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

Cleaning and Sanitization Guideline No.
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

4.1. GENERAL SANITARY REQUIREMENTS............................................................................................ 51
4.2. PRODUCT CONTACT SURFACE ........................................................................................................ 51
4.2.1. MATERIALS OF CONSTRUCTION........................................................................................... 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
C-P Confidential 2 Version 1.0
1.0 GL1_v1.doc 4/6/01
Printed on 03/15/02

Cleaning and Sanitization Guideline No.
Equipment and Piping Design Criteria
1
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
4.9. IQ/OQ DESIGN REQUIREMENTS...................................................................................................... 66

5.0 INSTRUMENTATION 67

5.1. GENERAL SANITARY REQUIREMENTS............................................................................................ 67
5.2. PRODUCT CONTACT SURFACE ........................................................................................................ 67
5.2.1. MATERIALS OF CONSTRUCTION........................................................................................... 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

6.1. GENERAL SANITARY REQUIREMENTS............................................................................................ 72
6.2. PRODUCT CONTACT SURFACE ........................................................................................................ 73
6.2.1. MATERIALS OF CONSTRUCTION........................................................................................... 73
6.2.2. SURFACE FINISH................................................................................................................... 73
6.3. SELECTION CRITERIA...................................................................................................................... 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
C-P Confidential 3 Version 1.0
1.0 GL1_v1.doc 4/6/01
Printed on 03/15/02

................................. C&S APPROACH ..................................................................................... 86 8......................1.................................................... 78 7..3........1........................... 77 7.1............ 91 9........ SPRAY DEVICES................3..2............................ 87 8.............................. 80 8........................................................................ TYPES ..........................1. AIR SENSING FILLERS ......................................... TIME-GRAVITY & TIME-PRESSURE FILLERS .............1........2...........................................................6...............5............................................3.....................................................................................0 SPECIALTY EQUIPMENT 78 7............1....................3...........2.................8.............. FILTERS ..... 88 8. 78 7.......................................1..................... NEEDLE .................................7............... 94 C-P Confidential 4 Version 1..............................................................7............ 77 6........................1......1........... POST ADDITION (PA) SKIDS ....... 78 7.........1........................3................... 78 7.......4.......2.. HOMOGENIZERS.......................................................................2.......................... 85 8.................................................................................1.........................1..................................2....................................................................... C&S APPROACH ............................ 85 8........................... OVERVIEW – CIP AND COP.................................................................................... MAGNETIC FLOW METER FILLERS ....... 88 8........................... FILLING EQUIPMENT OVERVIEW ................... 77 6................................ 83 8....1................................... Gear Driven ............ 82 8............................................................ 90 9.......................................................... 84 8........ 91 9............................ 94 9....................................................... PIPING ............... 81 8...........................................................................................................2.................... NOZZLES ................................................................................................ 86 8........ SELECTION CRITERIA ........................................................................................1. Cleaning and Sanitization Guideline No......................................................3...................................2........... HEAD TANKS..........................................................................................................................................0 FILLING EQUIPMENT 81 8............. CRITERIA FOR CLEANING CHANGEOVER TIMES ............................................................. PRESSURE OVERFLOW FILLERS .0 1.9........... 92 9...............................1.........0 GL1_v1.................... 76 6.......................................................6.....................2................... 83 8.............4....4.............. C&S APPROACH ..................................................................... 82 8.............................. HEAT EXCHANGERS................ Equipment and Piping Design Criteria 1 6.................. WEIGHT FILLERS ... C&S APPROACH ..........4............ PUROLATOR .................................................................. CHECK ................................................... PISTON FILLERS ...........................1............... BUTTERFLY (WAFER) ...1..................................................................................doc 4/6/01 Printed on 03/15/02 ..........................................................2......................1....... Static Spray Devices................................1................... SAMPLE ..1............................... 91 9. 84 8......................................................................... 87 8........................... C&S APPROACH ............................................................ C&S APPROACH ................................. 79 7........ Rotating Spray Devices .................................5..........................................1. Vessel Configuration....................2........................................................... 81 8...................................6........3...............................................................................2..................................7.............................................1....... OTHERS .......................... 92 9...2....................................................................2................................................ 89 9.................................0 CLEANING EQUIPMENT 90 9...................2.3............1........3............................

...........2.....................................................................7....................................3...................7......... Personal Care Products (Creams and Shampoos) ..................... Spray Coverage Procedure ...............................................4...2...... 101 9................8......................................................... 110 9............................1...................... 97 9.....................................6.... GUIDELINE COMPONENT SPECIFICATIONS ....3......2.............................. 104 9.....................6......................5......5.................................................... Application ............................3.........................................................2............ Cleaning time ........3............................................ 98 9...........3...2...................... 110 9.............. Return System ..3.................................3..............................................5................. 97 9....................... 99 9.................9........................... Soil ....... Available Nozzles ...2............................................................1.....................2...............2......................4.....3...........3...................2............................3........... 98 9...................................................................0 GL1_v1............... Materials......................................................................2.................... Detergent Liquids .....................3........... 107 9......................... Retesting.........3.2..........................2...................0 1..............................5.......3................. SPRAY DEVICE LOCATIONS .............. Shadowing............................4. COP UNITS ...............3......................3................2................................................................................................3..........4...........................................2.............2............ CIP SKID SELECTION CRITERIA .................... Controls and Instrumentation ....2........................................4.............3.. 100 9..............6.2...6.......... Validation Issues ... COVERAGE CRITERIA (FLOW/ SURFACE AREA) ...................................5................................. Nature of the Soil .........2............2..... 100 9. 111 9.............................................3.......... 98 9.......... 110 9..... 101 9.................................... 106 9............3........3................ Inspection . Reason for cleaning ...2............2............................................ Heat Exchanger ..................................................................5.......................2.3.....3............................................ 99 9...............................2............................... Process and Production Issues...............................................................5...............1...........1.................................................. Type of surface to be cleaned.5.3.......3.............................................. Top ......3.............................................................. 103 9...............2...... Purpose ...................2..............................3............2..............................................5..........4........................................................ Acceptance ............2.......................3.................. SPRAY COVERAGE TESTING PROTOCOL FOR TANK VENDORS .... Sanitary Requirements ............. 107 9............... 109 9...........................................4... 95 9.... OVERVIEW – WHAT IS A CIP SYSTEM/SKID?.....2............. FLOW VERIFICATION...........2.............................................................. 112 C-P Confidential 5 Version 1.... 106 9..............................................................................3....... Level of Automation ......3................2... 95 9......... Equipment and Piping Design Criteria 1 9...............................doc 4/6/01 Printed on 03/15/02 ............................................................................................................ 111 9................................................................................. Cleaning and Sanitization Guideline No.............................4... Equipment ........................................ 102 9..........4................................................................. Budget .................................. 95 9........2................................ Sidewall......5.............3.......3..5.. Supply Pump ................ Fabric Softeners........2..................2..............................2..........................4............ Chemicals Used for Cleaning...............1........................ CIP SKID SELECTION CRITERIA ...............................................................3................. 111 9..5...4............ 109 9.......................3......4..................... CIP SKIDS.................................................... 103 9.............................................................3...................... 108 9......................................... PROTOTYPE CLEANING REGIMENS ..7.. 112 9................ Equipment Being Cleaned......... 96 9..2....... 99 9.....2......... Chemical Injection .......2................................. 97 9.............................................3..................................8...... 96 9....................................................5.... 105 9..........2..................................................2.... 98 9.................................... 95 9..... 103 9................... 103 9.........3...........................1.... Utilities: Available vs Required ............................................... Tanks ........................2. 96 9..........................................2.............................. Toothpaste ............... 99 9........................................2............................... 97 9..............6..5.....3....2...................................3......................3....... 100 9.

...............................................................................................................0 CIP PIPING SYSTEMS 118 10. RETURN PUMPS .......... LINE CIRCUITS ...6.............. 113 9........................................................ CLEANING VS................. 124 10.............3.7.......................................4..............................2......................................5............................ AIR REMOVAL..... Cleaning and Sanitization Guideline No............. 122 10..................................................................................................2.....3................................................ STERILIZATION ....................... GRAVITY RETURNS .. 119 10...........1...........6.......... Validation Issues ....... 125 10....... 128 11......3..................................................4..................................4..................... Acids.............3... OVERVIEW – WHAT IS A COP SYSTEM/SKID ....3.......3...........3.........................1...5........ DOSING ......................6........2.....................2...............7........ Equipment and Piping Design Criteria 1 9..................................................... OVERPRESSURE ....................................................2.......................................................................................7.............1....................................................4......... 125 10.......................... 112 9............................................6................... 124 10....... EDUCTOR RETURNS.................. 129 C-P Confidential 6 Version 1..................... 113 9......................................................................... TANK CIRCUITS .......................................................1..........................3...........................4..0 GL1_v1............ PRESSURE VS................................ SELECTION CRITERIA ..... Level of Automation ........................................................................ COMBINATION CIRCUITS ....... RELATIVE CIP UNIT LOCATION CRITERIA...............................................2....7........................2....... Chemicals Used for Cleaning....................................................1............7.......... 122 10...................................2........7..........................................7... 127 11................ Nature of the Soil ................ PIPING SPECIFICATION .... 126 11. 126 11..................................................... 116 10........................................2...........1.......................6............. MONITORING FOR RESIDUAL LEVELS ..............................4....... 125 10................................. STEAM ......................................................... Solvents .7..................................................4...... 121 10............3. Emulsions ..... 115 9..............5.2....................................... OVERVIEW................... 126 10.......3........................................................... DEFINITION OF SANITIZATION.......................................2................... 114 9.4.............0 1.................. RETURN OPTIONS .................5........... 116 9........4...................................3.......................4...................1.....7. Equipment Being Cleaned........ 118 10..................................1.... CHEMICALS FOR CLEANING ............................... 120 10.............................4............................................................................................4................................................................. SANITIZATION .......................4........................................ 125 10........................................1................................................................... 121 10.........................................................1..................... 127 11..................... STORAGE RACKS ..4..................... 120 10....... 125 10..... 113 9........................................2............ ATMOSPHERIC STEAMING ... Enzymatics .....................7.. 125 10..3.............................................................................1. 114 9....................4.............................................1..........6....6.............. 116 9.................................................................................... Process and Production Issues.................................. 115 9................................................................3.............. OVERVIEW – GENERAL DESIGN CRITERIA FOR CIP PIPING ....................................... GUIDELINE COMPONENT SPECIFICATIONS ................................ COMBINED RETURN SYSTEMS ................................................. 127 11.........................doc 4/6/01 Printed on 03/15/02 ... Utilities: Available vs Required ................ 123 10............1...................1............................. 126 10.............. 126 11........ SAFETY AND HANDLING ............... 118 10............4...................................................0 SANITIZATION SYSTEMS 126 11.......7..............1................................................................................................................................3.................... TYPES .......4.................1............................ Alkalines.................

........................... 133 11.......... DOSING .............................................1............... 139 13.......1.................................................................................. ROOM FINISHES ..... Hypochlorites ........... 137 11................................................................................................... HOT WATER ....................................... 137 11........................ 131 11........ TIME/ TEMPERATURE MONITORING...............2.................................................................................................................... 143 13.......2.............4......................................4.....3...................................3............................3............... TRAPS ..............................3...... 137 11....................................................................4................ CEILING .................................................2..........................5............................................................3....4.......... ACCESS ................................0 1..........7................. STEAM FLOW CONTROL ..............................4................................................ FLOORS ........................................................................ 135 11......................................................3................................................... 141 13................................0 PROCESS ROOMS AND OPERATING AREAS 141 13..5.......3...4................2..............................................6.......4......... 131 11......... 133 11..... CHEMICAL TREATMENT ..................3........6................... 129 11.... 144 13........................ 141 13................................................6............................................1............ 137 12.......................................................................2..... 132 11..... COMPONENTS .......................................... 143 13................ Drip Traps ......................... 144 C-P Confidential 7 Version 1............................................................................................................3.............6....2........2......... 135 11.........................4...........................................1........................................... VALVES ...3...4......................................................................................................................3.........1................................................................... LIGHT FIXTURES................. 132 11........5.............................................................. 139 12................. Equipment and Piping Design Criteria 1 11................................................................. QUALITY REQUIREMENTS . MECHANICAL SEALS .... CHEMICALS FOR SANITIZATION ............................................ 143 13........................... EQUIPMENT ........................................... MATERIAL ........... QUALITY....... 137 11...doc 4/6/01 Printed on 03/15/02 ................................................................2....................... PIPING ........................................................................... TYPES ..................4....3..... 131 11.................................................... 134 11............................. PIPING SPECIFICATION .1..................................................... 142 13..................................................1...... SAFETY AND HANDLING .8........... 129 11.......................................1...........1..... WALLS .............1.....3.........................3...... OPEN PROCESSES – DOS AND DON’TS ........................ 132 11............... 139 12.........................................9......................................... 143 13............................ VENTILATION ................................... SUPPLY SYSTEM.............1..........4.... Ozone .................................................. 141 13............2..............................3............2...............................2............................... 132 11......................... Alcohols ..................................................6............................................................................................................... FACILITY FLOWS ............................1.................................. WALL GUARDS ...... SIP condensate traps.........................................2..4..5... 129 11...........................................................................................................4......... 143 13........................................................................ 141 13.......0 GL1_v1......... Quaternary Ammonium Compounds ..............4.3..... Acid Sanitizers ......1......................................2............. CONDENSATE REMOVAL ....................... PROCESS AIR CRITERIA ... DOORS .......................................................................................................................................... PURITY..0 COMPRESSED AIR SYSTEMS 139 12........ OVERVIEW...... MONITORING FOR RESIDUAL LEVELS ...................4....................................... 135 11............. 144 13.2.........................................6.............................................................2.........................2............ Cleaning and Sanitization Guideline No.................................................................................... 136 11.........................6............ 142 13.........................................................................

................doc 4/6/01 Printed on 03/15/02 ....1...........................................4.................................1.........................2......................................... PROCESS TANKS ...............................0 GL1_v1.............................................................................................. PROCESS VALVES .................................................................................. 146 14.........5.......1....................................1...............................1............. 146 14.... LIST OF FIGURES .....................................................................1....... 146 14.......... 146 14.. 146 14....... TRASH ..............0 1..... PROCESS PUMPS ........... LIST OF TABLES ............................................... 146 14.........3........3................. 145 14..........................................6.......................................0 APPENDIX 146 14.... CIP EQUIPMENT ............................ 146 14................. Cleaning and Sanitization Guideline No....6.............................................................................................................. Equipment and Piping Design Criteria 1 13........1..................................................................................1.....8...4......................................7. 146 14.............1................................................................................................... 146 14. PERSONNEL .... 146 14......................................... 152 C-P Confidential 8 Version 1............................1........................................ 145 13.................. TRANSFER PANELS ... SPECIALTY EQUIPMENT.................6. INSTRUMENTATION ....... COMPONENT SPECIFICATION SHEETS FOR C&S....................................................................3..........................2.............. COP EQUIPMENT.........................................................

will assist in the implementation of the following CP Quality Standards. Engineering. OBJECTIVE The Objective of this Guideline is to provide a technical reference of the Colgate- Palmolive (CP) related Industry’s “Best Practices” in equipment and piping design for Cleaning and Sanitization as adopted by CP and applied to our manufacturing philosophies. along with the other C&S Guidelines. Equipment and Piping Design Criteria 1 1. and facilities where system cleanability and microbial control is to be considered. but applies to cleaning and sanitization aspects of design to be considered with other CP process design guidelines.0 GL1_v1. Cleaning and Sanitization Guideline No. specify. C-P Confidential 9 Version 1. This document is not intended to be a process design guideline. and procure equipment. which focuses on unique characteristics of equipment.0 CHAPTER OVERVIEW 1. 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. Operations. C&S Guideline #1. Quality. The document is centered around good sanitary design. The Guideline will be applicable for new installations as well as existing facilities in need of system renovations or improvements. and Maintenance personnel will use this Guideline to design. components.1.doc 4/6/01 Printed on 03/15/02 . piping. and components that ensure effective cleaning and sanitization.0 1.2. 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.

• 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.3. history and definitions of manual cleaning. and other utilities that come into contact with the product. • Design and specification information for various types of cleaning and sanitization equipment that could be used for CP process systems.doc 4/6/01 Printed on 03/15/02 . Equipment and Piping Design Criteria 1 • Descriptions of design and installation techniques for process piping systems and components in cleanable systems. • 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. cleaning and sanitizing agents. discussion of various CIP/SIP system configurations and philosophies. spray ball types and uses. • Facility considerations for the proper design and maintenance of production areas in order to maintain proper quality control.0 1. C-P Confidential 10 Version 1. Since it is to be used as a design supplement to other CP documents. Cleaning and Sanitization Guideline No. 1.0 GL1_v1. or criteria for process design other than sanitary considerations. RELATED C&S GUIDELINES • C&S Guideline #2 – Principles and Practices This document serves as a Cleaning and Sanitization “fundamentals” course: general theory. • 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. cleaning mechanisms. COP. These assessments will help plants to identify potential hot spots in system design and installation. SOPs. CIP and SIP. • Design criteria for compressed air. which could affect microbial and quality control. • Sanitary piping system design strategies and details. water. this Guideline does not include complete design specifications. steam.

4.4. 1. The document outlines requirements for documenting master plans. Equipment and Piping Design Criteria 1 • C&S Guideline #6 – Validation This document provides an overview of general Validation principles and CP’s Validation program. Data is generated monthly (also 12 month rolling data). organized and presented in such a fashion as to rate formulas. Therefore. lines and their rate of change in managing that micro risk.0 GL1_v1. training. change control. RELATED QUALITY PROGRAMS 1.doc 4/6/01 Printed on 03/15/02 . C-P Confidential 11 Version 1.1. 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. Global Microbiology Group in Piscataway may be contacted to facilitate CPM implementation. Plants must prepare to implement CPM in line with C&S assessment findings. The purpose of the CPM is to improve understanding of how process and procedures impact microbial contamination risk. Cleaning and Sanitization Guideline No. 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 MSI allows one to identify those formulas or plant processes that pose the highest microbial risk as determined by the index number. It reflects the overall formula robustness and the plant/process micro-integrity robustness for that given formulation as an index number.0 1. C&S SOPs and protocols. establishing acceptance criteria. This information can be presented to management and be used to accomplish needed change in either formulation or plant processes. MICROSUSCEPTIBILITY INDEX (MSI) The Micro Susceptibility Index (MSI) is a data-based driven tool used to assess micro risk.2. 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.4. by shifting the focus to in-process preventive actions rather than end-product testing. 1. thus allowing concentration and focus of resources to best manage that risk.

a surface appears to be free of residual product and extraneous matter that adulterates.5.0 1. under well-lit and close inspection. and can be represented in terms of total microbial count. Surfaces and corners are smooth to minimize contamination. SIP: Sanitize In Place CIPS/R: CIP Supply and Return (piping) GMP: Good Manufacturing Practice. Cleaning and Sanitization Guideline No.doc 4/6/01 Printed on 03/15/02 . etc.0 GL1_v1. a term adopted by the US Food and Drug Administration (FDA) Micro Sensitivity: The degree a product’s 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. Equipment and Piping Design Criteria 1 1. contaminates. 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. EHEDG: European Hygienic Equipment Design Group Guidelines Profilometer: An instrument used to measure surface roughness Visually Clean: When examined visually. COP (Clean Out of Place): cleaning equipment or components out of their production location in a in a manual. or pollutes Sanitary Design: Design that is accessible and allows easy disassembly for cleaning and sanitization. semiautomatic or automatic manner. C-P Confidential 12 Version 1. KEY TERMINOLOGY Bioburden: A general term used to describe the microbiological loading or activity in a system. colony forming units (cfu). This term can cover a wide range of microbiological limits and categories.

g. MATERIALS OF CONSTRUCTION All materials that come into contact with the product must be non-toxic. Product contact materials must be 3A approved and/or consistent with European Hygienic Equipment Design Group (EHEDG) Guidelines for sanitary applications. There are several differences between various AISI stainless steel types.1. • Corrosive raw materials C-P Confidential 13 Version 1. 316 Acceptable uses in existing facilities: • Oral Care products not containing SLS • Non-corrosive Personal Care products • Non-corrosive HSC products.0 GL1_v1.1.commonly found in CP’s older facilities. e. 304L slightly reduced corrosion susceptibility and should be used where welding is required. Cleaning and Sanitization Guideline No.0 1..doc 4/6/01 Printed on 03/15/02 . STAINLESS STEEL Austenitic stainless steels are the most common materials used at CP for product contact surfaces.1.contains molybdenum. 2. and resistant to the product and cleaning solutions. mechanically stable. less expensive than 316 SS.0 STORAGE AND MIXING TANKS 2. can be susceptible to corrosion when exposed to chlorides at high temperatures and concentrations. SLS.1. inert. 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 . 316 will also slightly reduce corrosion with certain raw materials. The most common types of stainless steel are: AISI 304 .1.1. PRODUCT CONTACT SURFACE 2. which reduces corrosion when exposed to chlorides (below 60 C). Equipment and Piping Design Criteria 1 2.

FRP construction and fittings issues still apply. sheathing. PP. All flanges and fittings must be disassembled for manual cleaning in accordance with a validated SOP.0 GL1_v1. PVDF are becoming more widely used and should be considered on the cleaning and sanitization merits of the liner. but this liner is extremely thin and will erode over time and expose the tank to the more porous and rough inner surface. 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. nozzles. Also. Improperly made tanks may be subject to blistering that creates larger pockets for microbial growth. Generally side manways are standard on FRP tanks for the primary reason of accessibility to repair these defects.2. There is an inner layer applied to these tanks to aid in chemical compatibility. 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. but is not appropriate for product or raw material contact where bioburden is a concern. Costs of such composites are similar to C-P Confidential 14 Version 1. spray devices. sanitary fittings and manways are not available for FRP tanks. etc. non-microsusceptible products such as bleach. 2. Although FRP is indeed used in some food industries. and accessories.1. In general. sight glasses. FRP tanks are susceptible to bubbles just below the finish layer that can become pits. Furthermore. such as polypropylene. dip tubes. sheets. should be stainless steel. FRP Fiberglass Reinforced Plastic tanks are sometimes used as storage vessels and process tanks.) should meet the material and surface finish requirements of the interior of the vessel for which they are to be provided..0 1.1.g. FRP tanks that are lined with other plastics such as PVC. the materials and resins used to manufacture FRP are more porous and therefore more susceptible to microbial contamination than other polymers. Cleaning and Sanitization Guideline No. Equipment and Piping Design Criteria 1 AISI 316L Best practice for new facilities: 316L (low carbon content) should be used where welding is required. including plates. 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. jackets. such as certain acids or caustics.doc 4/6/01 Printed on 03/15/02 . 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. the smoothness is never measured or stated in terms that are comparable to stainless steel finishes or accepted plastics such as PVDF. This material is acceptable for non-microsusceptible raw materials. Although FRP tank suppliers may claim the surface finish is smooth.

but prior to electropolishing. Table 1 shows a comparison of various methods of measuring or “qualifying” the surface characteristics. The table not only compares units (micro-inch vs.2. C-P Confidential 15 Version 1. but also compares Ra (Arithmetic Mean) and RMS (Root Mean Square). 2B mill finish. 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). Cleaning and Sanitization Guideline No. 2. micron or micrometer). All interior welds should be ground smooth and successively polished and electropolished (where specified) to the same finish as the adjoining surfaces. The standard starting point for most SS sheet stock.38-. see Figure 4 – Profilometer). Where micro-susceptibility is a concern or the product is particularly difficult to clean.0 GL1_v1. the vessel may be electropolished after the mechanical polish has been completed. Therefore stainless steel is usually a better choice.doc 4/6/01 Printed on 03/15/02 .5 µm) Ra. Avg deviation Ra Mean Figure 1 . SURFACE FINISH Product contact surfaces should have an interior surface finish of 15-25 µ-inch (.1.Definition of Ra Surface finish should be measured by a profilometer (instrument used for measuring surface variations. has a surface finish of greater than 60 µ-inch (1.63 µm) Ra. Equipment and Piping Design Criteria 1 stainless steel and therefore should be considered only when corrosion is a key concern. after a successively built-up mechanical polish is completed.0 1. The current industry standard is to state the measurement in micro-inch (µm) or micron (µm – same as micrometer) Ra.

