ASME BPE 2012

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ASME BPE Bioprocessing Equipment

Published By	Publication Date	Number of Pages
ASME	2012	300

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Description

This ASME Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements. It covers materials, design, fabrication, inspections, testing and certification. ASME-BPE is unique in the world, having resulted from widespread industry requests for standardization. It is the leading Standard on how to design and build equipment and systems used in the production of biopharmaceuticals. It incorporates current best-practices for enhancing product purity and safety. Companies that rigorously apply ASME-BPE often can achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations. New topics from the last revision include: Transfer panel and jumper tolerances Documentation requirements Hygienic support systems/rotary lobe pumps/static & dynamic spray devices/sampling systems/filtration & chromatography systems design Weld discoloration acceptance criteria Dynamic seal performance Properties of polymeric materials Process instrumentation ASME-BPE is referenced in ASME

PDF Catalog

PDF Pages	PDF Title
3	Errata to ASME BPE-2012
13	CONTENTS
19	FOREWORD
20	STATEMENT OF POLICY ON THE USE OF CERTIFICATION MARKS AND CODE AUTHORIZATION IN ADVERTISING STATEMENT OF POLICY ON THE USE OF ASME MARKING TO IDENTIFY MANUFACTURED ITEMS
21	COMMITTEE ROSTER
25	SUMMARY OF CHANGES
29	Part GR General Requirements GR- 1 INTRODUCTION GR- 2 SCOPE OF THE ASME BPE STANDARD GR- 3 MANUFACTURER’S QUALITY ASSURANCE PROGRAM
30	GR- 4 INSPECTION GR- 4.1 Inspector/ Examiner GR- 4.2 Inspector’s Delegate
31	Tables Table GR- 4.2- 1 Inspector’s Delegate Capabilities
32	Table GR- 4.2- 1 Inspector’s Delegate Capabilities ( Cont’d)
33	GR- 4.3 Responsibilities GR- 4.4 Access for Inspectors GR- 5 DOCUMENTATION REQUIREMENTS GR- 5.1 Part SD
34	GR- 5.2 Part DT GR- 5.3 Part MJ
35	GR- 5.4 Part SF GR- 5.5 Part PM
36	GR- 5.6 Part SG GR- 6 METRIC GR- 7 REFERENCES
38	GR- 8 TERMS AND DEFINITIONS
45	Part SD Systems Design SD- 1 PURPOSE AND SCOPE SD- 2 GENERAL GUIDELINES SD- 2.1 Containment SD- 2.2 Bioburden Control SD- 2.3 Bioburden Reduction SD- 2.4 Fabrication
47	Table SD- 2.4.3.1- 1 Slope Designations for Gravity- Drained Lines
48	SD- 3 PROCESS COMPONENTS SD- 3.1 Connections, Fittings, and Piping
49	Figures Fig. SD- 3.1.1- 1 Flat Gasket Applications
50	Dimensions for Flow- Through Tee: Full- Size Standard Straight Tee With Blind Cap Table SD- 3.1.2.2- 1
51	Dimensions for Flow- Through Tee: Short Outlet Reducing Tee With Blind Cap Table SD- 3.1.2.2- 2
52	Dimensions for Flow- Through Tee: Short Outlet Reducing Tee With Blind Cap ( Cont’d) Table SD- 3.1.2.2- 2
53	Fig. SD- 3.1.2.2- 1 Accepted Point- of- Use Designs
54	Fig. SD- 3.1.2.3- 1 Double Block- and- Bleed Valve Assembly
55	SD- 3.2 Hose Assemblies SD- 3.3 Pumps
56	Fig. SD- 3.2.1- 1 Flexible Hygienic Hose Design
57	Fig. SD- 3.3.2.2- 1 Pump Impeller Configurations Fig. SD- 3.3.2.2- 2 Acceptable Impeller Attachments
58	Ratios Fig. SD- 3.3.2.2- 3 Casing Drain Configurations Fig. SD- 3.3.2.2- 4 Casing Drain
59	SD- 3.4 Vessels Fig. SD- 3.3.2.4- 1 Rotary Lobe Pump Rotor Attachment
60	Fig. SD- 3.4.2- 1 Nozzle Design
61	Fig. SD- 3.4.2- 2 Side and Bottom Connections Fig. SD- 3.4.2- 3 Sidewall Instrument Ports
