed to the bottle. Some piston fillers (for liquids) will have a
check valve instead of a rotary valve. Some other piston fillers will have a valve that
slides instead of one that rotates 90 (like the one in the illustration).
The piston is driven either with a pneumatic piston or mechanically (cams). Therefore the
piston end is usually exposed to contaminants, either from the compressed air or from

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machine components. Cleaning solutions never reach all piston surfaces. Moreover, in
many machines the piston is equipped with several seals. The seals require grooves. The
assembly is often tied together with screw threads.
Tank
Piston
Valve
Nozzle
Bottle
Figure 73 - Piston Filler

8.5.1. C&S APPROACH
Because of their complexity, piston fillers cannot be CIPd. All product contact surfaces
must be disassembled and COP'd. Extreme care in cleaning needs to be exercised with
piston seal grooves and threaded connectors.
Some manufactures claim that these fillers can be CIPd, but it depends on the standards
for CIP. CPs visually clean acceptance criteria for the pistons and smaller sub-
components would likely not be met in a CIP approach, so it is recommended that these
parts be manually cleaned and sanitized.
8.6. AIR SENSING FILLERS
Figure 74 corresponds to a Pneumatic Scale or Horix machines. The Pneumatic Scale

machines were very popular in Colgate and we still have several machines in our plants.
In this machine, an air jet determines the proper product level in the bottle, thus the name
air sensing. The product intake tank is often pressurized with air. The tank diagram is a
typical cross section view. Therefore this can represent a machine with 8, 16, 24, 48, and
even a larger number of nozzles.

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Product rotary union
Product distributor
Product delivery hose

Tank
Air logic control box
Nozzle
Product intake
Compressed air rotary union
Bottle
Figure 74 - Air Sensing Filler

8.6.1. C&S APPROACH
Air sensing fillers are flow-though systems, which means there is theoretically some
potential for a CIP cycle to be effective, however, these machines were designed before
C&S was an issue. The details of the machine internals make it impossible to clean using
an automatic cleaning cycle. First of all, air introduced into the bottles must be delivered
though a clean and sanitized pathway as it is product contact; the air system is not
designed to be cleanable. Next, the nozzles are very intricate, with threaded connections
and a ring shaped distributor that are not considered sanitary. Also, the inlet tank L/D
ration makes it very difficult to clean, even with a spray ball. These machines should be
completely disassembled for manual cleaning and sanitization.
8.7. PRESSURE OVERFLOW FILLERS
Figure 75 shows a cross section of an in-line machine. The same principle can be used
with a rotary machine.
Product is received by the machine overflow tank and pumped to the manifold. From the
manifold the product is directed to nozzle-valve. The cycle begins when the nozzle is
inserted to a predetermined height and begins dispensing product. The nozzle is made
with two concentric tubes. The inner tube is used to deliver the product. The outer tube is
used to remove product from the bottle. When the product reaches the predetermined
height, the excess product in the bottle is delivered to an overflow tank. The cycle ends
when the nozzle begins to retract and the product valve is closed. No new product is
delivered to the bottle.

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There are several versions of the pressure overflow filling technology. There is the
gravity overflow if no pump is used and there is the vacuum overflow.
Nozzle Manifold
Supply overflow tank

Bottle
Product supply
Pressure Pump
Figure 75 - Pressure Overflow Filler

8.7.1. C&S APPROACH
These machines are among the most complex fillers at CP and the most difficult to
automatically clean and sanitize. Good product is mixed with product removed from the
bottle in these machines. Besides the difficulty in C&S for this type of machine, one
contaminated bottle potentially can contaminate the entire batch as the product gets re-
circulated. These machines do not flow-though so CIP is essentially impossible.
Due to the limitation of this system, these machines should be ultimately eliminated from
CP facilities.

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9.0 CLEANING EQUIPMENT

9.1. OVERVIEW CIP AND COP
Processing equipment in CP manufacturing facilities is cleaned regularly to maintain

product integrity and proper operation of the processing equipment. The frequency of the
cleaning is a function of the stability and nature of the product. This section outlines
various methods to clean process equipment and how to specify and select cleaning
equipment. It does not address how to determine the necessity or frequency of cleaning.
The methodology to clean the following equipment will be reviewed.
Raw Material Storage Tanks and Lines

Mixing and Process Vessels
Product Storage Tanks
Product Transfer lines and Pump
Filtering and Homogenizing Equipment
Filling Equipment
Process equipment may be Cleaned-In-Place (CIP) or Cleaned-Out-of-Place (COP). CIP

is the cleaning method by which processing equipment is cleaned in its process location.
COP is the cleaning method where by process equipment is disassembled and the
equipment is cleaned in a remote location. In other words, the cleaning solution is
brought to the process equipment for CIP. For COP, the process equipment is taken to a
cleaning station.
CIP and COP systems are designed to provide proper cleaning by controlling the critical
parameters of the cleaning process. In both CIP and COP, the object is to apply cleaning
solutions in a consistent method that is repeatable and validatable.
The cleaning parameters Time-Action-Chemistry-Temperature (TACT) are reviewed in

Guideline #2 Principles and Practices in greater detail. These are cleaning parameters
that must be controlled and monitored to provide a validatable cleaning process. Alkaline
or acid detergents are the typical cleaning agents for most applications within CP. In rare
applications, oils, glycerins or solvents may be used as the active cleaning agents.
Cleaning systems can be divided into four functional sub-systems.
1. Time control and monitoring systems.

2. Action control and monitoring systems.
3. Chemical control and monitoring systems.
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4. Temperature control and monitoring systems.
A cleaning system may use a combination of automated and manual methods for each of
the sub-systems.
9.2. SPRAY DEVICES
9.2.1. TYPES
9.2.1.1. STATIC SPRAY DEVICES
Static spray balls (or rings, disks, nozzles) shall be sized and drilled to provide a flow rate
(per tank) that corresponds to a minimum of 3 gpm per linear foot of internal
circumference of the vessel. In addition, the hole pattern on the spray ball(s) shall be
such that all nozzles exposed to the inside of the vessel are completely wetted, as well as
all surfaces of all items inserted in the vessel during CIP cycles (e.g., dip tubes, sparge
tubes and rings, baffles, agitator shafts and impellers). Material type, welding, and
surface finish of the spray balls shall comply with all the material, weld, and polish
requirements indicated above for vessels. The spray balls shall be secured to the
upstream supply tubing by a removable pin with integral retaining clip; the entire ball and
tube assembly shall be removable from the vessel through the nozzle in which it will be
mounted. All spray balls shall have a drain hole at their low points when the balls are
installed in their operational orientation. Once the position of each spray ball is
determined and drill patterns have been set, they shall be configured with an external
locating pin that shall be mated with a locating bracket and hole that will prevent the
spray ball from being installed in any other position, or in any other spray ball port if
multiple spray balls are to be installed on a vessel. No threaded connections shall be
allowed. See Guideline #2, Section 3.2 for more details.
Figure 76 - Static Spray Ball

Sanimatic, Inc
Static spray devices may be left in the tank during processing. If they are to be removed,
they should be located within reach from the manway.
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9.2.1.2. ROTATING SPRAY DEVICES
Rotating, media-driven spray devices shall provide a flow rate that corresponds to a
minimum of 2 gpm per linear foot of internal circumference of the vessel. The spray
pattern shall completely wet, by direct impingement, all internal surfaces of the vessel,
including all nozzles and inserted accessories. The rotating action shall be powered by the
CIP solution flow, and all machinery required for operation shall be located externally to
the vessel. The spray balls shall be welded to the upstream supply tube; the entire ball
and tube assembly shall be removable from the vessel through the nozzle in which it will
be mounted. All spray balls shall have a drain hole at their low points when the balls are
installed in their operational orientation. Material type, welding, and surface finish of the
spray balls shall comply with all the material, weld, and polish requirements indicated
above for vessels. No threaded connections shall be allowed. See Guideline #2, Section
3.2 for more details.
Figure 77 Rotating Spray Ball
Figure 78 Typical Flow-Pressure Curves for Rotating Ball

These curves are samples (Toftejorg) intended to demonstrate the variables involved in selecting the proper
rotating spray device. Refer the vendor for curve data on specific spray devices.
9.2.1.3. GEAR DRIVEN
Rotating, gear driven spray devices shall completely wet, by direct impingement, all
internal surfaces of the vessel, including all nozzles and inserted accessories. This
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impingement shall occur as a spray pattern that shall be complete within a specified run
time. The rotating action shall be powered by the CIP solution flow, and all machinery
required for operation shall be located externally to the vessel. The spray device shall be
welded to the upstream supply tube; the entire assembly shall be removable from the
vessel through the nozzle in which it will be mounted. All spray devices shall have a
drain hole at their low points when the balls are installed in their operational orientation.
Material type, welding, and surface finish of the spray balls shall comply with all the
material, weld, and polish requirements indicated above for vessels. No threaded
connections shall be allowed.
Another type of gear
driven device by
Toftejorg
This GammaJet rotary device was pulled from a CP

dental cream mixer just prior to the CIP cycle. The
mixer has three of these devices in the top head, along
with three spray ball valves in the bottom head.
Figure 79 Example of a Gear Driven Spray Device
Figure 80 Typical Flow-Pressure Curves for Gear Driven Spray Device

These curves are samples (Toftejorg) intended to demonstrate the variables involved in selecting the proper
rotating spray device. Refer the vendor for curve data on specific spray devices.
Figure 80 shows several curves that are utilized in the selection of a gear driven spray
device. The first chart deals with flow vs. pressure as related to various nozzle sizes,
which is important in CIP supply pump sizing. Note that these devices require a
minimum pressure in order to operate, which must be considered in the design of the
complete cleaning circuit. Also, due to this high pressure and the impingement action
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imparted to the surface, the devices typically operate with a lower flow rate than static
devices.
One of the primary ways of determining the proper flow rate for gear driven devices is to
determine their effective throw length, or the distance from the device to the cleaned
surface. This is represented in the center chart.
The third chart outlines the effect of time on the number of rotations for the device. As
impingement is provided in narrow strips along the tank surface as the jet passes by, it is
important to allow for an adequate number of cycles to provide full coverage.
This section provides a general overview of issues to be considered when selecting a

spray device. Guideline #2, Section 3.1.5 will help to clarify details associated with these
issues.
This section is concerned with tanks that are designed are with C&S up front. With
existing tanks that may not have been designed with C&S in mind, the spray ball vendor
needs to be aware of all aspects of the tank & soil characteristics to ensure proper spray
coverage.
The major influences on spray device selection and cleaning, Time-Action-Chemistry

Temperature (TACT) are discussed in detail in Guideline #2. The basic trade-offs
between these variables should be understood, such as higher pressure (action) results in
lower required temperatures or chemical concentrations for the same cleaning time; or
that a 10 F increase in temperature may reduce the cleaning time by half. Proper
chemical concentration and selection can dramatically reduce the time, temperature, and
pressure requirements for cleaning. This is best determined in a lab through coupon
studies of actual process conditions for the soil. See also Guideline #2, Section 3.1.5.2.
9.2.2.1. VESSEL CONFIGURATION
Larger vessels have a higher surface area to cover, and surfaces may be a great
distance away from the spray dev ice. Complex vessels may have baffles or other
appurtenances that are difficult to clean with one spray device.
Impact to Spray Device Selection: Large tanks lead to multiple static devices
(increased coverage); or gear driven devices
(increased effective throw distance)

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Complex tanks lead to multiple static devices
(increased coverage); media driven devices
(increased deflection and splashing to achieve
coverage); or gear driven devices (increased
impingement and deflection)
9.2.2.2. TYPE OF SURFACE TO BE CLEANED
Highly polished stainless steel tanks will be easier to clean than FRP tanks, for
example, due to the surface finish.
Impact to Spray Device Selection: Can increase likelihood that lower flow rates
or static spray balls will be effective in
cleaning
9.2.2.3. SANITARY REQUIREMENTS
Sanitary devices will be more expensive and will likely require more flow than
typical industrial spray devices.
Impact to Spray Device Selection: Requires welds or clamps in lieu of threaded

connections
Static, media driven and gear driven devices
all available in sanitary designs
9.2.2.4. AVAILABLE NOZZLES
Some devices require up to 6 (150 mm) openings. Nozzles on existing vessels that
are being retrofitted for spray devices may be too small or they may be in the wrong
location.
Impact to Spray Device Selection: Gear driven devices require larger tank
openings than static and media driven devices
Gear and media driven devices do not always
function and drain properly when used in
sidewall nozzles
9.2.2.5. SHADOWING
If shadowing exists, extended cleaning times, or increased flow may be required to

meet cleaning requirement
Impact to Spray Device Selection: Shadow areas lead to multiple static devices
(increased coverage); media driven devices

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(increased deflection and splashing to achieve
coverage); or gear driven devices (increased
impingement and deflection)
9.2.2.6. CLEANING TIME
Production schedules may dictate the type of spray device used, as some will require
a longer residence time for cleaning.
Impact to Spray Device Selection: Cycle time for gear driven devices is primarily
based upon the time it takes to complete the
required rotation cycles for full coverage
Cycle time for static and media driven devices
is primarily based upon soil removal
9.2.2.7. REASON FOR CLEANING
The reason for cleaning, such as cross contamination prevention, product recovery,
microbial control, maintenance, fouling prevention, will have a bearing on the spray
device selection, e.g., cleaning for product recovery may lead to pigging only,
whereas cleaning the same system for cross contamination concerns would require
additional CIP. This also refers to the acceptance criteria for determining what level
of clean is clean.
Impact to Spray Device Selection: Gear driven devices can be more susceptible
to contamination as they have more moving
parts
Static spray devices are more effective for
sanitization cycles as they facilitate a longer
contact time on the tank surface
Gear driven devices require more maintenance
9.2.2.8. SOIL
Static devices may clean solvent storage tanks easily but may have difficulty cleaning
dried dental cream. See Guideline #2, Section 3.1.5.4 for additional information on
cleaning aspects for various CP products.
Impact to Spray Device Selection: Static devices are recommended or for easy to
clean light soils
Media driven devices are useful on more
difficult to clean soils, but will still require