76 180-240 28 .4 for discussion on cleaning flow rates). pits.06 180 34 . virus from 0. Mechanical polishing will expose these pockets and should be used on product contact surfaces.63 240 17 . mechanical polishing can still leave spikes in the surface that can trap impurities.20 42 1. Any of these organisms may find a hiding place in a crack or groove that is not thoroughly cleaned with turbulent flow (see Section 9.30 When specifying a desired surface finish.003 microns. Buffing may make a surface appear smooth visually.0 GL1_v1. Grit does not guarantee an end result.2.86 30 . Each polishing operation should completely remove the polishing marks from the previous polishing operation.36 12 .1-0. Figure 2 shows the difference in surface profile for various different polishing techniques. Ra values are a constant that are measurable and verifiable. 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. Manual buffing should only be performed on non- product contact surfaces. To amplify the importance of a smooth surface finish. Cleaning and Sanitization Guideline No. Electropolishing will slightly lower the surface Ra as well as round-off the spike. note that bacteria ranges in size from approximately 60-0.38 320 14 .doc 4/6/01 Printed on 03/15/02 . Surfaces in contact with product shall be free from visible scratches. However. C-P Confidential 16 Version 1.0 1. Mechanical polishing should be performed with multiple passes using appropriate abrasive material. Equipment and Piping Design Criteria 1 Table 1 – Surface Measurement Comparison Grit Size RMS RMS Ra Ra (µ-inch) (Micron) (µ-inch) (Micron) 80 80 2 03 71 1 80 120 58 1.32 150 47 1. crevices. minimizing areas for surface entrapment. burrs. but creates pockets where impurities can be trapped. operator subjectivity and the original surface finish. and other defects. folds. inclusions.43 15 . nicks. flash.72 25 .47 52 1. the Ra value (or RMS) value should be used in lieu of Grit. it only says how to polish a surface and is dependant on pressure. time.2 microns.

Figure 3 below shows five coupons with examples of various approaches to polishing welds. Cleaning and Sanitization Guideline No. The skid rides over imperfections in the surface and C-P Confidential 17 Version 1. Several methods can be used to establish an instrument reference line from which profile height can be measured.63 µm) Ra and flush with adjoining surfaces. and coloration.doc 4/6/01 Printed on 03/15/02 . The simplest approach is to use a skid riding on the surface itself as a reference. Surfaces in contact with product should be free from visible scratches. such as the one shown below in Figure 4. WELDS Welds exposed within the interior of tanks should be ground smooth and polished to 25 µ-inch (. Equipment and Piping Design Criteria 1 Buffing (Scotchbrite) Mechanical Polishing Electropolishing Figure 2 . folds. and other defects as discernible by profilometer inspection. is a device for measuring variations in the surface profile of a given material. crevices. flash. nicks. flow. Usually the arm to which the skid is tied pivots a long distance away from the measurement. No visible heat tint is permissible.1.3. pits. The skid assembly and transducer are designed to measure the difference in height between the skid height and the stylus tip height.Gas Tungsten Arc Weld) Figure 3 – Sample Weld Finishes A profilometer.0 GL1_v1. Backing and purging gases such as argon should be used in the appropriate purity and flow rate to promote the proper weld penetration. The three on the left may be appropriate for exterior surfaces but would not be suitable for product contact.0 1.Surface Profiles from Various Polishing Techniques 2. *GMAW = Gas Metal Arc Weld (sometimes GTAW . burrs. inclusions.

It applies to raw material and WIP storage tanks. Figure 4 – Profilometer This photo represents a laboratory model.4. mixing vessels. Radii for corners where a vessel head meets the vessel sidewall should not be less than ¾” (19. TANK CONFIGURATION This section covers vessel design parameters for process vessels that are cleaned and/or sanitized for product contact. Although substantial differences exist between vessels used for C-P Confidential 18 Version 1. Angles greater than 135° must have a continuous weld that is polished smooth.0 GL1_v1.doc 4/6/01 Printed on 03/15/02 .4 mm).1. 2. Equipment and Piping Design Criteria 1 acts as a mechanical filter of the surface: it smoothes out longer wavelength undulations in the surface. Figure 5 – Corner Details 2.1 mm). Cleaning and Sanitization Guideline No. Portable units are also available for use in the field. and head tanks. CORNER DETAILS All internal angles 135° or less on product contact surfaces should have a minimum radius of ¼” (6.2.0 1.

Cleaning and Sanitization Guideline No.doc 4/6/01 Printed on 03/15/02 . even a shallow F&D head will provide adequate sheeting and drainage when proper cleaning agents are employed.0 GL1_v1. a 30% slope is desired for CP facilities. Note that 3A establishes a 3% minimum slope. are undesirable from a cleaning perspective. etc – see Figure 6). which can be used to an advantage. The most common type of head for this application is a Flanged and Dished head (F&D). even when flanged as shown below.1. For example.0 1. TOP HEAD TYPES Depending on the use.2. In general the shape of the head should promote for free draining or sheeting of product and cleaning solutions. there are certain economies in tank head fabrication based upon dimensions. then a shallow F&D head would be preferred over an 80/10 head. Only certain head types are appropriate for manual or automated cleaning. However. Typically. which are often used at CP for large storage vessels. Unless there is a particular reason to the contrary. C-P Confidential 19 Version 1. which may be acceptable depending on product and cleaning characteristics. However. CLOSED TOPS Vessels intended for automated or semi automated cleaning cycles should be provided with closed top heads.2. mixing and so on. etc. and minimize residual hold-up. 80/10. specify an F&D head and let the tank fabricator choose the most economical type. 2.1. the fundamentals of design for good cleaning and sanitization are relatively consistent. oral care products. pressure ratings. 2. should have a minimum 30° slope to allow proper sheeting and drainage. tanks in the CP facilities may require various types of head configurations. The precise type can be specified if the application is clearly understood (shallow F&D. Equipment and Piping Design Criteria 1 personal care products vs. for storage vs. if headroom were a concern. allow for spray device ease of alignment with nozzles. ASME. Conical top heads. Flat top tanks.1.

The dish radius (DR) is equal to the outside diameter (OD) of the vessel.1. When used. OPEN AND REMOVABLE TOPS Often times CP will utilize open top vessels for mixing raw materials or other ingredients.2. Care should also be given to the gasket type and configuration. Cleaning and Sanitization Guideline No. 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. These tanks are typically cleaned manually.doc 4/6/01 Printed on 03/15/02 . particularly for smaller batch sizes. Elliptical – No true dish radius.0 GL1_v1. flat heads should be flanged as shown in Figure 6 in order to reduce product and cleaning solution hold-up in corners. C-P Confidential 20 Version 1. although there are systems that can be purchased and installed to clean open top vessels. this is the most commonly used head for closed vessels and is very cleanable. 80/10 – Another type of F & D head with a taller profile. the dish depth is equal to 25% of the tank ID. F&D heads weigh substantially more than flat top heads and are therefore often impractical to be manually removed. flat tops are typically seen due to cost and weight. 80/10 means the DR equals 80% of the OD.0 1. When removable lids are used. Equipment and Piping Design Criteria 1 Unacceptable for CIP Figure 6 – Top Head Types Examples of various heads used in closed top vessels.2. 2. ASME Flanged & Dished (F & D) – Along with a Standard F&D. and the knuckle radius (KR) equals 10% of the OD.

The outlet valve must be at the low point of the tank bottom. the design is not recommended. The critical issue with the tank bottom head is drainability. however they are often mixed and matched. Although this method can improve drainage for flat bottom tanks.0 1. 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. and the head shall be configured to allow the vessel to completely free drain through the outlet. C-P Confidential 21 Version 1. Stainless sheet stock will expand and deform during the fabrication process. See Figure 8 for half-pipe details. BOTTOM HEAD TYPES The same types of heads used in tank tops are also used as tank bottoms. You might find reason to use an ASME dished head bottom with a flat-flanged top head. Although this configuration is drainable.0 GL1_v1. particularly when it is heated for welding. Equipment and Piping Design Criteria 1 2. 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. Figure 7 . Cleaning and Sanitization Guideline No.2. care must be taken during fabrication so as not to create high spots in the tank bottom as a result of the welding process.doc 4/6/01 Printed on 03/15/02 .2. Dished or conical heads are preferred as they offer better draining.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. When flat bottom tanks are used they should be pitched at least ¼” per foot to the lower side outlet valve.

the C-P Confidential 22 Version 1. LOCATION Manways are typically located on the top head. Also. and its position promotes free draining much better than a horizontal manway.doc 4/6/01 Printed on 03/15/02 . When locating a manway in the sidewall. Although they are large in comparison to other nozzles and allow a substantial amount of water into the neck space during CIP. but can also be found on tank sidewalls for easier personnel access. vessels that are cleaned manually will require a manway for access to the vessel internals for cleaning and inspection. Equipment and Piping Design Criteria 1 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 .1. Of all the nozzles on the top head. 2. the top head is the preferred location as it is typically closer to the spray ball.3. Also. From a cleanability standpoint. creating shadows.Tank Half-Pipe Discharge Details 2. manways create some of the most challenging cleaning problems. Cleaning and Sanitization Guideline No. they are often poorly positioned with respect to spray ball coverage. and simply cannot be cleaned without disassembly. MANWAY Vessels large enough to require personnel entry for maintenance or modification will require a manway.0 1.3. many of the commonly used styles are not sanitary in their design.0 GL1_v1.

but the only way to get them clean is to open the manway and manually wipe the contact surface.2. The atmospheric manway only uses one clamp that provides a looser fit. Inc. The sanitary manway shown in Figure 12.0 1. Smaller vessels might be designed with a “handway. and is flared to allow more cleaning solution to enter the area between the lid and the collar. allowing product or CIP solution to reach beyond the interface of the O-ring where it cannot be cleaned or rinsed. It has an extra clamp to provide a more uniform seal around its circumference. TYPES Some manways simply are not CIP cleanable. However.” which is typically an 8” or 10” opening similar in design to a manway..0 GL1_v1. has a specially designed grooved gasket to minimize the product that “rolls over” to the back side of the O-ring. Unacceptable Acceptable Figure 9 – Manway and Nozzle Positions 2. Cleaning and Sanitization Guideline No. As a result. such as more uniform clamping and a dished head for better draining. Equipment and Piping Design Criteria 1 collar should be tapered or flared to increase contact from the spray ball and sloped at least 5 degree drain angle. these manways must be manually cleaned. as this style gasket will not be adequately cleaned during CIP.doc 4/6/01 Printed on 03/15/02 . which in this case is a K Series design from Precision Stainless. The standard ASME manway provides some inherent improvements as a result of the pressure rating. the seal interface is still a trouble spot. 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. Handways are not adequate for manual cleaning C-P Confidential 23 Version 1. They are designed to provide a seal to the process during operation.3. Position the spray ball below the manway wherever possible.

Cleaning and Sanitization Guideline No. Figure 13 on the following page shows pictures of some unacceptable combinations of manway design with cleaning procedures. C-P Confidential 24 Version 1. Equipment and Piping Design Criteria 1 or visual inspection of the vessel interior.doc 4/6/01 Printed on 03/15/02 .0 1.0 GL1_v1. These vessels should be CIP'd with a spray device or fitted with a removable top head for manual cleaning and inspection.

0 1.0 GL1_v1. 1 Equipment and Piping Design Criteria Unacceptable for CIP Figure 10 – Atmospheric Manway Acceptable for CIP w/ considerations Figure 11 – Standard ASME Manway Flare Figure 12 – Sanitary Manway C-P Confidential 25 Version 1. Cleaning and Sanitization Guideline No.doc 4/6/01 Printed on 03/15/02 .

seemingly negating the need for the handway. The manway is dished but the large diameter the gasket will retain product. Cleaning and Sanitization Guideline No. Unacceptable A handway on a tank that is manually cleaned. In the foreground. Also. half of the top head is removed for cleaning. Note the sight glass with wiper blade in the center of the manway – requires high impact or manual cleaning.doc 4/6/01 Printed on 03/15/02 . Unacceptable for CIP Atmospheric manway on a tank that is manually cleaned. the handway is attached with non-sanitary clamps and cover. Similar to the gasket shown in Figure 10. Equipment and Piping Design Criteria 1 Unacceptable for CIP Atmospheric manway on a F&D head that is CIP’d. This application is acceptable for manual cleaning only. but the gasket is still very flat and will retain product. The manway is more cleanable than the example above.0 GL1_v1. Figure 13 – Examples of unacceptable design/procedure combinations C-P Confidential 26 Version 1. Acceptable (w/ considerations) ASME manway on a F&D head that is CIP’d.0 1.

pitched blade. 2. Proper bolt practices (Figure 20) should be used The shaft should be polished consistent with the surface finish of the interior of the vessel.4. refer to Figure 20 for guidelines on acceptable practices. typically located internal to the vessel on the bottom head for shaft alignment. and crevices in the assembled wetted parts should be minimized in order to facilitate cleaning-in-place. split shafts.0 GL1_v1. Where necessary for flexibility. Appropriate cleaning chemistry and agitator rotation is required to clean the bottom of axial flow impellers from spray balls located above the impeller. Underside cavities in the hub. couplings and threads where possible.2. When bolts are necessary for flexibility. IMPELLERS Impellers should be welded to the shaft wherever possible. and are relatively easy to clean.0 1.2. One-piece welded construction of the impeller is preferred (see Figure 14). Various impellers used in CP facilities are outlined below. 2. Eliminate use of bolts. shaft couplings should be designed to prevent dead spaces and crevices in the product contact areas. Built chemical detergents with proper surfactants will also aid in cleaning. Equipment and Piping Design Criteria 1 2. or hydrofoil axial flow impellers. This type of cleaning action is limited to marine prop. AGITATORS 2.4. C-P Confidential 27 Version 1. mechanical connections. SHAFTS Shafts should be continuous without couplings and set screws where possible. the cleaning solutions will “roll” over the top surface and sheet the bottom surface while the impeller is spinning. Flooding is sometimes used to clean these impellers as well.4. Cleaning and Sanitization Guideline No. and will not work on flat or scraping blade impellers.1. with the weld surface polished consistent with the interior of the tank. but this would not be necessary with properly designed spray device coverage.1.doc 4/6/01 Printed on 03/15/02 . not cast. The impeller should be machined or forged stainless steel. AXIAL FLOW TYPE Pitched blade or hydrofoil impellers are used for storage and general compounding applications. Carrier or foot bearings. With proper flow. are not acceptable for CIP.4.

These agitators have a complex network of counter-rotating pitched blades and Teflon scrapers that continuously contact the interior surface of the vessel. employ a scraping blade agitator designed for highly viscous materials. These agitators are difficult to clean. but if properly designed can be effectively cleaned via automatic CIP equipment utilizing high pressure spray devices. Scraping blade agitators are typically mounted in the top center of the tank.doc 4/6/01 Printed on 03/15/02 .4.0 1. Cleaning and Sanitization Guideline No.2. Equipment and Piping Design Criteria 1 Pitched blade axial flow impeller one-piece construction with welded connection to shaft Figure 14 – Axial Flow Impeller 2. SCRAPING BLADE TYPE Certain compounding vessels. such as dental cream mixers. Figure 15 – Scraping Blade Agitator C-P Confidential 28 Version 1.2. and are often supported by complex hydraulics for removal from the vessel. sometimes supplemented with flooding the vessel.0 GL1_v1.

creating a C-P Confidential 29 Version 1.0 GL1_v1. Cleaning and Sanitization Guideline No. Sanitary designs for dry running split seals can also be cleanable. Because of their design. Agitator seals for closed vessels should typically be of a dry-running single mechanical or equivalent pharmaceutical seal design. Sanitary seals are designed to place the seal surface near the vessel nozzle.4. Equipment and Piping Design Criteria 1 2. In some cases a double mechanical lubricated seal. is used for a more aseptic application. such as a carbon catcher. Tanks with agitators entering the side or bottom (below the liquid level).doc 4/6/01 Printed on 03/15/02 . must be provided with a sanitary seal. to prevent seal debris from dropping into the vessel. the bottom of this impeller will not ordinarily get clean with spray from above. assuming they are located near the vessel (see next paragraph). side. solid disk with straight or pitched blades around the perimeter.0 1. but in general are designed to promote flow outward within the tank. 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.3. Open tanks or tanks with removable lids which will be manually cleaned may utilize an agitator without a seal. as opposed to standard configurations where the seal is well up into the motor housing. Flooding the vessel alone. This impeller should either be cleaned from below using a spray device in the bottom head or sidewall. or by flooding the vessel. This technique should only be used in conjunction with a CIP cycle using proper spray devices.3. however. Since there is such a large surface area in the horizontal plane.Radial Flow Impeller 2. SEALS Agitators and mixers may have shafts that enter the vessel from the top. Many seals have devices.4.2. is not considered an acceptable CIP cycle. and consisted of a flat. 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. as well as any tank to be CIP’d. or bottom. RADIAL FLOW TYPE Radial flow impellers come in various configurations. such as a John Crane type 21. Figure 16 .

LUBRICANTS Lubricants shall be approved for incidental food contact and comply fully with the requirements of FDA CFR 178. Seals should be located a maximum of 1. The preferred connection detail for all nozzle sizes for sanitary applications is an ANSI pad flange mounted flush to the vessel top head. Either of these cases is cleanable while rotating using spray balls from the top side. For small tanks.4.4.3.1. 2. Cleaning and Sanitization Guideline No.3. Agitators may utilize a sanitary clamp for connection to the tank when the nozzle is 4” (102 mm) or smaller. C-P Confidential 30 Version 1. See Figure 17.5 times the nozzle diameters away from the inside of the vessel. either from the top or bottom.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). 2. Agitator Shaft Captive Bolts ANSI pad flange welded to tank wall Seal Figure 17 .doc 4/6/01 Printed on 03/15/02 . Examples include food grade mineral oil or castor oil.2. the mixer will be mounted vertically.0 GL1_v1.0 1. In other cases. the mixers can be top-mounted at a 15° angle from vertical. Equipment and Piping Design Criteria 1 substantial dead leg. MOUNTING Axial flow agitators at CP are most often vertically mounted from the top. The flange should be polished smooth on the interior of the vessel and the bolts should be captive (not extended into the vessel interior).3570.

Cleaning and Sanitization Guideline No. C-P Confidential 31 Version 1.0 1. BAFFLES For proper mixing. welding.0 GL1_v1. Material type. weld. internal baffles may sometimes be required on the straight sidewall of the vessel.5. and surface finish of the baffles should comply with all of the material.Agitator Mounts for Open Processing 2. Equipment and Piping Design Criteria 1 Figure 18 .doc 4/6/01 Printed on 03/15/02 . and polish requirements indicated for vessels.

Cleaning and Sanitization Guideline No.2. INSTALLATION DETAILS The use of bolts to secure the baffles to the vessel should be avoided whenever possible. CONFIGURATION The baffle tabs should be welded continuously to the vessel wall and comply with all welding and finish requirements for the vessel. so care must be taken to place spray balls so the pattern contacts all surfaces.doc 4/6/01 Printed on 03/15/02 . The 1” clearance allows for cleaning solutions to get behind the baffle.5. LOCATION AND SHADOWING Baffles should be mounted approximately one (1) inch off the vessel wall and oriented perpendicular to the vessel wall. Whenever screwed fittings are used. Figure 19 – Shadowing at Baffles 2.0 GL1_v1.0 1. mechanical (manual) cleaning is recommended.3. When bolts are required for flexibility. See Section 9. refer to the practices shown in Figure 20 for proper selection and installation. All corners of each baffle (except where they are attached to the vessel) shall be configured with a minimum ½" (13 mm) radius. either by direct contact or deflections. C-P Confidential 32 Version 1. Equipment and Piping Design Criteria 1 2. and all edges shall be rounded and smooth.2 for further discussion on spray ball placement. Baffles can cause shadowing of spray ball coverage.1. 2.5.5.

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 ½” (40 mm) inside diameter to maximize cleaning solution penetrating into in the nozzle. Fittings are also made to use rupture disks in-line as well as for vessels. In these cases the vent pipe should be removed and cleaned manually between product changeovers. or Continental Disk are specifically designed for sanitary applications.6.3. Equipment and Piping Design Criteria 1 Product area Product Unacceptable Bolts Acceptable Bolts Figure 20 – Bolt Configurations for Product Contact 2. 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.6. Although the vent is a product contact surface. 2.6.2. C-P Confidential 33 Version 1.0 1. not commercial use) and is perhaps less heavily scrutinized during cleaning. and will clamp directly on a sanitary clamp ferrule. Consideration should be given to residual in the vent line from product to product. The distance from the tank nozzle connection to the inner surface of the rupture disk is minimal. as this could be a potential source of contamination. Cleaning and Sanitization Guideline No.1. VENTS 2. it is often considered part of the waste stream in the event of overflow (product passing through this surface goes to waste.6.0 GL1_v1. RUPTURE DISKS Rupture disks by BS&B. SAFETY RELIEF VENTS 2. Fike.1. OVERFLOW AND BREATHER VENTS Tank overflow or breather vents are typically cleaned from the inside of the vessel with the spray device. 2. check the impact pressure rating of the disk to avoid rupturing the disk during cleaning.6.doc 4/6/01 Printed on 03/15/02 . When using high-pressure rotary spray devices.3.

and others. Where sterile venting is required. In either case. 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.45 micron should be used in a Code 7 style stainless steel housing sized for the maximum inflow and outflow conditions of the vessel.3. where rupture disks are not acceptable because of the need to reset the device. VENT FILTERS For processes that are highly susceptible to bioburden or where aseptic conditions are warranted. 2. C-P Confidential 34 Version 1.3. but Code 7 configurations are the most standard for sanitary applications. 0. tanks should be provided with a sterile vent filter. This minimizes the dead leg as well as protects the membrane. 3.3. Cleaning and Sanitization Guideline No. PRESSURE SAFETY VALVES There are few truly sanitary pressure safety valves (PSVs).2. and those available are reasonably inexpensive. and 2. Other AB styles include Code 8. but a T-style is easier to service. Filter housings can be either in-line or T-style: in-line uses less space. but only a few are appropriate for sterile vent service.0 GL1_v1.0 1. Membranes used for sterile vent filtration are typically hydrophobic (not water tolerant) and must be isolated during cleaning. particulate filters sized at either 0. Many different types of filters are available for tank venting. Code 7 refers to an AB cartridge style for sanitary applications (Pall or equal). However. Cashco.doc 4/6/01 Printed on 03/15/02 . Otherwise.22 or 0. which have double O-ring connections and a locking tab at the filter outlet to ensure proper alignment. the housing should be removed during CIP. Equipment and Piping Design Criteria 1 Figure 21 – Sanitary Rupture Disk Housing 2. there are sanitary PSVs available from Tuchenhagen.6.6. and b) cannot be cleaned in-place. these filter housings a) create a substantial dead leg in the vent pipe at the vessel.1.

and should not be used as sterile tank vent filters..7. they cannot be relied upon to prevent particles of a certain size (such as bacteria) from passing consistently.0 GL1_v1. These filters do not have an “absolute” cutoff of particle size (e. DIP/DIVERT TUBES The inside of dip tubes must be cleaned via the transfer or product pipe. Nozzles should be minimum of 1.22 micron). Dip tubes should be welded through the sanitary clamp that connects to the vessel ferrule. C-P Confidential 35 Version 1. Equipment and Piping Design Criteria 1 Inline Housing T-Style Housing Figure 22 . but are not considered “sterile” filters.g.0 1. and surface finish on all surfaces that will be exposed to the interior of the vessel should comply with the material. Material.7. HEPA filters are not suitable for tank venting. Smaller diameter (1-2”/25-50 mm) dip tubes can be removed and cleaned out of place. Cleaning and Sanitization Guideline No. and should terminate outside the vessel at a sanitary tri-clamp style ferrule for process connection.5” (38mm) diameter.1.. with a minimum ½” (13mm) gap between the tube and the nozzle for cleaning. which limit particulate from passing through by creating a very tortuous path and capturing particles within its filter media. The outside of the tubes should be cleaned via the spray device (or manually cleaned). etc. weld. 0.doc 4/6/01 Printed on 03/15/02 . welding. TANK INLETS 2. Pump-around loops are often set up around vessels in order to recirculate cleaning solution through a dip tube during a CIP cycle.Sterile Vent Filters HEPA (High Efficiency Particulate Air) filters are often used in facility HVAC systems for clean rooms. so although they may be effective in reducing overall particulate count. HEPA filters are more similar to depth filters. 2. and polish requirements indicated above for vessels.

0 1.Dip Tube CIP 2.7. 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. Holes should not be drilled in a product or ingredient dip tube. DEAD LEGS Product inlet valves should be close to the vessel nozzle in order to minimize the dead leg for cleaning. Equipment and Piping Design Criteria 1 CIP SUPPLY Product/ingredient Dip Tube Holes for cleaning tank nozzle at the spray device are satisfactory (See Figure 28). The tank side of the inlet valve (without a dip tube) is typically cleaned from the inside using a spray device. Cleaning and Sanitization Guideline No. Figure 23 . C-P Confidential 36 Version 1.doc 4/6/01 Printed on 03/15/02 .2. VALVE LOCATION. The location of valves for dip tube lines is not critical.0 GL1_v1. as they will be cleaned internally via the piping system.