62	Fig. SD- 3.4.2- 4 Accepted Nozzle Penetrations Table SD- 3.4.2- 1 Annular Spacing Recommendations for Hygienic Dip Tubes
63	Fig. SD- 3.4.2- 5 Vessel Design Tangential Nozzles
64	Fig. SD- 3.4.2- 6 Sight Glass Design ( Accepted)
65	SD- 3.5 Agitators and Mixers Fig. SD- 3.4.2- 7 Typical Nozzle Detail
66	Fig. SD- 3.4.3- 1 Internal Support Members
68	Fig. SD- 3.5.1- 1 Agitator Mounting Flanges
69	Fig. SD- 3.5.2- 1 Shaft Coupling Construction Fig. SD- 3.5.2- 2 Shaft Coupling Seal Arrangements
70	Fig. SD- 3.5.2- 3 Fastener Seal Arrangements
71	Fig. SD- 3.5.5- 1 Shaft Steady Bearing
72	SD- 3.6 Heat Exchange Equipment Fig. SD- 3.5.5- 2 Magnetically Coupled Mixer ( Typical Bottom- Mount)
73	SD- 3.7 Transfer Panels
74	Fig. SD- 3.6.1- 1 Double Tubesheet Heat Exchanger Bonnet Design
75	Fig. SD- 3.7.1- 1 Transfer Panel Looped Headers
76	Fig. SD- 3.7.2- 1 Transfer Panel Tolerances ( Reference Table DT- 7- 2)
77	SD- 3.8 Filters SD- 3.9 Spray Devices
78	Fig. SD- 3.7.4- 1 Transfer Panel Jumpers
79	Fig. SD- 3.9.1- 1 Dynamic Spray Device: Single Axis ( Spray Pattern for Illustration Purposes) Fig. SD- 3.9.1- 2 Two Axes Dynamic Spray Device ( Number of Jets Are for Illustration Purposes)
81	Fig. SD- 3.9.2.1- 1 Static Spray Device Fig. SD- 3.9.2.1- 2 Flow Rate Guideline for Vertical Cylindrical Vessels
82	Fig. SD- 3.9.2.1- 3 Flow Rate Guideline for Horizontal Cylindrical Vessels Fig. SD- 3.9.2.3- 1 Impact Pattern Build- Up
83	SD- 3.10 Disposables That Require Pre- Sterilization or Post- Sterilization SD- 3.11 Sampling Systems SD- 3.12 Steam Traps SD- 3.13 Check Valves SD- 3.14 Orifice Plates SD- 3.15 Relief Devices
84	Fig. SD- 3.12- 1 Steam Traps for Clean Steam Systems SD- 3.16 Liquid Pressure Regulators SD- 4 PROCESS UTILITIES SD- 4.1 Compendial Water Systems
85	Fig. SD- 4.1.2.1- 1 Point- of- Use Piping
86	Fig. SD- 4.1.2.2- 1 Physical Break in Point- of- Use Piping SD- 4.2 Clean/ Pure Steam Systems
87	Fig. SD- 4.2.2- 1 Typical Clean Steam System Isometric
88	Fig. SD- 4.2.2- 2 Clean Steam Point- of- Use Design SD- 4.3 Process Gases
89	SD- 4.4 Process Waste Systems SD- 5 PROCESS SYSTEMS SD- 5.1 Upstream Systems
90	Fig. SD- 5.1.1.1- 1 Fermentor Sterile Envelope
91	Fig. SD- 5.1.1.1- 2 Bioreactor Sterile Envelope
93	Fig. SD- 5.1.1.2.3- 1 Gas Sparging Assembly — Lance
94	Fig. SD- 5.1.1.2.3- 2 Gas Sparging Assembly — Sintered
95	Fig. SD- 5.1.1.2.3- 3 Gas Sparging Assembly — Ring
96	Fig. SD- 5.1.1.2.3- 4 Gas Sparging Assembly — Single Orifice
97	Fig. SD- 5.1.1.3.1- 1 Exhaust Gas Condenser Fig. SD- 5.1.1.3.1- 2 Exhaust Gas Heater
98	Fig. SD- 5.1.1.3.1- 3 Electrically Heat Traced Filter Housing
100	Fig. SD- 5.2.1- 1 Tank/ Vessel Vent Filters SD- 5.2 Downstream Systems
101	SD- 5.3 Process Support Systems
104	Table SD- 5.3.3.3- 1 Flow Rates to Achieve 5 ft/ sec ( 1.52 m/ s)
105	Fig. SD- 5.3.3.5.1- 1 CIP Looped Header ( Supply or Return)
106	Fig. SD- 5.3.3.5.1- 2 Zero- Static Chain Fig. SD- 5.3.3.5.1- 3 Swing Elbow Arrangement
107	SD- 6 TESTING SD- 6.1 Spray Device Coverage Test SD- 6.2 Cleaning, Steaming, and Bioburden Control Testing SD- 6.3 Hydrostatic Test SD- 6.4 Vessel Drainability Test
109	Part DT Dimensions and Tolerances for Process Components DT- 1 PURPOSE AND SCOPE DT- 2 PRESSURE RATING DT- 3 WALL THICKNESS DT- 4 DIMENSIONS DT- 4.1 Fitting Dimensions DT- 4.2 Nonstandard Fitting Dimensions DT- 4.3 Special Angle Fittings Dimensions DT- 4.4 Valve Dimensions