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chemical action to break down soil than gear
driven devices
Gear driven devices are recommended for
heavy soils such as dental cream
9.2.2.9. BUDGET
Cost for cleaning devices range from $100 to over $3000. Water consumption can
also vary dramatically, affecting operation costs. Labor for manual cleaning should
also be considered as an alternative.
Impact to Spray Device Selection: Static Spray devices are the lowest cost
Media driven devices are intermediate cost
Gear driven devices are the highest cost
9.2.3. SPRAY DEVICE LOCATIONS
9.2.3.1. TOP
The location of spray balls in the top head is completely dependent on the components
inside the vessels that the spray device is responsible for cleaning, as well as the type of
spray device being used. Sometimes a vessel that might require 2-3 static spray balls can
be adequately cleaned with 1-2 gear driven spray balls due to the increased impingement
force and deflection spray within the tank. Simple tanks with a single agitator and no
baffles can typically be cleaned with one static spray ball for tanks up to 5 to 6 feet in
diameter. Complicated vessel internals, such as those in dental cream mixers, require
multiple spray devices and are best cleaned through high impact direct impingement
spray devices.
Spray devices should typically be mounted 20 to 30 below the top head, but placement
should be aligned to optimize coverage for top and upper sidewall nozzles (see Figure 9
on page 23). The height is also dependant on whether the spray device is left in the tank
during processing. It is typically undesirable to have the spray device below the liquid
level of the tank during normal operation. Rotary and gear driven spray devices should
never be located below the liquid level, and only sanitary designs that are truly self-
cleaning should be left in the tank during operation.
9.2.3.2. SIDEWALL
If the vessel has nozzles on the lower sidewall, such as shown in Figure 9, consideration
should be given to using a spray device in the sidewall of the vessel, preferably opposite
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the nozzle to be cleaned. Using a spray device in the lower sidewall can also be used to
eliminate shadowing of baffles if the upper and lower spray balls are placed in opposing
quadrants (see Figure 19 on page 32).
Avoid using rotating spray balls in sidewall applications, as they will tend to bind in a
horizontal position. If using a gear driven spray device, make sure that it will drain in the
horizontal position and that the seals are rated for this application. Also, rotary or gear
driven devices should be either be a retractable design or removed during operation.
Devices when not in use should be stored in an enclosed cabinet or enclosure, similar to
the practice used for any small parts that are cleaned and ready for use in process
equipment.
9.2.4. COVERAGE CRITERIA (FLOW/ SURFACE AREA)
The formula below is a rough estimate for calculating flow rates for static spray balls for
tanks with aspect ratios less than 3:1.
Rule of Thumb:
m (flow in gpm) = [2 to 3] x [Tank Circumference (ft)]*
*rotary spray balls use 2 gpm/ft.

*static spray ball use 3 gpm/ft.
9.2.5. SPRAY COVERAGE TESTING PROTOCOL FOR TANK VENDORS
The following is a specification for Spray Ball coverage testing. If the vendor cannot
provide this test, it should be included in the vessel OQ. In this case, the tank
specification should include the pressure and flows required for the test based on spray
ball selections.
9.2.5.1. PURPOSE
This test shall be for the purpose of evaluating the spray device(s) for coverage and
shadowing.
9.2.5.2. MATERIALS
The test indicator solution shall be an aqueous riboflavin solution at a nominal

concentration of 100 ppm of Eastman Kodak #EK117712 Reagent Grade Riboflavin
Orange powder (1 gram of powder per 10 liters of water).

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9.2.5.3. EQUIPMENT
The vessel manufacturer shall provide a surge vessel, hoses and circulating pump capable
of the required flow rate and pressure (not to exceed vessel pressure) for the proper
operation of the spray device(s) of each vessel to be tested. All wetted components of the
test equipment shall be either stainless steel or plastic, and shall leave no residue other
than the test indicator solution on the vessel(s) to be tested.
9.2.5.4. APPLICATION
All internal, wetted accessories that are indicated on each vessel's data sheet shall be
installed on that vessel as part of the spray coverage testing of that vessel. The test
indicator solution shall be applied to all the interior surfaces of the vessel (including the
inside of all nozzles and their associated caps, the exterior of all dip tubes, vortex
breakers, agitator, and the complete interior of the manway(s)) by some method other
than using the actual spray devices and the test equipment (e.g., a spray bottle and/or by
filling the vessel completely with the test indicator solution, then draining it completely).
The test indicator solution shall be allowed to completely drain from the vessel, and the
interior of the vessel, including internal accessories, shall be inspected for complete
coverage with the test indicator solution, prior to beginning the spray coverage testing.
The inspection shall be conducted with a UV "black" light, and more test indicator
solution shall be re-applied to any areas that are not covered.
9.2.5.5. SPRAY COVERAGE PROCEDURE
Test water flow shall be initiated at the flow rate and pressure required for the correct
operation of the spray device(s), and shall flow for two or three bursts of 30 seconds
each, with a 30 second delay between each burst. Verify that the vessel is completely
drained prior to beginning the next burst, and increase delay time if necessary to ensure
the vessel is empty. The initiation of flow shall mark the beginning of the spray coverage
test.
9.2.5.6. INSPECTION
After the test has ended and the vessel allowed to drain, the interior of the vessel,
including accessories, shall be completely inspected with a UV light to determine if ANY
residual test indicator solution remains after the test. If any residual test indicator
solution is detected, one additional 30-second rinse burst may be applied, and the interior
of the vessel re-inspected.

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9.2.5.7. RETESTING
If any residual test indicator solution is detected after four 30 second burst rinses, the
spray device(s) shall be adjusted and/or modified (e.g., more or larger holes in spray
balls, re-positioning of spray device(s), increased flow rate and/or pressure), and the
entire test repeated, including a fresh application of test indicator solution.
9.2.5.8. ACCEPTANCE
Once a satisfactory test has been completed (no residual test indicator solution detected),
it shall be repeated two more times to verify the successful results. The test will be
considered successful only when three (3) successful test runs have been completed in
series using the same operating criteria (coating technique, rinse time, water temperature,
water pressure, spray device configuration).
The vessel manufacturer shall document each and every test, and shall include the time
and date of each test, rinse (spray) time, flow, pressure, modifications made (if any), and
the areas that failed the visual inspection, if any, in every test.
9.2.6. FLOW VERIFICATION
It is critical that the CIP cycle is both repeatable and verifiable. A common concern
expressed over using rotary spray devices is how to know the wand was spinning the
whole cycle. Flow and pressure monitoring can verify that cleaning solutions were
delivered to the spray devices consistently, but do not verify that the spray device
delivered the solution consistently to the vessel wall.
Various methods are available for verifying rotation, and they fall into two categories.
One type is outside of the process and measures shaft rotations/speed via tachometers or
proximity sensors. The other type actually measures the impact of the water inside the
vessel through a proximity switch (pressure sensor) (see Figure 81).

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Proximity switch
mounted in nozzle cap
counts revolutions of
the spray device.
Figure 81 Flow Verification for a Rotary Wand
9.3. CIP SKIDS
9.3.1. OVERVIEW WHAT IS A CIP SYSTEM/SKID?
A CIP system is a piece of equipment designed to automatically or semi-automatically

deliver cleaning solution in a controlled, repeatable fashion to other pieces of process
equipment. The term skid means that the components of the CIP system are fabricated
on a common frame so as to function as a single unit operation. There are many different
types of CIP systems that are designed for a variety of process conditions. The
fundamentals of these types of skids designs are outlined in Guideline #2 Principles
and Practices. In general, the CIP skids are comprised of several common components,
which will be outlined in the subsequent sections. Figure 82 shows a typical 2-tank
recirculating CIP system, with key items for system operation highlighted.

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Divert to drain for Wash and

final rinse solutions prerinse make- CIP return from
and completion of up water through process equipment.
recirc steps. Rinse conductivity,
sprayball.
temp , and/or TOC
might be monitored
Vent filters may be here.
required on final rinse
tank.
Final Rinse tank; Wash/Recirc tank; Final

purified water enters rinse from previous cycle
via sprayball and is Water can be stored here for
once-through to prerinse.
process equipment
then drain.
Sanitary heat
exchanger to
Rinse tank heat wash
located behind and rinse.
wash tank to
rinse piping
circuit on CIP
skid
Flush CIP SUPPLY

mounted DP
level sensors.
CIP supply line

to equipment
with wash
Cleaning chemicals conductivity,
may be added here or temp, pressure,
Sanitary supply and flow
directly into the recirc pump with
tank. monitored.
automatic casing
drain.
Figure 82 - Typical 2 Tank CIP Skid
9.3.2. GUIDELINE COMPONENT SPECIFICATIONS
Listed below are the primary components of a CIP skid. Refer to preceding sections for a
more detailed discussion on many of these items.

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9.3.2.1. HEAT EXCHANGER
CIP temperatures are commonly 160 F (70 C). Specify a sanitary, 316L SS U-tube,
double tube sheet heat exchanger to ensure that contaminants from the plant steam
system do not enter the product piping. If this is not a concern, there is no reason to
specify a double tube sheet. Although plate and frame heat exchangers may operate more
efficiently, they are not considered sanitary and are not generally used on CIP systems.
9.3.2.2. TANKS
Recirculation tanks should be atmospheric vessels, 316L SS, 15-25 -inch Ra on the
internal surface. The tank should preferably have F&D top and bottom heads, and have a
breather or overflow vent, vortex breaker, level probe and/or switches, a dip/divert tube
for the CIP return line and a spray ball for the fresh water inlet.
Final Rinse tanks should be atmospheric, 316L SS, 15-25 -inch Ra on the internal
surface. The tank should preferably have F&D top and bottom heads, and have a
breather or overflow vent, vortex breaker, level probe and/or switches, a dip/divert tube
for the CIP return line and a spray ball for the fresh water inlet. When high purity water
is used for the final rinse, the tank should be an ASME pressure rated vessel with a .22
micron vent filter in lieu of the breather/overflow vent. Depending on the operating
pressures, it may also need a pressure safety device, such as a rupture disk.
9.3.2.3. SUPPLY PUMP
Sanitary centrifugal pump, 316 SS casing, impellers and shaft, single mechanical seal and
automated casing drain (diaphragm valve), 3500 rpm.
9.3.2.4. RETURN SYSTEM
A recirculating CIP circuit must return the cleaning solution back to the CIP skid for
chemical adjustment and extend the cleaning time for the given step. When the cleaning
circuit is a piping system, the supply pump at the CIP skid typically supplies the motive
force to return the cleaning solution back to the skid. Where tanks or other equipment
with air breaks are in the cleaning circuit, an additional motive force must be employed to
return the solution back to the skid. Basket strainers, which are often used in the dairy
industry, are typically not needed on the return system unless large particulate is expected
to be returned to the skid.
If applications exist where there is a need or additional suction head for a return pump at
the discharge of a process vessel, it is not recommended to use a remote atmospheric
surge tank to provide this break. This will create unnecessary complication in the system
and will add an additional vessel in the circuit for cleaning. When suction head is not

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available for return, eductor systems, overpressure, or combined eductor assist with
return pumps should be used. (See Section 10.6).
9.3.2.4.1. Return Pump
Sanitary centrifugal pump, 316 SS casing, impellers and shaft, single mechanical seal and
automated casing drain (diaphragm valve), 1750 rpm. Self Priming pumps (Fristam FZX
or FZ series or equivalent as Shown in Figure 83) should be used where distances from
the vessel discharge to the pump suction exceed 10 ft (3m), or where multiple circuits
with varying pressure drops are manifolded into a single return pump.
Figure 83 - Self Priming Pumps

9.3.2.4.2. Eductor
Eductor shall be 316 stainless steel Tri-Clover or equal and shall have the capacity to
return the specified flow at 160 F (70 C) solution with required suction head through the
recirculating motive loop.
9.3.2.4.3. Gravity
All process vessels are above the CIP skid and drain back to the recirculation tank by
gravity. No return pump or eductor is required.
9.3.2.4.4. Hybrid
A combination of remote located returns pump (near the process equipment) and eductor
may be used in order to increase the efficiency of the return system.
9.3.2.5. CHEMICAL INJECTION
Cleaning chemicals are typically injected either in the suction side of the pump or directly
into the wash tank. When injecting into the wash tank, utilize dip tubes (see Section
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2.7.1) for injections to prevent degradation where concentrated chemicals will contact the
tank wall. Cleaning chemicals can be stored remotely in drums or totes and transferred
via metering pumps controlled by a wash conductivity sensor. Chemicals for multiple
CIP systems can be used out of the same drum/tote by either using dedicated metering
pumps or a common distribution system with control valves dedicated to each CIP skid.
Venturi type systems scan also be used to feed chemicals into a circulating line.
Chemical delivery pumps should be either double diaphragm type of magnetically

coupled rotary gear pumps suitable for use with the cleaning agents.
9.3.2.6. CONTROLS AND INSTRUMENTATION
Various types of control systems can be used to operate the CIP system, depending on the
complexity of the system, number of I/O, and desired integration with other process unit
operations.
Stepper controls or sequencers are the most basic type of control system. These systems
have no logic capabilities and simply advance the process from step to step based on
preprogrammed time intervals. Although simple, these systems can be validated given
the appropriate documented output and validation approach.
PLC/DCS systems are the most commonly used method of controlling a CIP system.
Historically PLCs have been the workhorse for CIP systems as they were the most cost
effective solution to manage the discrete and analog I/O typical of these systems.
However, new DCS systems such as Fischers Delta V and others offer a distributed
control solution that can compete with PLCs at the skid level. The final decision on
which type of control system to use should be based on the platform used for the process
equipment in the facility, as integration between CIP and process cycles is the most
crucial part of the control system design.
Instruments on typically provided on a CIP skid include the following:
Supply Pressure Transmitter: Locate downstream of supply pump