C-P Confidential 37 Version 1.doc 4/6/01 Printed on 03/15/02 .0 1.g. Also. Some ingredient lines may not be cleaned. the rules for same general rules as for sanitary piping (see Section 4. Cleaning and Sanitization Guideline No. placing the water line the farthest away from the vessel. TANK MANIFOLDS In cases where multiple lines are manifolded together to enter the tank at a single inlet point.0) will apply.0 GL1_v1.. the manifold must be pitched towards the tank in order to promote draining. e.7. Deflection can be counted on from rotating spray devices. the isolation valves or interconnection points at the manifold may need to be disassembled and cleaned manually if the dead legs are to great. and the sequence of the lines on the manifold should be organized to optimize rinses. depending on the type of material it is carrying. Also. Figure 24 . These lines should be isolated from the cleaning circuit by a physical break prevent and cross contamination. 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).3. not from static spray balls. Equipment and Piping Design Criteria 1 Inlet valves should be oriented to allow maximum coverage from the spray device. Figure 25 shows a tank inlet valve with multiple lines feeding into the same nozzle. In general. the valves for each ingredient line should be located to minimize the dead leg at the manifold.Inlet Valve CIP 2.

0 1.doc 4/6/01 Printed on 03/15/02 .2.000 – 300. C-P Confidential 38 Version 1. Reference the Appendix Section 1. CIP return flow rates should govern outlet sizing in all vessels except for those used for highly viscous liquids (200.8. valve CV. use short Water or flush outlet tees.4 for flow rate calculations) in order to prevent flooding of the vessel and a “bathtub ring” in the bottom sidewall.11 for tables on turbulent flow in sanitary tubing. however.8. It is important.Tank Inlet Pitched Manifold 2. For pressure rated vessels. can be used to provide a starting point for outlet nozzle sizing relative to CIP flow rates. etc. Although the discharge rate is affected by many factors such as overlay pressure. Cleaning and Sanitization Guideline No.1. These tanks will inherently have large diameter outlets for process needs.000 Cps) such as dental creams. Equipment and Piping Design Criteria 1 Locate valves near manifold to minimize dead legs. compressed air or gas overlays can be applied at 2-5 psig to assist in draining the tank. distance to CIPR pump.0 GL1_v1. pitch line material at the end of the manifold Figure 25 . DRAINABILITY CRITERIA AND DRAIN RATES Tank outlets should be sized to handle to full flow required for the spray devices (see Section 9. that adequate flow is achieved in these vessel outlets to achieve turbulent flow. TANK OUTLETS 2.

VORTEX BREAKERS Vortex breakers should be used at the tank outlet where cavitations of CIP return pumps is a concern. and all edges should be rounded and smooth. such as a recirculation tank on a CIP skid.2. 1/8" (3 mm) flat bar.0 GL1_v1. The device should be constructed of the same material. The corners of the flat bar not welded to the vessel should be configured with a minimum ½" (13 mm) radius. finished to the same polish.8. It is possible to retrofit a vortex breaker in an existing tank without welding. The cross style is more cleanable than the disk style. C-P Confidential 39 Version 1.Tank Discharge Flow Rates Outlet Nozzle Size Discharge Flow Rate 1 ½” 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. Cleaning and Sanitization Guideline No. and should be used where possible. Equipment and Piping Design Criteria 1 Table 2 . This should be avoided for process vessels. In this case. The vortex breaker should be continuously welded to the bottom head of the vessel. The fabrication should consist of a 3” (75 mm) wide.doc 4/6/01 Printed on 03/15/02 .0 1. Vortex breakers should be centered and located directly over the center of the bottom outlet port or valve of the vessel. but would be acceptable for a vessel that sees primarily water or cleaning solutions. the cross is designed to fit loosely inside the tank bottom outlet and overlap on the bottom head as described above. and match the same weld criteria as the internal surface of the vessel for which it is installed. with each leg of the cross extending a minimum of 2” (50 mm) beyond the edge of the opening made by the bottom outlet.

If the tank will be CIP cleaned. Valve outlet shall be in the vertical position. Equipment and Piping Design Criteria 1 Disk Style Cross Style Figure 26 – Vortex Breakers 2. Cavity fillers and adjustable seals are recommended. the cleaning of the valve should be included in the validation procedure. The valve body shall be machined or forged. with PTFE or stainless filled reinforced PTFE seats and gaskets. Piping and utilities at the tank bottom should allow for the swing of the valve. It remains possible that manual cleaning will be required. constructed of 316L stainless steel. Therefore three-piece swing-out construction is recommended.1. SELECTION AND SPECIFICATION CRITERIA The following are samples of typical specifications. and should be flush welded to the tank bottom with sanitary clamp-type connections on all other process line connections. not cast. 2. C-P Confidential 40 Version 1. Cleaning and Sanitization Guideline No. 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.3.3. Finishes and elastomers for these valves should be in accordance with relevant sections in the Guideline. VALVES Bottom outlet valves should be mounted at the low point of the bottom head to allow complete draining.0 GL1_v1.8.0 1.8. Ball Valve: Bottom outlet valves shall be of the flush-mounted welded body ball type as manufactured by PBM or equal.doc 4/6/01 Printed on 03/15/02 .

constructed of 316L stainless steel. bottom outlet valve and sample ports together.8. re-polish the weld seams (mechanical polish). Valves shall be purchased with a mechanical polish but without being electropolished. to meet the tank surface specification. and finally electropolish the tank. C-P Confidential 41 Version 1. 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. Valves shall be purchased with a mechanical polish but without being electropolished. Elbows should be used in lieu of tees where possible to minimize product hold-up and increase cleaning effectiveness.0 1.doc 4/6/01 Printed on 03/15/02 .2. Valve outlet shall be in the horizontal position. If the tank will not be electropolished. DEAD LEGS Piping downstream of the bottom valve should be designed to minimize dead legs. bottom outlet valve and sample ports together. Cleaning and Sanitization Guideline No. bottom outlet valve and sample ports together. If the tank will be electropolished. with EPDM diaphragm and CIP port. Radial Diaphragm Valve: Bottom outlet valves shall be of the flush-mounted welded body radial diaphragm type as manufactured by Asepco or equal. and finally electropolish the tank. Equipment and Piping Design Criteria 1 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. Manufacturer shall weld the valve bodies to the tanks.0 GL1_v1. re- polish the weld seams (mechanical polish).3. with EPDM diaphragm and CIP port. to meet the tank surface specification. Manufacturer shall weld the valve bodies to the tanks. 2. re-polish the weld seams (mechanical polish). Valve outlet shall be in the horizontal position. and finally electropolish the tank. valves may be purchased with a mechanical polish but without being electropolished. to meet the tank surface specification. Manufacturer shall weld the valve bodies to the tanks. Purge ports are only used in aseptic operations where cleaning is done after every batch. constructed of 316L stainless steel.

promote free draining.5 pipe diameter rule. Analytical instruments such as pH. should be of sanitary design with the distance from the tank inside wall to the O-ring or sealing surface kept to a minimum.0. The blind side of the tee will not be properly cleaned. Figure 27 – Dead Leg at Tank Discharge 2. which is to minimize dead legs.9. and eliminate pockets and crevices.doc 4/6/01 Printed on 03/15/02 . Cleaning and Sanitization Guideline No. which require O-ring couplings into the vessel. INSTRUMENTS Instrument connections are discussed in detail in Section 5. C-P Confidential 42 Version 1. 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. Tank nozzles to accommodate instruments should follow the same general rules as process piping.9. Spray devices should be positioned to align with the instrument nozzles where possible. MISCELLANEOUS NOZZLES 2.0 GL1_v1. Thermowells should be welded into the vessels for temperature elements in lieu of direct insertion or threaded fittings. Sanitary clamp connections should be used with short outlet nozzles.1. minimum size of 1½” (38 mm) for clamp-on style instruments. which valve tee . Equipment and Piping Design Criteria 1 Although this dead leg would meet the 1. the use of a tee instead of a valve should be avoided wherever possible due to product loss and contamination.0 1.dead leg creates dead leg for mixing within the tank.

2. This would mean that a 1” (25 mm) drop tube would require a minimum 2” (50 mm) nozzle. SPRAY DEVICES Nozzles for spray devices should be oversized to provide a ½” (12 mm) minimum annular space between the drop tube and the nozzle for proper contact of the cleaning solutions. C-P Confidential 43 Version 1. Figure 28 – Nozzle Detail for Spray Devices 2.9. SAMPLE VALVES Sample valves shall be of the flush-mounted welded body radial diaphragm type as manufactured by Asepco or equal. and shall comply with the weld and polish requirements indicated for vessels above and on the corresponding data sheet. If the vessel is insulated.0 GL1_v1. The material of construction and surface finish of the valve body shall match that of the vessel to which it will be connected.3. The discharge nozzle of the valve shall be oriented at a 45° angle pointing out and down.0 1. Equipment and Piping Design Criteria 1 2. The body shall be of the two- piece design held together with a tri-clamp style connection. To aid in cleaning this area.doc 4/6/01 Printed on 03/15/02 . and the diaphragm material shall be as specified in the data sheet. Cleaning and Sanitization Guideline No. The vessel side of the valve body shall be continuously welded to the sidewall of the vessel. including the clamp. 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.9. 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.

Equipment and Piping Design Criteria 1 Radial Diaphragm Valve welded flush here to tank Sample outlet wall Figure 29 . ANSI pad flange used with a sight glass Figure 30 –Sight Glass C-P Confidential 44 Version 1.0 1. The material and surface finish of the stainless portion of each unit shall match that of the vessel to which it will be installed. 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.0 GL1_v1.doc 4/6/01 Printed on 03/15/02 .4. Each unit shall mount to the vessel using a sanitary clamp or pad flange connection and shall provide a flush surface after mounting. Cleaning and Sanitization Guideline No.9.Side Mounted Radial Diaphragm Valve for Sample 2.

etc. will be required for visual inspection during cleaning validation • Schedule coordination– in order to test certain aspects of the CIP system.2. certain items may be required earlier than normal. manways. substantial coordination through specification and factory acceptance tests is required up front. See Section 9. tank nozzles must be sealed. • Access for inspection – even if not needed for process. etc. Equipment and Piping Design Criteria 1 2. 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.doc 4/6/01 Printed on 03/15/02 .10. For example. Cleaning and Sanitization Guideline No.0 GL1_v1.0 1. so electrical connection are required. the agitator must be run to test the spray coverage. C-P Confidential 45 Version 1. sight glasses.5.

cleaning and sanitizing solutions. Equipment and Piping Design Criteria 1 3. Confirm that seal material is compatible with product. Pumps for CIP are designed to allow complete flow of cleaning solutions throughout the housing.0 PUMPS 3. impeller. GENERAL SANITARY REQUIREMENTS Pumps for CIP use should be designed either inherently cleanable or easily disassembled for manual cleaning. a casing drain should be installed at the bottom of the impeller housing. C-P Confidential 46 Version 1. mechanically stable. Typical materials for pump construction should be 316 SS. and various carbon and ceramic materials used in mechanical seals. to minimize (or eliminate) the potential of seal materials entering the product stream.1. MATERIALS OF CONSTRUCTION All materials that come into contact with the product must be non-toxic. 3. The rotors are designed to promote turbulent flow of cleaning solution in front as well as behind the impeller. and pin shall be 316 stainless steel. Cleaning and Sanitization Guideline No. Product contact materials must be 3A approved and/or consistent with EHEDG Guidelines for sanitary applications.0 GL1_v1. stub shaft. and resistant to the product and cleaning solutions. Chromium Oxide (CrO) and Silicon Carbide (SiC) seals are typically acceptable. Impeller mounting. back plate. When the pump is a low point in the system. and to be self draining.0 1.doc 4/6/01 Printed on 03/15/02 . Single mechanical seals shall be carbon and 316 stainless steel.3. Pumps for manual disassembly should have quick opening housings for access to the impeller and seals. 3.2. SANITARY CENTRIFUGAL PUMPS Base mounted sanitary centrifugal pumps should have sanitary type connections with the pump casing. Teflon. inert. and shaft constructed of 316 stainless steel.

the housing and impeller should be cleaned manually.0 GL1_v1. Cleaning and Sanitization Guideline No. but this should be coordinated through the pump manufacturer as the heat of welding can affect the lobe tolerances.doc 4/6/01 Printed on 03/15/02 . SANITARY ROTARY LOBE PD PUMPS Where positive displacement pumps are required for process use. sanitary clamp connections. Although these pumps are CIP’able.0 1.4. C-P Confidential 47 Version 1. When the pump cannot be vertically mounted. and shafts. cleanable PD pumps include 316 SS pump body. rotary lobe pumps are typically used at CP. Equipment and Piping Design Criteria 1 Figure 31 - Sanitary Centrifugal Pump 3. Features in sanitary. If full drainability is required. cover. single mechanical seals (in lieu of O-rings seals). 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. they are not fully drainable in the typical mounting position (Figure 34). and a housing design that eliminates pockets and dead zones.

Figure 33 below shows an example of sanitary rotor. These pumps are also positive displacement pumps. Equipment and Piping Design Criteria 1 Figure 32 .0 GL1_v1. The impeller is a rotor and stator type design serves as the motive force to push fluid through the channel. SANITARY PROGRESSIVE CAVITY PUMPS Progressive cavity pumps are often used in high viscosity applications and shear sensitive. Figure 33 . Cleaning and Sanitization Guideline No.doc 4/6/01 Printed on 03/15/02 . and can be sanitary and CIPable if properly specified and designed.5.Vertical Position 3.0 1.Rotary Lobe Pump .Progressive Cavity Rotor C-P Confidential 48 Version 1.

These sections have a large entrance diameter into the pump housing and therefore difficult to achieve turbulent flow. Cleaning and Sanitization Guideline No. These bypass loops. in this case for a progressive cavity pump.0 GL1_v1. Close-coupled compression valves (diaphragm valves would also work well) are installed to create a bypass around the pump during CIP. Valves should be located adjacent to the tee. 1 Equipment and Piping Design Criteria There are several things to consider when specifying a progressive cavity pump for CIP applications. is an acceptable practice.6. During normal processing. can create a dead leg when installed improperly. Close coupling the pump directly to a tank discharge that has proper spray devices for CIP. preferably on the upstream and downstream side. as seen below. a three-way valve with a vent open to atmosphere is installed on the inlet side of the bypass. in order to minimize the dead leg. CIP BYPASS DESIGNS FOR PD PUMPS PD pumps are often installed with a bypass loop to allow a higher flow for CIP. The open port C-P Confidential 49 Version 1. 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. • 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. the valves are both in the closed position.0 1.doc 4/6/01 Printed on 03/15/02 . • Do not specify open throat suction hoppers such as often used in food applications. 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. 3. however. This is discussed in more detail in the next section. In this case.

Progressive Cavity Pump Bypass C-P Confidential 50 Version 1.doc 4/6/01 Printed on 03/15/02 . Cleaning and Sanitization Guideline No. Equipment and Piping Design Criteria 1 provides a method for leak detection should the valve seal fail and cause product to flow into the bypass line. Figure 35 .0 GL1_v1.0 1.

1. Bright annealed or pickled O.2. with maximum Rockwell B hardness of 90.2. Cleaning and Sanitization Guideline No. 4. Various types of plastic pipe may also be used for sanitary applications.3.D. stainless steel sanitary seamless (1/2” (13mm) and smaller) or weld- seam (3/4” (19mm) and larger) per ASTM A270. as they can be fusion butt- welded to avoid cracks at the joints.0 PROCESS PIPING 4. 4.1. Sanitary tubing connections should be used in lieu of threaded fittings.2. mechanically stable. there will be temperature limitations with these materials that should be considered. ELASTOMERS Elastomers used as seals and gaskets for product contact service shall comply with USP Class VI requirements (see Appendix Section 1. and resistant to the product and cleaning solutions. drawn and bright annealed. inert.0 1. PTFE. For new applications.2. PRODUCT CONTACT SURFACE 4.doc 4/6/01 Printed on 03/15/02 . particularly in heated systems. Ra of 30 µ-inch surface finish for non- insulated exposed tubing.7) for shedding and off gassing (see Appendix Section 1. specify type 316L. Each elastomer should be C-P Confidential 51 Version 1. Definitions and Abbreviations). MATERIALS OF CONSTRUCTION Austenitic stainless steels are the most common material used at CP for product contact surfaces. Mechanically polished O. SURFACE FINISH Stainless steel should be mechanically polished on 15-25 µ-inch Ra (240 grit) on the internal surface.D.1. however.0 GL1_v1. 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. Product contact materials must be 3A approved and/or consistent with EHEDG Guidelines for sanitary applications. GENERAL SANITARY REQUIREMENTS All materials that come into contact with the product must be non-toxic. 4. Equipment and Piping Design Criteria 1 4. PVC and CPVC are more porous materials and are therefore more difficult to clean. Also. and wherever possible tubing and components should be welded. Polypropylene (PP) and PVDF are the best choices from a sanitary standpoint (when they are compatible with the product and temperature range). for non-exposed or insulated tubing.3). All tubing shall meet the requirements of ASME BPE 97 (See Appendix Section 1. 316L is the material of choice for all new applications.

C-P Confidential 52 Version 1. which would cause dead zones which are difficult to clean. Cleaning and Sanitization Guideline No. Equipment and Piping Design Criteria 1 reviewed for product and cleaning solution compatibility.1. ASME Boiler and Pressure Vessel Code. 4. JOINTS 4.4.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. Welding and Brazing Qualifications or AWS B3.0 as applicable to the work being performed.1.0 1.4. Welder's qualification documentation for each welder involved in the project. Section IX. B31. Piping and clamp systems should be designed to control extrusion onto the product zone.4. as a minimum. Qualification shall be made in accordance with ASME B31. the qualifications of the welders should be carefully controlled.1. In order to ensure consistent welds. Only approved welders shall be used.1.doc 4/6/01 Printed on 03/15/02 . WELDER PROGRAM QUALIFICATION The welding contractor or fabricator should provide.0 GL1_v1. WELDS Welds should be used wherever possible to minimize the number of clamped connections. WELDER QUALIFICATIONS All welders shall be qualified in accordance with applicable code requirements. Types of elastomers that may be used include: Table 3 .1. the following: 1. 4.9.2.4. and there are no exceptions.

In areas where qualified welders are not available. 4. Joining methods shall assure joints are free of gaps. Heat sensitive materials such as gaskets. sanitary clamps and roll-on ferules are preferred over the use of substandard welders for either automatic or manual production welds. Written documentation for automatic welding equipment calibration. All manual welds shall be documented.doc 4/6/01 Printed on 03/15/02 .0 1. The thickness of the weldment shall not fall below 90% of the nominal tube wall thickness.4. etc. or other non-self-cleaning pockets or ridges. 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") C-P Confidential 53 Version 1. Owner or Owner's Representative approval for all equipment utilized in the welding process including welding head. accumulations of material. deburring tools. crevices. Cleaning and Sanitization Guideline No. Manual welding is acceptable only when absolutely necessary and shall be performed by approved welder(s). power supplies. and seats shall be removed from components prior to welding to prevent damage. rough areas.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. seals. Fully automatic orbital welders of appropriate size and type shall be utilized for all welds. • One tack weld. Three (3) sample welds for each tube size used in project for owner approval prior to any system welding. facing tools. • One weld using program with last weld time reduced to zero. crevices. All welds performed during the project will be compared to these welds. 4. The three samples shall consist of the following: • One completed weld. pits. 3.0 GL1_v1.1. 1 Equipment and Piping Design Criteria 2.

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. Equipment and Piping Design Criteria 1 4.4. Type 304. “TEFSTEEL. This material will provide the C-P Confidential 54 Version 1.0 GL1_v1. high pressure by Triclover or equal. polished. polished. 4. Triclover 13MHHM or equal. Cleaning and Sanitization Guideline No. Figure 36 – Sanitary Clamps ½". Rated to 400°F continuous service.4. molded flanged O-ring type for sanitary clamp fittings. heavy duty. 4" to 6" Stainless steel. Sanitary clamps still have gaskets that can degrade and leak. so their use should be minimized. Type 304. maintenance.” 50% Teflon and 50% passivated 316L SS powder. The use of sanitary clamps should be limited only to areas where the connection needs to be taken apart for cleaning. Triclover 13MHHS-3/4-S or equal 1" to 4" Stainless steel.3. SANITARY CLAMPS Sanitary clamps are the most common type of joining method next to welding for sanitary tubing. such as gaskets and seals. piping systems and components should be welded in place. polished.2. ¾" Stainless steel.0 1. or process requirements. heavy duty. Rubber Fab.doc 4/6/01 Printed on 03/15/02 . Three-segment clamps also permissible. GASKETS The preferred gasket for sanitary CIP use is a USP Class IV. Type 304. bolted. They are designed to provide a smooth inner surface with no holdup of material in the pipe. Wherever possible.

5. Equipment and Piping Design Criteria 1 longest life in high temperature applications or where cleaning chemicals are frequently used.4. but are a moderately higher risk for contamination than sanitary clamps with gaskets. Cleaning and Sanitization Guideline No. Proper mating and alignment is critical for this class of fittings.4. QUICK-CONNECTS Most quick-connects (Swagelok. Parker. These fittings do not have threads exposed to the process solution.Bevel Seat Fitting C-P Confidential 55 Version 1. and are an acceptable alternative as long as temperature requirements of the material are met.Camlock Connectors 4.doc 4/6/01 Printed on 03/15/02 . Figure 38 . Quick-connects and temporary couplings should be manually cleaned between product changeovers. etc. See Figure 37. They typically have a dead space between the two mating ends that is not completely cleanable.4.0 GL1_v1. Figure 37 .0 1. BEVEL SEAT FITTINGS Bevel seat fittings or “dairy style” fittings are often used in CP facilities and are acceptable for 3A or EHEDG applications. 4.) used to temporarily join flex hoses to piping systems are not sanitary. Camlock. Black EPDM gaskets are a lower cost alternative.

Cleaning and Sanitization Guideline No.
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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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Front (panel side) of ferrules should be sanitary clamp. schedule 40.0 GL1_v1. 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. while the back of the ferrule is a weld connection. the designer should first establish the following information: • Size and length of pipe • Pipe specification (304. The pigging system consists of cleaning bullets. Cleaning must be validated in accordance with Guideline 6. Although this system will remove the majority of the product in the piping circuit. 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. 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. In order to properly specify these components. Cleaning and Sanitization Guideline No.7.) • Product type • Product viscosity • Product temperature • Cleaning and sanitizing solution type and temperatures C-P Confidential 59 Version 1. All sanitary piping shall be fully drainable. Launchers can also be detachable which require a full line size isolation ball valve but can be used detached and used in multiple locations. 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.0 1. Provide end caps and clamps for all sanitary connections. Provide extension rod with target at centerline of U-bend to activate concealed proximity sensor in panel. 4. there will be some residual. Spool pieces shall be welded continuous on both sides to the faceplate. pigging terminal (bullet launcher and catcher) and propellant. etc. The type used has important cleaning implications. and the system monitored through CPM.doc 4/6/01 Printed on 03/15/02 . 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). This emphasizes the importance of established acceptance criteria for residual soil. Equipment and Piping Design Criteria 1 Figure 43 shows a freestanding transfer panel with U-bend flow diverters.

When fixed units are used.doc 4/6/01 Printed on 03/15/02 . WIPING DISK GUIDE DISK Figure 44. filter housings. The detachable devices are preferred over fixed units as they can easily be removed for COP. which avoids the needs for an isolating valve and can be loaded when the system is empty. uni-mold construction.0 GL1_v1.Pigging System Cleaning Bullet The bullet launcher is not a CIP’able component. and ancillary components disassembled and COP’d. Bullet launchers are typically fixed. Cleaning and Sanitization Guideline No.1. Launchers can also be detachable which require a full line size isolation valve but can be used detached and used in multiple locations.5 times the pipe diameter. they must be flushed through completely after the bullet has been sent. and be capable of passing over a standard tee without losing its seal. flexible and capable of traversing radius bends of 1. The bullet should be bi-directional. such as neoprene. and then the manual valves. 1 Equipment and Piping Design Criteria • Propellant • Interior condition of pipe • Valve and fitting specifications 4. SELECTION CRITERIA Cleaning bullets should be made of Food Grade material.0 1. It should provide a tight seal between the bullet and the pipe for separation of the product and propellant. C-P Confidential 60 Version 1.7. and be of a solid.

welded couplings for pressure gauge. Cleaning and Sanitization Guideline No. C-P Confidential 61 Version 1. and line size product discharge. propellant inlet.0 GL1_v1.doc 4/6/01 Printed on 03/15/02 . launchers are typically not CIPable as they have a blind flange closure.0 1. Equipment and Piping Design Criteria 1 Figure 45 – Fixed Launcher/Receiver As shown in Figure 45. pressure recorder.