110	DT- 5 MATERIALS DT- 6 TESTS DT- 7 TOLERANCES DT- 8 WELD ENDS DT- 9 HYGIENIC CLAMP UNIONS DT- 9.1 Typical Hygienic Clamp Unions DT- 9.2 Hygienic Gaskets DT- 9.3 Connections DT- 9.4 Hygienic Clamps DT- 10 MINIMUM EXAMINATION REQUIREMENTS DT- 10.1 Visual Inspection
111	DT- 10.2 Documentation Verification DT- 10.3 Physical Examination DT- 11 MARKING DT- 11.1 Fitting Marking Information DT- 11.2 Valve Marking Information DT- 12 PACKAGING
112	Table DT- 2- 1 Hygienic Unions: Rated Internal Working Pressure
113	Fig. DT- 2- 1 Clamp Conditions at Installation
114	Table DT- 3- 1 Final Tolerances for Mechanically Polished Fittings and Process Components
115	Table DT- 3- 2 Final Tolerances for Electropolished Fittings and Process Components Table DT- 4- 1 Nominal O. D. Tubing Sizes Table DT- 4.1- 1 Tangent Lengths
116	Table DT- 4.1.1- 1 Automatic Tube Weld: 90- deg Elbow Table DT- 4.1.1- 2 Automatic Tube Weld: Hygienic Clamp Joint, 90- deg Elbow
117	Table DT- 4.1.1- 3 Hygienic Clamp Joint: 90- deg Elbow Table DT- 4.1.1- 4 Automatic Tube Weld: 45- deg Elbow
118	Table DT- 4.1.1- 5 Automatic Tube Weld: Hygienic Clamp Joint, 45- deg Elbow Table DT- 4.1.1- 6 Hygienic Clamp Joint: 45- deg Elbow
119	Table DT- 4.1.1- 7 Automatic Tube Weld: 180- deg Return Bend Table DT- 4.1.1- 8 Hygienic Clamp Joint: 180- deg Return Bend
120	Table DT- 4.1.2- 1 Automatic Tube Weld: Straight Tee and Cross Table DT- 4.1.2- 2 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee
121	Table DT- 4.1.2- 3 Hygienic Mechanical Joint: Short Outlet Run Tee Table DT- 4.1.2- 4 Hygienic Clamp Joint: Straight Tee and Cross
122	Table DT- 4.1.2- 5 Hygienic Clamp Joint: Short Outlet Tee Table DT- 4.1.2- 6 Automatic Tube Weld: Reducing Tee
123	Table DT- 4.1.2- 7 Automatic Tube Weld: Short Outlet Hygienic Clamp, Joint Reducing Tee
124	Table DT- 4.1.2- 8 Hygienic Clamp Joint: Reducing Tee
125	Table DT- 4.1.2- 9 Hygienic Clamp Joint: Short Outlet Reducing Tee Table DT- 4.1.2- 10 Automatic Tube Weld: Instrument Tee Table DT- 4.1.2- 11 Hygienic Clamp Joint: Instrument Tee
126	Table DT- 4.1.3- 1( a) Automatic Tube Weld: Concentric and Eccentric Reducer
127	Table DT- 4.1.3- 1( b) Automatic Tube Weld: Concentric and Eccentric Reducer
128	Table DT- 4.1.3- 2( a) Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
129	Table DT- 4.1.3- 2( b) Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
130	Table DT- 4.1.3- 3( a) Hygienic Clamp Joint: Concentric and Eccentric Reducer
131	Table DT- 4.1.3- 3( b) Hygienic Clamp Joint: Concentric and Eccentric Reducer
132	Table DT- 4.1.4- 1 Automatic Tube Weld: Ferrule
133	Table DT- 4.1.5- 1 Automatic Tube Weld: Cap Table DT- 4.1.5- 2 Hygienic Clamp Joint: Solid End Cap Table DT- 4.4.1- 1 Hygienic Clamp Joint: Weir Style Diaphragm Valve
134	Table DT- 7- 1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances
135	Table DT- 7- 1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances ( Cont’d)
136	Table DT- 7- 2 Transfer Panel and Jumper Tolerances
137	Table DT- 9.3- 1 Hygienic Clamp Ferrule: Design Criteria
138	Part MJ Material Joining MJ- 1 PURPOSE AND SCOPE MJ- 2 MATERIALS MJ- 2.1 Base Metals MJ- 2.2 Filler Metals MJ- 2.3 Nonmetallics MJ- 3 WELD JOINT DESIGN AND PREPARATION MJ- 3.1 General