Supply Temperature: Locate downstream of heat exchanger
Supply Flow Rate: Locate downstream of supply pump and heat exchanger
Wash Solution Resistivity/Conductivity: Locate downstream of supply pump and
heat exchanger
Wash Solution pH: Optional; used to verify switching from caustic to acid cleaning
solutions, as conductivity will not sense this change; weigh this benefit vs.
maintenance of pH probe; locate in wash tank if used
Rinse Solution Temperature: Locate on CIP return line or remote at the process
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vessel if rinse will not return to the CIP skid
Final Rinse Solution Resistivity/Conductivity: Locate on CIP return line
Final Rinse Solution TOC: Optional; used to verify rinse water quality where
conductivity is not adequate; locate on CIP return line
Chemical delivery flow rate: Locate on each chemical feed line
9.3.3. CIP SKID SELECTION CRITERIA
When designing and specifying a cleaning system the following issues should be
considered. Answers to these questions will determine how the optimum cleaning system
is designed. Configuration, level of automation, and complexity of the cleaning system
will vary extensively. CIP systems are available in a variety of sizes and configurations.
One and two tank CIP configurations are typical. However, systems may be designed
with no tanks or up to three or four tanks.
9.3.3.1. NATURE OF THE SOIL
Is the soil water-soluble?

The typical CIP skids described in these guidelines are for water-based systems. If
solvents or flammable cleaning agents are required the CIP system will look quite
different. In fact, it is unlikely that a CIP skid would be appropriate at all if the materials
such as methanol or toluene are required, as the process system itself can typically be
utilized for cleaning steps without the assistance of a CIP skid.
What is the optimum rinse temperature?

This will determine if an exchanger is needed on the CIP skid, and what type of water
should be supplied to the CIP skid from the facility. If, for example, there is a hot
purified water loop available, this could be used to eliminate the requirement for a heat
exchanger on the skid.
What chemistry releases soil from the equipment surface?

This will determine if chemical cleaning agents will be needed to supplement cleaning, or
if water alone will suffice. If cleaning agents are needed, once-through system becomes
less cost efficient.
Is the soil fresh, dried on, or cooked on to the equipment surface?

If the soil will be dried on or cooked on, then a recirculating skid with chemical
capability would be appropriate. The recirculation capability allows for extended wash

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steps without using additional water and utilities. Cleaning chemicals may help to break
down any residue on the equipment surface.
9.3.3.2. EQUIPMENT BEING CLEANED
Is the equipment designed for CIP?

If the equipment is not designed for CIP, then the expectation of the CIP skids should be
clearly stated. If manual cleaning will still be part of the cleaning protocol for the
equipment, then the CIP skid may be less automated since operator intervention will be
necessary regardless.
Is a static or dynamic spray device required?

This will impact pump sizing and pressure rating requirements for the skid. Gear driven
devices operate at higher pressures than static or rotary devices.
What is the flow rate and pressure required for the spray devices or pipeline circuits?
It is necessary to select the cleaning circuits first (tank, pipe, etc), cleaning method
second (spray device, pumped recirculation, etc.), and then the CIP skid last. The flow
and pressure requirements to clean the circuit will affect sizing of all components on the
CIP skid.
What are the temperature limits for the equipment being cleaned?
If the equipment has elastomers or other components that have a limited temperature
range, this may lead the CIP design to a system that relies more heavily on time
(recirculation), cleaning agents (chemical addition) or impingement (higher pressures) for
cleaning.
Where is the equipment located in relationship to the cleaning equipment?

This may impact the opportunity to use a portable vs. a fixed CIP system, the size
constraints of the CIP skid, etc. It is certainly possible to split the CIP skid into separate
component skids (tanks, pumps skid) in order to optimize space. The location and
distances between process equipment and the CIP skid will also impact the pump sizing
and return system configuration (remote return pump, eductor, gravity).
9.3.3.3. PROCESS AND PRODUCTION ISSUES
Frequency of cleaning: daily, weekly, monthly, or yearly?

The frequency of cleaning will impact the diversity and selection of the CIP system. A
process that is cleaned once a year should not warrant a dedicated CIP skid that is fully
automated. The equipment should be evaluated to see if it can serve as its own CIP
skid by batching in chemicals, or if a portable system can be used on a periodic basis.
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Otherwise, jumpers may be permanently or temporarily installed to connect the process
equipment with a CIP system for another area.
Time available for cleaning?

Short cleaning times typically lead to more tanks (3 or 4 tank skid) on the CIP skid so the
system can commence with one step while draining the solution from the previous step.
9.3.3.4. UTILITIES: AVAILABLE VS REQUIRED
What water quality will be used for each step?

CP standards require all water to be used for cleaning purposes must be of CP feed water
or better. Water used or final rinse steps should be consistent with the grade of water used
in the formulation or manufacturing process. This may impact the number of tanks
required for the skid; i.e., separate final rinse tank, etc.
What is flow rate is required for hot and cold water??

Some facilities will have limitations on available water supply pressure and delivery rate
for the hot and cold water systems. This may necessitate large tanks for surge capacity in
cleaning cycles.
What is the facility steam pressure and capacity?

If heated solutions are required, the available steam pressure and capacity will need to be
known in order to properly specify the heat exchanger and control valves.
Are there any drain flow and temperature limits or chemistry?

Most municipalities will have a limit on total volume discharge to the sewer. This may
be a simple permitting issue, but CIP systems can generate (and discharge) substantial
amounts of water. Check the local jurisdiction for limits on daily or peak flow limits, and
see if they are negotiable. Once-through systems will use substantially more water than
recirculating systems. If discharge volume is a concern, then a series of recirculating
rinse steps after the final wash may help reduce the time (and volume) of the once-
through final rinse.
Many codes place a limit on the temperature of solution entering a sanitary plumbing
system. In the US, this temperature limit is typically 140 F (60 C). If wash solutions
are heated, then consideration may need to be given to cooling the solution prior to
sending it to drain in order to comply with local codes. The other option is to carefully
define where the process ends and the drainage system begins, and take advantage of
mixing in order to cool the solution before sending it to drain.

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In addition to temperature, there may be restrictions on pH range or other physical
properties of the waste discharge. This may dictate the need to neutralize cleaning
solutions with on the skid before draining or at a separate location prior to discharge to
sanitary sewer, depending on materials of construction.
Location of available utilities?

The location of available utilities, such as water, purified water steam and compressed air
may also impact the skid configuration.
9.3.3.5. CHEMICALS USED FOR CLEANING
Number of different cleaning chemicals?

This simply affects the number of chemical metering pumps and control points required
for the skid. Most skids will allow for at least two chemicals, even if one chemical is
proven to be effective for the anticipated soils.
Type of Chemical?
Although the specific chemical may not be known at the time of specifying the CIP skid,
the class of chemicals (acid, caustic, etc.) that will be utilized should be established. This
will affect design decisions on where to inject the chemicals, whether they can be mixed
or if separate wash tanks will be needed, etc.
Concentration of chemical?
The concentration (range) of the chemical, and the accuracy required to measure the
concentration should be established. This will affect the type of control system used to
meter in the chemicals.
How are chemicals stored?

Details for the supply of chemicals to the skid are a part of the design, and should be
considered within the skid specification. Chemical delivery pump selection will depend
on the storage container type, location, maintenance access, etc.
9.3.3.6. LEVEL OF AUTOMATION
Type of automation used for process equipment?

First and foremost, the automation used for the CIP skid should be consistent with the
control systems in the rest of the facility. If the facility has undergone recent renovations
or added process equipment, the controls should match the philosophy and methodology
used in these new systems. The facility should not be forced into a proprietary system
being sold by a CIP supplier, but should specify the type of system they are familiar with.
Leading CIP vendors can be adaptable to various control platforms.
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Skill level of cleaning personnel (cleaning, maintenance, engineering, lab support)?

The control philosophy used for the CIP skid should also match the capabilities of the
plant personnel, so long as it does not compromise the validatability of the system. A
fully automated CIP system with online conductivity and TOC analysis will be more of a
burden than a tool if the facility is not staffed to manage the equipment, including
protocols for TOC analysis and deviations. Simple systems even using stepper type
controllers can still be validated with the right approach.
9.3.3.7. VALIDATION ISSUES
The approach to validation should be understood prior to finalizing the CIP skid design.
Sampling plans and methods to be used for cleaning analysis need to be considered, as
they will impact the location of sample valves and selection of online instrumentation.
Specification issues that have a particular impact include:
Vent filters on purified water final rinse tanks

Flow measurement on diverging paths
Rinse water temperature monitoring
Sample points
Online TOC measurement
9.3.4. CIP SKID SELECTION CRITERIA
Based upon the selection criteria outlined in the previous section, the following are
general criteria for CIP skid selection for the primary product groups at CP. Refer to the
GL1 Appendix 14.1.6 for a sample CIP skid specification sheet.
9.3.4.1. TOOTHPASTE
Based on the above criteria, the primary considerations for selecting CIP equipment for
cleaning dental cream process equipment, a highly viscous water-soluble product,
include:
Heat exchanger to elevate wash temperature, aiding the release of the soil from the
equipment surface
Capability for chemical additions to aid in soil release and to reduce foaming
Capability to supply 100 psig to operate gear driven spray devices due to complexity
of internal components on mixers

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Variable speed drives on the supply pump in order to deliver cleaning solution to a
wide range of spray devices (some storage vessels may not require gear driven
devices)
Two tank (wash and rinse) minimum system
9.3.4.2. FABRIC SOFTENERS
cleaning fabric softener process equipment include:
equipment surface
9.3.4.3. PERSONAL CARE PRODUCTS (CREAMS AND SHAMPOOS)
cleaning personal care process equipment include:
equipment surface
9.3.4.4. DETERGENT LIQUIDS
cleaning detergent liquid process equipment include:
equipment surface

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9.3.5. PROTOTYPE CLEANING REGIMENS
A major component in the selection of a CIP skid is the development of the cleaning
cycle itself. Guideline #2 offers several sections outlining steps for the development of
cleaning chemistries, cleaning temperatures and cycle times (Section 3.1.5.4), and typical
steps in a CIP cycle (Section 4.5).
9.4. COP UNITS
9.4.1. OVERVIEW WHAT IS A COP SYSTEM/SKID
Clean Out of Place (COP) units offer a location for equipment and components which
have been disassemble to be cleaned, using some combination of manual cleaning, spray
wands, or recirculation washing. COP washer are batch type washer used primarily to
clean cylindrical parts, tubing, clamps, filling nozzles, small valves or spool pieces, etc.
COP skids employ different types of cleaning action to help remove soil from product
surfaces, as can be seen by the example in Figure 85.
Figure 84 - Typical
COP Washer

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Figure 85 - COP Recirculation Action
9.4.2. GUIDELINE COMPONENT SPECIFICATIONS
Components for a COP skid such as valves, piping, pumps, heat exchangers, and
instruments are similar to CIP skids. Specifications for these individual components
should be used from CIP Component Specification Section 9.3.2. Refer to the GL1
Appendix 14.1.7 for a sample COP skid specification.
Although the design characteristics of a COP system are quite different than a CIP
system, the process of selecting the proper equipment is must the same. The criteria used
for CIP selection is also listed below, this time with COP equipment impact listed for
each category.
9.4.3.1. NATURE OF THE SOIL
Is the soil water-soluble?

Typical COP cabinets are for aqueous based cleaning. This impacts materials of
construction, components selection, and operator safety. If solvents or flammable
cleaning agents are required a custom unit will be required.

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What is the optimum rinse temperature?
Heat exchangers are common on COP units where rinse, or wash solutions are beneficial
to be heated. Steam heat exchangers are typically used for rinse solutions where water
needs to be heated quickly or in a single pass. Electric sump heaters are often used to
maintain wash solution temperatures during cycle.
What chemistry releases soil from the equipment surface?

This will determine if chemical cleaning agents will be needed to supplement cleaning, or
if water alone will suffice. If cleaning agents are needed, chemical delivery system will
be required. These can be delivered via a CIP system or they can be dedicated to the COP
unit.
Is the soil fresh, dried on, or cooked on to the equipment surface?

If the soil will be dried on or cooked on, then a recirculating skid with chemical
capability would be appropriate. The recirculation capability allows for additional
mechanical action to aid in removal of soil though agitating jets and nozzles. See Figure
85.
9.4.3.2. EQUIPMENT BEING CLEANED
Is the equipment designed for COP?