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 . Since in-line catchers are removed to replace the pig. and then the entire assembly is removed for bullet removal.doc 4/6/01 Printed on 03/15/02 . Equipment and Piping Design Criteria 1 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. These terminals can also be used as a launcher.0 GL1_v1.0 1. Cleaning and Sanitization Guideline No. Bullet catchers are also not cleanable via automatic CIP cycles. which makes for easier removal.Bullet Catchers C-P Confidential 62 Version 1. In-line catchers stop the bullet with a stopper rod in the lower catcher section. Either fixed or in-line catchers must be removed after the pigging process and COP’d. Fixed catchers collect the bullet in the end cap and product in the lower section.

o Are helpful in monitoring the bullet’s travel through the pipe.5 meters per second). • Valves should be full port for best pig performance.0 1. note that pigging does not “clean” the line to a visually clean standard. 4. Cleaning and Sanitization Guideline No. o Can alert the operator not to open the system while under pressure. Typically. • Pressure gauges: o Can help verify that the bullet has been launched or received. INSTALLATION DETAILS Figures Figure 48 and Figure 49 below show some examples of how pigging systems are used with multiple tanks and drums. Again.doc 4/6/01 Printed on 03/15/02 . Regardless of the pigging sequence. a subsequent cleaning cycle (either manual.7. 4. See Section 12. PROPELLANTS Compressed air or nitrogen is typically used to propel the cleaning bullet down the piping system.7.0 for compressed air and nitrogen criteria or C&S.9-1. A magnet in the cleaning device activates the signal. Ideal displacement speed is considered 3-5 feet per second (0. The compressed gas must have established quality standards per validated protocol. • Pressure and flow control valves are used to regulate travel speed and reduce pressure fluctuations. C-P Confidential 63 Version 1. Non-intrusive magnetic signals are best for process piping systems.0 GL1_v1.2. • Signal devices indicate passage of the cleaner and can activate other accessories. the propellant should be filtered at the point of use. • Gauge plugs and probes allow addition or removal of accessory items without major changes to the piping system. • Pressure relief valves can prevent dangerous over pressurization of the system.3. • Pressure recorders are used to compare pig runs and indicate changes or problems in the process piping and control system. Equipment and Piping Design Criteria 1 Listed below are some general criteria for the proper selection of terminals for pigging applications: • For best results. CIP or combination of COP/CIP) should be completed. the launchers and receivers should be designed for a specific bullet type and size.

non-porous and non-aging.Pigging Detail .2 Tanks air tank A tank B drum Figure 49 . FLEX HOSES Tubing shall be Sani-Tech Sani-Flo FB series (or equal) ferruled.Pigging Details . Tubing shall be of smooth bore construction and shall be manufactured for sanitary applications. Tubing fittings shall be 316L stainless steel and shall be of the sanitary type unless otherwise noted. End connections should be C-P Confidential 64 Version 1. Tubing material shall be non-toxic. Equipment and Piping Design Criteria 1 tank A tank B Figure 48.0 GL1_v1.1.8. Tubing shall be capable of operating at process design temperatures and pressures. Cleaning and Sanitization Guideline No.8. non- contaminating.Tanks and Drum 4. PIPING SPECIALTIES 4. sanitary braided tubing or Sani-Flex reinforced silicone tubing.doc 4/6/01 Printed on 03/15/02 .0 1.

doc 4/6/01 Printed on 03/15/02 .0 1. C-P Confidential 65 Version 1. Convoluted lining aids in Smooth bore bending radius and lining preferred operation but is not suitable product contact. Equipment and Piping Design Criteria 1 attached to the hose in a manner that minimizes the crevices and promotes free draining in either direction. CIP or COP Figure 50 . Cleaning and Sanitization Guideline No. Hoses that are dry should be capped while being stored.Flex Hoses Good: Hose ends are not on the floor Bad: Hose ends are open to atmosphere.0 GL1_v1. 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.

Equipment and Piping Design Criteria 1 4. Figure 52 . C-P Confidential 66 Version 1. and free draining internals.8. Cleaning and Sanitization Guideline No. dead legs. areas within piping systems that are improperly designed for CIP service (e.2.doc 4/6/01 Printed on 03/15/02 . • Inspection – As visual inspection will be a key component of the CP cleaning validation approach (See GL6).9.0 GL1_v1. STATIC MIXERS Static mixers must be of sanitary design (Sani-matic or equal) with welded.g. pockets) should be able to be disassembled for visual inspection during validation. polished. An example of a static mixer that would not be considered sanitary is shown in Figure 52 below.0 1..Non-Sanitary Static Mixers 4. IQ/OQ DESIGN REQUIREMENTS 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. inadequate velocity. Sanitary designs should have simple internals (cross style) with smooth inner surfaces and no dead spots. sample points will need to be provided after each unit operation or piping section to be cleaned.

2.0 INSTRUMENTATION 5. inert.1.2.doc 4/6/01 Printed on 03/15/02 . Equipment and Piping Design Criteria 1 5. but the U-tube configurations will have some product hold-up. and resistant to the product and cleaning solutions. as this creates a deadleg.1. Product contact materials must be 3A approved and/or consistent with EHEDG Guidelines for sanitary applications.D.0 GL1_v1. 5. FLOW Coriolis (mass flow) meters by Micro-Motion.1. PRODUCT CONTACT SURFACE 5. SURFACE FINISH Stainless steel should be mechanically polished on 15-25 µ-inch Ra on the internal surface. mechanically stable. Cleaning and Sanitization Guideline No.2. Ra of 30 µ-inch surface finish for non-insulated exposed tubing. MATERIALS OF CONSTRUCTION Austenitic stainless steels are the most common material used at CP for product contact surfaces. SELECTION CRITERIA 5. In general.0 1. with product flowing from bottom to top. for non-exposed or insulated tubing is acceptable. C-P Confidential 67 Version 1. similar to the tee position previously described. they should be installed either in an inverted position (Figure 53) or at position 5°-15° above horizontal. The straight through style is properly installed vertically. 5. These meters are available in sanitary configurations. which provide the ability to fully drain the line after cleaning. 316L is the material of choice for all new applications in product contact services. isolation valves should not be used to isolate the instrument from the process line for maintenance reasons.2.D. Straight through designs are also available. GENERAL SANITARY REQUIREMENTS All materials that come into contact with the product must be non-toxic.3. Mechanically polished O. 5. Endress & Hauser (or equal) are used for highly accurate flow measurements. Bright annealed or pickled O. In order to free drain.3.

These flow meters are more appropriate for CIP supply and return lines than for product service. Equipment and Piping Design Criteria 1 Figure 53 . Turbine meter Vortex meter Figure 54 .Mass Flow Meters Magnetic flow meters are also available in designs that are suitable for CIP. sanitary 316 stainless steel turbine or vortex shedding type meters may be used. each of these devices has internal components that may not be appropriate for cleaning high viscosity fluids. Cleaning and Sanitization Guideline No.0 1. Where accuracy is less critical.doc 4/6/01 Printed on 03/15/02 . However.Flow Meters C-P Confidential 68 Version 1.0 GL1_v1.

Gauges shall be a minimum of 3-1/2" in diameter. clean in place sanitary applications. Indicating range shall be suitable for the application.3.doc 4/6/01 Printed on 03/15/02 . see Figure 58. C-P Confidential 69 Version 1.0 1. Sensor element shall be provided with 316 stainless steel housing and all probe elements in contact with process fluid shall be polished (25 µinch. Cleaning and Sanitization Guideline No. PRESSURE Gauges shall be of pharmaceutical grade and shall meet 3A and/or EHEDG sanitary requirements. TEMPERATURE Indicators shall be suitable for sanitary applications and connections shall be made by the use of sanitary clamp fittings.0 GL1_v1. 5.3. Equipment and Piping Design Criteria 1 5. Connections shall be made by the use of sanitary clamp fittings.3. Sensing element shall be 3A approved and/or consistent with EHEDG Guidelines for sanitary applications.2. The diaphragm should be close coupled to the process line to minimize the deadleg. Ra) 316 stainless steel suitable for high purity. All wetted surfaces shall be electropolished 316 stainless steel. 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. All wetted parts shall be compatible with cleaning solutions. Indicators shall be provided with polished 316 stainless steel well assembly and bi-metallic dial thermometer. Pressure elements should not be isolated from the process line with a shutoff valve for maintenance or calibration.

Pressure Indicator 5. Microbial growth is also minimized as there are no O-rings in this design. These nozzles are often tilted 5-15% up so as to drain into the process vessel. 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.4. These nozzles are recessed farther away from the tank. This o-ring minimizes the dead space for solution to clean around the cavity. but allow a greater gap (much like a dip tube) for cleaning solution to enter and flush the cavity. Cleaning and Sanitization Guideline No.doc 4/6/01 Printed on 03/15/02 . Equipment and Piping Design Criteria 1 Figure 56 . however does pose cleaning and sanitization problems when located long distances from the spray device. PH & ORP pH and ORP (Oxidation Reduction Potential) probes are similar in their C&S characteristics. C-P Confidential 70 Version 1. Sanitary clamp fittings are also available for C&S applications.3.0 GL1_v1. The only way to truly clean these nozzles is to have impingement from a spray device aimed directly at the nozzle itself.0 1.

such as purified water or low viscosity solutions. Equipment and Piping Design Criteria 1 Ingold nozzle Sanitary Clamp Nozzle Figure 57 . 5.3. suitable for end of tee/in-line installation. and have a titanium electrode. LEVEL Various types of level measurement can be considered “sanitary”. Capacitance: Cleaning chemicals often have a different capacitance range than process solutions.3.0 1.pH & ORP Tank Connections 5. Cleaning and Sanitization Guideline No. float. 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. Sensor shall have a sanitary connection with the preferred mounting configuration as shown in Figure 58. Float: Available in SS for sanitary applications. Not recommended for agitated or foaming products. CONDUCTIVITY Conductivity/Resistivity sensor housing shall be of PVDF. including capacitance. ultrasonic. However. so although these probes can be easily cleaned they are often inappropriate for CIP applications. C-P Confidential 71 Version 1.6.0 GL1_v1.doc 4/6/01 Printed on 03/15/02 . DP: pressure differential is a common and reliable method of measuring level. Not recommended for high viscosity or “sticky” product solutions. and when flush mounted sensors are properly located on the tank or piping manifold. radar. and DP.5. they are easily cleaned with a CIP system. each of these styles has particular issues that must be addressed to ensure that it is being used in the appropriate application. these probes are a simple design and easy to clean in certain applications. allowing adequate coverage from internal spray devices.

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. and a well defined sampling plan (Reference Guideline 6 – Cleaning Validation). GENERAL SANITARY REQUIREMENTS All materials that come into contact with the product must be non-toxic. inert.0 VALVES 6. Cleaning and Sanitization Guideline No.1. mechanically stable. Equipment and Piping Design Criteria 1 Preferred – Unacceptable Minimum Dead leg installation Figure 58 . including established acceptance criteria. Instruments that are likely to be used for ongoing cycle monitoring include: • Temperature • Timed step sequences (process controller) • Conductivity • TOC • pH 6.4.Conductivity Sensor Installation 5. and resistant to the product and cleaning solutions. IQ/OQ DESIGN REQUIREMENTS In some cases. selection of analytical methods. additional instruments may be appropriate for CIP only.0 1. In order to show that cleaning cycles subsequent to validation are performed in a consistent and repeatable manner. C-P Confidential 72 Version 1.0 GL1_v1.doc 4/6/01 Printed on 03/15/02 . Product contact materials must be 3A approved and/or consistent with EHEDG Guidelines for sanitary applications.

Cleaning and Sanitization Guideline No.
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6.2. PRODUCT CONTACT SURFACE

6.2.1. MATERIALS OF CONSTRUCTION

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 in product contact
services.

6.2.2. SURFACE FINISH

Stainless steel should be mechanically polished on 15-25 µ-inch Ra on the internal
surface, mechanically polished O.D. Ra of 30 µ-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 CIP’d
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 µ-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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1.0 GL1_v1.doc 4/6/01
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Equipment and Piping Design Criteria 1 6. 20 psig saturated steam.0 1.0 GL1_v1. As the stem is connected on two sides of the valve interior.3.Mixproof Valve 6. and EPDM O-rings. BUTTERFLY (WAFER) This valve is often used for shut-off application in larger line sizes. 6. with throttling and positive shut off capabilities. The seal is the primary source of contamination and should be designed for minimal holdup.doc 4/6/01 Printed on 03/15/02 .3. These valves are not fully sanitary. the valve stem should be located C-P Confidential 76 Version 1.3. Valve shall be quarter turn. suitable for sanitary operations. PLUG 316 stainless steel valve body. MIXPROOF Double-seat mixproof or “rising stem” sanitary valves are common to the food and dairy industry. These valves are often arranged in a matrix to consolidate product and CIP lines for product transfer and cleaning. These valves are not fully sanitary. Cleaning and Sanitization Guideline No. therefore they may require CPM and manual cleaning. safely preventing the two liquids from mixing. A mixproof double-seat valve is a self-draining compression valve that allows two dissimilar fluids to flow through a single body. suitable for continuous operation with 260°F. They are designed to separate incompatible products or products from CIP solutions. Provide with butt weld or sanitary clamp fittings. therefore they may require CPM and manual cleaning.5. Product path CIP path Mixproof zone open to atmosphere Figure 62 .4.6. TFE coated 316 stainless steel plug. with seal materials compatible with the cleaning solutions. Provide with large orifice and straight through flow for minimum pressure drop. See Figure Figure 62. The internal wafer should be smooth and polished consistent with the line size specifications. and preferably electropolished.

These valves are not fully sanitary. 6.3. These valves are not fully sanitary.0 GL1_v1. Representative style would include the Tri-Clover disk type or a ball type check valve. 6.doc 4/6/01 Printed on 03/15/02 . therefore they may require CPM and manual cleaning. Sample valves should be located in easily accessible areas and should be connected to process lines with short outlet tees. although some processes may use ball valves if they are used in the process lines. NEEDLE Used for flow control in small lines. Cleaning and Sanitization Guideline No. bellows type.8. Representative style would include the Nupro Series 4BMRW (or equal) needle valve. CHECK Check valves should be avoided where possible in process lines. Tees for sample valves may be pointed down as they are a low point and can be used for system draining if needed. 6. Equipment and Piping Design Criteria 1 horizontally to minimize pooling at the stem interface. therefore they may require CPM and manual cleaning.3.0 1.7. This valve is not very cleanable. Short outlet tee is preferred over this fitting Sample valve outlet Figure 63 – Sample Valve C-P Confidential 77 Version 1. These valves are not fully sanitary.9.3. neither of which is truly sanitary. therefore they may require CPM and manual cleaning. 25 µ-inch Ra internal polish. SAMPLE Sanitary diaphragm valves are preferred or sanitary plug valves (ITT or equal). as they are difficult to clean. 316 stainless steel body and internals.

or a sink with manual cleaning.0 GL1_v1. OTHERS Other types of process filters generally follow the rules as described for cleaning the Purolator filter. the housing. and the filter assembly. Most filter elements.doc 4/6/01 Printed on 03/15/02 . HEAT EXCHANGERS Various types of heat exchangers are used for process applications.1. FILTERS 7. PUROLATOR Purolator filters are used in the dental cream process and include fine mesh screens and a motor driven scraper blade. too.0 1.2. but all sanitary designs fall into either the shell-and-tube or tube-in-tube category. is mounted on a cart so it. 7.1. Plate and frame heat C-P Confidential 78 Version 1. and therefore must be removed and cleaned either manually or with a COP system. The filter assembly. are meant to be replaced and not cleaned. There are two aspects to cleaning these filters. The remaining piping segment can be CIP’d if a spool piece is installed at the location of the removed filter housing. ultrasonic cleaner. Equipment and Piping Design Criteria 1 7. Housings should be cleaned out of place using a COP system. the filter head can be left in place and CIP’d by capping the housing connection after removal of the filter and housing. separate from the housing.1. as shown in Figure 64. Alternatively. Cleaning and Sanitization Guideline No. can be cleaned out of place.0 SPECIALTY EQUIPMENT 7. Figure 64 – Purolator Filter (housing not shown) 7. other than sintered stainless steel.1.2. Filter housings generally have too large a diameter to clean with the process piping CIP sequence.

Plate and frame HEX’s that can be fully disassembled for manual cleaning may be used if proper procedures are followed for COP. Allegheny Bradford. with double tube. fully drainable with removable U-tube or flow-through bundle. Exchanger shall be provided by YULA. Equipment and Piping Design Criteria 1 exchangers are not CIP’able due to crevices in the frame and a seal design that creates pockets. Representative specification would be a double tube sheet. Ra.Sanitary U-Tube Heat Exchanger 7. Shell-and-tube heat exchangers are available in flow-through and U-tube configurations. Sanitary exchangers for product contact should also be specified with a double tube sheet. or equal. HOMOGENIZERS Some of the newer dental cream processes utilize homogenizers after the mixer in lieu of Purolator filters. Tube seal shall be welded to tubesheet. as there is only one headplate to fabricate. All parts of unit in contact with CIP solutions shall be 316L SS. They also do not free drain. U-tubes are more common and less expensive to fabricate than flow-through exchangers. Pressure drop shall be no greater than an 15 psig (1 Bar). and serpentine configurations. the tube side or shell side fluid would visibly leak to the outside without crossing over into the other fluid. This design eliminates the possibility of contamination of the tube side with shell side fluid due to a joint failure. Unit shall possess a minimum 1-1/2" sanitary fitting connections for water inlet/outlet. multiple sections. However.0 1. single pass.0 GL1_v1. Figure 65 . Tubeside shall be polished to 25 µ inch. Feldmeier. Unit shall be ASME code stamped.3. Cleaning and Sanitization Guideline No. as evidenced by the C-P Confidential 79 Version 1. If a leak develops. ITT. Along with increasing yield and handling larger process flow rates. homogenizers are more robust and flexible than filters.doc 4/6/01 Printed on 03/15/02 . 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. parts not in contact with CIP solutions shall be 304 SS.

Cleaning and Sanitization Guideline No. For product changeover cleaning. are by nature designed for dedicated product and are therefore often overlooked from a cleaning perspective. If a spray ball is specified. Therefore. These skids. surface finish. a spray ball might be appropriate for the tank even though it is not cleaned between each batch. Nonetheless. these systems should be designed with cleaning in mind from the beginning. Rules for dead legs. piping. the head should be disassembled as shown and cleaned manually or in a COP system. valves. Ingredient tanks may be used for dedicated product. CIP cycles for this equipment should undergo engineering trials and cycle development prior to cleaning validation. pumps.0 1. the cleaning requirements and expectations of the system need to be detailed clearly in the specification.4. etc. the homogenizer is still difficult to clean in place and should not be presumed to be CIP’able upon specification and purchase. then test and acceptance criteria (such as a riboflavin test) also should be specified initially (See Section 9. or fabricated assemblies. just as any other piece of process equipment would be. fragrance. Equipment and Piping Design Criteria 1 intricacy of the rotor and stator below. however. but that tank may still need periodic cleaning and sanitizing due to the micro-susceptibility of the ingredient. If an outside vendor fabricates these skids. PA skids. POST ADDITION (PA) SKIDS Post addition skids are used in various making systems for adding color. consist of many of the components described in this guide such as tanks.0) C-P Confidential 80 Version 1. Figure 66 - Homogenizer with rotor and stator (inset) 7. cleaning solution velocity. Component specifications should be included using the information from this Guideline. or other ingredients. and instrumentation.0 GL1_v1. all apply.doc 4/6/01 Printed on 03/15/02 .

8. The last two machines on the list are complex and must be manually cleaned. Some have been designed or modified to be automatically cleaned in place by delivering cleaning solution through the machine product contact areas between batches. following criteria for tanks in this and other related Guidelines.0 1. CIP may prove to be effective for the first three machines in the list.Head Tanks C-P Confidential 81 Version 1. etc. however.0 GL1_v1. etc.1.1. valves. hoppers. should be manually cleaned for all six of these machines. The 6 primary types of fillers in the CP facilities.0 FILLING EQUIPMENT 8.doc 4/6/01 Printed on 03/15/02 . Also.) must be designed with C&S criteria as described in pertinent sections of this Guideline. there are still components of the nozzle area that will not be completely cleaned in a CIP cycle. Cleaning and Sanitization Guideline No. 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. listed in order of the simplest to the most complex design. Even so. Equipment and Piping Design Criteria 1 8. HEAD TANKS Head tanks should be cleaned separately from the filling equipment.. but for others it is virtually impossible to automatically clean the entire filler automatically without disassembly. FILLING EQUIPMENT OVERVIEW There are many different types of filling machines within the CP facilities throughout the world. hoses. Figure 67 . these components (head tanks.1. this can be achieved for certain types of fillers. Some combination of CIP and COP would be the most desirable for these machines. pistons.

following criteria for piping in this and other related Guidelines.doc 4/6/01 Printed on 03/15/02 .1. See GL2. as seen in Figure 68.Filling Line Piping Systems 8. Equipment and Piping Design Criteria 1 8. Section 4.0 GL1_v1. These piping systems are often designed as manifolds that have substantial dead legs. qualification criteria for the acceptable hold duration must be in place and documented.5 for criteria on cleaning nozzles and small parts for filling machines. Cleaning and Sanitization Guideline No. NOZZLES Filling nozzles should be manually cleaned.2 and 4. Figure 68 . In some cases the lines will remain full of product when not in use n order to minimize waste.0 1. In these cases.1.2.Filling Nozzles Being Manually Cleaned C-P Confidential 82 Version 1. Figure 69 . PIPING Piping systems leading up to tanks and filling machines should be cleaned separately from the filling equipment.3.

1.0 GL1_v1. Both systems are similar. and the machine size. Valves in the most current machines are ball valves driven pneumatically. Furthermore the procedure needs to be validated. These systems are typically used with in-line fillers. and be ready for changeover. In some other machines the valve will be a simple solenoid actuated valve. The valve will be of the plunger type. This may involve adapting or changing the machine configuration to accept other package sizes or changing the product. In that case. complex and difficult to clean. 8. For example. the procedure needs to be statistically validated. The only difference is that in time-pressure filling compressed air is added to the tank. The diagram is not intended to represent a particular machine. no matter its complexity. If possible. the machine type. identify filling machine spare parts that can be cleaned and sanitized in advance. 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. the time designated for changing the machine configuration is not necessarily equal to the time needed to C&S the machine. World-class manufacturers can changeover a filling machine. Equipment and Piping Design Criteria 1 8. C-P Confidential 83 Version 1. Figure 70 illustrates the operating principles and the major components. On another hand. if the changeover process requires the filling machine to have a different nozzle. changeovers requiring C&S will most likely take longer than the current world standards mentioned earlier.4. This means that any parts that are added to the machine must meet the C&S criteria. then the new nozzle must be perfectly cleaned and sanitized. It is not enough to pretend the machine has been cleaned and sanitized.0 1. rather the operating principles for these types of fillers. TIME-GRAVITY & TIME-PRESSURE FILLERS Time Gravity or Time-Pressure systems are used for liquid products. the period designated for the changeover is often used for C&S purposes. In-line fillers will have from 1 to 14 nozzles. The nozzles and valves are. The time needed to C&S a machine depends obviously on the product. as in the case of many other machines. in order to minimize changeover time. By a changeover. it is understood the process of changing over from one SKU to another. within 15-30 minutes.2. CRITERIA FOR CLEANING CHANGEOVER TIMES Modern manufacturing methods emphasize on quick machine changeovers. which increases the product fill velocity. As a result. Cleaning and Sanitization Guideline No.doc 4/6/01 Printed on 03/15/02 .