139	MJ- 3.2 Pressure Vessels and Tanks MJ- 3.3 Piping MJ- 3.4 Tubing MJ- 3.5 Tube- Attachment Welds MJ- 4 JOINING PROCESSES AND PROCEDURES MJ- 4.1 Welds Finished After Welding MJ- 4.2 Welds Used in the As- Welded Condition
140	MJ- 5 PROCEDURE QUALIFICATIONS MJ- 5.1 Pressure Vessels and Tanks MJ- 5.2 Piping MJ- 5.3 Tubing MJ- 5.4 Duplex Stainless Steels MJ- 6 PERFORMANCE QUALIFICATIONS MJ- 6.1 Pressure Vessels and Tanks MJ- 6.2 Piping MJ- 6.3 Tubing MJ- 7 EXAMINATION, INSPECTION, AND TESTING Table MJ- 6.2- 1 Tube/ Pipe Diameter Limits for Orbital GTAW Performance Qualification Table MJ- 6.2- 2 Weld Thickness Limits for Orbital GTAW Performance Qualification
141	MJ- 7.1 Examination Procedures MJ- 7.2 Personnel Requirements MJ- 7.3 Examination, Inspection, and Testing Requirements
142	MJ- 7.4 Records MJ- 8 WELD ACCEPTANCE CRITERIA MJ- 8.1 General MJ- 8.2 Pressure Vessels and Tanks MJ- 8.3 Piping MJ- 8.4 Tubing MJ- 8.5 Tube- Attachment Welds MJ- 9 DOCUMENTATION REQUIREMENTS MJ- 10 PASSIVATION
143	Table MJ- 8.2- 1 Acceptance Criteria for Welds on Pressure Vessels and Tanks
144	Table MJ- 8.3- 1 Acceptance Criteria for Welds on Pipe
145	Table MJ- 8.4- 1 Acceptance Criteria for Groove Welds on Tube- to- Tube Butt Joints
146	Table MJ- 8.4- 1 Acceptance Criteria for Groove Welds on Tube- to- Tube Butt Joints ( Cont’d)
147	Fig. MJ- 8.4- 1 Acceptable and Unacceptable Weld Profiles for Tube Welds
148	Fig. MJ- 8.4- 2 Discoloration Acceptance Criteria for Weld Heat- Affected Zones on Electropolished 316L Tubing
149	Fig. MJ- 8.4- 3 Discoloration Acceptance Criteria for Weld Heat- Affected Zones on Mechanically Polished 316L Tubing
150	Table MJ- 8.5- 1 Acceptance Criteria for Tube- Attachment Welds [ See Note ( 1)]
151	Part SF Product Contact Surface Finishes SF- 1 PURPOSE AND SCOPE SF- 2 METALLIC APPLICATIONS SF- 2.1 Applicable Systems SF- 2.2 Acceptance Criteria SF- 2.3 Inspection and Techniques Employed in the Classification of Product Contact Surface Finishes SF- 2.4 Surface Condition SF- 2.5 Electropolishing Procedure Qualification SF- 2.6 Passivation Procedure
152	Table SF- 2.2- 1 Acceptance Criteria for Metallic Product Contact Surface Finishes
153	SF- 2.7 Normative References Table SF- 2.2- 2 Additional Acceptance Criteria for Electropolished Metallic Product Contact Surface Finishes Table SF- 2.4- 1
154	SF- 2.8 Rouge and Stainless Steel SF- 3 POLYMERIC APPLICATIONS SF- 3.1 Applicable Systems SF- 3.2 Materials SF- 3.3 Inspection and Techniques Employed in the Classification of Product Contact Surface Finishes Table SF- 2.6- 1 Acceptance Criteria for Metallic Passivated Product Contact Surface Finishes
155	Readings for Polymeric Product Contact Surfaces SF- 3.4 Surface Condition Table SF- 3.3- 1 Acceptance Criteria for Polymeric Product Contact Surface Finishes Table SF- 3.4- 1
156	Part SG Sealing Components SG- 1 PURPOSE AND SCOPE SG- 2 SEALING COMPONENT TYPES SG- 2.1 General SG- 2.2 Static Seals SG- 2.3 Dynamic Seals
157	Fig. SG- 2.2.2- 1 Hygienic Union per Table DT- 7- 1 Fig. SG- 2.2.2- 2 Hygienic Clamp Union per Table DT- 7- 1
158	Fig. SG- 2.2.2- 3 Hygienic Union per DIN 11864 Fig. SG- 2.2.2- 4 Hygienic Clamp Union per DIN 11864
159	Fig. SG- 2.2.2- 5 Nonhygienic Connections
160	Fig. SG- 2.3.1.2- 1 Weir Valves
161	Fig. SG- 2.3.1.2- 2 Radial Valves Fig. SG- 2.3.1.2- 3 Weirless Diaphragm Valve
162	Fig. SG- 2.3.1.2- 4 Linear Control Valves Fig. SG- 2.3.1.2- 5 Regulator Valve