If the equipment is not designed to be cleaned in a COP unit, then it will likely have
intricate or complicated components that require disassembly or additional agitation.
Ultrasonic cleaning action may also be an option for small parts that cannot be easily
disassembled.
What are the temperature limits for the equipment being cleaned?
If the equipment has elastomers or other components which cannot be removed for
cleaning and have a limited temperature range, this may lead the COP design to a system
that relies more heavily on time (recirculation), cleaning agents (chemical addition) or
impingement (higher pressures) for cleaning.
9.4.3.3. PROCESS AND PRODUCTION ISSUES
Frequency of cleaning: daily, weekly, monthly, or yearly?

Components that are cleaned very frequently demand a more rugged COP unit that has
been specifically designed to accommodate these items. Custom racks, baskets, and
other accessories that help to make the load profile more consistent will help provide
repeatability and quick turn-around times when cleaning these items. Components that

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are only cleaned a few times a year can stand to have more time spent on set-up and
preparation for cleaning.
9.4.3.4. UTILITIES: AVAILABLE VS REQUIRED
What water quality will be used for each step?

CP standards require all water to be used for cleaning purposes must be of CP feed water
or better. Water used or final rinse steps should be consistent with the grade of water used
in the formulation or manufacturing process. This may impact the number of tanks
required for the skid, or in some cases a separate rinse line feeding the cabinet.
What is the facility steam pressure and capacity?

If heated solutions are required, the available steam pressure and capacity will need to be
known in order to properly specify the heat exchanger and control valves.
Are there any drain flow and temperature limits or chemistry?

The same concerns described for CIP skids regarding discharge of waste applies to COP
cabinets, as the same cleaning chemicals are often used for these systems.
Location of available utilities?

The location of available utilities, such as water, purified water steam and compressed air
may also impact the COP skid configuration.
9.4.3.5. CHEMICALS USED FOR CLEANING
Number of different cleaning chemicals?

This simply affects the number of chemical metering pumps and control points required
for the skid. Most skids will allow for at least two chemicals, even if one chemical is
proven to be effective for the anticipated soils.
Type of Chemical?
Although the specific chemical may not be known at the time of specifying the CIP skid,
the class of chemicals (acid, caustic, etc.) that will be utilized should be established. This
will effect design decisions on where to inject the chemicals, whether they can be mixed
or if separate wash tanks will be needed, etc.

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Concentration of chemical?
The concentration (range) of the chemical, and the accuracy required to measure the
concentration should be established. This will affect the type of control system used to
meter in the chemicals.
How are chemicals stored?

Details for the supply of chemicals to the skid are a part of the design, and should be
considered within the skid specification. Chemical delivery pump selection will depend
on the storage container type, location, maintenance access, etc.
9.4.3.6. LEVEL OF AUTOMATION
Type of automation used for process equipment?

COP skids are thought to be very simple, non-automated parts washers. This can be true
and it can also be desirable. However, COP systems can provide fully automated, timed
cycles with sequential cleaning and rinsing steps just like a CIP skid. In many cases, the
more automated the system, the more repeatable the cleaning cycle. One way of
managing this control is to have the CIP system serve as the brains of the COP
controllers, providing all control functions and delivering cleaning solutions to the
controllers.
Skill level of cleaning personnel (cleaning, maintenance, engineering, lab support)?

The control philosophy used for the COP skid should also match the capabilities of the
plant personnel, so long as it does not compromise the validatability of the system. The
same criteria for evaluating a CIP skid should be used for analyzing the adaptability of a
COP skid into an existing plant.
9.4.3.7. VALIDATION ISSUES
The approach to validation should be understood prior to finalizing the COP skid design.
Methods for analyzing the effectiveness and repeatability of the COP cycle should be
established prior to the design. Some automated batch type units can provide printouts
documenting the successful completion of a cycle. Manual systems will require more
operator intervention and sign-offs.
9.4.4. STORAGE RACKS
Storage is an extremely important aspect of cleaning manual components. Several items

should be considered regarding the selection, placement and use of storage racks and
cabinets:

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Dirty and clean components should be segregated on separate racks; in separate
rooms if possible
Racks should be constructed of easily cleanable materials, such as stainless steel
(304 SS) or a smooth polymer such as PVC or polypropylene
Racks should be compatible with the cleaning chemical which will be used in the
sinks and COP units nearby; painted storage components or those constructed of
aluminum or carbon steel are not acceptable
Open systems such as Metro shelves are acceptable and appropriate where parts
need to dry, however assure that components do not drip on other clean and dry
parts on shelves below

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10.0 CIP PIPING SYSTEMS
10.1. OVERVIEW GENERAL DESIGN CRITERIA FOR CIP PIPING
CIP supply and return piping systems should be designed with the same sanitary
principles as the process piping and equipment it is cleaning. The CIP system should be
as validatably clean as the process itself. The combination of the supply piping, the
component (piping or equipment) being cleaned, the return piping, and the CIP skid itself
comprise the cleaning circuit.
Cleaning circuits can be very small, isolated piping sections around a piece of process
equipment, or they can be very long and complex sections of transfer piping between unit
operations. These complex circuits can be very difficult to clean and validate, but on the
other hand hundreds of very small circuits can also create timing and utility problems
during start-up, validation and operation. In general, it is best to segregate cleaning
circuits based upon a few primary guidelines:
Separate circuits based upon process unit operations whenever possible, e.g., raw
material tank and a mixer should be cleaned separately.
Clean line segments with tanks when possible, e.g., the line from the raw material
tank to the mixer should be cleaned with the raw material tank.
Isolate circuits using physical breaks (transfer panels, swing-elbows) or valves in
order to optimize their size and complexity.
Always have a physical break or 2 valves between pressurized cleaning solutions
and the product.
Avoid tees and branch circuits, as it is difficult to validate split flow paths. Use
block and divert valves to sequence cleaning through these paths.
10.2. TANK CIRCUITS
CIP circuits that clean a tank or any other component that has an air break and/or spray
ball will require an additional motive force to return solution back to the CIP skid.
Return pump alternatives are discussed below. The valving to divert cleaning or
sanitizing solution between multiple pieces of equipment on a circuit should be designed
to minimize dead legs, as shown in Figure 86.

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Minimum dead leg

RINSE RECIRC
CIP SKID
(SIMPLIFIED)
Figure 86 - Tank CIP Circuit

10.3. LINE CIRCUITS
Line circuits that do not have an air break can typically use the supply pump on the CIP
skid to return the cleaning solution to the skid, without the use of an additional pump.
Proper velocities (5 ft./sec) must be maintained in both the process lines and the CIPS/R
lines in order to maintain turbulent flow for effective cleaning. Reference flow tables in
the Appendix Section 1.11.
RINSE RECIRC
CIP SKID
(SIMPLIFIED)
TRANSFER TRANSFER
PANEL PANEL
Figure 87 - Process Line Circuit

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10.4. COMBINATION CIRCUITS
In some cases, a return pump will already be in the path of a piping circuit, as it was used
to clean a tank. If centrifugal pumps are used, it is acceptable to have the second pump
(CIP return) in series with the CIP supply pump as shown in Figure 88.
Tank circuit Piping circuit

RINSE RECIRC
CIP SKID
Although return (SIMPLIFIED)
pump is needed
for tanks and not
for piping, it can
be left in the
circuit when
piping is cleaned.
Figure 88 Tank & Piping CIP Circuit
10.5. RELATIVE CIP UNIT LOCATION CRITERIA
CIP skids can be located in many areas relative to the cleaning circuits. The location of
the skid will largely dictate the return options as described in the next section. For
example, if a system can be located in a basement, then gravity return becomes an option.
If a system is only designed to clean circuits in a small area, it may be desirable to locate
the CIP skid very near or even in the same room as the process equipment. When CIP
systems are located in process areas, more attention is given to assuring the CIP skid is
designed with cleanable exterior surfaces, even the framing.
The chemical delivery system can also be located directly at the skid, in a remote location
for a single skid, or as a central system with a distribution system to multiple CIP skids.
Again, if a CIP skid is located within a process area a remote chemical delivery is
preferred, as it is typically unacceptable to deliver drums of cleaning solution into the
process room

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10.6. RETURN OPTIONS
For recirculating tank circuits, an additional motive force is required to return solution
back to the skid. The solution must be returned to the CIP skid as fast as it was delivered
in order to prevent starving and cavitating the supply pump. The four primary methods of
returning are pumps, eductors, gravity, or overpressure.
10.6.1. RETURN PUMPS
Return pump systems are the most common type of CIP return. They can be applied to a
wide variety of cleaning systems, and can operate at very high flow rates and distances.
Return pumps must be sized to return flow at greater rate than the CIP supply to maintain
system balance.
CIP return pumps carry a difficult duty, as there is typically a great deal of air entrained
in the cleaning solutions exiting process tanks and equipment. This is also compounded
by the fact that the return rates are as high or higher than the supply rates. Vortex
breakers in the process vessel can help this problem, but some vessels cannot use these
devices due to process constraints. Mechanical air vents can be added to the suction side
of the return pump to reduce the air, but these devices create an additional cleaning
concern and will only reduce the air, not eliminate it.
In some cases, it may be acceptable to let the return pump cavitate. In this case, the
pump must be oversized (up to 50%) as necessary to maintain suction and prime.
Variable speed drives are typically not effective in return pump application due to the
constantly fluctuating flow rates. Self-priming liquid ring pumps (see Section 9.3.2.4)
will help to maintain this prime throughout the cleaning cycle, and are the recommended
pump or CIP return at CP.
Advantages:
Wide variety of applications

Multiple return capabilities
Capable of high flow rates
Remote cleaning applications
Disadvantages:
Requires return pump at each set of process tanks

Higher installation cost

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10.6.2. EDUCTOR RETURNS
Eductor returns use suction to draw return flow back to the CIP tank (See Figure 89).
The systems incorporate a motive pump that recirculates water from a motive tank
(during drain steps) or recirculation tank (during wash steps) through an eductor. The
water levels in the tanks must be maintained to prevent cavitation of the motive pump.
Due to the venturi effect of the eductor, this system will not work effectively at
temperatures above 150F (65C).
EDUCTOR
MOTIVE
RINSE RECIRC
CIP SKID
(SIMPLIFIED)
Figure 89 Eductor Return System

Advantages:
Single pump at the CIP skid required for returns from many areas
Provides complete evacuation of vessels during recirculation
Disadvantages:
Requires additional motive pumps, which may not be sanitary

Applications are limited in flow rates, temperature, and distance
Larger return lines are required
10.6.3. GRAVITY RETURNS
Gravity return works when the vessels being cleaned are located above the CIP system.
Return flow must be adequate to provide suction head to the supply pump, and line
design must be carefully evaluated for proper drainage and cleaning (See Figure 90).

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RECIRC RINSE
CIP SKID
(SIMPLIFIED)
Figure 90 - Gravity Return System

Advantages:
Low capital and installation costs

Low maintenance
Disadvantages:
Limited applications based upon location (elevation, distance)

Drain times will be longer
Difficult to get turbulent flow in CIP return lines
10.6.4. OVERPRESSURE
If the process tanks are pressure vessels, a constant pressure can be applied on the vessel
during the CIP cycle to provide a pressurized return. The return line requires a blocking
valve to maintain hydraulic balance of the system, and the tank will need a regulated
clean air or nitrogen source (See Figure 91).

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CCA CCA
RECIRC RINSE
CIP SKID
(SIMPLIFIED)
Figure 91 - Gravity w/ Overpressure Return System

Advantages:
Fewer connections prior to CIP cycle

Lower capital equipment cost
Can be combined with other return methods for optimization
Disadvantages:
Limited to pressure vessels

Cycle times may be longer for pressurization of vessels
10.6.5. COMBINED RETURN SYSTEMS
In addition of the four basic systems described, there are many combinations of these
systems that may be effective for a specific situation. Overpressure is often combined
with remote return pumps in order to help get a faster time. Eductors are also used in
conjunction with gravity and overpressure systems for the same reasons.
10.7. CHEMICALS FOR CLEANING
GL2 (Section 3.1.5.4) provides a more in-depth background on the characteristics of

various cleaning solutions used for CIP. Regardless of the chemicals used, water for
"cleaning operations" must at least comply with CP FEED water specifications as per
TIL 98-030.
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10.7.1. TYPES
10.7.1.1. ALKALINES
Alkaline (caustic) cleaners are most effective against:
Organic acids
Acid salts
Proteins, fats, and greases
Unsaturated oils
Sugars
10.7.1.2. ACIDS
Acid cleaners are most effective against:
Particulates
Alkaline salts
Metal oxides
Alkaloids
Hard water scale
10.7.1.3. ENZYMATICS
Enzymatic cleaners will be formulated for cleaning very specific types of soils. Two of
the most common enzymes used are proteases (for cleaning proteins) and lipases (for
cleaning fats and greases). Because of their specificity, they are useful for a limited
range of soils (e.g., lipases cannot be used for proteins and vice versa).
10.7.1.4. EMULSIONS
Emulsion cleaners have been used to clean residues that have traditionally been cleaned
with solvents. These cleaners contain solvent/surfactant combination, and produce a
more or less stable emulsion in water. They are of limited use in a validated facility, as
they tend to leave a residue behind.
10.7.1.5. SOLVENTS
Compounds such as Trichlor, Benzene, Toluene, Methanol, Acetone, and citrus

cleaners typify solvent cleaners. These cleaning agents are being phased out in
preference to other less hazardous, more environmentally safe aqueous based cleaners.
These cleaners work on solvation only, without the benefit of any other cleaning
mechanisms.