C&S APPROACH Only machines specifically designed for pharmaceutical products with a water-like viscosity are designed for CIP-SIP applications.0 GL1_v1. MAGNETIC FLOW METER FILLERS Figure 71 shows a magnetic flow meter machine. perhaps not as frequently as some of the other machine types. 8. Valves need to be sanitary design. the magnetic flow meter can be substituted with a mass flow meter. Hoses with barb and clamp-type connections. ball valves. The flow meter measures the amount liquid being dispensed to the bottle. except a few discrete areas. the nozzles (at a minimum) will need to be removed and cleaned manually on a periodic basis. Time-gravity machines will require manual cleaning of the tank if it is atmospheric.1. but upon examination fall short of the criteria outlined in this Guideline for C&S design practices. and intricate nozzles all pose areas that could not be cleaned via an automatic CIP cycle. These machines are often marketed by manufacturers as being CIP’able.Time-Gravity & Time-Pressure Fillers 8. Of course. whereas spray ball could be provided on the closed tank for time-pressure filling equipment.doc 4/6/01 Printed on 03/15/02 . Equipment and Piping Design Criteria 1 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 .3. Regardless of the specification. Cleaning and Sanitization Guideline No. Careful attention to these and other critical components during specification could lead to a machine that is well suited for CIP and SIP.0 1.2. C-P Confidential 84 Version 1.

When product is not needed at the machine.Magnetic Flow Meter 8. 8. C-P Confidential 85 Version 1. Unless these are validated with a CIP cycle. 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. creating a dead leg. Cleaning the machine depends on the fluid velocity as determined by the pump and the nozzle configuration. they should be cleaned manually.3. C&S APPROACH In general the machine is very sanitary. but this approach still requires further evaluation by the machine manufacturer.1.doc 4/6/01 Printed on 03/15/02 . the machine has a pump that is followed by solenoid valve (not shown). The load cell under the bottle measures the amount of liquid being dispensed to the bottle.0 GL1_v1. there are two primary areas of concern: Nozzle: Again. Equipment and Piping Design Criteria 1 Rotary joint Distributor Magnetic flow meter Valve Nozzle Bottle Pump Figure 71 . Although this machine is perhaps more suitable for CIP than many of the others. the valve is closed and product simply circulates around the pump. WEIGHT FILLERS Figure 72 shows a diagram of a weight filler. Cleaning and Sanitization Guideline No.0 1. In some installations the dead leg can be eliminated and control the product by shutting off the pump.4. Pump: As shown.

Some piston fillers (for liquids) will have a check valve instead of a rotary valve. because of the “laminar flow” nozzle configuration. the nozzles still will need to be disassembled for manual cleaning and sanitization.Weight Filler 8. As the piston retracts. 8. Hygienic-conscious weight filler manufacturers are revising this concept and eliminating the plunger mechanism by replacing it with a magnet. C&S APPROACH In general the machine is considered to be sanitary and the tank is equipped with spray balls.1. The diagram is not intended to illustrate a particular machine. the piston travel direction reverses and the valve rotates 90°so that the product is directed to the bottle. it draws product into the cylinder.0 GL1_v1.0 1. Piston fillers are best used with viscous products. The piston is driven either with a pneumatic piston or mechanically (cams). Equipment and Piping Design Criteria 1 Product intake Nozzle positive shut-off mechanism Tank Nozzle Bottle Load cell Figure 72.5. Cleaning and Sanitization Guideline No. When the cylinder reaches the predetermined stroke length.4. Figure 73 illustrates the operation and filling principles. Although new machines will feature a better design. Some other piston fillers will have a valve that slides instead of one that rotates 90° (like the one in the illustration). All toothpaste fillers are piston fillers.doc 4/6/01 Printed on 03/15/02 . Therefore the piston end is usually exposed to contaminants. either from the compressed air or from C-P Confidential 86 Version 1. The nozzle shut off mechanism inside the product tank is not typically a good sanitary design. PISTON FILLERS There are innumerable versions of this filling concept.

C&S APPROACH Because of their complexity. Some manufactures claim that these fillers can be CIP’d.” The product intake tank is often pressurized with air. 48. All product contact surfaces must be disassembled and COP'd. The Pneumatic Scale machines were very popular in Colgate and we still have several machines in our plants. Extreme care in cleaning needs to be exercised with piston seal grooves and threaded connectors.5. piston fillers cannot be CIP’d. In this machine. 16. Moreover. 1 Equipment and Piping Design Criteria machine components. C-P Confidential 87 Version 1.doc 4/6/01 Printed on 03/15/02 . thus the name “air sensing. The seals require grooves. and even a larger number of nozzles. The assembly is often tied together with screw threads. Tank Piston Valve Nozzle Bottle Figure 73 .6. so it is recommended that these parts be manually cleaned and sanitized. CP’s visually clean acceptance criteria for the pistons and smaller sub- components would likely not be met in a CIP approach. an air jet determines the proper product level in the bottle.Piston Filler 8. Therefore this can represent a machine with 8. but it depends on the standards for CIP. 24.0 1. in many machines the piston is equipped with several seals.0 GL1_v1. The tank diagram is a typical cross section view. Cleaning and Sanitization Guideline No. 8. Cleaning solutions never reach all piston surfaces. AIR SENSING FILLERS Figure 74 corresponds to a Pneumatic Scale or Horix machines.1.

These machines should be completely disassembled for manual cleaning and sanitization.6. C-P Confidential 88 Version 1. the air system is not designed to be cleanable. The outer tube is used to remove product from the bottle. Product is received by the machine overflow tank and pumped to the manifold. these machines were designed before C&S was an issue. When the product reaches the predetermined height. The same principle can be used with a rotary machine.1. with threaded connections and a ring shaped distributor that are not considered sanitary. the excess product in the bottle is delivered to an overflow tank.7. The cycle begins when the nozzle is inserted to a predetermined height and begins dispensing product. air introduced into the bottles must be delivered though a clean and sanitized pathway as it is product contact. Cleaning and Sanitization Guideline No. Also. which means there is theoretically some potential for a CIP cycle to be effective.Air Sensing Filler 8. The inner tube is used to deliver the product. The nozzle is made with two concentric tubes. C&S APPROACH Air sensing fillers are flow-though systems.0 GL1_v1.0 1. First of all. however. even with a spray ball.doc 4/6/01 Printed on 03/15/02 . the nozzles are very intricate. No new product is delivered to the bottle. The details of the machine internals make it impossible to clean using an automatic cleaning cycle. 8. Next. The cycle ends when the nozzle begins to retract and the product valve is closed. the inlet tank L/D ration makes it very difficult to clean. PRESSURE OVERFLOW FILLERS Figure 75 shows a cross section of an in-line machine. Equipment and Piping Design Criteria 1 Product rotary union Product distributor Product delivery hose Tank Air logic control box Nozzle Product intake Compressed air rotary union Bottle Figure 74 . From the manifold the product is directed to nozzle-valve.

doc 4/6/01 Printed on 03/15/02 . Good product is mixed with product removed from the bottle in these machines. Nozzle Manifold Supply overflow tank Bottle Product supply Pressure Pump Figure 75 . Equipment and Piping Design Criteria 1 There are several versions of the pressure overflow filling technology. one contaminated bottle potentially can contaminate the entire batch as the product gets re- circulated. Due to the limitation of this system. There is the gravity overflow if no pump is used and there is the vacuum overflow. C&S APPROACH These machines are among the most complex fillers at CP and the most difficult to automatically clean and sanitize.0 GL1_v1. Besides the difficulty in C&S for this type of machine. Cleaning and Sanitization Guideline No. these machines should be ultimately eliminated from CP facilities. C-P Confidential 89 Version 1.Pressure Overflow Filler 8.1.7. These machines do not flow-though so CIP is essentially impossible.0 1.

These are cleaning parameters that must be controlled and monitored to provide a validatable cleaning process. oils.0 GL1_v1. Cleaning and Sanitization Guideline No. Cleaning systems can be divided into four functional sub-systems. 1.0 1. The cleaning parameters Time-Action-Chemistry-Temperature (TACT) are reviewed in Guideline #2 – Principles and Practices in greater detail. CIP and COP systems are designed to provide proper cleaning by controlling the critical parameters of the cleaning process. Alkaline or acid detergents are the typical cleaning agents for most applications within CP. Equipment and Piping Design Criteria 1 9. glycerins or solvents may be used as the active cleaning agents. In other words. the cleaning solution is brought to the process equipment for CIP. OVERVIEW – CIP AND COP Processing equipment in CP manufacturing facilities is cleaned regularly to maintain product integrity and proper operation of the processing equipment. It does not address how to determine the necessity or frequency of cleaning. In both CIP and COP. C-P Confidential 90 Version 1. In rare applications. CIP is the cleaning method by which processing equipment is cleaned in its process location. • 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). The methodology to clean the following equipment will be reviewed. Action control and monitoring systems. For COP. 2.0 CLEANING EQUIPMENT 9. the object is to apply cleaning solutions in a consistent method that is repeatable and validatable. 3.1. Time control and monitoring systems. The frequency of the cleaning is a function of the stability and nature of the product. COP is the cleaning method where by process equipment is disassembled and the equipment is cleaned in a remote location. the process equipment is taken to a cleaning station. Chemical control and monitoring systems.doc 4/6/01 Printed on 03/15/02 . This section outlines various methods to clean process equipment and how to specify and select cleaning equipment.

doc 4/6/01 Printed on 03/15/02 . they should be located within reach from the manway. Inc Static spray devices may be left in the tank during processing.2.Static Spray Ball Sanimatic. Figure 76 . sparge tubes and rings. welding. Cleaning and Sanitization Guideline No.0 1. SPRAY DEVICES 9. baffles. Material type. Equipment and Piping Design Criteria 1 4. the hole pattern on the spray ball(s) shall be such that all nozzles exposed to the inside of the vessel are completely wetted. STATIC SPRAY DEVICES Static spray balls (or rings. weld. and surface finish of the spray balls shall comply with all the material. and polish requirements indicated above for vessels.1. or in any other spray ball port if multiple spray balls are to be installed on a vessel.2. If they are to be removed. agitator shafts and impellers). Temperature control and monitoring systems. A cleaning system may use a combination of automated and manual methods for each of the sub-systems. as well as all surfaces of all items inserted in the vessel during CIP cycles (e. 9. 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.2 for more details. 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.1.2.g..1. dip tubes. 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. In addition. Once the position of each spray ball is determined and drill patterns have been set. Section 3. No threaded connections shall be allowed. TYPES 9. See Guideline #2.0 GL1_v1. The spray balls shall be secured to the upstream supply tubing by a removable pin with integral retaining clip. C-P Confidential 91 Version 1. disks.

by direct impingement. including all nozzles and inserted accessories.0 GL1_v1. 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. Section 3. and polish requirements indicated above for vessels. Material type.2. by direct impingement.2. All spray balls shall have a drain hole at their low points when the balls are installed in their operational orientation.3.2. weld. Refer the vendor for curve data on specific spray devices. gear driven spray devices shall completely wet. ROTATING SPRAY DEVICES Rotating. all internal surfaces of the vessel. See Guideline #2. and all machinery required for operation shall be located externally to the vessel. Cleaning and Sanitization Guideline No. 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 entire ball and tube assembly shall be removable from the vessel through the nozzle in which it will be mounted. 9.doc 4/6/01 Printed on 03/15/02 .1. This C-P Confidential 92 Version 1. The spray balls shall be welded to the upstream supply tube. Equipment and Piping Design Criteria 1 9. The rotating action shall be powered by the CIP solution flow.1. welding.2 for more details. No threaded connections shall be allowed.0 1. including all nozzles and inserted accessories. The spray pattern shall completely wet. all internal surfaces of the vessel. and surface finish of the spray balls shall comply with all the material. GEAR DRIVEN Rotating.

along with three spray ball valves in the bottom head. which is important in CIP supply pump sizing. and surface finish of the spray balls shall comply with all the material.0 GL1_v1. Refer the vendor for curve data on specific spray devices. All spray devices shall have a drain hole at their low points when the balls are installed in their operational orientation. 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. Material type. The mixer has three of these devices in the top head. due to this high pressure and the impingement action C-P Confidential 93 Version 1. Note that these devices require a minimum pressure in order to operate. The first chart deals with flow vs. The rotating action shall be powered by the CIP solution flow. and polish requirements indicated above for vessels. Cleaning and Sanitization Guideline No. Also. weld. The spray device shall be welded to the upstream supply tube. Figure 80 shows several curves that are utilized in the selection of a gear driven spray device. No threaded connections shall be allowed.doc 4/6/01 Printed on 03/15/02 . Equipment and Piping Design Criteria 1 impingement shall occur as a spray pattern that shall be complete within a specified run time. welding. and all machinery required for operation shall be located externally to the vessel. 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. pressure as related to various nozzle sizes. which must be considered in the design of the complete cleaning circuit.0 1. the entire assembly shall be removable from the vessel through the nozzle in which it will be mounted.

2.2. and pressure requirements for cleaning. or that a 10° F increase in temperature may reduce the cleaning time by half. This is represented in the center chart. With existing tanks that may not have been designed with C&S in mind. 9. The third chart outlines the effect of time on the number of rotations for the device. Section 3. the spray ball vendor needs to be aware of all aspects of the tank & soil characteristics to ensure proper spray coverage. Complex vessels may have baffles or other appurtenances that are difficult to clean with one spray device.1. The basic trade-offs between these variables should be understood. the devices typically operate with a lower flow rate than static devices.doc 4/6/01 Printed on 03/15/02 . 9.2. and surfaces may be a great distance away from the spray dev ice.0 1. such as higher pressure (action) results in lower required temperatures or chemical concentrations for the same cleaning time. or gear driven devices (increased effective throw distance) C-P Confidential 94 Version 1. This is best determined in a lab through coupon studies of actual process conditions for the soil. or the distance from the device to the cleaned surface. it is important to allow for an adequate number of cycles to provide full coverage. The major influences on spray device selection and cleaning. See also Guideline #2. Section 3. One of the primary ways of determining the proper flow rate for gear driven devices is to determine their effective throw length. SELECTION CRITERIA This section provides a general overview of issues to be considered when selecting a spray device.5.2. Cleaning and Sanitization Guideline No. Proper chemical concentration and selection can dramatically reduce the time. temperature.0 GL1_v1. Guideline #2.5 will help to clarify details associated with these issues. Impact to Spray Device Selection: • Large tanks lead to multiple static devices (increased coverage). Time-Action-Chemistry– Temperature (TACT) are discussed in detail in Guideline #2. VESSEL CONFIGURATION Larger vessels have a higher surface area to cover.2. As impingement is provided in narrow strips along the tank surface as the jet passes by.1. This section is concerned with tanks that are designed are with C&S up front.1. Equipment and Piping Design Criteria 1 imparted to the surface.

2. Equipment and Piping Design Criteria 1 • Complex tanks lead to multiple static devices (increased coverage).2.4.3. 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. SANITARY REQUIREMENTS Sanitary devices will be more expensive and will likely require more flow than typical industrial spray devices.0 1.0 GL1_v1.2. due to the surface finish. or gear driven devices (increased impingement and deflection) 9. Cleaning and Sanitization Guideline No. media driven devices (increased deflection and splashing to achieve coverage). media driven devices C-P Confidential 95 Version 1. 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). TYPE OF SURFACE TO BE CLEANED Highly polished stainless steel tanks will be easier to clean than FRP tanks.2.2. media driven and gear driven devices all available in sanitary designs 9.2. Nozzles on existing vessels that are being retrofitted for spray devices may be too small or they may be in the wrong location.2. AVAILABLE NOZZLES Some devices require up to 6” (150 mm) openings. Impact to Spray Device Selection: • Requires welds or clamps in lieu of threaded connections • Static. SHADOWING If shadowing exists. Impact to Spray Device Selection: • Can increase likelihood that lower flow rates or static spray balls will be effective in cleaning 9. for example.doc 4/6/01 Printed on 03/15/02 .

will have a bearing on the spray device selection.. or gear driven devices (increased impingement and deflection) 9.2.5. Equipment and Piping Design Criteria 1 (increased deflection and splashing to achieve coverage).4 for additional information on cleaning aspects for various CP products. REASON FOR CLEANING The reason for cleaning.2.0 GL1_v1. SOIL Static devices may clean solvent storage tanks easily but may have difficulty cleaning dried dental cream.2. fouling prevention. CLEANING TIME Production schedules may dictate the type of spray device used.7. e. product recovery. 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. 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. maintenance.g. such as cross contamination prevention.8.6. Section 3. but will still require C-P Confidential 96 Version 1. See Guideline #2. microbial control.0 1. 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. Cleaning and Sanitization Guideline No.2. This also refers to the acceptance criteria for determining what level of clean is clean.2.doc 4/6/01 Printed on 03/15/02 .2. as some will require a longer residence time for cleaning. cleaning for product recovery may lead to pigging only. whereas cleaning the same system for cross contamination concerns would require additional CIP.1.

2. Labor for manual cleaning should also be considered as an alternative. It is typically undesirable to have the spray device below the liquid level of the tank during normal operation. consideration should be given to using a spray device in the sidewall of the vessel.3.9.3. 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. Cleaning and Sanitization Guideline No. Equipment and Piping Design Criteria 1 chemical action to break down soil than gear driven devices • Gear driven devices are recommended for heavy soils such as dental cream 9.2. and only sanitary designs that are truly self- cleaning should be left in the tank during operation. require multiple spray devices and are best cleaned through high impact direct impingement spray devices. SIDEWALL If the vessel has nozzles on the lower sidewall. Water consumption can also vary dramatically.2. Spray devices should typically be mounted 20” to 30” below the top head. 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.3. Complicated vessel internals.2.1. as well as the type of spray device being used. 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. such as shown in Figure 9. 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. BUDGET Cost for cleaning devices range from $100 to over $3000. affecting operation costs. such as those in dental cream mixers.doc 4/6/01 Printed on 03/15/02 . SPRAY DEVICE LOCATIONS 9. 9.2.0 GL1_v1.0 1. The height is also dependant on whether the spray device is left in the tank during processing. preferably opposite C-P Confidential 97 Version 1. but placement should be aligned to optimize coverage for top and upper sidewall nozzles (see Figure 9 on page 23).2. Rotary and gear driven spray devices should never be located below the liquid level.

as they will tend to bind in a horizontal position. the tank specification should include the pressure and flows required for the test based on spray ball selections.2. Also. Cleaning and Sanitization Guideline No.4. 9.5. 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). 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). If the vendor cannot provide this test. *static spray ball use 3 gpm/ft. • Rule of Thumb: m (flow in gpm) = [2 to 3] x [Tank Circumference (ft)]* *rotary spray balls use 2 gpm/ft. it should be included in the vessel OQ. Devices when not in use should be stored in an enclosed cabinet or enclosure. 9. rotary or gear driven devices should be either be a retractable design or removed during operation. 9. Equipment and Piping Design Criteria 1 the nozzle to be cleaned. Avoid using rotating spray balls in sidewall applications.5. If using a gear driven spray device. C-P Confidential 98 Version 1.2. similar to the practice used for any small parts that are cleaned and ready for use in process equipment.0 GL1_v1. make sure that it will drain in the horizontal position and that the seals are rated for this application.2.2. SPRAY COVERAGE TESTING PROTOCOL FOR TANK VENDORS The following is a specification for Spray Ball coverage testing. In this case.0 1.doc 4/6/01 Printed on 03/15/02 .5. PURPOSE This test shall be for the purpose of evaluating the spray device(s) for coverage and shadowing.1.2. 9. 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.

Verify that the vessel is completely drained prior to beginning the next burst. 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. C-P Confidential 99 Version 1. The initiation of flow shall mark the beginning of the spray coverage test. prior to beginning the spray coverage testing.0 1.5. and more test indicator solution shall be re-applied to any areas that are not covered.2. vortex breakers. 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.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). INSPECTION After the test has ended and the vessel allowed to drain.6.2. 9. agitator.5.. The test indicator solution shall be allowed to completely drain from the vessel. including accessories. 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.5. Equipment and Piping Design Criteria 1 9. 9. 9. Cleaning and Sanitization Guideline No. All wetted components of the test equipment shall be either stainless steel or plastic.doc 4/6/01 Printed on 03/15/02 .2.2. shall be completely inspected with a UV light to determine if ANY residual test indicator solution remains after the test. The inspection shall be conducted with a UV "black" light. APPLICATION All internal. and shall flow for two or three bursts of 30 seconds each. with a 30 second delay between each burst. and increase delay time if necessary to ensure the vessel is empty. If any residual test indicator solution is detected. and the complete interior of the manway(s)) by some method other than using the actual spray devices and the test equipment (e.3. and the interior of the vessel re-inspected. EQUIPMENT The vessel manufacturer shall provide a surge vessel. the interior of the vessel. shall be inspected for complete coverage with the test indicator solution. a spray bottle and/or by filling the vessel completely with the test indicator solution. the exterior of all dip tubes.5.0 GL1_v1. one additional 30-second rinse burst may be applied. then draining it completely). including internal accessories. and shall leave no residue other than the test indicator solution on the vessel(s) to be tested.4. and the interior of the vessel.g.

Cleaning and Sanitization Guideline No.
Equipment and Piping Design Criteria
1
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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Cleaning and Sanitization Guideline No.
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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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Cleaning and Sanitization Guideline No.
Equipment and Piping Design Criteria
1

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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there is no reason to specify a double tube sheet. Equipment and Piping Design Criteria 1 9.0 GL1_v1. a dip/divert tube for the CIP return line and a spray ball for the fresh water inlet. an additional motive force must be employed to return the solution back to the skid. 9. 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. 15-25 µ-inch Ra on the internal surface. it may also need a pressure safety device. When the cleaning circuit is a piping system. 316L SS. such as a rupture disk. 3500 rpm. Depending on the operating pressures. which are often used in the dairy industry. vortex breaker. Cleaning and Sanitization Guideline No. HEAT EXCHANGER CIP temperatures are commonly 160° F (70° C). 9. level probe and/or switches.3. single mechanical seal and automated casing drain (diaphragm valve).1.2. the supply pump at the CIP skid typically supplies the motive force to return the cleaning solution back to the skid. Basket strainers. level probe and/or switches. Although plate and frame heat exchangers may operate more efficiently. a dip/divert tube for the CIP return line and a spray ball for the fresh water inlet. The tank should preferably have F&D top and bottom heads. 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.2.2. Specify a sanitary.2. 316L SS. are typically not needed on the return system unless large particulate is expected to be returned to the skid.22 micron vent filter in lieu of the breather/overflow vent. When high purity water is used for the final rinse.3. Where tanks or other equipment with air breaks are in the cleaning circuit.3.3. If applications exist where there is a need or additional suction head for a return pump at the discharge of a process vessel. they are not considered sanitary and are not generally used on CIP systems. SUPPLY PUMP Sanitary centrifugal pump. 15-25 µ-inch Ra on the internal surface. and have a breather or overflow vent. double tube sheet heat exchanger to ensure that contaminants from the plant steam system do not enter the product piping. 9. vortex breaker. the tank should be an ASME pressure rated vessel with a .3. 316L SS U-tube. The tank should preferably have F&D top and bottom heads. Final Rinse tanks should be atmospheric. TANKS Recirculation tanks should be atmospheric vessels. and have a breather or overflow vent. If this is not a concern.2. When suction head is not C-P Confidential 103 Version 1.4.doc 4/6/01 Printed on 03/15/02 . impellers and shaft.0 1. 316 SS casing.

3.6).4.2. 9.5.0 1. When injecting into the wash tank.0 GL1_v1.2. impellers and shaft. (See Section 10. 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. Equipment and Piping Design Criteria 1 available for return. 316 SS casing.4. or where multiple circuits with varying pressure drops are manifolded into a single return pump.3.2. CHEMICAL INJECTION Cleaning chemicals are typically injected either in the suction side of the pump or directly into the wash tank.4.3. 1750 rpm. eductor systems.2.3. Return Pump Sanitary centrifugal pump. overpressure. Gravity All process vessels are above the CIP skid and drain back to the recirculation tank by gravity. 9. 9.4. 9.4.1.Self Priming Pumps 9.doc 4/6/01 Printed on 03/15/02 .3. or combined eductor assist with return pumps should be used. Cleaning and Sanitization Guideline No. single mechanical seal and automated casing drain (diaphragm valve). Eductor Eductor shall be 316 stainless steel Tri-Clover or equal and shall have the capacity to return the specified flow at 160º F (70º C) solution with required suction head through the recirculating motive loop. Figure 83 .2. utilize dip tubes (see Section C-P Confidential 104 Version 1. 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).3. No return pump or eductor is required.2.