163	Fig. SG- 2.3.1.3- 1 Ball Valves Fig. SG- 2.3.1.4- 1 Rising Stem Single Valve, Double Seat Mix Proof Valve, and Needle Valve
164	Fig. SG- 2.3.1.5- 1 Butterfly Valve Fig. SG- 2.3.1.7- 1 Back Pressure Control Valve
165	Fig. SG- 2.3.1.8- 1 Pinch Valve Fig. SG- 2.3.1.9- 1 Pressure Relief and Check Valves Fig. SG- 2.3.1.10- 1 Plug Valve
166	Fig. SG- 2.3.2.2- 1 Single Mechanical Seal Fig. SG- 2.3.2.2- 2 Single Seal for Top Entry Agitator
167	Fig. SG- 2.3.2.3- 1 Dual Pressurized Mechanical Seal for Pumps Fig. SG- 2.3.2.3- 2 Dual Pressurized Mechanical Seal for Top Entry Agitator Fig. SG- 2.3.2.3- 3 Dual Unpressurized Mechanical Seal for Pumps
168	Fig. SG- 2.3.2.4- 1 Flush Plan 01 Fig. SG- 2.3.2.4- 2 Flush Plan 02 Fig. SG- 2.3.2.4- 3 Flush Plan 11
169	Fig. SG- 2.3.2.4- 4 Flush Plan 32 Fig. SG- 2.3.2.4- 5 Flush Plan 52 for Pump
170	Fig. SG- 2.3.2.4- 6 Flush Plan 52 for Top Entry Agitator Fig. SG- 2.3.2.4- 7 Flush Plan BPE52 for Pump Fig. SG- 2.3.2.4- 8 Flush Plan 53 for Pump Fig. SG- 2.3.2.4- 9 Flush Plan 53 for Top Entry Agitator
171	Fig. SG- 2.3.2.4- 10 Flush Plan 54 for Pump Fig. SG- 2.3.2.4- 11 Flush Plan 54 for Top Entry Agitator Fig. SG- 2.3.2.4- 12 Flush Plan 74 for Pump Fig. SG- 2.3.2.4- 13 Flush Plan 74 for Top Entry Agitator
172	SG- 3 SEALING COMPONENTS GENERAL DESIGN REQUIREMENTS ( GENERAL PROVISIONS) SG- 3.1 Seal Design Conditions SG- 3.2 System Requirements SG- 3.3 Seal Construction
174	Fig. SG- 3.3.2.2- 1 Static O- Ring
176	Fig. SG- 3.3.2.3- 1 Seals for Rising Stem Valves
177	SG- 3.4 Compliance Requirements for Sealing Elements
178	SG- 3.5 Seal Identification SG- 3.6 Other Seal Requirements SG- 4 SEAL PERFORMANCE REQUIREMENTS SG- 4.1 General Requirements SG- 4.2 Static Seal Performance
179	SG- 4.3 Dynamic Seal Performance Fig. SG- 4.2- 1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion
180	SG- 5 SEAL APPLICATIONS SG- 5.1 General Considerations SG- 5.2 Process Systems SG- 5.3 Compendial Water Systems SG- 5.4 Clean/ USP Pure Steam SG- 5.5 CIP
181	Part PM Polymeric and Other Nonmetallic Materials PM- 1 PURPOSE AND SCOPE PM- 2 MATERIALS PM- 2.1 Materials of Construction
182	PM- 2.2 General Requirements Table PM- 2.1.1- 1 Common Thermoplastic Polymers and Applications Table PM- 2.1.2- 1 Common Thermoset Polymers and Applications
183	PM- 3 PROPERTIES AND PERFORMANCE PM- 3.1 Biocompatibility Table PM- 2.1.3- 1 Examples of Nonmetallics
184	PM- 3.2 Extractables and Leachables Table PM- 2.2.1- 1 Information of Certificate of Compliance
185	PM- 3.3 Physical and Mechanical Properties of Thermoplastic Polymers PM- 3.4 Chemical Compatibility of Thermoplastic Polymers PM- 3.5 Physical and Mechanical Properties of Thermoset Polymers PM- 3.6 Chemical Compatibility of Thermoset Elastomers PM- 3.7 Polymeric Surface Finish PM- 4 APPLICATIONS PM- 4.1 Single- Use Components and Assemblies
187	PM- 4.2 Piping
188	Table PM- 4.2.1- 1 Size Comparison of Common Thermoplastic Sizing Standards
191	PM- 4.3 Hose Assemblies Fig. PM- 4.2.8.1- 1 Acceptable and Unacceptable Weld Profiles for Beadless Welds
193	PM- 4.4 Chromatography Columns PM- 4.5 Filtration Elements and Components
194	Part CR Certification CR- 1 PURPOSE AND SCOPE CR- 2 GENERAL CR- 2.1 ASME Procedures and Policies CR- 2.2 ASME BPE Certificate Holders CR- 2.3 ASME BPE Certificate Holder’s Responsibilities Fig. CR- 2.3.1- 1 ASME Mark With BPE Designator