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10.7.2. DOSING
Chemicals may be injected into the process line via a pump or eductor, or directly into a
recirculating wash tank. Preferred pumps for this service are double diaphragm pumps or
magnetically coupled rotary gear pumps suitable for service with the selected cleaning
agents. Dosing concentrations are typically measured using on-line conductivity.
10.7.3. SAFETY AND HANDLING
Handling and storage of all cleaning compounds fall under the CP safety guidelines. All
personnel should be trained for the proper use of all cleaning compounds and supplied
with appropriate safety clothing.
Cleaning compounds should be stored in the area remote from normal plant traffic, with
dry floors, and moderate temperature (to prevent freezing of liquid products). This area
should be equipped with pallets, skids, or storage racks to keep the containers off of
floors.
MSDS of all cleaning compounds should be readily available, along with all necessary
emergency phone numbers.
10.7.4. MONITORING FOR RESIDUAL LEVELS
At the completion of the cleaning cycle, the cleaning agent must be removed to
predescribed acceptance levels. Guideline 6 Validation describes the analytical
methods used for detecting residual cleaning agents, as well as guidance on establishing
practical, achievable, and verifiable acceptance criteria.
On-line monitoring, such as pH, TOC or conductivity is recommended in many instances.

The degree of on-line monitoring depends on system variables and repeatability, and
should be tied to the initial validation approach and acceptance criteria.
11.0 SANITIZATION SYSTEMS

11.1. OVERVIEW
11.1.1. DEFINITION OF SANITIZATION, STERILIZATION
Sterilization is the complete removal or biological kill of all microbial organisms.

Sanitization is the reduction of microbial organisms to be a specified level. Colgate
facilities sanitize processes; they do not sterilize, as it is not warranted.

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11.1.2. CLEANING VS. SANITIZATION
Although many consider cleaning and sanitization to be synonymous, and although they
are often performed in conjunction with each other, they are quite different functions
done for very different reasons. Cleaning may be performed to increase product yield,
aid in maintenance, or to reduce cross contamination. In addition, cleaning will aid in
sanitization by removing part of the bioburden and lodged substrate (product) that would
provide sites for accelerated microbial growth if not removed. Cleaning must be done
before sanitization.
Sanitization is performed on clean equipment for one reason, to reduce the microbial
contamination or bioburden. Sanitization does not clean the equipment, and cleaning
does not inherently sanitize the equipment.
This section outlines the various techniques for sanitization of equipment and piping
systems and reviews the three primary mediums used for sanitization: steam, hot water,
and chemicals.
11.2. STEAM
Steam sanitization is a common procedure for reducing microbial contamination in the

pharmaceutical industry, and is generally considered to be the most effective method of
sanitization pressure vessels, pipe, and small equipment. However, it should be noted
that steam sterilization is not a standard practice for all CP equipment, and is not
appropriate for large non-pressurized vessels.
The information that follows details the standards and common practices for the
pharmaceutical industry. These pharmaceutical standards are considerably more
demanding than CP sites are accustomed to, and should only be considered where FDA
regulated products are produced with a strict microbial control regime.
CP clean steam is steam whose condensate meets the requirements of the formulation
water for the product under consideration. See water TIL (98-030). Volatile inhibitors
such as amines should not be used. If condensate analysis reveals chemicals unspecified
in TIL 98-030, formulator approval is required for use.
CP clean steam is an excellent media for sanitizing pressure vessels and piping systems
under pressure (~30 psig or 2 bar). Steam creates a driving force that can reach areas not
normally contacted by hot water or chemicals, and because of the higher temperature the
contact time can be substantially reduced for the same effective reduction in bioburden.
However, thermal sanitization with steam in lieu of hot water creates additional design
and operational considerations that are outlined in the sections below.
11.2.1. PIPING SPECIFICATION

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Since clean steam has the same aggressive properties of high purity water, it should be
treated in a similar manner. Piping specifications and requirements will be similar to
those for purified water. Clean steam should be run in stainless steel tubing that is
specified with the following requirements:
Orbital welded joints

Purged internally with Argon during welding
Sanitary connections
Complete drainability
20 to 25 inch Ra, non-electropolished internal finish
Minimized dead legs
surfaces. For new applications, specify type 316L, stainless steel sanitary seamless (1/2
and smaller) or weld-seam (3/4 and larger) per ASTM A270, drawn and bright annealed,
with maximum Rockwell B hardness of 90. All tubing shall meet the requirements of
ASME BPE 97.
All stainless steel tubing should be installed using orbital welding machines with an
internal argon purge during welding. All removable connections used should be tri-
clamp style connections, flanged and threaded connections are not recommended and
should only be used if there is no alternative.
Piping shall be sloped to provide complete system drainability. Install piping at 1/4 per
1-0 slope in the appropriate direction. Where necessary due to physical constraints,
piping slope may be reduced to minimum of 1/8 per 1-0. Clean steam systems do not
have dirtlegs (low points to collect sediment prior to traps typically used on plant steam
systems) and should not contain air vents, as they are a potential source of
contamination. Although it is necessary to remove air from the system to avoid cold
spots, this can be accomplished through proper piping by venting air though system traps.
An internal surface finish of 20 to 25 inch Ra will be sufficient for clean steam service.
While most process designs using stainless steel tubing will require electropolishing the
internals of the tubing, it is not necessary in clean steam systems. Electropolishing tubing
makes it easier to clean and therefore makes good sense for process lines. Clean steam
systems however are by nature clean systems, they will never see cleaning solutions since
there is no product held up in the line that needs to be flushed out.
11.2.2. PRESSURE VS. ATMOSPHERIC STEAMING
It is recommend that sanitization using clean steam occur at 250F (121C) for 20
minutes, the corresponding saturated pressure is 15 psig (1 bar). Therefore to achieve a
good driving force between the steam temperature and the required equipment
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temperature, it is recommended that the equipment sanitization pressure is 15 psig (1 bar)
or higher. A good design pressure for a clean steam system is 30 psig (2 bar), this will
allow for line, and control valve losses while still supplying steam to the equipment at the
required pressure.
Atmospheric steaming is not recommended since the change in pressure will cause the
steam to condense and create cold spots within the equipment, this will ultimately
result in poor sanitization. Hot water sanitization should be sufficient for atmospheric
vessels in a non-pharmaceutical application, and will be addressed later in this document.
11.2.3. AIR REMOVAL
Air pockets in the clean steam system can lead to isolated cold spots and as a result will
increase sanitizing cycle times. Air can be removed from the system in several ways.
Air that is not removed through the steam traps can be vented from the system at the
equipment being sterilized. A typical solution in the pharmaceutical industry is to let air
escape through the vent filter of a process vessel during sanitization.
11.2.4. MECHANICAL SEALS
Mechanical seals, such as at agitator and pumps shafts, are prone to failure during a
steaming cycle. First, the seal must be rated for at least 260F (130C) for intermittent
steaming applications (as opposed to continuous operation), as it will degrade the seal
under these conditions. The shaft should also not be turned during the steaming
operation. This means pumps and agitators that were run during a CIP cycle should not
be operated during a pressurized steam cycle.
11.2.5. CONDENSATE REMOVAL
Condensate must not be allowed to collect in the system since by definition condensate is
at a lower temperature than the steam and will create a non-sterile situation. All
condensate should be removed through the use of steam traps, which will be discussed
later in this section. Tubing should be sloped to the steam traps to aid in drainability of
the condensate from the system. Clean steam condensate which has been contaminated
by product (not end of main drips) should be sent to drain, and is not to be reused by a
plant steam system. The possibility of cross contamination exists anytime that a sanitary
system is hooked directly into a non-sanitary one. Condensate cannot usually be
discharged directly into the sewer system. It is usually much hotter than the city would
allow and will quickly damage materials in and around the sewer. The most common
solution is to install a blow down cooler in the discharge line before the hot condensate
enters the sewer system.
11.2.6. TRAPS

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Steam traps should be located at system low points and after process equipment, as
shown in Figure 92, to remove condensate that will collect in the piping.
Drip traps on main steam line
Steam trap
after SIP
circuit
Figure 92 - Sanitary Trap Configurations

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11.2.6.1. DRIP TRAPS
A thermostatic trap should be used for all drip trap applications. Thermostatic traps have
a high steam leak rate that allows constant movement of steam through the distribution
system, even at very low loads. This will prevent stagnant unsanitary areas within the
piping.
Figure 93 - Sanitary Steam Trap

Spraix Sarco thermostatic steam trap
11.2.6.2. SIP CONDENSATE TRAPS
A thermostatic trap that can be easily opened (See Figure 93) for cleaning should be used
for all traps on a process system SIP circuit. Impurities in the equipment being cleaned
will collect in the steam trap downstream from the equipment, and therefore it will need
to be cleaned often.
11.2.7. VALVES
Isolation and on/off valves should be stainless steel ball valves. Sanitary diaphragm
valves are not acceptable for shut off in steam systems as they do not provide a steam
tight seal and may expose maintenance workers to the danger of live steam.
Additionally, the diaphragm itself will quickly break down during the extreme conditions
of steam service. 316SS ball valves of a sanitary design are acceptable in this service
as they are not in contact with a product which must be cleaned so cleanability is not at
issue, and the valve remains hot at all times in steam service so bioburden remain in
control.

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11.2.8. STEAM FLOW CONTROL
Steam flow and pressure control can be accomplished using sanitary control valves by
Cashco or equivalent sanitary control valves. Drip traps should be installed before and
after these valves (many styles are angle seated) in order to eliminate condensate n the
lines.
11.2.9. QUALITY, PURITY, CHEMICAL TREATMENT
The FDA defines Clean Steam as steam that when condensed meets the requirements
for WFI (Water For Injection). It follows then that clean steam should be held to the
same quality and purity requirements as WFI. Industry standard values for WFI quality
and purity are as follows:
pH - between 5.0 and 7.0

Conductivity Will meet USP XXIV requirements
TOC - Less than 500 ppb
Bacterial Purity - not more than 10 cfu per 100 ml
Bacterial Endotoxin - not more than 0.25 EU per ml
By comparison CP clean steam (where condensate meets the requirements of the

formulation water for the product under consideration) would need to meet quality
criteria per TIL 98-030.
11.3. HOT WATER
11.3.1. PIPING SPECIFICATION
Hot water sanitization is performed using same water specifications as the water used for
formulation and as such should be run in stainless steel tubing that is specified with the
following requirements:
Orbitally welded joints

Purged internally with Argon during welding
Sanitary connections
Complete drainability
20 to 25 inch Ra, non-electropolished internal finish
Minimized dead legs
surfaces. For new applications, specify type 316L, stainless steel sanitary seamless (1/2
and smaller) or weld-seam (3/4 and larger) per ASTM A270, drawn and bright annealed,
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with maximum Rockwell B hardness of 90. All tubing shall meet the requirements of
ASME BPE 97.
All stainless steel tubing should be installed using orbital welding machines with an
internal argon purge during welding. All removable connections used should be tri-
clamp style connections; flanged and threaded connections are not recommended and
should only be used if there is no alternative.
Piping shall be sloped to provide complete system drainability. Install piping at 1/4 per
1-0 slope in the appropriate direction. Where necessary due to physical constraints,
piping slope may be reduced to minimum of 1/8 per 1-0.
An internal surface finish of 20 to 25 inch Ra will be sufficient for hot water service.
While most process designs using stainless steel tubing will require electropolishing the
internals of the tubing, it is not necessary in hot water systems. Electropolishing tubing
makes it easier to clean and therefore makes good sense for process lines. Sanitization
systems however are by nature clean systems; they will never see cleaning solutions since
there is no product held up in the line that needs to be flushed out.
11.3.2. TIME/ TEMPERATURE MONITORING
The success of a hot water or steam sanitization cycle depends on achieving a specific
temperature for a specific time. These variables should be monitored and recorded for
each sanitization cycle. This can be captured from of a trend chart that shows actual
time/temperature relationships for the duration of the cycle, or it can be a pass-fail
indication based upon instrument readings. As long as the cycle is validated, there is no
requirement for trending. If the instruments can verify that the temperature was reached
and held for the required time, a printout stating that the cycle was successfully
completed is perfectly acceptable.
In a completely manual operation with no instrumentation, the operator should be

required to take readings to assure that the temperature reaches the required levels and is
held for the required time.
11.3.3. SUPPLY SYSTEM, QUALITY REQUIREMENTS
The water system will continuously recirculate, and will be provided with a single pump
and an uninstalled spare. System backpressure will be maintained in each loop by
pressure control valves installed in the return loop piping.
The storage tanks will be ASME designed vessels, and will usually be operated at
atmospheric pressure. Sterile vent filters (0.2 micron) will be provided at each tank. All
process connections to the tanks will be sanitary clamp. Controls will be provided to
monitor, control, and alarm head pressure and water level.
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The pumps will be sanitary, centrifugal pumps with single mechanical seals.
In non-process areas the distribution piping will be insulated with non-chloride fiberglass
insulation with an all-purpose jacket. In clean areas or areas where maintenance
activities could damage the insulation, ridged insulation with a PVC jacket will be used.
Utility drops will be of the U-bend configuration with zero dead leg diaphragm valves
such as the one shown in Figure 94 for use points.
Figure 94 - U-bend Use Point Drop for Purified Water
11.4. CHEMICALS FOR SANITIZATION
GL2 provides a more in-depth background on the characteristics of various sanitizing

solutions used for CIP. Regardless of the chemicals used, water for "cleaning operations"
must at least comply with CP FEED water specifications as per TIL 98-03. Figure 95
below shows a comparison of various sanitizing agents and their relative effectiveness
against different organisms.