These systems have no logic capabilities and simply advance the process from step to step based on preprogrammed time intervals. as conductivity will not sense this change.2.doc 4/6/01 Printed on 03/15/02 . depending on the complexity of the system.6. 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. locate in wash tank if used • Rinse Solution Temperature: Locate on CIP return line or remote at the process C-P Confidential 105 Version 1. Chemical delivery pumps should be either double diaphragm type of magnetically coupled rotary gear pumps suitable for use with the cleaning agents. 9. weigh this benefit vs. number of I/O. 1 Equipment and Piping Design Criteria 2. Cleaning and Sanitization Guideline No. maintenance of pH probe. 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.7. However. new DCS systems such as Fischer’s Delta V and others offer a distributed control solution that can compete with PLCs at the skid level.1) for injections to prevent degradation where concentrated chemicals will contact the tank wall. Venturi type systems scan also be used to feed chemicals into a circulating line. as integration between CIP and process cycles is the most crucial part of the control system design. Cleaning chemicals can be stored remotely in drums or totes and transferred via metering pumps controlled by a wash conductivity sensor. and desired integration with other process unit operations. Although simple.0 1.0 GL1_v1.3. 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. PLC/DCS systems are the most commonly used method of controlling a CIP system. used to verify switching from caustic to acid cleaning solutions. Stepper controls or sequencers are the most basic type of control system. CONTROLS AND INSTRUMENTATION Various types of control systems can be used to operate the CIP system. 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. these systems can be validated given the appropriate documented output and validation approach.

level of automation. systems may be designed with no tanks or up to three or four tanks.1. NATURE OF THE SOIL • Is the soil water-soluble? The typical CIP skids described in these guidelines are for water-based systems. If. Configuration. it is unlikely that a CIP skid would be appropriate at all if the materials such as methanol or toluene are required. CIP SKID SELECTION CRITERIA When designing and specifying a cleaning system the following issues should be considered.3.0 GL1_v1. this could be used to eliminate the requirement for a heat exchanger on the skid. as the process system itself can typically be utilized for cleaning steps without the assistance of a CIP skid. Answers to these questions will determine how the optimum cleaning system is designed. and what type of water should be supplied to the CIP skid from the facility. and complexity of the cleaning system will vary extensively. The recirculation capability allows for extended wash C-P Confidential 106 Version 1. 9. dried on. or cooked on to the equipment surface? If the soil will be dried on or cooked on. or if water alone will suffice. there is a hot purified water loop available.0 1. • What is the optimum rinse temperature? This will determine if an exchanger is needed on the CIP skid.3. locate on CIP return line • Chemical delivery flow rate: Locate on each chemical feed line 9. Cleaning and Sanitization Guideline No. • What chemistry releases soil from the equipment surface? This will determine if chemical cleaning agents will be needed to supplement cleaning. If cleaning agents are needed. However.3.3. once-through system becomes less cost efficient. • Is the soil fresh. Equipment and Piping Design Criteria 1 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. for example. One and two tank CIP configurations are typical.doc 4/6/01 Printed on 03/15/02 . CIP systems are available in a variety of sizes and configurations. If solvents or flammable cleaning agents are required the CIP system will look quite different. used to verify rinse water quality where conductivity is not adequate. In fact. then a recirculating skid with chemical capability would be appropriate.

3. Cleaning and Sanitization Guideline No. EQUIPMENT BEING CLEANED • Is the equipment designed for CIP? If the equipment is not designed for CIP. this may lead the CIP design to a system that relies more heavily on time (recirculation). weekly. • 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.0 1. etc). pumped recirculation. 9. or yearly? The frequency of cleaning will impact the diversity and selection of the CIP system. The location and distances between process equipment and the CIP skid will also impact the pump sizing and return system configuration (remote return pump.). It is certainly possible to split the CIP skid into separate component skids (tanks. or if a portable system can be used on a periodic basis. etc. the size constraints of the CIP skid.doc 4/6/01 Printed on 03/15/02 .2.3. • Is a static or dynamic spray device required? This will impact pump sizing and pressure rating requirements for the skid. eductor. cleaning agents (chemical addition) or impingement (higher pressures) for cleaning.3. A process that is cleaned once a year should not warrant a dedicated CIP skid that is fully automated. PROCESS AND PRODUCTION ISSUES • Frequency of cleaning: daily. then the expectation of the CIP skids should be clearly stated. monthly. 9. etc. If manual cleaning will still be part of the cleaning protocol for the equipment. pipe. • Where is the equipment located in relationship to the cleaning equipment? This may impact the opportunity to use a portable vs.3. Equipment and Piping Design Criteria 1 steps without using additional water and utilities.3. The flow and pressure requirements to clean the circuit will affect sizing of all components on the CIP skid. cleaning method second (spray device.0 GL1_v1. C-P Confidential 107 Version 1. The equipment should be evaluated to see if it can serve as its own “CIP skid” by batching in chemicals. gravity). a fixed CIP system. pumps skid) in order to optimize space. Gear driven devices operate at higher pressures than static or rotary devices. and then the CIP skid last. then the CIP skid may be less automated since operator intervention will be necessary regardless. Cleaning chemicals may help to break down any residue on the equipment surface. • What are the temperature limits for the equipment being cleaned? If the equipment has elastomers or other components that have a limited temperature range.

If wash solutions are heated. If discharge volume is a concern. but CIP systems can generate (and discharge) substantial amounts of water. Once-through systems will use substantially more water than recirculating systems. 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.. In the US. jumpers may be permanently or temporarily installed to connect the process equipment with a CIP system for another area.0 GL1_v1. Many codes place a limit on the temperature of solution entering a sanitary plumbing system. then consideration may need to be given to cooling the solution prior to sending it to drain in order to comply with local codes. • 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. this temperature limit is typically 140° F (60° C). Water used or final rinse steps should be consistent with the grade of water used in the formulation or manufacturing process. separate final rinse tank. Equipment and Piping Design Criteria 1 Otherwise.3. i. Cleaning and Sanitization Guideline No. The other option is to carefully define where the process ends and the “drainage system” begins.e. then a series of recirculating rinse steps after the final wash may help reduce the time (and volume) of the once- through final rinse. 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. This may necessitate large tanks for surge capacity in cleaning cycles. C-P Confidential 108 Version 1. This may be a simple permitting issue.4.doc 4/6/01 Printed on 03/15/02 . This may impact the number of tanks required for the skid.0 1. and take advantage of mixing in order to cool the solution before sending it to drain.3. 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. and see if they are negotiable. • What is the facility steam pressure and capacity? If heated solutions are required. Check the local jurisdiction for limits on daily or peak flow limits. 9.

6. LEVEL OF AUTOMATION • Type of automation used for process equipment? First and foremost. The facility should not be forced into a proprietary system being sold by a CIP supplier. location.0 GL1_v1. 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. but should specify the type of system they are familiar with. the controls should match the philosophy and methodology used in these new systems.doc 4/6/01 Printed on 03/15/02 . If the facility has undergone recent renovations or added process equipment. This will affect design decisions on where to inject the chemicals.0 1.5. maintenance access. This will affect the type of control system used to meter in the chemicals. Chemical delivery pump selection will depend on the storage container type.) that will be utilized should be established. the class of chemicals (acid. Cleaning and Sanitization Guideline No. purified water steam and compressed air may also impact the skid configuration. etc. • How are chemicals stored? Details for the supply of chemicals to the skid are a part of the design. depending on materials of construction. the automation used for the CIP skid should be consistent with the control systems in the rest of the facility.3. etc. • Location of available utilities? The location of available utilities. 9. whether they can be mixed or if separate wash tanks will be needed. and should be considered within the skid specification. Equipment and Piping Design Criteria 1 In addition to temperature. caustic. Leading CIP vendors can be adaptable to various control platforms. C-P Confidential 109 Version 1. there may be restrictions on pH range or other physical properties of the waste discharge. 9. etc. 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. Most skids will allow for at least two chemicals. such as water. • Type of Chemical? Although the specific chemical may not be known at the time of specifying the CIP skid.3.3.3. • Concentration of chemical? The concentration (range) of the chemical. and the accuracy required to measure the concentration should be established. even if one chemical is proven to be effective for the anticipated soils.

3. Cleaning and Sanitization Guideline No. the following are general criteria for CIP skid selection for the primary product groups at CP.6 for a sample CIP skid specification sheet.3. engineering. 9. 9. maintenance. Refer to the GL1 Appendix 14. VALIDATION ISSUES The approach to validation should be understood prior to finalizing the CIP skid design.1.doc 4/6/01 Printed on 03/15/02 .1. so long as it does not compromise the validatability of the system. a highly viscous water-soluble product. as they will impact the location of sample valves and selection of online instrumentation. 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. Simple systems even using stepper type controllers can still be validated with the right approach.4. lab support)? The control philosophy used for the CIP skid should also match the capabilities of the plant personnel. CIP SKID SELECTION CRITERIA Based upon the selection criteria outlined in the previous section.3. the primary considerations for selecting CIP equipment for cleaning dental cream process equipment. 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 C-P Confidential 110 Version 1. include: • Heat exchanger to elevate wash temperature. TOOTHPASTE Based on the above criteria.0 1.7.3.4. including protocols for TOC analysis and deviations. 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 9.0 GL1_v1. 1 Equipment and Piping Design Criteria • Skill level of cleaning personnel (cleaning. Sampling plans and methods to be used for cleaning analysis need to be considered.

doc 4/6/01 Printed on 03/15/02 .3. aiding the release of the soil from the equipment surface • Capability for chemical additions to aid in soil release and to reduce foaming • Two tank (wash and rinse) minimum system 9. Equipment and Piping Design Criteria 1 • 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 9.4. the primary considerations for selecting CIP equipment for cleaning fabric softener process equipment include: • Heat exchanger to elevate wash temperature. Cleaning and Sanitization Guideline No. aiding the release of the soil from the equipment surface • Capability for chemical additions to aid in soil release and to reduce foaming • Two tank (wash and rinse) minimum system C-P Confidential 111 Version 1. DETERGENT LIQUIDS Based on the above criteria. the primary considerations for selecting CIP equipment for cleaning detergent liquid process equipment include: • Heat exchanger to elevate wash temperature. PERSONAL CARE PRODUCTS (CREAMS AND SHAMPOOS) Based on the above criteria.0 1.2.4.4. the primary considerations for selecting CIP equipment for cleaning personal care process equipment include: • Heat exchanger to elevate wash temperature. FABRIC SOFTENERS Based on the above criteria.0 GL1_v1.3.3. aiding the release of the soil from the equipment surface • Capability for chemical additions to aid in soil release and to reduce foaming • Two tank (wash and rinse) minimum system 9.4.3.

using some combination of manual cleaning. filling nozzles. as can be seen by the example in Figure 85. COP skids employ different types of cleaning action to help remove soil from product surfaces. COP UNITS 9.4.doc 4/6/01 Printed on 03/15/02 . spray wands.5. Guideline #2 offers several sections outlining steps for the development of cleaning chemistries.4. small valves or spool pieces. Equipment and Piping Design Criteria 1 9. Cleaning and Sanitization Guideline No.5. or recirculation washing. etc.0 1. tubing. COP washer are batch type washer used primarily to clean cylindrical parts. and typical steps in a CIP cycle (Section 4.Typical COP Washer C-P Confidential 112 Version 1. Figure 84 . cleaning temperatures and cycle times (Section 3.0 GL1_v1.4).3. 9.1. PROTOTYPE CLEANING REGIMENS A major component in the selection of a CIP skid is the development of the cleaning cycle itself.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.5). clamps.

Refer to the GL1 Appendix 14.2. 9.7 for a sample COP skid specification. Specifications for these individual components should be used from CIP Component Specification Section 9.1.0 GL1_v1. GUIDELINE COMPONENT SPECIFICATIONS Components for a COP skid such as valves.2. components selection.3. heat exchangers. piping.1. 9. Equipment and Piping Design Criteria 1 Figure 85 .doc 4/6/01 Printed on 03/15/02 .0 1.3. NATURE OF THE SOIL • Is the soil water-soluble? Typical COP cabinets are for aqueous based cleaning.4.COP Recirculation Action 9.4. and instruments are similar to CIP skids. pumps.4. C-P Confidential 113 Version 1. this time with COP equipment impact listed for each category. SELECTION CRITERIA Although the design characteristics of a COP system are quite different than a CIP system.3. The criteria used for CIP selection is also listed below. If solvents or flammable cleaning agents are required a custom unit will be required. Cleaning and Sanitization Guideline No. This impacts materials of construction. and operator safety. the process of selecting the proper equipment is must the same.

9. • Is the soil fresh. Ultrasonic cleaning action may also be an option for small parts that cannot be easily disassembled. baskets. These can be delivered via a CIP system or they can be dedicated to the COP unit.doc 4/6/01 Printed on 03/15/02 . Steam heat exchangers are typically used for rinse solutions where water needs to be heated quickly or in a single pass. or wash solutions are beneficial to be heated. Custom racks. The recirculation capability allows for additional mechanical action to aid in removal of soil though agitating jets and nozzles. cleaning agents (chemical addition) or impingement (higher pressures) for cleaning. • What chemistry releases soil from the equipment surface? This will determine if chemical cleaning agents will be needed to supplement cleaning.4. EQUIPMENT BEING CLEANED • Is the equipment designed for COP? If the equipment is not designed to be cleaned in a COP unit. If cleaning agents are needed. dried on. monthly. this may lead the COP design to a system that relies more heavily on time (recirculation). or yearly? Components that are cleaned very frequently demand a more rugged COP unit that has been specifically designed to accommodate these items. or if water alone will suffice. PROCESS AND PRODUCTION ISSUES • Frequency of cleaning: daily.3. 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. 9.2.3. Cleaning and Sanitization Guideline No. or cooked on to the equipment surface? If the soil will be dried on or cooked on. chemical delivery system will be required. See Figure 85. weekly. Electric sump heaters are often used to maintain wash solution temperatures during cycle. then it will likely have intricate or complicated components that require disassembly or additional agitation.3. • 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. Components that C-P Confidential 114 Version 1. then a recirculating skid with chemical capability would be appropriate.0 1.0 GL1_v1. Equipment and Piping Design Criteria 1 • What is the optimum rinse temperature? Heat exchangers are common on COP units where rinse.4.

4. • Type of Chemical? Although the specific chemical may not be known at the time of specifying the CIP skid.3. Cleaning and Sanitization Guideline No.4.0 GL1_v1. such as water. the class of chemicals (acid. 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. • Location of available utilities? The location of available utilities. etc. C-P Confidential 115 Version 1. Most skids will allow for at least two chemicals. 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. etc. This will effect design decisions on where to inject the chemicals. 9. purified water steam and compressed air may also impact the COP skid configuration. • 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.0 1. Equipment and Piping Design Criteria 1 are only cleaned a few times a year can stand to have more time spent on set-up and preparation for cleaning.4. 9. as the same cleaning chemicals are often used for these systems.doc 4/6/01 Printed on 03/15/02 .3. This may impact the number of tanks required for the skid. even if one chemical is proven to be effective for the anticipated soils. or in some cases a separate rinse line feeding the cabinet. • What is the facility steam pressure and capacity? If heated solutions are required. caustic. Water used or final rinse steps should be consistent with the grade of water used in the formulation or manufacturing process. whether they can be mixed or if separate wash tanks will be needed.) that will be utilized should be established. the available steam pressure and capacity will need to be known in order to properly specify the heat exchanger and control valves.5.

7. etc. lab support)? The control philosophy used for the COP skid should also match the capabilities of the plant personnel. Manual systems will require more operator intervention and sign-offs. 9. engineering. 9. This will affect the type of control system used to meter in the chemicals. providing all control functions and delivering cleaning solutions to the controllers. and should be considered within the skid specification. • How are chemicals stored? Details for the supply of chemicals to the skid are a part of the design. Several items should be considered regarding the selection. timed cycles with sequential cleaning and rinsing steps just like a CIP skid. 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.4.3. non-automated parts washers. maintenance access. Chemical delivery pump selection will depend on the storage container type.3. Equipment and Piping Design Criteria 1 • Concentration of chemical? The concentration (range) of the chemical. In many cases. Some automated batch type units can provide printouts documenting the successful completion of a cycle.4.0 1. so long as it does not compromise the validatability of the system. COP systems can provide fully automated.4. and the accuracy required to measure the concentration should be established. Cleaning and Sanitization Guideline No. One way of managing this control is to have the CIP system serve as the brains of the COP controllers. • Skill level of cleaning personnel (cleaning. The same criteria for evaluating a CIP skid should be used for analyzing the adaptability of a COP skid into an existing plant. This can be true and it can also be desirable. the more automated the system.doc 4/6/01 Printed on 03/15/02 . the more repeatable the cleaning cycle. 9. maintenance. STORAGE RACKS Storage is an extremely important aspect of cleaning manual components.4. placement and use of storage racks and cabinets: C-P Confidential 116 Version 1. location. However. LEVEL OF AUTOMATION • Type of automation used for process equipment? COP skids are thought to be very simple.0 GL1_v1.6.

0 1. however assure that components do not drip on other clean and dry parts on shelves below C-P Confidential 117 Version 1.doc 4/6/01 Printed on 03/15/02 .0 GL1_v1. 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. Cleaning and Sanitization Guideline No. Equipment and Piping Design Criteria 1 • Dirty and clean components should be segregated on separate racks. 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. in separate rooms if possible • Racks should be constructed of easily cleanable materials.

as shown in Figure 86.doc 4/6/01 Printed on 03/15/02 . and the CIP skid itself comprise the cleaning “circuit. or they can be very long and complex sections of transfer piping between unit operations. the line from the raw material tank to the mixer should be cleaned with the raw material tank.” Cleaning circuits can be very small.. • Isolate circuits using physical breaks (transfer panels. • Clean line segments with tanks when possible. • Avoid tees and branch circuits. 10. Return pump alternatives are discussed below. 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. • Always have a physical break or 2 valves between pressurized cleaning solutions and the product. but on the other hand hundreds of very small circuits can also create timing and utility problems during start-up. The CIP system should be as validatably clean as the process itself. as it is difficult to validate split flow paths.0 CIP PIPING SYSTEMS 10. The combination of the supply piping. These complex circuits can be very difficult to clean and validate.2. e.1. The valving to divert cleaning or sanitizing solution between multiple pieces of equipment on a circuit should be designed to minimize dead legs. swing-elbows) or valves in order to optimize their size and complexity.. raw material tank and a mixer should be cleaned separately. it is best to segregate cleaning circuits based upon a few primary guidelines: • Separate circuits based upon process unit operations whenever possible.g.0 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.0 GL1_v1. the return piping. isolated piping sections around a piece of process equipment. C-P Confidential 118 Version 1.g. the component (piping or equipment) being cleaned. Use block and divert valves to sequence cleaning through these paths. Equipment and Piping Design Criteria 1 10. Cleaning and Sanitization Guideline No. In general. e. validation and operation.

Proper velocities (5 ft.0 1./sec) must be maintained in both the process lines and the CIPS/R lines in order to maintain turbulent flow for effective cleaning.3. Cleaning and Sanitization Guideline No. Reference flow tables in the Appendix Section 1.11.Tank CIP Circuit 10. without the use of an additional pump.doc 4/6/01 Printed on 03/15/02 .Process Line Circuit C-P Confidential 119 Version 1.0 GL1_v1. RINSE RECIRC CIP SKID (SIMPLIFIED) TRANSFER TRANSFER PANEL PANEL Figure 87 . 1 Equipment and Piping Design Criteria Minimum dead leg RINSE RECIRC CIP SKID (SIMPLIFIED) Figure 86 . 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.

as it is typically unacceptable to deliver drums of cleaning solution into the process room C-P Confidential 120 Version 1. if a system can be located in a basement. COMBINATION CIRCUITS In some cases. Figure 88 – Tank & Piping CIP Circuit 10. When CIP systems are located in process areas. then gravity return becomes an option.4. in a remote location for a single skid. Tank circuit Piping circuit RINSE RECIRC CIP SKID Although return (SIMPLIFIED) pump is needed for tanks and not for piping. if a CIP skid is located within a process area a remote chemical delivery is preferred. it may be desirable to locate the CIP skid very near or even in the same room as the process equipment. Again. The chemical delivery system can also be located directly at the skid.5. it can be left in the circuit when piping is cleaned. The location of the skid will largely dictate the return options as described in the next section. If a system is only designed to clean circuits in a small area.0 GL1_v1. or as a central system with a distribution system to multiple CIP skids. Cleaning and Sanitization Guideline No.doc 4/6/01 Printed on 03/15/02 . a return pump will already be in the path of a piping circuit. For example. it is acceptable to have the second pump (CIP return) in series with the CIP supply pump as shown in Figure 88.0 1. Equipment and Piping Design Criteria 1 10. RELATIVE CIP UNIT LOCATION CRITERIA CIP skids can be located in many areas relative to the cleaning circuits. as it was used to clean a tank. If centrifugal pumps are used. even the framing. more attention is given to assuring the CIP skid is designed with cleanable exterior surfaces.

The four primary methods of returning are pumps. Mechanical air vents can be added to the suction side of the return pump to reduce the air. it may be acceptable to let the return pump cavitate.3. 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 C-P Confidential 121 Version 1. Variable speed drives are typically not effective in return pump application due to the constantly fluctuating flow rates. 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.doc 4/6/01 Printed on 03/15/02 . and are the recommended pump or CIP return at CP. Self-priming liquid ring pumps (see Section 9. Cleaning and Sanitization Guideline No.6. RETURN OPTIONS For recirculating tank circuits.4) will help to maintain this prime throughout the cleaning cycle. or overpressure. Vortex breakers in the process vessel can help this problem. but some vessels cannot use these devices due to process constraints. 10. Equipment and Piping Design Criteria 1 10. This is also compounded by the fact that the return rates are as high or higher than the supply rates. and can operate at very high flow rates and distances. the pump must be oversized (up to 50%) as necessary to maintain suction and prime. They can be applied to a wide variety of cleaning systems.1.6. 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.0 GL1_v1. but these devices create an additional cleaning concern and will only reduce the air.0 1. gravity. an additional motive force is required to return solution back to the skid. as there is typically a great deal of air entrained in the cleaning solutions exiting process tanks and equipment. not eliminate it. In this case.2. In some cases. eductors. RETURN PUMPS Return pump systems are the most common type of CIP return.

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.2.doc 4/6/01 Printed on 03/15/02 . and distance • Larger return lines are required 10. Return flow must be adequate to provide suction head to the supply pump. which may not be sanitary • Applications are limited in flow rates. GRAVITY RETURNS Gravity return works when the vessels being cleaned are located above the CIP system.6. this system will not work effectively at temperatures above 150°F (65°C).0 GL1_v1. temperature.6.0 1. 1 Equipment and Piping Design Criteria 10. Due to the venturi effect of the eductor. EDUCTOR RETURNS Eductor returns use suction to draw return flow back to the CIP tank (See Figure 89). 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. C-P Confidential 122 Version 1.3. and line design must be carefully evaluated for proper drainage and cleaning (See Figure 90). Cleaning and Sanitization Guideline No. The water levels in the tanks must be maintained to prevent cavitation of the motive pump.

0 1.Gravity Return System Advantages: • Low capital and installation costs • Low maintenance Disadvantages: • Limited applications based upon location (elevation.6.doc 4/6/01 Printed on 03/15/02 . OVERPRESSURE If the process tanks are pressure vessels. C-P Confidential 123 Version 1. 1 Equipment and Piping Design Criteria RECIRC RINSE CIP SKID (SIMPLIFIED) Figure 90 .4. and the tank will need a regulated clean air or nitrogen source (See Figure 91). The return line requires a blocking valve to maintain hydraulic balance of the system. Cleaning and Sanitization Guideline No. distance) • Drain times will be longer • Difficult to get turbulent flow in CIP return lines 10.0 GL1_v1. a constant pressure can be applied on the vessel during the CIP cycle to provide a pressurized return.

Eductors are also used in conjunction with gravity and overpressure systems for the same reasons. 10. water for "cleaning operations" must at least comply with CP FEED water specifications as per TIL 98-030. Overpressure is often combined with remote return pumps in order to help get a faster time.0 1. Cleaning and Sanitization Guideline No.4) provides a more in-depth background on the characteristics of various cleaning solutions used for CIP. CHEMICALS FOR CLEANING GL2 (Section 3.7.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 10.5. Equipment and Piping Design Criteria 1 CCA CCA RECIRC RINSE CIP SKID (SIMPLIFIED) Figure 91 . there are many combinations of these systems that may be effective for a specific situation.6. C-P Confidential 124 Version 1.doc 4/6/01 Printed on 03/15/02 .5. Regardless of the chemicals used.1. COMBINED RETURN SYSTEMS In addition of the four basic systems described.0 GL1_v1.