195	Fig. CR- 2.3.2- 1 Options for Certification of Organizations
197	CR- 3 ACQUIRING AN ASME BPE CERTIFICATE CR- 3.1 Application for Certification CR- 3.2 Verification of Qualification
198	CR- 3.3 Issuance of ASME BPE Certificate
199	CR- 3.4 Denial or Loss of ASME BPE Certificate of Authorization CR- 4 REQUIREMENTS SUBJECT TO CHANGE
200	Part MM Metallic Materials MM- 1 PURPOSE AND SCOPE MM- 2 ALLOY DESIGNATIONS MM- 2.1 General MM- 3 USES OF SPECIFICATIONS MM- 3.1 General MM- 3.2 Listed Specifications MM- 3.3 Unlisted Specifications MM- 3.4 Unknown Materials MM- 3.5 Reclaimed Materials MM- 3.6 Designation of Alloy and Fluid Service
201	MM- 4 REFERENCED SPECIFICATIONS MM- 4.1 General MM- 4.2 Tubing/ Piping Table MM- 2.1- 1 Wrought Stainless Steels: Nominal Compositions ( wt. %)
202	MM- 4.3 Castings Table MM- 2.1- 2 Wrought Nickel Alloys: Nominal Compositions ( wt. %)
203	MM- 4.4 Forgings MM- 4.5 Plate, Sheet, and Strip Table MM- 2.1- 3 Stainless Steel and Nickel Alloy Cast Designations
204	MM- 4.6 Hollow Products, Rod, and Bar Stock MM- 5 FABRICATION MM- 5.1 General
205	Table MM- 5.1.2- 1 Filler Metals
206	Table MM- 5.1.2- 1 Filler Metals ( Cont’d)
207	Table MM- 5.1.2- 2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels Table MM- 5.1.4- 1 Predicted Ferrite Number ( FN) Ranges for Various 316 Product Forms and Welds
208	MM- 5.2 Filler Metals and Consumable Inserts MM- 5.3 Field Bending of Tubing MM- 5.4 Heat Treatment MM- 6 MECHANICAL PROPERTIES MM- 6.1 General MM- 6.2 Tubing/ Piping MM- 6.3 Fittings and Welded Components
209	MM- 6.4 Toughness MM- 6.5 Testing MM- 7 CORROSION RESISTANCE REQUIREMENTS MM- 7.1 General MM- 7.2 Corrosion Testing MM- 8 UNLISTED ALLOYS MM- 8.1 General
210	Part PI Process Instrumentation PI- 1 PURPOSE AND SCOPE PI- 2 PROCESS INSTRUMENTATION GENERAL REQUIREMENTS PI- 2.1 General Considerations PI- 2.2 Instrumentation Categories
211	PI- 3 INSTRUMENT RECEIVING, HANDLING, AND STORAGE PI- 3.1 Introduction PI- 3.2 Instrument Receiving PI- 3.3 Instrument Handling: Protection of Process Connections and Surface Finish PI- 3.4 Instrument Storage PI- 4 FLOWMETERS PI- 4.1 Coriolis Flowmeter Fig. PI- 2.2.1- 1 In- Line and At- Line Instrument Installation Examples
212	Fig. PI- 2.2.2- 1 Accepted Insertion Device Installation Examples
213	Fig. PI- 4.1.3.2- 1 Manifold or Flow Splitter for Dual Tube Construction Flowmeters and Potential for Product Holdup
214	Fig. PI- 4.1.3.3- 1 Concentrically Reducing Process Connection Fig. PI- 4.1.4.3- 1 Vertical Installation Fig. PI- 4.1.4.4- 1 Minimum Angle of Inclination,
215	PI- 5 LEVEL INSTRUMENTS PI- 6 PRESSURE INSTRUMENTS PI- 7 TEMPERATURE INSTRUMENTS PI- 8 ANALYTICAL INSTRUMENTS PI- 8.1 Conductivity
216	Fig. PI- 8.1.2- 1 Conductivity Type Examples
217	Fig. PI- 8.1.3- 1 Accepted Installations for Conductivity Sensors
218	PI- 8.2 pH — Glass Measuring Electrode Fig. PI- 8.1.3.6- 1 Installation Clearance Requirements
219	Fig. PI- 8.2.2- 1 pH Sensor Components
220	Fig. PI- 8.2.3- 1 Accepted pH Sensor Installations
221	Fig. PI- 8.2.3.4- 1 Accepted Mounting Orientations
222	PI- 9 OPTICAL PI- 9.1 Optical Devices Fig. PI- 8.2.3.5- 1 Insertion Length or Depth
224	Fig. PI- 9.1.3.3- 1 Vessel Light Glass Design and Mounting
225	Fig. PI- 9.1.3.5- 1 In- Line Insertion Length Fig. PI- 9.1.3.5- 2 Insertion Probe Length