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Figure 95 - Sanitizers
11.4.1. TYPES
11.4.1.1. HYPOCHLORITES
Hypochlorites are the most active of the chlorine compounds and are most widely used as
a chemical sanitizer. Calcium hypochlorite and sodium hypochlorite are the major
compounds of the hypochlorites. These sanitizers are effective in deactivating microbial
cells in aqueous suspensions and require a contact time of approximately 1.5 to 100
seconds.
11.4.1.2. QUATERNARY AMMONIUM COMPOUNDS
Quaternary ammonium compounds, frequently called quats, are used most frequently on
floors, walls, furnishing and equipment. Quats are good penetrants, providing an added
advantage for porous surfaces. They are natural wetting agents with built-in detergent
properties and are referred to as synthetic surface-active agents.

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11.4.1.3. ACID SANITIZERS
Acid sanitizers are considered to be toxicologically safe and biologically active. Organic
acids, such as acetic, peroxyacetic, lactic, propionic, and formic acid, are most frequently
used. The acid neutralized excess alkalinity that remains from the cleaning compound (if
one is used), prevents formation of alkaline deposits and sanitizes.
Carboxylic Acid Sanitizers
Carboxylic acid sanitizers are effective over a broad range of bactericidal activity. They
are stable in dilutions in the presence of organic matter and at high temperatures. They
are non-corrosive to stainless steel, provide a good shelf life, are cost effective and act as
a sanitizer and acid rinse. This sanitizer is corrosive to non-stainless steels, plastics, and
some rubber.
Acid Anionic Sanitizers
Acid-anionic sanitizers, such as phosphoric acid, are formulated with low levels of
anionic surfactant, an organic or inorganic acid with a solubilizer and with or without a
small amount of nonionic surfactant. Acid Anionic sanitizers act rapidly and kill a broad
spectrum of bacteria. They have good stability, effective in a wide temperature range,
and not affected by water hardness. These sanitizers can be corrosive to unprotected
metals.
Peroxyacetic Acid Sanitizers
Peroxyacetic acid (PAA) sanitizers provide a rapid, broad-spectrum kill, works on the
oxidation principle through the reaction with the components of the cell membranes.
PAA is an effective biocide without toxic residuals. PAA remains effective at slightly
increased concentrations in the presence of organic matter. PAA can function at low
temperatures as well as high temperatures. PAA is affected by pH with greater activity at
lower pH. PAA should be stored at ordinary temperatures (preferably cool) in original
containers. Pure aluminum, stainless and tin plated iron are resistant to PAA, but plain
steel, galvanized iron, copper, brass, and bronze are susceptible to reactions and
corrosion.
CP has successfully used a blend of 5% peracetic (peroxyacetic) acid and 25% hydrogen
peroxide as a sanitizer. It can also be supplied at higher concentrations but CP has no
experience at the higher concentrations. It can be supplied from Henkel/Eco Lab with the
Oxonia brand name, from DeGussa with Peraclean 5% brand name, and from FMC with
Vigorox brand name.

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11.4.1.4. OZONE
Ozone is more stable in gas phase than is aqueous phase. Ozone needs to be generated
on-site as needed for disinfection and sterilization. Ozone is an effective inactivation
agent for bacteria. Ozone is known to be a more effective bactericide and virucide than
chlorine and chlorine dioxide.
11.4.1.5. ALCOHOLS
The use of alcohols as a sanitizer has been appreciated for centuries for their antiseptic
qualities. Alcohols are relatively inexpensive, easily manageable and relatively nontoxic
with topical application. Alcohols have a cleansing action and evaporate readily.
The three common types of alcohols associated with sanitizing are Methyl, Ethyl and
Isopropyl alcohol. Methyl alcohol has the weakest bactericidal action of the alcohols and
is seldom considered for use as an antibacterial agent. Bactericidal action of isopropyl
alcohol is slightly greater than that of ethyl alcohol.
11.4.2. DOSING
Chemicals may be injected into the process line via a pump or eductor, or directly into a
recirculating wash tank. Preferred pumps for this service are double diaphragm pumps or
magnetically coupled rotary gear pumps suitable for service with the selected sanitizing
agents. Dosing concentrations are typically measured using on-line conductivity.
11.4.3. SAFETY AND HANDLING
Handling and storage of all cleaning compounds fall under the CP safety guidelines. All
personnel should be trained for the proper use of all cleaning compounds and supplied
with appropriate safety clothing.
Sanitizing compounds should be stored in the area remote from normal plant traffic, with
dry floors, and moderate temperature (to prevent freezing of liquid products). This area
should be equipped with pallets, skids, or storage racks to keep the containers off of
floors.
MSDS of all sanitizing compounds should be readily available, along with all necessary
emergency phone numbers.
11.4.4. MONITORING FOR RESIDUAL LEVELS
At the completion of the sanitization cycle, the sanitizing agent must be removed to
predescribed acceptance levels. Guideline 6 Validation describes the analytical

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methods used for detecting residual cleaning agents, as well as guidance on establishing
practical, achievable, and verifiable acceptance criteria.
On-line monitoring, such as pH, TOC or conductivity is recommended in many instances.

The degree of on-line monitoring depends on system variables and repeatability, and
should be tied to the initial validation approach and acceptance criteria.

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12.0 COMPRESSED AIR SYSTEMS

12.1. PROCESS AIR CRITERIA
Process air used for pressure transfers, pigging, etc. that comes into contact with the
product be designed with some sanitary considerations. These systems should be
validated as critical systems and therefore system design, component selection, and
documentation should be appropriately scrutinized.
For sanitary applications, process or clean compressed air should be delivered with a dew
point of -60F (-51C) and condensed hydrocarbons of 5 Mg/m3 or less.
12.2. PIPING
Piping used for process air systems is preferred to be stainless steel tubing. Copper
tubing may be used upstream of final filters or in non-production areas if the system is
brazed as opposed to sweat. Sweat fittings will deposit solder and flux which will cause
the system to have unacceptably high hydrocarbons after start-up. Avoid in production
areas as cleaning chemicals will discolor and degrade the exposed copper. Compression
fittings are acceptable for use in gas systems for process use.
12.3. COMPONENTS
Process Compressed Air Filter feeding the CIP line shall be a 0.2-micron vent filtration
unit, 316L SS housing, interior polish of 25 inch, gasket materials of Buna, EPDM, or
Viton. Vent filter shall be mounted to tank outlet by means of a sanitary connection.
Supply mounting plate on tank. Provide vertical clearance so that filter may be changed
within available headroom requirement. CCA supply pressure shall be 60-80 psi (4-6
Bar). The maximum allowable pressure drop shall be 5 psi (.5 Bar) across filter. Filter
body shall be line size.

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Figure 96 Clean Compressed Air System

Figure 96 shows a typical compressed air system used in the Food and Dairy industry.
This system uses a compressor that is not oil free but follows with a coalescing filter after
the receiver. There is no filtration in the distribution system, but each user has a point of
use filter at the take-off from the main. Often times these may be combined with local
regulators and pressure gauges in one component.
Systems that utilize an oil-free compressor would not need the coalescing filter and,
depending on the acceptance criteria for hydrocarbons, moisture content, particulate, etc.,
could more consistently meet these values within the distribution system. The system
above could only meet these criteria after the final filter. This highlights the need to
coordinate validation philosophy prior to system design. The system above could not
meet many validation criteria upstream of the point of use filters if that were to be a
requirement. However, this system might be a perfectly acceptable solution to
consistently providing the quality of air needed for the process, and should not be ruled
out due to a hastily derived validation sampling plan.

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13.0 PROCESS ROOMS AND OPERATING AREAS
13.1. OVERVIEW
The intent of these Guidelines is to focus on equipment; however, this section provides a
brief overview of some of the primary areas of concern for C&S in processing areas. For
more specific design criteria, consult the category engineers.
In general, extensive use of open tanks or manual cleaning of closed tanks necessitates
increased cleanliness of the surrounding process area. The facility, and specifically the
processing areas where product is exposed to the surrounding environment, also has an
impact on cleaning and sanitization. In these areas the facility must be designed and
operated to GMP standards in order to minimize contamination of the product.
13.2. OPEN PROCESSES DOS AND DONTS
General Guidelines for facility design in Open Processing areas:
Minimize horizontal surfaces where possible; where these surfaces are necessary
ensure that they are easily accessible for cleaning
Avoid tight areas for equipment and piping placement; enclose piping and exposed
ductwork in chases or hold it of the wall so all surfaces can be cleaned
Provide proper areas for storage of small components and hoses; keep hose ends off
of the floor
Keep traffic areas free from staged portable equipment
Provide separate storage and staging areas for clean and dirty equipment
Minimize paper and cardboard in areas near exposed final product; provide protective
screens where needed in filling areas
Train operators in room cleaning procedures and document the training
13.3. ROOM FINISHES
13.3.1. FLOORS
Floors should be an impervious material, easily cleaned, and capable of withstanding

repeated exposure to sanitizing agents (e.g. alcohol, bleach, quaternary ammonium,
phenols). Corners and wall junctions should be caulked to facilitate easy cleaning and
strengthen the floor to wall transition. A light grit may be incorporated into the flooring
surface to enhance traction when wet. However, the grit must not inhibit cleaning.

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Pads of similar construction to the floor should elevate equipment, tanks, stairs, etc., from
the floor for easy cleaning. See Figure 97.
Figure 97 - Equipment Pads
13.3.2. WALLS
Walls should be constructed as a rigid continuous structure covered and sealed as to

provide a smooth easily cleaned surface capable of withstanding repeated exposure to
cleaning and sanitizing agents (e.g. alcohol, bleach, quaternary ammonium, phenols).
Corners and ceiling and wall junctions will be caulked or provided with a 2 radius cove
to facilitate easy cleaning and strengthen the wall to floor, wall to wall, and wall to
ceiling transitions. All protrusions into the room such as electrical outlets, light switches,
plumbing fixtures, etc. should be sealed.
13.3.3. CEILING
The ceiling will be constructed as a rigid continuous structure covered and sealed to
provide a smooth easily cleaned surface capable of withstanding repeated exposure to
cleaning and sanitizing agents (e.g., alcohol, bleach, quaternary ammonium, phenols).
Wall junctions will be caulked to facilitate easy cleaning and strengthen the wall to
ceiling transitions. All protrusions into the room such as sprinklers and light fixtures will
be sealed. The ceiling must be capable of withstanding a minimum of 15 mm W.C.
differential pressure.
For process rooms with minimal product exposure, suspended lay-in type ceilings may be
used with washable Mylar faced panels and hold-down clips to keep the panels in-place
during operation and cleaning. These ceilings are not acceptable for hose-down
applications.
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13.3.4. WALL GUARDS
Wall guards are required for all exposed, protruding corners. Wall guards will be capable
of withstanding repeated collisions with the carts, tanks or other equipment to be used in
the process area. All wall guards should be smooth, easily cleaned, and capable of
repeated exposure to sanitizing agents (e.g., alcohol, bleach, quaternary ammonium,
phenols).
13.3.5. DOORS
Doors can be constructed of epoxy painted steel or fiberglass. All exposed surfaces will
be sealed and impervious to moisture. Doors will be capable of withstanding repeated
exposure to sanitizing agents (e.g., alcohol, bleach, quaternary ammonium, phenols).
Doors will be equipped with static seals capable of allowing the door to withstanding 15
mm W.C. differential pressure with minimal leakage when fully closed. Door will be
self- closing with all concealed mechanisms and hardware. All doors will be equipped
with windows installed in the upper half of the door.
13.3.6. LIGHT FIXTURES
All fixtures will be mounted flush to the ceiling and sealed. All exposed surfaces will be
smooth and easily cleaned and be capable of withstanding repeated exposure to sanitizing
agents (e.g. alcohol, bleach, quaternary ammonium, phenols).
13.4. ACCESS
Access should be left around equipment not only for operations and maintenance, but
also for cleaning. GMP inspectors will quickly cite areas that are claimed to be manually
cleaned or wiped down, but cannot be accessed. The best examples of this are the areas
between tanks or equipment and walls. Equipment is often placed so that maintainable
components are located on the front for easy access, and adequate clearance is maintained
on 1, 2 or 3 sides. Unfortunately, the equipment is then placed 6 (150 mm) or so from a
wall, leaving an area that cannot be adequately cleaned. If the room or item is to be
cleaned, 3 foot (~ 1 meter) access needs to be maintained around all sides to allow
cleaning personnel to clean walls and surfaces adjacent to the equipment.
13.5. VENTILATION
Minimum room air pressure differentials should be maintained. The HVAC design for
processing and filling areas needs to be evaluated for each particular area. In general, the
minimum recommended HVAC criteria for processing spaces at CP facilities is:
Positively ventilated

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95% ASHRAE filters
10-18 air changes per hour
Some CP process areas will require more stringent HVAC requirements, which should be
coordinated with MET and local Plant Engineering. References are available to assist in
this analysis, such as ANSI/ASHRAE Standard 62 (Appendix Section 1.12) Ventilation
for Acceptable Indoor Air Quality, which defines minimum ventilation rates and indoor
air quality that will be acceptable to human occupants and are intended to minimize the
potential for adverse health effects.
13.6. FACILITY FLOWS
The traffic patterns in facilities and functional areas should be considered so as to

minimize cross traffic and allow adequate space for operators to do their job without
being crowded. One of the most prominent aspects of a GMP facility is that it is
typically more spacious than non-regulated production facilities of the same function. It
is simply not acceptable to pack people and processes in a space that induces unsafe
practices and is difficult to clean. This causes people to rub against dirty equipment,
walls, and each other, increasing the risk for contaminating a clean piece of equipment or
the product itself.
13.6.1. MATERIAL
Material should flow from dirty to clean, raw material to final product. Powder
operations should be isolated from final filling operations (powder operations in making
areas is acceptable, given proper separations and controls).
13.6.2. EQUIPMENT
Clean and dirty equipment should be segregated where possible (See Figure 98).
Components that are disassembled and brought to a COP station should be transferred in
an organized manner that keeps the dirty away from the clean. Staging areas for dirty
equipment should be provided (not in corridors). Sinks and hose stations can be used in
component prep areas where rough cleaning might occur. Washing, whether it is COP
tanks, sinks, or hose stations, should be flow-through when possible (dirty to clean pass
through). If this is not feasible, then equipment flow should be organized to manage the
cross-contamination of flow from dirty to clean.