Cleaning and Sanitization Guideline No.
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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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Equipment and Piping Design Criteria 1 Since clean steam has the same aggressive properties of high purity water. the corresponding saturated pressure is 15 psig (1 bar). piping slope may be reduced to minimum of 1/8” per 1’-0”. flanged and threaded connections are not recommended and should only be used if there is no alternative. For new applications. Piping shall be sloped to provide complete system drainability. this can be accomplished through proper piping by venting air though system traps. as they are a potential source of contamination. with maximum Rockwell B hardness of 90.doc 4/6/01 Printed on 03/15/02 . Although it is necessary to remove air from the system to avoid cold spots. An internal surface finish of 20 to 25 µ inch Ra will be sufficient for clean steam service. Where necessary due to physical constraints. ATMOSPHERIC STEAMING It is recommend that sanitization using clean steam occur at 250°F (121°C) for 20 minutes.2. 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. Clean steam systems however are by nature clean systems. stainless steel sanitary seamless (1/2” and smaller) or weld-seam (3/4” and larger) per ASTM A270. Piping specifications and requirements will be similar to those for purified water. they will never see cleaning solutions since there is no product held up in the line that needs to be flushed out. non-electropolished internal finish • Minimized dead legs Austenitic stainless steels are the most common material used at CP for product contact surfaces. Electropolishing tubing makes it easier to clean and therefore makes good sense for process lines. 11. it should be treated in a similar manner. Install piping at 1/4” per 1’-0” slope in the appropriate direction. While most process designs using stainless steel tubing will require electropolishing the internals of the tubing. it is not necessary in clean steam systems. Cleaning and Sanitization Guideline No.0 1.0 GL1_v1. All removable connections used should be “tri- clamp” style connections. Therefore to achieve a good “driving force” between the steam temperature and the required equipment C-P Confidential 128 Version 1. drawn and bright annealed. 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 µinch Ra. PRESSURE VS. specify type 316L. All tubing shall meet the requirements of ASME BPE 97.2. All stainless steel tubing should be installed using orbital welding machines with an internal argon purge during welding.

0 GL1_v1. 11. The most common solution is to install a “blow down cooler” in the discharge line before the hot condensate enters the sewer system.2.4. and is not to be reused by a plant steam system. Air that is not removed through the steam traps can be vented from the system at the equipment being sterilized. A good design pressure for a clean steam system is 30 psig (2 bar). 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. 11. It is usually much hotter than the city would allow and will quickly damage materials in and around the sewer. Hot water sanitization should be sufficient for atmospheric vessels in a non-pharmaceutical application. Air can be removed from the system in several ways. such as at agitator and pumps shafts. A typical solution in the pharmaceutical industry is to let air escape through the vent filter of a process vessel during sanitization. Clean steam condensate which has been contaminated by product (not end of main drips) should be sent to drain.2. MECHANICAL SEALS Mechanical seals. AIR REMOVAL Air pockets in the clean steam system can lead to isolated “cold spots” and as a result will increase sanitizing cycle times. The possibility of cross contamination exists anytime that a sanitary system is hooked directly into a non-sanitary one.2. are prone to failure during a steaming cycle. and control valve losses while still supplying steam to the equipment at the required pressure. TRAPS C-P Confidential 129 Version 1. Atmospheric steaming is not recommended since the change in pressure will cause the steam to condense and create “cold spots” within the equipment. All condensate should be removed through the use of steam traps. Cleaning and Sanitization Guideline No. it is recommended that the equipment sanitization pressure is 15 psig (1 bar) or higher.doc 4/6/01 Printed on 03/15/02 .5. this will allow for line. 11. the seal must be rated for at least 260°F (130°C) for intermittent steaming applications (as opposed to continuous operation). Condensate cannot usually be discharged directly into the sewer system.0 1. Equipment and Piping Design Criteria 1 temperature.2.6. this will ultimately result in poor sanitization. 11. which will be discussed later in this section. and will be addressed later in this document. This means pumps and agitators that were run during a CIP cycle should not be operated during a pressurized steam cycle. as it will degrade the seal under these conditions. The shaft should also not be turned during the steaming operation. Tubing should be sloped to the steam traps to aid in drainability of the condensate from the system. First.3.

0 1. Cleaning and Sanitization Guideline No. 1 Equipment and Piping Design Criteria Steam traps should be located at system low points and after process equipment.Sanitary Trap Configurations C-P Confidential 130 Version 1.doc 4/6/01 Printed on 03/15/02 . 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 .0 GL1_v1.

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.0 GL1_v1. 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. 1 Equipment and Piping Design Criteria 11.0 1. DRIP TRAPS A thermostatic trap should be used for all drip trap applications. Cleaning and Sanitization Guideline No.1.doc 4/6/01 Printed on 03/15/02 . even at very low loads. C-P Confidential 131 Version 1.Sanitary Steam Trap Spraix Sarco thermostatic steam trap 11. and the valve remains hot at all times in steam service so bioburden remain in control. Additionally. 11. the diaphragm itself will quickly break down during the extreme conditions of steam service. Thermostatic traps have a high steam leak rate that allows constant movement of steam through the distribution system. Impurities in the equipment being cleaned will collect in the steam trap downstream from the equipment. VALVES Isolation and on/off valves should be stainless steel ball valves.6. 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.6.2.2. and therefore it will need to be cleaned often.2. This will prevent stagnant unsanitary areas within the piping.7. Figure 93 .2.

3. drawn and bright annealed. specify type 316L. PURITY.0 and 7.2. Equipment and Piping Design Criteria 1 11.not more than 0. non-electropolished internal finish • Minimized dead legs Austenitic stainless steels are the most common material used at CP for product contact surfaces.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.doc 4/6/01 Printed on 03/15/02 .0 Conductivity – Will meet USP XXIV requirements TOC . 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 µinch Ra. Industry standard values for WFI quality and purity are as follows: pH . STEAM FLOW CONTROL Steam flow and pressure control can be accomplished using sanitary control valves by Cashco or equivalent sanitary control valves. CHEMICAL TREATMENT The FDA defines “Clean Steam” as steam that when condensed meets the requirements for WFI (Water For Injection). Drip traps should be installed before and after these valves (many styles are angle seated) in order to eliminate condensate n the lines. C-P Confidential 132 Version 1.8.0 GL1_v1. HOT WATER 11.Less than 500 ppb Bacterial Purity . 11.1.9.not more than 10 cfu per 100 ml Bacterial Endotoxin . 11.2.3. QUALITY. It follows then that clean steam should be held to the same quality and purity requirements as WFI.between 5. For new applications.0 1. Cleaning and Sanitization Guideline No. stainless steel sanitary seamless (1/2” and smaller) or weld-seam (3/4” and larger) per ASTM A270.

All tubing shall meet the requirements of ASME BPE 97. As long as the cycle is validated. it is not necessary in hot water systems. These variables should be monitored and recorded for each sanitization cycle.0 GL1_v1.3.2. Install piping at 1/4” per 1’-0” slope in the appropriate direction. Piping shall be sloped to provide complete system drainability. or it can be a pass-fail indication based upon instrument readings. Where necessary due to physical constraints. Controls will be provided to monitor. Electropolishing tubing makes it easier to clean and therefore makes good sense for process lines. An internal surface finish of 20 to 25 µinch Ra will be sufficient for hot water service. Equipment and Piping Design Criteria 1 with maximum Rockwell B hardness of 90. System backpressure will be maintained in each loop by pressure control valves installed in the return loop piping. While most process designs using stainless steel tubing will require electropolishing the internals of the tubing. If the instruments can verify that the temperature was reached and held for the required time. and will be provided with a single pump and an uninstalled spare. C-P Confidential 133 Version 1.3. they will never see cleaning solutions since there is no product held up in the line that needs to be flushed out. All removable connections used should be “tri- clamp” style connections. Sanitization systems however are by nature clean systems. a printout stating that the cycle was successfully completed is perfectly acceptable. TIME/ TEMPERATURE MONITORING The success of a hot water or steam sanitization cycle depends on achieving a specific temperature for a specific time. Cleaning and Sanitization Guideline No. control. QUALITY REQUIREMENTS The water system will continuously recirculate. and will usually be operated at atmospheric pressure. 11. The storage tanks will be ASME designed vessels.3. SUPPLY SYSTEM. there is no requirement for trending. Sterile vent filters (0. In a completely manual operation with no instrumentation. All process connections to the tanks will be sanitary clamp. the operator should be required to take readings to assure that the temperature reaches the required levels and is held for the required time. piping slope may be reduced to minimum of 1/8” per 1’-0”. 11.0 1.doc 4/6/01 Printed on 03/15/02 . flanged and threaded connections are not recommended and should only be used if there is no alternative. This can be captured from of a trend chart that shows actual time/temperature relationships for the duration of the cycle. All stainless steel tubing should be installed using orbital welding machines with an internal argon purge during welding.2 micron) will be provided at each tank. and alarm head pressure and water level.

centrifugal pumps with single mechanical seals.0 1. In clean areas or areas where maintenance activities could damage the insulation. water for "cleaning operations" must at least comply with CP FEED water specifications as per TIL 98-03.0 GL1_v1. ridged insulation with a PVC jacket will be used.U-bend Use Point Drop for Purified Water 11.doc 4/6/01 Printed on 03/15/02 . Equipment and Piping Design Criteria 1 The pumps will be sanitary. In non-process areas the distribution piping will be insulated with non-chloride fiberglass insulation with an all-purpose jacket. CHEMICALS FOR SANITIZATION GL2 provides a more in-depth background on the characteristics of various sanitizing solutions used for CIP. Figure 95 below shows a comparison of various sanitizing agents and their relative effectiveness against different organisms. 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.4. Cleaning and Sanitization Guideline No. C-P Confidential 134 Version 1. Regardless of the chemicals used. Figure 94 .

0 1.0 GL1_v1. Cleaning and Sanitization Guideline No. providing an added advantage for porous surfaces.2. QUATERNARY AMMONIUM COMPOUNDS Quaternary ammonium compounds.1.doc 4/6/01 Printed on 03/15/02 . frequently called quats.1.4. Calcium hypochlorite and sodium hypochlorite are the major compounds of the hypochlorites. 11. They are natural wetting agents with built-in detergent properties and are referred to as synthetic surface-active agents. These sanitizers are effective in deactivating microbial cells in aqueous suspensions and require a contact time of approximately 1. furnishing and equipment. walls.1.1. C-P Confidential 135 Version 1.4.4.5 to 100 seconds. Equipment and Piping Design Criteria 1 Figure 95 .Sanitizers 11. TYPES 11. Quats are good penetrants. HYPOCHLORITES Hypochlorites are the most active of the chlorine compounds and are most widely used as a chemical sanitizer. are used most frequently on floors.

Acid Anionic Sanitizers Acid-anionic sanitizers. PAA is an effective biocide without toxic residuals. prevents formation of alkaline deposits and sanitizes. The acid neutralized excess alkalinity that remains from the cleaning compound (if one is used). It can be supplied from Henkel/Eco Lab with the Oxonia brand name. stainless and tin plated iron are resistant to PAA. and some rubber.4. These sanitizers can be corrosive to unprotected metals. plastics. They have good stability. Cleaning and Sanitization Guideline No. but plain steel. Equipment and Piping Design Criteria 1 11.3. Acid Anionic sanitizers act rapidly and kill a broad spectrum of bacteria.0 1. effective in a wide temperature range. It can also be supplied at higher concentrations but CP has no experience at the higher concentrations. They are stable in dilutions in the presence of organic matter and at high temperatures. such as phosphoric acid.doc 4/6/01 Printed on 03/15/02 . This sanitizer is corrosive to non-stainless steels. PAA remains effective at slightly increased concentrations in the presence of organic matter. copper. lactic. Carboxylic Acid Sanitizers Carboxylic acid sanitizers are effective over a broad range of bactericidal activity. broad-spectrum kill. and formic acid. works on the oxidation principle through the reaction with the components of the cell membranes. such as acetic. propionic.0 GL1_v1. PAA can function at low temperatures as well as high temperatures. and not affected by water hardness. galvanized iron.1. Organic acids. peroxyacetic. PAA is affected by pH with greater activity at lower pH. an organic or inorganic acid with a solubilizer and with or without a small amount of nonionic surfactant. C-P Confidential 136 Version 1. brass. PAA should be stored at ordinary temperatures (preferably cool) in original containers. are formulated with low levels of anionic surfactant. They are non-corrosive to stainless steel. Pure aluminum. from DeGussa with Peraclean 5% brand name. provide a good shelf life. CP has successfully used a blend of 5% peracetic (peroxyacetic) acid and 25% hydrogen peroxide as a sanitizer. and from FMC with Vigorox brand name. are most frequently used. Peroxyacetic Acid Sanitizers Peroxyacetic acid (PAA) sanitizers provide a rapid. are cost effective and act as a sanitizer and acid rinse. and bronze are susceptible to reactions and corrosion. ACID SANITIZERS Acid sanitizers are considered to be toxicologically safe and biologically active.

and moderate temperature (to prevent freezing of liquid products). Alcohols have a cleansing action and evaporate readily. Equipment and Piping Design Criteria 1 11. The three common types of alcohols associated with sanitizing are Methyl.doc 4/6/01 Printed on 03/15/02 . SAFETY AND HANDLING Handling and storage of all cleaning compounds fall under the CP safety guidelines. Ozone needs to be generated on-site as needed for disinfection and sterilization. MSDS of all sanitizing compounds should be readily available. with dry floors. Guideline 6 – Validation describes the analytical C-P Confidential 137 Version 1. Bactericidal action of isopropyl alcohol is slightly greater than that of ethyl alcohol.4.5. OZONE Ozone is more stable in gas phase than is aqueous phase.4. ALCOHOLS The use of alcohols as a sanitizer has been appreciated for centuries for their antiseptic qualities. Ozone is an effective inactivation agent for bacteria. Methyl alcohol has the weakest bactericidal action of the alcohols and is seldom considered for use as an antibacterial agent. or directly into a recirculating wash tank. Cleaning and Sanitization Guideline No. Ozone is known to be a more effective bactericide and virucide than chlorine and chlorine dioxide. All personnel should be trained for the proper use of all cleaning compounds and supplied with appropriate safety clothing. Ethyl and Isopropyl alcohol. or storage racks to keep the containers off of floors.2.4.4.4. Dosing concentrations are typically measured using on-line conductivity.3. MONITORING FOR RESIDUAL LEVELS At the completion of the sanitization cycle.0 GL1_v1. This area should be equipped with pallets. 11. 11. Alcohols are relatively inexpensive. the sanitizing agent must be removed to predescribed acceptance levels. 11. DOSING Chemicals may be injected into the process line via a pump or eductor.1.4. Sanitizing compounds should be stored in the area remote from normal plant traffic. 11. Preferred pumps for this service are double diaphragm pumps or magnetically coupled rotary gear pumps suitable for service with the selected sanitizing agents. easily manageable and relatively nontoxic with topical application.0 1.4. skids.1. along with all necessary emergency phone numbers.

achievable. and should be tied to the initial validation approach and acceptance criteria.doc 4/6/01 Printed on 03/15/02 . such as pH. On-line monitoring.0 GL1_v1. C-P Confidential 138 Version 1.0 1. and verifiable acceptance criteria. Cleaning and Sanitization Guideline No. Equipment and Piping Design Criteria 1 methods used for detecting residual cleaning agents. TOC or conductivity is recommended in many instances. as well as guidance on establishing practical. The degree of on-line monitoring depends on system variables and repeatability.

pigging. COMPONENTS Process Compressed Air Filter feeding the CIP line shall be a 0. Compression fittings are acceptable for use in gas systems for process use. PIPING Piping used for process air systems is preferred to be stainless steel tubing. that comes into contact with the product be designed with some sanitary considerations. process or clean compressed air should be delivered with a dew point of -60°F (-51°C) and condensed hydrocarbons of 5 Mg/m3 or less. C-P Confidential 139 Version 1.2. Filter body shall be line size. Provide vertical clearance so that filter may be changed within available headroom requirement. The maximum allowable pressure drop shall be 5 psi (.5 Bar) across filter. 316L SS housing. or Viton.0 GL1_v1. 12. Cleaning and Sanitization Guideline No. and documentation should be appropriately scrutinized. Equipment and Piping Design Criteria 1 12. 12. These systems should be validated as critical systems and therefore system design. PROCESS AIR CRITERIA Process air used for pressure transfers. gasket materials of Buna. Avoid in production areas as cleaning chemicals will discolor and degrade the exposed copper.3. interior polish of 25 µinch. Sweat fittings will deposit solder and flux which will cause the system to have unacceptably high hydrocarbons after start-up. EPDM. For sanitary applications.0 1. Supply mounting plate on tank. Vent filter shall be mounted to tank outlet by means of a sanitary connection.2-micron vent filtration unit.0 COMPRESSED AIR SYSTEMS 12.1.doc 4/6/01 Printed on 03/15/02 . CCA supply pressure shall be 60-80 psi (4-6 Bar). Copper tubing may be used upstream of final filters or in non-production areas if the system is brazed as opposed to sweat. component selection. etc.

could more consistently meet these values within the distribution system. this system might be a perfectly acceptable solution to consistently providing the quality of air needed for the process. etc.doc 4/6/01 Printed on 03/15/02 . There is no filtration in the distribution system. 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. Cleaning and Sanitization Guideline No. but each user has a point of use filter at the take-off from the main. depending on the acceptance criteria for hydrocarbons.0 1. This system uses a compressor that is not oil free but follows with a coalescing filter after the receiver. 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. particulate. However. moisture content.. The system above could only meet these criteria after the final filter. C-P Confidential 140 Version 1.0 GL1_v1. and should not be ruled out due to a hastily derived validation sampling plan. Equipment and Piping Design Criteria 1 Figure 96 –Clean Compressed Air System Figure 96 shows a typical compressed air system used in the Food and Dairy industry.

ROOM FINISHES 13. this section provides a brief overview of some of the primary areas of concern for C&S in processing areas.doc 4/6/01 Printed on 03/15/02 . however. and capable of withstanding repeated exposure to sanitizing agents (e. In general.0 GL1_v1. However.0 1.0 PROCESS ROOMS AND OPERATING AREAS 13.3. bleach. OVERVIEW The intent of these Guidelines is to focus on equipment. For more specific design criteria. quaternary ammonium. In these areas the facility must be designed and operated to GMP standards in order to minimize contamination of the product. the grit must not inhibit cleaning.3. where these surfaces are necessary ensure that they are easily accessible for cleaning • Avoid tight areas for equipment and piping placement. and specifically the processing areas where product is exposed to the surrounding environment. A light grit may be incorporated into the flooring surface to enhance traction when wet. extensive use of open tanks or manual cleaning of closed tanks necessitates increased cleanliness of the surrounding process area. easily cleaned.2. consult the category engineers. 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. phenols). Corners and wall junctions should be caulked to facilitate easy cleaning and strengthen the floor to wall transition. The facility. Equipment and Piping Design Criteria 1 13. Cleaning and Sanitization Guideline No. OPEN PROCESSES – DOS AND DON’TS General Guidelines for facility design in Open Processing areas: • Minimize horizontal surfaces where possible. 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. C-P Confidential 141 Version 1.g. also has an impact on cleaning and sanitization.1. alcohol.1. provide protective screens where needed in filling areas • Train operators in room cleaning procedures and document the training 13. FLOORS Floors should be an impervious material. 13.

etc. C-P Confidential 142 Version 1.0 GL1_v1. alcohol. For process rooms with minimal product exposure. and wall to ceiling transitions. Cleaning and Sanitization Guideline No. Equipment and Piping Design Criteria 1 Pads of similar construction to the floor should elevate equipment.g. quaternary ammonium. Wall junctions will be caulked to facilitate easy cleaning and strengthen the wall to ceiling transitions. tanks. from the floor for easy cleaning.g. 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. bleach. differential pressure..Equipment Pads 13. stairs.C. Figure 97 . All protrusions into the room such as electrical outlets. bleach.2.0 1. light switches.. wall to wall. phenols). alcohol. These ceilings are not acceptable for hose-down applications. quaternary ammonium.3.3. etc. 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. 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. See Figure 97. 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.doc 4/6/01 Printed on 03/15/02 . plumbing fixtures. All protrusions into the room such as sprinklers and light fixtures will be sealed. should be sealed. phenols). 13. The ceiling must be capable of withstanding a minimum of 15 mm W.3.

closing with all concealed mechanisms and hardware. bleach.doc 4/6/01 Printed on 03/15/02 . protruding corners. Cleaning and Sanitization Guideline No. and adequate clearance is maintained on 1. phenols). alcohol. 13.6. bleach. Door will be self. quaternary ammonium. easily cleaned. Equipment is often placed so that maintainable components are located on the front for easy access.. WALL GUARDS Wall guards are required for all exposed. 13.C.3. If the room or item is to be cleaned. quaternary ammonium.5. and capable of repeated exposure to sanitizing agents (e. tanks or other equipment to be used in the process area. Wall guards will be capable of withstanding repeated collisions with the carts.0 1. LIGHT FIXTURES All fixtures will be mounted flush to the ceiling and sealed. 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. the equipment is then placed 6” (150 mm) or so from a wall. VENTILATION Minimum room air pressure differentials should be maintained. the minimum recommended HVAC criteria for processing spaces at CP facilities is: • Positively ventilated C-P Confidential 143 Version 1.5. but also for cleaning. In general. 13. bleach. ACCESS Access should be left around equipment not only for operations and maintenance.4. Unfortunately. Doors will be capable of withstanding repeated exposure to sanitizing agents (e. All exposed surfaces will be smooth and easily cleaned and be capable of withstanding repeated exposure to sanitizing agents (e. GMP inspectors will quickly cite areas that are claimed to be manually cleaned or wiped down. quaternary ammonium. 13. differential pressure with minimal leakage when fully closed. phenols).0 GL1_v1. All exposed surfaces will be sealed and impervious to moisture. All doors will be equipped with windows installed in the upper half of the door. All wall guards should be smooth.4. leaving an area that cannot be adequately cleaned. DOORS Doors can be constructed of epoxy painted steel or fiberglass.3. Equipment and Piping Design Criteria 1 13.g. The best examples of this are the areas between tanks or equipment and walls.. 2 or 3 sides.g. phenols).3. but cannot be accessed. alcohol. alcohol. The HVAC design for processing and filling areas needs to be evaluated for each particular area.g. Doors will be equipped with static seals capable of allowing the door to withstanding 15 mm W.

Sinks and hose stations can be used in component prep areas where rough cleaning might occur. which should be coordinated with MET and local Plant Engineering. should be flow-through when possible (dirty to clean pass through). This causes people to rub against dirty equipment. Staging areas for dirty equipment should be provided (not in corridors). 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. walls. or hose stations. sinks. 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”. Powder operations should be isolated from final filling operations (powder operations in making areas is acceptable. References are available to assist in this analysis.6.doc 4/6/01 Printed on 03/15/02 . Equipment and Piping Design Criteria 1 • 95% ASHRAE filters • 10-18 air changes per hour Some CP process areas will require more stringent HVAC requirements. then equipment flow should be organized to manage the cross-contamination of flow from dirty to clean.12) Ventilation for Acceptable Indoor Air Quality. such as ANSI/ASHRAE Standard 62 (Appendix Section 1. C-P Confidential 144 Version 1. 13.2. Cleaning and Sanitization Guideline No. 13.6. 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.1. 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.6. raw material to final product. whether it is COP tanks.0 GL1_v1. MATERIAL Material should flow from dirty to clean. increasing the risk for contaminating a clean piece of equipment or the product itself.0 1. 13. given proper separations and controls). If this is not feasible. Washing. and each other. EQUIPMENT Clean and dirty equipment should be segregated where possible (See Figure 98). It is simply not acceptable to pack people and processes in a space that induces unsafe practices and is difficult to clean.

0 GL1_v1.3. 13. C-P Confidential 145 Version 1. 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. 1 Equipment and Piping Design Criteria DIRTY COMPONENT CLEAN STAGING PREP STAGING COP Figure 98 . hair. PERSONNEL Personnel flow should also be considered so as to avoid situations where operators or maintenance personnel can contaminate the product with their clothing.6.6. or exposed skin. Cleaning and Sanitization Guideline No.4. TRASH Solid waster and trash from production rooms should also be considered.doc 4/6/01 Printed on 03/15/02 .Equipment Flow 13.0 1.

.....0 CHAPTER OVERVIEW 9 1..0 GL1_v1..........1................................................. PROCESS TANKS 14........ INSTRUMENTATION 14..... KEY TERMINOLOGY .......0 GL1 APPENDIX 14.. 9 1........................ LIST OF TABLES 1.............8....5....... Equipment and Piping Design Criteria 1 14..4......4..... CPM – CONTROL POINT MONITORING .....doc 4/6/01 Printed on 03/15/02 ...................6.....................................................................................1....................... 11 1.........1....................2.......... 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........1................ Cleaning and Sanitization Guideline No...............2........... COP EQUIPMENT 14.............. 9 1........ 11 1.....3........................... CIP EQUIPMENT 14.................. PROCESS VALVES 14........ 10 1......4....3.........1.1................1......................................1.2......1........................1.... 14.................................................................................................1..... SPECIALTY EQUIPMENT 14.................. 13 C-P Confidential 146 Version 1........... TRANSFER PANELS 14............. 11 1.................... PRODUCT CONTACT SURFACE ......2...........1...... PROCESS PUMPS 14.. RELATED C&S GUIDELINES ............. 12 2................................................... 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......................4... OBJECTIVE ...... RELATED QUALITY PROGRAMS ....0 1........... SCOPE ..1................... MICROSUSCEPTIBILITY INDEX (MSI)............................0 STORAGE AND MIXING TANKS 13 2.........5...............7.........