227	MANDATORY APPENDIX MANDATORY APPENDIX I SUBMITTAL OF TECHNICAL INQUIRIES TO THE BIOPROCESSING EQUIPMENT ( BPE) COMMITTEE I- 1 INTRODUCTION I- 2 INQUIRY FORMAT I- 3 REVISIONS OR ADDITIONS
228	I- 4 CODE CASES I- 5 INTERPRETATIONS I- 6 SUBMITTALS
229	NONMANDATORY APPENDICES NONMANDATORY APPENDIX A COMMENTARY: SLAG A- 1 GENERAL
230	NONMANDATORY APPENDIX B MATERIAL EXAMINATION LOG AND WELD LOG
235	NONMANDATORY APPENDIX C SLOPE MEASUREMENT C- 1 GENERAL
236	NONMANDATORY APPENDIX D ROUGE AND STAINLESS STEEL D- 1 GENERAL D- 2 CONSIDERATIONS FOR REDUCING ROUGE FORMATION D- 2.1 System Fabrication D- 2.2 System Operation D- 3 EVALUATION METHODS TO MEASURE ROUGE D- 3.1 Process Fluid Analyses D- 3.2 Solid Surface Analyses D- 4 METHODS TO REMEDIATE THE PRESENCE OF ROUGE IN A SYSTEM D- 4.1 Class I Rouge Remediation
237	Table D- 2- 1 Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System
238	Table D- 2- 2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System
239	Table D- 2- 2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System ( Cont’d) D- 4.2 Class II Rouge Remediation
240	Table D- 3.1- 1 Process Fluid Analyses for the Identification of Mobile Constituents of Rouge D- 4.3 Class III Rouge Remediation D- 4.4 Remediation Variables
241	Table D- 3.2- 1 Solid Surface Analyses for the Identification of Surface Layers Composition
242	Table D- 4.1- 1 Rouge Remediation Processes Summary
243	Table D- 4.1- 1 Rouge Remediation Processes Summary ( Cont’d)
244	NONMANDATORY APPENDIX E PASSIVATION PROCEDURE QUALIFICATION E- 1 GENERAL E- 2 PURPOSE OF PASSIVATION TREATMENTS E- 2.1 Why Passivation Is Necessary E- 2.2 When Passivation Is Necessary
245	Table E- 3.2- 1 Minimum Surface Requirements for Process Qualification Samples E- 3 PASSIVATION PROCEDURE ( SEE SF- 2.6) E- 3.1 Procedure Description E- 3.2 Procedure Qualification E- 3.3 Procedure Documentation Requirements E- 4 PASSIVATION QUALITY CONTROL E- 4.1 Quality Control Surveillance
246	Table E- 3.2- 2 Passivation Processes
247	Table E- 3.2- 2 Passivation Processes ( Cont’d)
248	Table E- 3.2- 2 Passivation Processes ( Cont’d) E- 4.2 Certificate of Passivation Compliance E- 5 EVALUATION OF CLEANED AND PASSIVATED SURFACES E- 5.1 Acceptance Criteria for Cleaned and/ or Passivated Product Contact Surfaces ( See Table SF- 2.6- 1)
250	Table E- 5- 1 Test Matrix for Evaluation of Cleaned and/ or Passivated Surfaces
251	Table E- 5- 1 Test Matrix for Evaluation of Cleaned and/ or Passivated Surfaces ( Cont’d)
252	Table E- 5- 1 Test Matrix for Evaluation of Cleaned and/ or Passivated Surfaces ( Cont’d)
253	Table E- 5- 1 Test Matrix for Evaluation of Cleaned and/ or Passivated Surfaces ( Cont’d)
254	NONMANDATORY APPENDIX F CORROSION TESTING F- 1 GENERAL F- 2 CORROSION TESTS F- 3 PITTING RESISISTANCE EQUIVALENT ( PRE) NUMBER
255	Table F- 1- 1 ASTM Corrosion Tests
256	Table F- 1- 1 ASTM Corrosion Tests ( Cont’d) Table F- 3- 1 PRE Numbers for Some Alloys
257	NONMANDATORY APPENDIX G FERRITE G- 1 GENERAL G- 2 INFLUENCE OF FERRITE IN BIOPHARMACEUTICAL SERVICE G- 3 CONTROL OF FERRITE CONTENT IN WELDS OF 316 STAINLESS STEELS
258	NONMANDATORY APPENDIX H ELECTROPOLISHING PROCEDURE QUALIFICATION H- 1 SCOPE H- 2 PURPOSE H- 3 ELECTROPOLISH PROCEDURE QUALIFICATION H- 3.1 Method Procedure H- 3.2 Essential Variables H- 3.3 Vendor Documentation H- 3.4 Certificate of Compliance
259	Table H- 3.3- 1 Minimum Surface Requirements for Process Qualification Samples
260	NONMANDATORY APPENDIX I VENDOR DOCUMENTATION REQUIREMENTS FOR NEW INSTRUMENTS I- 1 OVERVIEW I- 1.1 Section 1: VDR Definitions I- 1.2 Section 2: Instrument Types and Required Documents I- 2 INSTRUCTIONS FOR USE
261	Table I- 1.1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions
262	Table I- 1.1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions ( Cont’d)
263	Table I- 1.2 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents
264	NONMANDATORY APPENDIX J STANDARD PROCESS TEST CONDITIONS ( SPTC) FOR SEAL PERFORMANCE EVALUATION J- 1 HYGIENIC UNION SEAL PERFORMANCE EVALUATION J- 1.1 Material Evaluation J- 1.2 Simulated Steam- in- Place ( SIP) Testing
265	J- 2 MECHANICAL SEAL PERFORMANCE EVALUATION J- 2.1 Mechanical Seal Performance Evaluation J- 2.2 Exceptions to Normal Seal Performance J- 2.3 Mechanical Seal Integrity Tests
268	J- 2.4 Mechanical Seal Testing Notes
269	NONMANDATORY APPENDIX K STANDARD TEST METHODS FOR POLYMERS K- 1 STANDARD TEST METHODS FOR THERMOPLASTIC POLYMERS K- 2 STANDARD TEST METHODS FOR THERMOSET POLYMERS K- 3 THERMOSET POLYMER TEST PROPERTIES K- 4 INTERPRETATION OF THERMOSET MATERIAL PROPERTY CHANGES K- 5 TESTING PROTOCOLS FOR THERMOSET POLYMERS K- 5.1 Samples K- 5.2 Immersion Fluids K- 5.3 Qualification Testing K- 5.4 Elastomer Testing: Property Retention
270	Table K- 3- 1 Thermoset Polymer Test Properties
271	Table K- 4- 1 Interpretation of Thermoset Material Property Changes
272	NONMANDATORY APPENDIX L SPRAY DEVICE COVERAGE TESTING L- 1 SCOPE L- 2 PURPOSE L- 3 MATERIALS L- 4 PROCEDURE L- 4.1 Equipment Preparation L- 4.2 Application of Fluorescent Solution L- 4.3 Execute Rinse
273	L- 4.4 Inspection L- 5 ACCEPTANCE CRITERIA L- 6 RECOMMENDED DOCUMENTATION
274	NONMANDATORY APPENDIX M COMMENTARY: 316L WELD HEAT- AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA M- 1 GENERAL
275	NONMANDATORY APPENDIX N GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS
276	NONMANDATORY APPENDIX O REFERENCES: GENERAL BACKGROUND FOR EXTRACTABLES AND LEACHABLES
277	NONMANDATORY APPENDIX P TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS P- 1 GENERAL P- 2 COMPONENTS P- 2.1 Sensors P- 2.2 Thermowells P- 2.3 External Support Components P- 3 INSTALLATION P- 3.1 Drainability P- 3.2 Cleanability P- 3.3 Mounting Location P- 3.4 Orientation
278	Fig. P- 3- 1 Typical Installation Styles P- 3.5 Insertion Length/ Depth
279	Fig. P- 3.4- 1 Accepted Elbow Orientation and Flow Direction Fig. P- 3.4- 2 Accepted Nonintrusive Orientation and Flow Direction P- 3.6 Special Considerations
280	Fig. P- 3.5- 1 Sensor Insertion Length, Tee Installations
281	Fig. P- 3.5- 2 Sensor Insertion Length, Elbow Installations P- 4 PERFORMANCE P- 4.1 Accuracy
282	P- 4.2 Response Time P- 4.3 Process Influences P- 4.4 Ambient Influences P- 5 SELECTION P- 5.1 Sensor Selection P- 5.2 Thermowell Selection P- 5.3 Transmitter Selection
283	P- 6 MAINTENANCE P- 6.1 Sensor Calibration Verification P- 6.2 Sensor Inspection
284	NONMANDATORY APPENDIX Q INSTRUMENT RECEIVING, HANDLING, AND STORAGE Q- 1 INTRODUCTION Q- 2 INSTRUMENT RECEIVING Q- 2.1 Warnings and Documentation Q- 2.2 Incoming Inspection Q- 3 INSTRUMENT HANDLING Q- 3.1 Instrument Assembly Segregation Q- 3.2 Component Labels Q- 4 STORAGE
285	NONMANDATORY APPENDIX R APPLICATION DATA SHEET
287	Form R- 1 Application Data Sheet ( Cont’d)
288	INDEX