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DIRTY COMPONENT CLEAN

STAGING PREP STAGING
COP
Figure 98 - Equipment Flow
13.6.3. PERSONNEL
Personnel flow should also be considered so as to avoid situations where operators or

maintenance personnel can contaminate the product with their clothing, hair, or exposed
skin.
13.6.4. TRASH
Solid waster and trash from production rooms should also be considered. Designs and
procedures should establish a path that does not force the trash to be removed from the
area by going past a clean process.

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14.0 GL1 APPENDIX

14.1. COMPONENT SPECIFICATION SHEETS FOR C&S
General specification sheets are attached for major process equipment and piping to
support the designer in including cleaning and sanitization criteria from these Guidelines.
The designer/engineer should clarify whenever possible any comments on manual or CIP
cleaning that can effect the design or structural integrity of the equipment.
14.1.1. PROCESS TANKS
14.1.2. PROCESS PUMPS
14.1.3. SPECIALTY EQUIPMENT
14.1.4. PROCESS VALVES
14.1.5. INSTRUMENTATION
14.1.6. CIP EQUIPMENT
14.1.7. COP EQUIPMENT
14.1.8. TRANSFER PANELS
14.2. LIST OF TABLES
1.0 CHAPTER OVERVIEW 9
1.1. OBJECTIVE ......................................................................................................................................... 9

1.2. SCOPE ................................................................................................................................................. 9
1.3. RELATED C&S GUIDELINES ........................................................................................................... 10
1.4. RELATED QUALITY PROGRAMS ..................................................................................................... 11
1.4.1. CPM CONTROL POINT MONITORING .................................................................................... 11
1.4.2. MICROSUSCEPTIBILITY INDEX (MSI)...................................................................................... 11
1.5. KEY TERMINOLOGY ........................................................................................................................ 12
2.0 STORAGE AND MIXING TANKS 13

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2.1.1. MATERIALS OF CONSTRUCTION............................................................................................... 13
2.1.2. SURFACE FINISH....................................................................................................................... 15
2.1.3. WELDS ..................................................................................................................................... 17
2.1.4. CORNER DETAILS ..................................................................................................................... 18
2.2. TANK CONFIGURATION ................................................................................................................... 18
2.2.1. TOP HEAD TYPES ..................................................................................................................... 19
2.2.2. BOTTOM HEAD TYPES ............................................................................................................. 21
2.3. MANWAY .......................................................................................................................................... 22
2.3.1. LOCATION ................................................................................................................................ 22
2.3.2. TYPES ....................................................................................................................................... 23
2.4. AGITATORS....................................................................................................................................... 27
2.4.1. SHAFTS ..................................................................................................................................... 27
2.4.2. IMPELLERS ............................................................................................................................... 27
2.4.3. SEALS ....................................................................................................................................... 29
2.5. BAFFLES ........................................................................................................................................... 31
2.5.1. LOCATION AND SHADOWING ................................................................................................... 32
2.5.2. CONFIGURATION ...................................................................................................................... 32
2.5.3. INSTALLATION DETAILS .......................................................................................................... 32
2.6. VENTS ............................................................................................................................................... 33
2.6.1. OVERFLOW AND BREATHER VENTS ........................................................................................ 33
2.6.2. NOZZLE SIZING FOR C&S ........................................................................................................ 33
2.6.3. SAFETY RELIEF VENTS ............................................................................................................ 33
2.7. TANK INLETS .................................................................................................................................... 35
2.7.1. DIP/DIVERT TUBES .................................................................................................................. 35
2.7.2. VALVE LOCATION; DEAD LEGS ................................................................................................ 36
2.7.3. TANK MANIFOLDS ................................................................................................................... 37
2.8. TANK OUTLETS ................................................................................................................................ 38
2.8.1. DRAINABILITY CRITERIA AND DRAIN RATES .......................................................................... 38
2.8.2. VORTEX BREAKERS .................................................................................................................. 39
2.8.3. VALVES .................................................................................................................................... 40
2.9. MISCELLANEOUS NOZZLES............................................................................................................. 42
2.9.1. INSTRUMENTS .......................................................................................................................... 42
2.9.2. SPRAY DEVICES ....................................................................................................................... 43
2.9.3. SAMPLE VALVES ...................................................................................................................... 43
2.9.4. SIGHT AND LIGHT GLASSES ..................................................................................................... 44
2.10. IQ/OQ DESIGN REQUIREMENTS ...................................................................................................... 45
3.0 PUMPS 46

3.2. MATERIALS OF CONSTRUCTION ..................................................................................................... 46
3.3. SANITARY CENTRIFUGAL PUMPS .................................................................................................... 46
3.4. SANITARY ROTARY LOBE PD PUMPS ............................................................................................. 47
3.5. SANITARY PROGRESSIVE CAVITY PUMPS ...................................................................................... 48
3.6. CIP BYPASS DESIGNS FOR PD PUMPS ............................................................................................. 49

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4.0 PROCESS PIPING 51

4.2.2. SURFACE FINISH....................................................................................................................... 51
4.3. ELASTOMERS.................................................................................................................................... 51
4.4. JOINTS............................................................................................................................................... 52
4.4.1. WELDS ..................................................................................................................................... 52
4.4.2. SANITARY CLAMPS .................................................................................................................. 54
4.4.3. GASKETS .................................................................................................................................. 54
4.4.4. QUICK-CONNECTS ................................................................................................................... 55
4.4.5. BEVEL SEAT FITTINGS ............................................................................................................. 55
4.4.6. COMPRESSION FITTINGS .......................................................................................................... 56
4.5. INSTALLATION ................................................................................................................................. 56
4.5.1. DEAD LEGS .............................................................................................................................. 56
4.5.2. TEE ORIENTATION ................................................................................................................... 56
4.5.3. PIPE SLOPE ............................................................................................................................... 57
4.5.4. PIPE SUPPORTS ......................................................................................................................... 58
4.6. U BEND TRANSFER PANELS .............................................................................................................. 58
4.7. PIGGING TERMINAL DESIGN FOR CLEANABILITY .......................................................................... 59
4.7.1. SELECTION CRITERIA ............................................................................................................... 60
4.7.2. PROPELLANTS .......................................................................................................................... 63
4.7.3. INSTALLATION DETAILS .......................................................................................................... 63
4.8. PIPING SPECIALTIES ........................................................................................................................ 64
4.8.1. FLEX HOSES ............................................................................................................................. 64
4.8.2. STATIC MIXERS ........................................................................................................................ 66
5.0 INSTRUMENTATION 67

5.2.2. SURFACE FINISH....................................................................................................................... 67
5.3.1. FLOW ........................................................................................................................................ 67
5.3.2. TEMPERATURE ......................................................................................................................... 69
5.3.3. PRESSURE ................................................................................................................................. 69
5.3.4. PH & ORP................................................................................................................................ 70
5.3.5. LEVEL....................................................................................................................................... 71
5.3.6. CONDUCTIVITY ........................................................................................................................ 71
5.4. IQ/OQ DESIGN REQUIREMENTS..................................................................................................... 72
6.0 VALVES 72
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6.2.2. SURFACE FINISH....................................................................................................................... 73
6.3.1. BALL ........................................................................................................................................ 73
6.3.2. DIAPHRAGM ............................................................................................................................. 74
6.3.3. COMPRESSION .......................................................................................................................... 75
6.3.4. MIXPROOF ................................................................................................................................ 76
6.3.5. PLUG ........................................................................................................................................ 76
6.3.6. BUTTERFLY (WAFER) ............................................................................................................... 76
6.3.7. NEEDLE .................................................................................................................................... 77
6.3.8. CHECK ...................................................................................................................................... 77
6.3.9. SAMPLE .................................................................................................................................... 77
7.0 SPECIALTY EQUIPMENT 78
7.1. FILTERS ............................................................................................................................................ 78

7.1.1. PUROLATOR ............................................................................................................................. 78
7.1.2. OTHERS .................................................................................................................................... 78
7.2. HEAT EXCHANGERS......................................................................................................................... 78
7.3. HOMOGENIZERS............................................................................................................................... 79
7.4. POST ADDITION (PA) SKIDS ............................................................................................................ 80
8.0 FILLING EQUIPMENT 81
8.1. FILLING EQUIPMENT OVERVIEW ................................................................................................... 81

8.1.1. HEAD TANKS ............................................................................................................................ 81
8.1.2. PIPING ...................................................................................................................................... 82
8.1.3. NOZZLES .................................................................................................................................. 82
8.1.4. CRITERIA FOR CLEANING CHANGEOVER TIMES ...................................................................... 83
8.2. TIME-GRAVITY & TIME-PRESSURE FILLERS ................................................................................ 83
8.2.1. C&S APPROACH ...................................................................................................................... 84
8.3. MAGNETIC FLOW METER FILLERS ................................................................................................ 84
8.3.1. C&S APPROACH ...................................................................................................................... 85
8.4. WEIGHT FILLERS ............................................................................................................................. 85
8.4.1. C&S APPROACH ...................................................................................................................... 86
8.5. PISTON FILLERS ............................................................................................................................... 86
8.5.1. C&S APPROACH ...................................................................................................................... 87
8.6. AIR SENSING FILLERS ..................................................................................................................... 87
8.6.1. C&S APPROACH ...................................................................................................................... 88
8.7. PRESSURE OVERFLOW FILLERS ..................................................................................................... 88
8.7.1. C&S APPROACH ...................................................................................................................... 89

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9.0 CLEANING EQUIPMENT 90
9.1. OVERVIEW CIP AND COP............................................................................................................ 90

9.2. SPRAY DEVICES................................................................................................................................ 91
9.2.1. TYPES ....................................................................................................................................... 91
9.2.2. SELECTION CRITERIA ............................................................................................................... 94
9.2.3. SPRAY DEVICE LOCATIONS ..................................................................................................... 97
9.2.4. COVERAGE CRITERIA (FLOW/ SURFACE AREA) ........................................................................ 98
9.2.5. SPRAY COVERAGE TESTING PROTOCOL FOR TANK VENDORS .................................................. 98
9.2.6. FLOW VERIFICATION.............................................................................................................. 100
9.3. CIP SKIDS....................................................................................................................................... 101
9.3.1. OVERVIEW WHAT IS A CIP SYSTEM/SKID? ......................................................................... 101
9.3.2. GUIDELINE COMPONENT SPECIFICATIONS ............................................................................. 102
9.3.3. CIP SKID SELECTION CRITERIA .............................................................................................. 106
9.3.4. CIP SKID SELECTION CRITERIA .............................................................................................. 110
9.3.5. PROTOTYPE CLEANING REGIMENS ........................................................................................ 112
9.4. COP UNITS ..................................................................................................................................... 112
9.4.1. OVERVIEW WHAT IS A COP SYSTEM/SKID ......................................................................... 112
9.4.2. GUIDELINE COMPONENT SPECIFICATIONS ............................................................................. 113
9.4.3. SELECTION CRITERIA ............................................................................................................. 113
9.4.4. STORAGE RACKS .................................................................................................................... 116
10.0 CIP PIPING SYSTEMS 118
10.1. OVERVIEW GENERAL DESIGN CRITERIA FOR CIP PIPING ..................................................... 118
10.2. TANK CIRCUITS ............................................................................................................................. 118
10.3. LINE CIRCUITS ............................................................................................................................... 119
10.4. COMBINATION CIRCUITS .............................................................................................................. 120
10.5. RELATIVE CIP UNIT LOCATION CRITERIA................................................................................... 120
10.6. RETURN OPTIONS ........................................................................................................................... 121
10.6.1. RETURN PUMPS .................................................................................................................... 121
10.6.2. EDUCTOR RETURNS ............................................................................................................. 122
10.6.3. GRAVITY RETURNS .............................................................................................................. 122
10.6.4. OVERPRESSURE .................................................................................................................... 123
10.6.5. COMBINED RETURN SYSTEMS ............................................................................................. 124
10.7. CHEMICALS FOR CLEANING ......................................................................................................... 124
10.7.1. TYPES ................................................................................................................................... 125
10.7.2. DOSING ................................................................................................................................. 126
10.7.3. SAFETY AND HANDLING ...................................................................................................... 126
10.7.4. MONITORING FOR RESIDUAL LEVELS .................................................................................. 126
11.0 SANITIZATION SYSTEMS 126
11.1. OVERVIEW...................................................................................................................................... 126