........................................ 46 3........................ 18 2.................................... 29 2.......... SANITARY CENTRIFUGAL PUMPS ..................4......................... AGITATORS....... 43 2..........................................................................................................1......................... SANITARY ROTARY LOBE PD PUMPS ............................................7.. 22 2..................................................................... CONFIGURATION .............................9..........................1.... BAFFLES .....................9.....1.................................doc 4/6/01 Printed on 03/15/02 ......................... LOCATION AND SHADOWING ......................................1......................3.................................................................... 49 C-P Confidential 147 Version 1.................. GENERAL SANITARY REQUIREMENTS.....3............................... SANITARY PROGRESSIVE CAVITY PUMPS ........................0 GL1_v1...........3..............2..........4.............................................5. 19 2.......................2....................8................. SPRAY DEVICES .......................... WELDS ................................................................. VENTS ...............................9.........2........................................................ VALVE LOCATION.........................................3............................................ 32 2............................................................................. 35 2........ 43 2............................... CORNER DETAILS .......... TANK MANIFOLDS ...................................... IQ/OQ DESIGN REQUIREMENTS ........................... 15 2.....................2..6................................................................................................. 38 2..................................... 27 2.......................................................................................................... 40 2........2..................... 36 2.......................................................................................................................................................4......... 27 2.......... DEAD LEGS ............3...................2......3..................................... 23 2..............................3........... Equipment and Piping Design Criteria 1 2....................................7..................................... 33 2......................... INSTALLATION DETAILS ..........................................................................................1...............1.............6.......................... OVERFLOW AND BREATHER VENTS ........................1........................ 39 2..... MATERIALS OF CONSTRUCTION................................6...................... VALVES ........................7..3...................................................................................................8.....................4............................ Cleaning and Sanitization Guideline No........... 42 2.............................................5...................................... CIP BYPASS DESIGNS FOR PD PUMPS .............................. TANK INLETS ............... IMPELLERS ...................... 48 3........ SAFETY RELIEF VENTS .................. 33 2..........2...................................... SHAFTS ..................4........ 27 2................................................................................................. 13 2........................................................................................................... MANWAY ..2......1.....4................ 42 2.............................................. 44 2..... 32 2............ DRAINABILITY CRITERIA AND DRAIN RATES .................................................... VORTEX BREAKERS .......................................................................................................................................3..........7.....9.......................2.................... BOTTOM HEAD TYPES ............ SURFACE FINISH............................................ 33 2.....6........................................... INSTRUMENTS ..4..................................2................5.............. 22 2.................................8............................6...... MISCELLANEOUS NOZZLES.....................................................................................1..... TYPES ..........2....... NOZZLE SIZING FOR C&S ..... SAMPLE VALVES ...3... TANK OUTLETS ........ 17 2................ 37 2.............10......................................................... 18 2...............................................................1.............................. 45 3... DIP/DIVERT TUBES ........................................8....................................2.............. MATERIALS OF CONSTRUCTION .....9.............................................................. 46 3........................... SIGHT AND LIGHT GLASSES . 35 2........................................................... 31 2................. 21 2........1.................1...................................0 1.............2..................................5............................................... 46 3......... 47 3........ LOCATION .......1.........................3........ TANK CONFIGURATION ... 32 2. 38 2............................................................................... SEALS .........................................0 PUMPS 46 3................................ 33 2.........................................................................................................................................5.......................................................................................................................................1................................................................................................... TOP HEAD TYPES ...............................................................................................

.............. PIPING SPECIALTIES ...........................................0 VALVES 72 C-P Confidential 148 Version 1..4.................................................................................... SELECTION CRITERIA........4.....6................. 64 4.................................... FLEX HOSES ................................................................... 71 5......... SANITARY CLAMPS .................................2.......0 INSTRUMENTATION 67 5............3......... 67 5...............................7........................................................ GENERAL SANITARY REQUIREMENTS.................................................3............................................................................................................................................................. IQ/OQ DESIGN REQUIREMENTS... 51 4.................................... SURFACE FINISH...............................................................................................................................................................3...........2................................................2....3...... CONDUCTIVITY ...4......4........... PIPE SLOPE ............. U BEND TRANSFER PANELS ............................. 51 4......................................................................... 67 5............4............. 56 4........................................2.......5....................4.............1................................................................. 64 4.................doc 4/6/01 Printed on 03/15/02 ............................................................... PRODUCT CONTACT SURFACE .........3......................................... PROPELLANTS ..............1.........................2....................................................................................... PH & ORP.....1........................... IQ/OQ DESIGN REQUIREMENTS..........1. 69 5...................4........ 58 4...............3................... 67 5.......................................... 67 5............................. 55 4.................................. 51 4..... BEVEL SEAT FITTINGS ..........5...................... GENERAL SANITARY REQUIREMENTS............... 56 4...............1.................................................................... INSTALLATION .........0 1.............................................1...................8.....................................8.............. INSTALLATION DETAILS ................ FLOW ................ 51 4.......6...... TEMPERATURE .............................. STATIC MIXERS .. SURFACE FINISH................................. 51 4.................. 66 4.....................0 GL1_v1.................................... 63 4.. COMPRESSION FITTINGS .................................................................. 54 4............................... 71 5....................................2............................................... 70 5....................... MATERIALS OF CONSTRUCTION............ ELASTOMERS..............4........... SELECTION CRITERIA ................................................. 55 4.......................4..3...2........................................................... 59 4..................................................................................................9.......................................................................... 69 5...............................................................2...... PRESSURE ....... WELDS .................................2........ GASKETS .......... 56 4............................ Equipment and Piping Design Criteria 1 4...5. MATERIALS OF CONSTRUCTION.......................4..............5.................... PRODUCT CONTACT SURFACE ........7........................................................................7......3........ TEE ORIENTATION ...................................8.....................................................1............................................................................................................. 67 5...3........ 52 4........3.................................................................................................................................0 PROCESS PIPING 51 4....................................................................2.......2............................. JOINTS...................................... 58 4........... DEAD LEGS ......................................................4...................... LEVEL... PIGGING TERMINAL DESIGN FOR CLEANABILITY ................1.................................................................................................................................................5.........7....................................................................................................................... 63 4......5.................................................................. 66 5... QUICK-CONNECTS ...............................................1.......................5......2............ 60 4.............................3................... 54 4.................................................... 52 4..............2........................................... 56 4............................................................................... PIPE SUPPORTS ...................................................................................................................... 57 4.....3........6........ 67 5.. Cleaning and Sanitization Guideline No........................................................ 72 6.................................................................

..................................................................................................... Cleaning and Sanitization Guideline No. 75 6...... 82 8................................................................................................................ 83 8............................................................................................................................................................... BALL .......................................................... 85 8................................................................................................................. DIAPHRAGM ............ C&S APPROACH .............. MAGNETIC FLOW METER FILLERS .............................................................................. HOMOGENIZERS...............................3. HEAD TANKS ............................................ 86 8................................. C&S APPROACH ...........................3.................................................... OTHERS ...................0 1.........3. C&S APPROACH ...................................... 74 6.................................................7..........................2.........................................doc 4/6/01 Printed on 03/15/02 ......................1........................................................................................................................................................................................................ PRESSURE OVERFLOW FILLERS ....... FILTERS ... 83 8.............. FILLING EQUIPMENT OVERVIEW ............. HEAT EXCHANGERS...........2. 73 6............... NEEDLE ................................................ 89 C-P Confidential 149 Version 1......1................9....... PISTON FILLERS ............ 73 6.............1............................................6.......... 81 8...................................................................................... AIR SENSING FILLERS .......... 84 8............................. SURFACE FINISH.............................2................................................................................................................................3............. BUTTERFLY (WAFER) ................................... 85 8.............................................................................................2....................................................... 86 8.........................................................................................................................................................................................1........................ MATERIALS OF CONSTRUCTION..........................1........................... 76 6...........................................4......... 82 8... GENERAL SANITARY REQUIREMENTS...........................1.................. 78 7....... 78 7....................................................4.............................................1............. COMPRESSION ...........8.................................1............................................. 73 6....... 88 8........... 73 6......... SAMPLE ..........................3.........2.............................. MIXPROOF .3.....1...................................................................2..................... C&S APPROACH ................... CRITERIA FOR CLEANING CHANGEOVER TIMES ................................0 GL1_v1............2...........0 FILLING EQUIPMENT 81 8........................... POST ADDITION (PA) SKIDS .... 81 8......................................................... 78 7..........................................................1............................4... 77 6............................ 87 8................7.....................1.............................3............................... 80 8..................................... PRODUCT CONTACT SURFACE .................................6........................................... PUROLATOR .... TIME-GRAVITY & TIME-PRESSURE FILLERS ..4............................... 77 7.............. Equipment and Piping Design Criteria 1 6......................... 84 8....5................................... PLUG ..................3.................. 79 7....................................5..........................................................0 SPECIALTY EQUIPMENT 78 7...1...................3................... PIPING ...........................5............................................................ 87 8............... 76 6.........3........................3........................................................................... C&S APPROACH ...............................................6........................................ 72 6............. 88 8....................................................... WEIGHT FILLERS ....... 76 6...... 73 6.......................................................................................4.........................................1..........1.................1...2.............................................................................................................................................................. SELECTION CRITERIA....... 77 6............................................. 78 7..........................1....... CHECK .....................2...... C&S APPROACH ................................2.........3.....7.......1......3...............3.................1......................... NOZZLES ...1....3.................................................

...........................6.............3........................................................................4........................................2...... RELATIVE CIP UNIT LOCATION CRITERIA........3......... 98 9..................................2.................3.......................... SPRAY DEVICES......................................... FLOW VERIFICATION................................. OVERPRESSURE .............................................................................................................................................. DOSING ........... 125 10.........4.................................... 121 10.... SELECTION CRITERIA .........2....................................7......................................................5.......................................................... TYPES ............................................................. 102 9.................................................................... SELECTION CRITERIA ................3......... CIP SKIDS............ 118 10............. 120 10....... 120 10.................3................................... Cleaning and Sanitization Guideline No...................................................................................................3....................6.........................3.2....4............................................. TANK CIRCUITS ........................... 122 10..................... GRAVITY RETURNS ... SPRAY DEVICE LOCATIONS .............2. OVERVIEW – GENERAL DESIGN CRITERIA FOR CIP PIPING . 112 9.....................................4....................................................... 101 9............1... OVERVIEW – WHAT IS A CIP SYSTEM/SKID? ............................0 SANITIZATION SYSTEMS 126 11.2............................................................................................................................................. OVERVIEW – WHAT IS A COP SYSTEM/SKID ................................. RETURN OPTIONS ......doc 4/6/01 Printed on 03/15/02 ..................4.........................1............. Equipment and Piping Design Criteria 1 9....... OVERVIEW – CIP AND COP................................... 123 10..........................................4.............................3.........................................................................2........................... CHEMICALS FOR CLEANING ............ 119 10................................2................................... 113 9.........................3............................................. COMBINED RETURN SYSTEMS .......3....1..........................................................................................1....................................................6...........0 CLEANING EQUIPMENT 90 9..... PROTOTYPE CLEANING REGIMENS ............... RETURN PUMPS ..3.................................... OVERVIEW................................ MONITORING FOR RESIDUAL LEVELS ..... 112 9......4.........5................................................ CIP SKID SELECTION CRITERIA .............. SAFETY AND HANDLING ................................................................................... 122 10.3......................1................ GUIDELINE COMPONENT SPECIFICATIONS ....... 97 9........................................................................................................................6.............................4........................0 1...... 106 9.... 118 10............................................2........................................... COMBINATION CIRCUITS ...................... 98 9.............. 110 9..... 100 9.........................................7.....................0 CIP PIPING SYSTEMS 118 10....................................................7....... 90 9............................6......................2....5..... 112 9........................................................4......................................................................1................................2................................................... 124 10......................................................4..................................................................................2........5..................... 101 9....... EDUCTOR RETURNS .......2......... 91 9................ STORAGE RACKS ......................................0 GL1_v1..6...... LINE CIRCUITS ....... 94 9..... CIP SKID SELECTION CRITERIA .................. 126 C-P Confidential 150 Version 1........................................... GUIDELINE COMPONENT SPECIFICATIONS ................................4........................................... 116 10............7................................................................ 113 9....................7.................... 91 9.......................... 124 10........ COVERAGE CRITERIA (FLOW/ SURFACE AREA) ........................... SPRAY COVERAGE TESTING PROTOCOL FOR TANK VENDORS ......................... 126 10..........6.............................................................. COP UNITS ............. 126 10.............1. 121 10.1..................... TYPES ................... 126 11..............

................................................. 127 11............ 137 11.................................0 GL1_v1......... 133 11...... 139 13....................... 144 13............... 132 11........................... LIGHT FIXTURES .......................4.......................... OPEN PROCESSES – DOS AND DON’TS ...................3....... 129 11....................... SANITIZATION ................................................................................................................................................3.....1...... TIME/ TEMPERATURE MONITORING ........................ 129 11............................ ROOM FINISHES ............0 PROCESS ROOMS AND OPERATING AREAS 141 13..3...............................................................4.............................................................................. 126 11........................................................2..........3.............................................. TYPES ...............................................................................................4..................... Equipment and Piping Design Criteria 1 11....................2.................................0 COMPRESSED AIR SYSTEMS 139 12................. QUALITY.......................................................................4.................................................... MONITORING FOR RESIDUAL LEVELS ....................................3............. 144 13....... 131 11................ WALLS................ 144 13......................................... STEAM ......................2....2.............3.. 142 13...................................................................9..................................3..................................... 132 11............. DEFINITION OF SANITIZATION................................... PIPING ........4..................................3.. FACILITY FLOWS ................8.....................1....................... CLEANING VS......3.....................6.. 141 13...........................................................................................................3.....................2.........................................1........................................................ 143 13........... SUPPLY SYSTEM...... PURITY......................2......................... DOSING .............................................................................3..... 129 11........... DOORS .....1........... OVERVIEW.... PRESSURE VS............. 139 12.................... HOT WATER .. PERSONNEL ........................................2....................................2...................2....1....................... 129 11....................................6................................ 143 13........... 128 11................................ ACCESS ................. 133 11................................................ 141 13.................... CEILING .............3........4..............................................................................................................................3....................................................5.. PIPING SPECIFICATION ...................... Cleaning and Sanitization Guideline No.............1...................................6................................................2......................................3................... 132 11.......................... 143 13................................................................................................................6........................................ QUALITY REQUIREMENTS ............................... VENTILATION .................................... 141 13.4....... TRAPS ................ 143 13............................. 135 11.........................................4.........................................2......... CONDENSATE REMOVAL .....................................................................3............2.......... CHEMICALS FOR SANITIZATION .....1.................2.................................... MATERIAL ...... FLOORS................................................................................................................. 134 11............................. STERILIZATION .............................................................. 132 11.................................... MECHANICAL SEALS .........................................1................. STEAM FLOW CONTROL ............................. EQUIPMENT ................................... COMPONENTS .....4........1................................... 127 11.2.......... 139 12........................ 142 13....2................................. CHEMICAL TREATMENT ........................................doc 4/6/01 Printed on 03/15/02 ...........3..... 137 11.............................................................................................................3............1.. PROCESS AIR CRITERIA .................................................... 127 11............... VALVES ..............................6.2...................................................................... 145 C-P Confidential 151 Version 1.................. SAFETY AND HANDLING ..... AIR REMOVAL .......................................................................................................................................2...............5...7........... 143 13..............................5............................ PIPING SPECIFICATION ........................................0 1......................................................................................................2.............................. 137 12............ 141 13.................................... ATMOSPHERIC STEAMING .................6.. WALL GUARDS .......

................................................1........................................................................ 146 14......................1...........................................................1.............................................................................................................................................................................. INSTRUMENTATION ...................... 146 14..... 146 14......................................... COMPONENT SPECIFICATION SHEETS FOR C&S.....1....2.8................................ 146 14................. 25 Figure 13 – Examples of unacceptable design/procedure combinations ................. PROCESS TANKS .. TRANSFER PANELS ............................................................................................................. 152 14.. 20 Figure 7 .......... 145 14...............................................................3..............1..................................................................................................... 30 C-P Confidential 152 Version 1..............Radial Flow Impeller...6................Definition of Ra.............. 17 Figure 4 – Profilometer.......................................... COP EQUIPMENT ...... 18 Figure 6 – Top Head Types ................................................................5................................................. 17 Figure 3 – Sample Weld Finishes ... LIST OF FIGURES . 28 Figure 16 .............. CIP EQUIPMENT ...........................................2..........................0 GL1_v1. LIST OF FIGURES Figure 1 ........................6..................................................... 26 Figure 14 – Axial Flow Impeller .............0 GL1 APPENDIX 146 14.................................................... LIST OF TABLES ..................................................................................... Equipment and Piping Design Criteria 1 13...................................................................1.......................... Cleaning and Sanitization Guideline No........ 29 Figure 17 ................... PROCESS VALVES .................Pad Flange.........................4..............................................doc 4/6/01 Printed on 03/15/02 ......................................................................................................... 28 Figure 15 – Scraping Blade Agitator ............................................................. 25 Figure 12 – Sanitary Manway...................................................................................................4.....0 1............................................................. 15 Figure 2 .........................1.......................... 21 Figure 8 .... 146 14...................................Tank Bottom Configurations....................................................................................................................................................... 146 14................................................... PROCESS PUMPS .....................................................Tank Half-Pipe Discharge Details .... 146 14.... TRASH ....... 18 Figure 5 – Corner Details.............................................................................................................................................................................................................................................3................................................1.................................................................................... 146 14................1.............................................. 146 14..... 146 14..3................................................................... SPECIALTY EQUIPMENT ................................................Surface Profiles from Various Polishing Techniques ............ 22 Figure 9 – Manway and Nozzle Positions ...............7............................................. 23 Figure 10 – Atmospheric Manway ......................................................1................................. 25 Figure 11 – Standard ASME Manway...

................... 44 Figure 30 –Sight Glass..Pigging System Cleaning Bullet ....................................................................................... 58 Figure 44.................................................................................................................... 57 Figure 41 – Example of Tee Orientation ... 50 Figure 36 – Sanitary Clamps.......................... 34 Figure 22 ............................... 48 Figure 34 – Incorrect Pump Bypass.. 48 Figure 33 ..........................Inlet Valve CIP............................................Tank Inlet Pitched Manifold ............................ 62 Figure 47 ...........................................Bullet Catchers .................. 49 Figure 35 ................................................................. 62 Figure 48............................................... 33 Figure 21 – Sanitary Rupture Disk Housing................0 GL1_v1......................................................................................................Dead Legs..Bevel Seat Fitting............................ Cleaning and Sanitization Guideline No.. 57 Figure 43 – U-Bend Transfer Panel ..................................................................................................... 55 Figure 38 ........ 61 Figure 46 – Bullet Launchers................ 37 Figure 25 .........................................Tanks and Drum ..................................................................................................................Sterile Vent Filters ....................... 64 C-P Confidential 153 Version 1.......Side Mounted Radial Diaphragm Valve for Sample.................................................... 60 Figure 45 – Pig Launcher/Receiver ............ 32 Figure 20 – Bolt Configurations for Product Contact....... Equipment and Piping Design Criteria 1 Figure 18 ...........................................................................................Pigging Detail ....................................................................Vertical Position .......................................0 1.............................. 38 Figure 26 – Vortex Breakers......................................................... 42 Figure 28 – Nozzle Detail for Spray Devices .........................................................Dip Tube CIP ..2 Tanks........................................................................................................ 44 Figure 32 ............................................................................................................................................................................................................................................doc 4/6/01 Printed on 03/15/02 ......................................Rotary Lobe Pump ..................................................................................................................... 43 Figure 29 ............................................................Progressive Cavity Rotor .................................................................... 36 Figure 24 .... 54 Figure 37 ............................................................... 64 Figure 49 .................... 55 Figure 39 ............................ 56 Figure 40 ........................................... 35 Figure 23 .................................... 40 Figure 27 – Dead Leg at Tank Discharge ...........................................Agitator Mounts for Open Processing............................Progressive Cavity Pump Bypass...........................................................................................Camlock Connectors .............................................................................................................................................Tee Orientation............................................................................................ 31 Figure 19 – Shadowing at Baffles...........................................................................................................Pigging Details .........................

.....................................Head Tanks............................... 74 Figure 60 .....................................Flow Meters ...........................Filling Nozzles Being Manually Cleaned ..................Diaphragm Divert Valves ................................................................ 79 Figure 67 . 82 Figure 69 ...............................................................................................................Mixproof Valve...........Filling Line Piping Systems ............................................................................................................ 65 Figure 51 – Flex Hose Stored Out of Use............ 76 Figure 63 – Sample Valve........................Time-Gravity & Time-Pressure Fillers ..........................................................................Pressure Overflow Filler ...................................................................... 71 Figure 58 ........................................................ 92 Figure 79 – Example of a Gear Driven Spray Device .................................................. 84 Figure 71 ................................................................................... 66 Figure 53 .......................................................................................................................................................... 75 Figure 62 .............................. 68 Figure 54 ....................................Mass Flow Meters ....................... 65 Figure 52 ............................................... 81 Figure 68 ....................................................................................... 68 Figure 55 – Temperature Indicator Mounting .................................................................................... 92 Figure 78 – Typical Flow-Pressure Curves for Rotating Ball .... 93 Figure 80 – Typical Flow-Pressure Curves for Gear Driven Spray Device ............................................................................................Pressure Indicator.................... 70 Figure 57 .........................Piston Filler ........... 82 Figure 70 ........................................................... 93 C-P Confidential 154 Version 1.......................................... 75 Figure 61 ....................................................................................................Flex Hoses..............................................Static Spray Ball.Sanitary U-Tube Heat Exchanger .....Air Sensing Filler ............... 77 Figure 64 – Purolator Filter (housing not shown)...................... Equipment and Piping Design Criteria 1 Figure 50 .........................Magnetic Flow Meter...............Weight Filler ......................................................................................................... 91 Figure 77 – Rotating Spray Ball ..................................................................pH & ORP Tank Connections......................... 85 Figure 72..................................................... 88 Figure 75 .........Diaphragm Shutoff Valve ............................ 89 Figure 76 ................................................................................................. Cleaning and Sanitization Guideline No............................................................................................................................................................................................................... 87 Figure 74 ..................................0 1.......... 86 Figure 73 ............................................................Compression (Stem) Valve .......................... 69 Figure 56 ..doc 4/6/01 Printed on 03/15/02 ............................0 GL1_v1................... 78 Figure 65 ...........................................................................Conductivity Sensor Installation ............... 72 Figure 59 ...........................................................Non-Sanitary Static Mixers.......................................

.........................................................Sanitary Steam Trap.................................................... 104 Figure 85 .............Process Line Circuit ..............0 1............................ 130 Figure 93 ...................... 140 Figure 97 ......................................................................................................................Gravity w/ Overpressure Return System..................................................... 123 Figure 91 .... 120 Figure 89 – Eductor Return System.....................U-bend Use Point Drop for Purified Water... 135 Figure 96 –Clean Compressed Air System..................................... 134 Figure 95 ............Tank CIP Circuit ................................ 122 Figure 90 ........................................................................ 124 Figure 92 ......................................................................... 119 Figure 88 – Tank & Piping CIP Circuit .............. Equipment and Piping Design Criteria 1 Figure 81 – Flow Verification for a Rotary Wand.................................................................................Sanitizers .................. 113 Figure 86 ............................................................... 101 Figure 82 ............................................................................................................................................................................doc 4/6/01 Printed on 03/15/02 ...................................................................................................................Sanitary Trap Configurations....... 142 Figure 98 .............Gravity Return System.....................................0 GL1_v1........................................................Equipment Flow ...Typical 2 Tank CIP Skid.......................................................................................................................COP Recirculation Action................. 131 Figure 94 ................ 102 Figure 83 ................ Cleaning and Sanitization Guideline No...Equipment Pads......................... 145 C-P Confidential 155 Version 1.......................Self Priming Pumps ........................................................................ 119 Figure 87 ..............................................................