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11.1.1. DEFINITION OF SANITIZATION, STERILIZATION ................................................................... 126
11.1.2. CLEANING VS. SANITIZATION .............................................................................................. 127
11.2. STEAM ............................................................................................................................................. 127
11.2.1. PIPING SPECIFICATION ......................................................................................................... 127
11.2.2. PRESSURE VS. ATMOSPHERIC STEAMING ............................................................................ 128
11.2.3. AIR REMOVAL ...................................................................................................................... 129
11.2.4. MECHANICAL SEALS ............................................................................................................ 129
11.2.5. CONDENSATE REMOVAL ...................................................................................................... 129
11.2.6. TRAPS ................................................................................................................................... 129
11.2.7. VALVES ................................................................................................................................ 131
11.2.8. STEAM FLOW CONTROL ........................................................................................................ 132
11.2.9. QUALITY, PURITY, CHEMICAL TREATMENT ........................................................................ 132
11.3. HOT WATER ................................................................................................................................... 132
11.3.1. PIPING SPECIFICATION ......................................................................................................... 132
11.3.2. TIME/ TEMPERATURE MONITORING ..................................................................................... 133
11.3.3. SUPPLY SYSTEM, QUALITY REQUIREMENTS ......................................................................... 133
11.4. CHEMICALS FOR SANITIZATION ................................................................................................... 134
11.4.1. TYPES ................................................................................................................................... 135
11.4.2. DOSING ................................................................................................................................. 137
11.4.3. SAFETY AND HANDLING ...................................................................................................... 137
11.4.4. MONITORING FOR RESIDUAL LEVELS .................................................................................. 137
12.0 COMPRESSED AIR SYSTEMS 139
12.1. PROCESS AIR CRITERIA ................................................................................................................ 139

12.2. PIPING ............................................................................................................................................. 139
12.3. COMPONENTS ................................................................................................................................. 139
13.0 PROCESS ROOMS AND OPERATING AREAS 141
13.1. OVERVIEW...................................................................................................................................... 141

13.2. OPEN PROCESSES DOS AND DONTS .......................................................................................... 141
13.3. ROOM FINISHES ............................................................................................................................. 141
13.3.1. FLOORS................................................................................................................................. 141
13.3.2. WALLS.................................................................................................................................. 142
13.3.3. CEILING ................................................................................................................................ 142
13.3.4. WALL GUARDS ..................................................................................................................... 143
13.3.5. DOORS .................................................................................................................................. 143
13.3.6. LIGHT FIXTURES .................................................................................................................. 143
13.4. ACCESS ........................................................................................................................................... 143
13.5. VENTILATION ................................................................................................................................. 143
13.6. FACILITY FLOWS ........................................................................................................................... 144
13.6.1. MATERIAL ............................................................................................................................ 144
13.6.2. EQUIPMENT .......................................................................................................................... 144
13.6.3. PERSONNEL .......................................................................................................................... 145
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13.6.4. TRASH .................................................................................................................................. 145
14.0 GL1 APPENDIX 146
14.1. COMPONENT SPECIFICATION SHEETS FOR C&S......................................................................... 146

14.1.1. PROCESS TANKS ................................................................................................................... 146
14.1.2. PROCESS PUMPS ................................................................................................................... 146
14.1.3. SPECIALTY EQUIPMENT ....................................................................................................... 146
14.1.4. PROCESS VALVES ................................................................................................................. 146
14.1.5. INSTRUMENTATION .............................................................................................................. 146
14.1.6. CIP EQUIPMENT ................................................................................................................... 146
14.1.7. COP EQUIPMENT ................................................................................................................. 146
14.1.8. TRANSFER PANELS ............................................................................................................... 146
14.2. LIST OF TABLES ............................................................................................................................. 146
14.3. LIST OF FIGURES ............................................................................................................................ 152
14.3. LIST OF FIGURES
Figure 1 - Definition of Ra............................................................................................................ 15

Figure 2 - Surface Profiles from Various Polishing Techniques .................................................. 17
Figure 3 Sample Weld Finishes ................................................................................................. 17
Figure 4 Profilometer................................................................................................................. 18
Figure 5 Corner Details.............................................................................................................. 18
Figure 6 Top Head Types .......................................................................................................... 20
Figure 7 - Tank Bottom Configurations........................................................................................ 21
Figure 8 - Tank Half-Pipe Discharge Details ............................................................................... 22
Figure 9 Manway and Nozzle Positions .................................................................................... 23
Figure 10 Atmospheric Manway ............................................................................................... 25
Figure 11 Standard ASME Manway.......................................................................................... 25
Figure 12 Sanitary Manway....................................................................................................... 25
Figure 13 Examples of unacceptable design/procedure combinations ...................................... 26
Figure 14 Axial Flow Impeller .................................................................................................. 28
Figure 15 Scraping Blade Agitator ............................................................................................ 28
Figure 16 - Radial Flow Impeller.................................................................................................. 29
Figure 17 - Pad Flange.................................................................................................................. 30

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Figure 18 - Agitator Mounts for Open Processing........................................................................ 31
Figure 19 Shadowing at Baffles................................................................................................. 32
Figure 20 Bolt Configurations for Product Contact................................................................... 33
Figure 21 Sanitary Rupture Disk Housing................................................................................. 34
Figure 22 - Sterile Vent Filters ..................................................................................................... 35
Figure 23 - Dip Tube CIP ............................................................................................................. 36
Figure 24 - Inlet Valve CIP........................................................................................................... 37
Figure 25 - Tank Inlet Pitched Manifold ...................................................................................... 38
Figure 26 Vortex Breakers......................................................................................................... 40
Figure 27 Dead Leg at Tank Discharge ..................................................................................... 42
Figure 28 Nozzle Detail for Spray Devices ............................................................................... 43
Figure 29 - Side Mounted Radial Diaphragm Valve for Sample.................................................. 44
Figure 30 Sight Glass.................................................................................................................. 44
Figure 32 - Rotary Lobe Pump - Vertical Position ....................................................................... 48
Figure 33 - Progressive Cavity Rotor ........................................................................................... 48
Figure 34 Incorrect Pump Bypass.............................................................................................. 49
Figure 35 - Progressive Cavity Pump Bypass............................................................................... 50
Figure 36 Sanitary Clamps......................................................................................................... 54
Figure 37 - Camlock Connectors .................................................................................................. 55
Figure 38 - Bevel Seat Fitting....................................................................................................... 55
Figure 39 - Dead Legs.................................................................................................................. 56
Figure 40 - Tee Orientation........................................................................................................... 57
Figure 41 Example of Tee Orientation ...................................................................................... 57
Figure 43 U-Bend Transfer Panel .............................................................................................. 58
Figure 44- Pigging System Cleaning Bullet ................................................................................. 60
Figure 45 Pig Launcher/Receiver .............................................................................................. 61
Figure 46 Bullet Launchers........................................................................................................ 62
Figure 47 - Bullet Catchers ........................................................................................................... 62
Figure 48- Pigging Details - 2 Tanks............................................................................................ 64
Figure 49 - Pigging Detail - Tanks and Drum .............................................................................. 64
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Figure 50 - Flex Hoses.................................................................................................................. 65
Figure 51 Flex Hose Stored Out of Use..................................................................................... 65
Figure 52 - Non-Sanitary Static Mixers........................................................................................ 66
Figure 53 - Mass Flow Meters ...................................................................................................... 68
Figure 54 - Flow Meters ............................................................................................................... 68
Figure 55 Temperature Indicator Mounting .............................................................................. 69
Figure 56 - Pressure Indicator....................................................................................................... 70
Figure 57 - pH & ORP Tank Connections.................................................................................... 71
Figure 58 - Conductivity Sensor Installation ................................................................................ 72
Figure 59 - Diaphragm Shutoff Valve .......................................................................................... 74
Figure 60 - Diaphragm Divert Valves .......................................................................................... 75
Figure 61 - Compression (Stem) Valve ........................................................................................ 75
Figure 62 - Mixproof Valve.......................................................................................................... 76
Figure 63 Sample Valve............................................................................................................. 77
Figure 64 Purolator Filter (housing not shown)......................................................................... 78
Figure 65 - Sanitary U-Tube Heat Exchanger .............................................................................. 79
Figure 67 - Head Tanks................................................................................................................. 81
Figure 68 - Filling Line Piping Systems ....................................................................................... 82
Figure 69 - Filling Nozzles Being Manually Cleaned .................................................................. 82
Figure 70 - Time-Gravity & Time-Pressure Fillers ...................................................................... 84
Figure 71 - Magnetic Flow Meter................................................................................................. 85
Figure 72- Weight Filler ............................................................................................................... 86
Figure 73 - Piston Filler ................................................................................................................ 87
Figure 74 - Air Sensing Filler ....................................................................................................... 88
Figure 75 - Pressure Overflow Filler ............................................................................................ 89
Figure 76 - Static Spray Ball......................................................................................................... 91
Figure 77 Rotating Spray Ball ................................................................................................... 92
Figure 78 Typical Flow-Pressure Curves for Rotating Ball ...................................................... 92
Figure 79 Example of a Gear Driven Spray Device .................................................................. 93
Figure 80 Typical Flow-Pressure Curves for Gear Driven Spray Device ................................. 93
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Figure 81 Flow Verification for a Rotary Wand...................................................................... 101
Figure 82 - Typical 2 Tank CIP Skid.......................................................................................... 102
Figure 83 - Self Priming Pumps ................................................................................................. 104
Figure 85 - COP Recirculation Action........................................................................................ 113
Figure 86 - Tank CIP Circuit ...................................................................................................... 119
Figure 87 - Process Line Circuit ................................................................................................. 119
Figure 88 Tank & Piping CIP Circuit ...................................................................................... 120
Figure 89 Eductor Return System............................................................................................ 122
Figure 90 - Gravity Return System............................................................................................. 123
Figure 91 - Gravity w/ Overpressure Return System.................................................................. 124
Figure 92 - Sanitary Trap Configurations................................................................................... 130
Figure 93 - Sanitary Steam Trap................................................................................................. 131
Figure 94 - U-bend Use Point Drop for Purified Water.............................................................. 134
Figure 95 - Sanitizers .................................................................................................................. 135
Figure 96 Clean Compressed Air System................................................................................. 140
Figure 97 - Equipment Pads........................................................................................................ 142
Figure 98 - Equipment Flow ....................................................................................................... 145

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Cleaning and Sanitization Guideline No.

1.0 CHAPTER OVERVIEW 9

1.1. OBJECTIVE ......................................................................................................................................... 9

2.0 STORAGE AND MIXING TANKS 13

2.1. PRODUCT CONTACT SURFACE ........................................................................................................ 13

3.1. GENERAL SANITARY REQUIREMENTS............................................................................................ 46

4.0 PROCESS PIPING 51

4.1. GENERAL SANITARY REQUIREMENTS............................................................................................ 51

5.1. GENERAL SANITARY REQUIREMENTS............................................................................................ 67

6.1. GENERAL SANITARY REQUIREMENTS............................................................................................ 72

7.0 SPECIALTY EQUIPMENT 78

7.1. FILTERS ............................................................................................................................................ 78

8.0 FILLING EQUIPMENT 81

8.1. FILLING EQUIPMENT OVERVIEW ................................................................................................... 81

9.0 CLEANING EQUIPMENT 90

9.1. OVERVIEW CIP AND COP............................................................................................................ 90

C-P Confidential 5 Version 1.0

10.0 CIP PIPING SYSTEMS 118

11.0 SANITIZATION SYSTEMS 126

11.1. OVERVIEW...................................................................................................................................... 126

12.0 COMPRESSED AIR SYSTEMS 139

12.1. PROCESS AIR CRITERIA ................................................................................................................ 139

13.0 PROCESS ROOMS AND OPERATING AREAS 141

13.1. OVERVIEW...................................................................................................................................... 141

14.0 APPENDIX 146

14.1. COMPONENT SPECIFICATION SHEETS FOR C&S......................................................................... 146

C-P Confidential 8 Version 1.0

1.0 CHAPTER OVERVIEW

The Objective of this Guideline is to provide a technical reference of the Colgate-

020 Product Design

This Guideline includes:

Sanitary piping system design strategies and details.

Since it is to be used as a design supplement to other CP documents, this Guideline does

1.3. RELATED C&S GUIDELINES

C&S Guideline #2 Principles and Practices

This document serves as a Cleaning and Sanitization fundamentals course: general

C&S Guideline #3 Plant Assessment

C&S Guideline #4 Protocol for C&S Aspects of New Product Development

C&S Guideline #5 Guideline for C&S Plant Implementation

This document outlines organizational and resource requirements for successful

C-P Confidential 10 Version 1.0

This document provides an overview of general Validation principles and CPs

1.4. RELATED QUALITY PROGRAMS

1.4.1. CPM CONTROL POINT MONITORING

1.4.2. MICROSUSCEPTIBILITY INDEX (MSI)

C-P Confidential 11 Version 1.0

Bioburden: A general term used to describe the microbiological loading or activity in a

CCA: Clean Compressed Air

CIP (Clean In Place): An automated or semi-automated method of cleaning process

SIP: Sanitize In Place

CIPS/R: CIP Supply and Return (piping)

Micro Sensitivity: The degree a products quality characteristics are affected by

Sanitization: The reduction of microbial contamination to a specified level

Sterilization: The complete elimination of microbial contamination

Soil: Residual product on a surface which is being cleaned.

EHEDG: European Hygienic Equipment Design Group Guidelines

Profilometer: An instrument used to measure surface roughness

C-P Confidential 12 Version 1.0

2.1.1. MATERIALS OF CONSTRUCTION

2.1.1.1. STAINLESS STEEL

The most common types of stainless steel are:

Acceptable uses in existing facilities: