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: • Compendial Water Applications • New Valve Seal Performance requirements • Thermal Treatment Systems (HTST/UHT) • Process Waste Systems • Solution Prep Systems • Washers and Diaphragm Pumps • Particulates • Change Management • Filtration ASME-BPE is referenced in ASME’s B31.3 Code on Process Piping. Moreover, two weld discoloration acceptance criteria color charts, ASME BPE MP-2012 and EP-2012, are available separately. They allow you to match acceptable discoloration levels perfectly, so as to help assure optimum safety and code-compliance. Intended for regulatory agencies, multinational corporations, plant owners, pressure-equipment fabricators, designers, constructors, materials suppliers, inspection organizations, and others.

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PDF Pages	PDF Title
4	CONTENTS
5	Figures
8	Tables
11	FOREWORD
13	STATEMENT OF POLICY
14	COMMITTEE ROSTER
18	SUMMARY OF CHANGES
26	CHAPTER 1 INTRODUCTION, SCOPE, AND DEFINITIONS Part GR General Requirements GR-1 INTRODUCTION GR-2 SCOPE OF THE ASME BPE STANDARD
27	GR-3 MANUFACTURER’S QUALITY ASSURANCE PROGRAM GR-4 INSPECTION GR-4.1 Inspector/Examiner GR-4.2 Inspector’s Delegate GR-4.2.1 Levels of Qualification. GR-4.2.2 Qualification Requirements.
28	Table GR-4.2-1 Inspector’s Delegate Capabilities
30	GR-4.2.3 Certification. GR-4.2.4 Recertification. GR-4.3 Responsibilities GR-4.3.1 Pressure Vessels. GR-4.3.2 Piping, Tubing, and Non-Code Vessels.
31	GR-4.4 Access for Inspectors GR-5 DOCUMENTATION GR-5.1 General GR-5.2 Document Requirements GR-5.2.1 General List of Documents GR-5.2.1.1 Metallic Materials GR-5.2.1.1.1 Turnover Package Documentation. GR-5.2.1.1.2
32	GR-5.3 Material Test Reports/Certificates of Compliance GR-5.3.1 Metallic Materials. GR-5.3.2 Polymeric and Other Nonmetallic Material Components. GR-5.3.2.1 Seal Documentation. GR-5.3.2.2 Sealed Unions. GR-5.3.3 Electropolishing. GR-5.3.4 Passivation. GR-5.4 Weld and Examination/Inspection Log
33	GR-5.5 Records Retention GR-5.5.1 Vessel Documentation. GR-5.5.2 Welding Documentation GR-6 U.S. CUSTOMARY AND SI UNITS GR-7 REFERENCES
34	GR-8 TERMS AND DEFINITIONS
43	CHAPTER 2 DESIGN 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-2.3.1 Thermal Sanitization. SD-2.3.1.1 Steam-in-Place. SD-2.3.1.2 Depyrogenation. SD-2.3.2 Chemical Sanitization.
44	SD-2.4 Fabrication SD-2.4.1 Materials of Construction SD-2.4.1.1 General. SD-2.4.1.2 Process Compatibility SD-2.4.1.3 Surface Coatings. SD-2.4.1.4 Transparent Materials SD-2.4.2 Cleanability
45	SD-2.4.3 Drainability SD-2.4.3.1 General. SD-2.4.3.2 Drainability Design Considerations. SD-2.4.3.3 Slope Considerations. SD-2.4.3.4 Drain Points SD-2.4.4 Miscellaneous Design Details SD-2.4.4.1 Lubricants SD-2.4.4.2 Exterior Design. Table SD-2.4.3.1-1 Slope Designations for Gravity-Drained Lines
46	SD-2.4.4.3 Surface Finishes. SD-3 PROCESS COMPONENTS SD-3.1 Connections, Fittings, and Piping SD-3.1.1 General SD-3.1.2 System Design SD-3.1.2.1 General SD-3.1.2.2 Dead Legs.
47	Fig. SD-3.1.1-1 Flat Gasket Applications
48	Table SD-3.1.2.2-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With Blind Cap
49	Table SD-3.1.2.2-2 L/D Dimensions for Flow-Through Tee: Short-Outlet Reducing Tee With Blind Cap
51	Fig. SD-3.1.2.2-1 Accepted Point-of-Use Designs
52	SD-3.1.2.3 System Piping Fig. SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly
53	SD-3.1.2.4 Hygienic Support Systems SD-3.1.2.4.1 Pipe Hangers and Supports for Metallic Piping. SD-3.1.2.4.2 Pipe Hangers and Supports for Nonmetallic Piping SD-3.2 Hose Assemblies SD-3.2.1 General SD-3.2.2 Flexible Element
54	SD-3.2.3 End Connections SD-3.3 Pumps SD-3.3.1 Diaphragm Pumps SD-3.3.2 Hygienic Pumps SD-3.3.2.1 General Fig. SD-3.2.1-1 Flexible Hygienic Hose Design
55	SD-3.3.2.2 Centrifugal Pumps SD-3.3.2.3 Positive Displacement Pumps SD-3.3.2.4 Rotary Lobe Pumps SD-3.4 Vessels SD-3.4.1 General. Fig. SD-3.3.2.2-1 Pump Impeller Configurations
56	Fig. SD-3.3.2.2-2 Acceptable Impeller Attachments Fig. SD-3.3.2.2-3 Casing Drain Configurations
57	Fig. SD-3.3.2.2-4 Casing Drain L/D Ratios Fig. SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment
58	SD-3.4.2 Vessel Openings SD-3.4.3 Internal Components SD-3.4.4 Fabrication
59	Fig. SD-3.4.2-1 Nozzle Design
60	Fig. SD-3.4.2-2 Side and Bottom Connections Fig. SD-3.4.2-3 Sidewall Instrument Ports
61	Fig. SD-3.4.2-4 Vessel Design Tangential Nozzles Fig. SD-3.4.2-5 Typical Nozzle Detail
62	Fig. SD-3.4.3-1 Accepted Nozzle Penetrations Table SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes
63	Fig. SD-3.4.3-2 Internal Support Members
64	SD-3.4.5 Finishes SD-3.4.6 Sight Glasses SD-3.4.7 Portable Tanks. SD-3.4.8 Media Bulk Containers. SD-3.4.9 Cryogenic Containers. SD-3.5 Agitators and Mixers SD-3.5.1 General SD-3.5.2 In-Tank Shaft Couplings
65	Fig. SD-3.4.6-1 Sight Glass Design (Accepted)
66	SD-3.5.3 Shafts and Keyways Fig. SD-3.5.1-1 Agitator Mounting Flanges
67	Fig. SD-3.5.2-1 Shaft Coupling Construction
68	Fig. SD-3.5.2-2 Shaft Coupling Seal Arrangements
69	SD-3.5.4 Hubs and Impellers SD-3.5.5 Impeller and Shaft Support Bearings Fig. SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs
70	Fig. SD-3.5.5-1 Shaft-Steady Bearing
71	SD-3.5.6 Mechanical Seals SD-3.6 Heat Exchange Equipment SD-3.6.1 General Fig. SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount)
72	SD-3.6.2 Cleaning and Steaming SD-3.6.3 Gaskets and Seals SD-3.7 Transfer Panels SD-3.7.1 General SD-3.7.2 Nozzles or Ports
73	Fig. SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design
74	Fig. SD-3.7.1-1 Transfer Panel Looped Headers
75	Fig. SD-3.7.2-1 Transfer Panel Tolerances
76	SD-3.7.3 Headers or Pre-Piped Manifolds SD-3.7.4 Jumpers or U-Bends SD-3.7.5 Drain or Drip Pans SD-3.7.6 Proximity Switches SD-3.8 Filters SD-3.8.1 Code 7 Cartridge Lock Design.
77	Fig. SD-3.7.4-1 Transfer Panel Jumpers
78	SD-3.8.1.1 Design Features. SD-3.8.1.2 Testing. SD-3.9 Spray Devices SD-3.9.1 General.
79	Fig. SD-3.9.1-1 Dynamic Spray Device: Single Axis Fig. SD-3.9.1-2 Two Axes Dynamic Spray Device
80	SD-3.9.2 Spray Device Requirements SD-3.9.2.1 Static Spray Device Requirements SD-3.9.2.2 Single-Axis Dynamic Spray Device Requirements SD-3.9.2.3 Multiaxis Dynamic Spray Device Requirements
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 Buildup
83	SD-3.10 Disposables That Require Presterilization or Poststerilization SD-3.11 Sampling Systems SD-3.11.1 General SD-3.11.2 Aseptic Sampling Systems SD-3.11.2.1 Basic Requirements SD-3.11.2.2 Installation. SD-3.11.2.3 Sample Collecting SD-3.11.3 Nonaseptic Sampling. SD-3.12 Steam Traps SD-3.13 Check Valves
84	SD-3.14 Orifice Plates SD-3.15 Relief Devices SD-3.16 Liquid Pressure Regulators SD-4 PROCESS UTILITIES SD-4.1 Compendial Water Systems Fig. SD-3.12-1 Steam Traps for Clean Steam Systems
85	SD-4.1.1 Compendial Water Generation SD-4.1.2 Compendial Water Distribution Systems SD-4.1.2.1 Point-of-Use Piping Design for Compendial Water Systems. SD-4.1.2.2 Critical Design Criteria for Point-of-Use Assemblies SD-4.2 Clean/Pure Steam Systems SD-4.2.1 Clean/Pure Steam Generation
86	Fig. SD-4.1.2.1-1 Point-of-Use Piping
87	SD-4.2.2 Clean/Pure Steam Distribution System SD-4.2.3 Clean/Pure Steam Valves. SD-4.3 Process Gases SD-4.3.1 Process Gas Distribution Systems. Fig. SD-4.1.2.2-1 Physical Break in Point-of-Use Piping
88	Fig. SD-4.2.2-1 Typical Clean Steam System Isometric
89	SD-4.4 Process Waste Systems SD-4.4.1 General. Fig. SD-4.2.2-2 Clean Steam Point-of-Use Design
90	SD-4.4.2 Bio-Inactiviation Systems. SD-5 PROCESS SYSTEMS SD-5.1 Upstream Systems SD-5.1.1 Bioreactors and Fermentors SD-5.1.1.1 General SD-5.1.1.2 Inlet Gas Assembly.
91	Fig. SD-5.1.1.1-1 Fermentor Sterile Envelope
92	Fig. SD-5.1.1.1-2 Bioreactor Sterile Envelope
93	SD-5.1.1.2.1 Flow Control Devices SD-5.1.1.2.2 Inlet Filter Assembly SD-5.1.1.2.3 Gas Sparging Assemblies SD-5.1.1.2.4 Inlet Gas Piping SD-5.1.1.3 Exhaust Gas Assembly. SD-5.1.1.3.1 Exhaust Filter SD-5.1.1.3.2 Exhaust Gas Piping
94	Fig. SD-5.1.1.2.3-1 Gas Sparging Assembly — Lance
95	Fig. SD-5.1.1.2.3-2 Gas Sparging Assembly — Sintered
96	Fig. SD-5.1.1.2.3-3 Gas Sparging Assembly — Ring
97	Fig. SD-5.1.1.2.3-4 Gas Sparging Assembly — Single Orifice
98	Fig. SD-5.1.1.3.1-1 Exhaust Gas Condenser Fig. SD-5.1.1.3.1-2 Exhaust Gas Heater
99	Fig. SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing
100	SD-5.1.1.3.3 Back Pressure Control Devices SD-5.1.1.4 Piping Systems SD-5.1.1.4.1 Feed Lines. SD-5.1.1.4.2 Dip Tubes. SD-5.1.1.4.3 Harvest Valves/Bottom Outlet Valve. SD-5.1.1.5 Miscellaneous Internal Components SD-5.1.1.5.1 Agitation Assemblies. SD-5.1.1.5.2 Mechanical Foam Breaker Assemblies. SD-5.1.1.5.3 Internal Coils SD-5.1.1.5.4 Baffles. SD-5.1.1.5.5 Sprayballs/Devices/Wands.
101	SD-5.1.1.6 Instrumentation SD-5.1.2 Cell Disrupters SD-5.1.3 Centrifuges SD-5.1.3.1 General Description. SD-5.1.3.2 Process Parameters. SD-5.1.3.3 Performance Requirements. SD-5.1.3.4 Disk Stack Centrifuge. SD-5.1.3.4.1 Operating Capabilities and System Function.
102	SD-5.2 Downstream Systems SD-5.2.1 Filtration SD-5.2.1.1 General SD-5.2.1.1.1 Cleaning SD-5.2.1.1.2 Sanitization. SD-5.2.1.2 Micro/Ultrafiltration Systems
103	SD-5.2.1.3 Depth Filtration. SD-5.2.1.4 Tangential/Cross Flow Filtration. SD-5.2.2 SD-5.2.3 Chromatography. SD-5.2.3.1 Cleaning. SD-5.2.3.2 Sanitization SD-5.2.3.2.1 Chemical Sanitization. SD-5.2.3.2.2 Thermal Sanitization. SD-5.3 Process Support Systems SD-5.3.1 Cabinet Washers SD-5.3.1.1 General Fig. SD-5.2.1.1-1 Tank/Vessel Vent Filters
104	SD-5.3.1.2 Cleaning Cycles SD-5.3.1.3 Rinse Requirements SD-5.3.1.4 Components SD-5.3.1.4.1 General SD-5.3.1.4.2 Washer Chamber SD-5.3.1.4.2.1 General SD-5.3.1.4.2.2 Chamber Openings
105	SD-5.3.1.4.3 Washer Door and Door Seals SD-5.3.1.4.4 Internal Components SD-5.3.1.4.5 Air Drying, Intake, and Exhaust Systems. SD-5.3.1.4.6 Spray Systems. SD-5.3.1.4.7 Chemical Addition Systems.
106	SD-5.3.1.4.8 Recirculation Pumps SD-5.3.1.4.9 Heat Exchangers SD-5.3.1.4.10 Instrumentation SD-5.3.1.5 Branch Connections SD-5.3.1.6 Fabrication SD-5.3.1.7 Maintenance SD-5.3.1.8 Testing. SD-5.3.1.8.1 Spray Device Coverage Test. SD-5.3.1.8.2 Drainability Test. SD-5.3.1.8.3 Cycle Performance Test. SD-5.3.1.9 Turnover Package Documentation.
107	SD-5.3.2 Steam Sterilizers/Autoclaves SD-5.3.2.1 General. SD-5.3.2.2 Cycle Types. SD-5.3.2.2.1 Hard Goods Cycles. SD-5.3.2.2.2 Liquid Cycles. SD-5.3.2.2.3 Air Filter Sterilization. SD-5.3.2.3 Components SD-5.3.2.3.1 General SD-5.3.2.3.2 Doors.
108	SD-5.3.2.3.3 Sterile Air/Vent Filters. SD-5.3.2.3.4 Steam Traps. SD-5.3.2.3.5 Loading Carts/Trays. SD-5.3.2.3.6 Valves. SD-5.3.2.3.7 Check Valves. SD-5.3.2.3.8 Jacket. SD-5.3.2.4 Other Features SD-5.3.2.4.1 Drain Temperature. SD-5.3.2.4.2 Instrumentation. SD-5.3.3 CIP Systems and Design SD-5.3.3.1 General SD-5.3.3.1.1 Scope and Definitions SD-5.3.3.1.2 CIP System Operating Capabilities SD-5.3.3.1.3 CIP System Functionality
109	SD-5.3.3.2 CIP Skid Design SD-5.3.3.3 CIP Flow Rate Guidelines for Process Lines Table SD-5.3.3.3-1 Flow Rates to Achieve 5 ft/sec (1.52 m/s)
110	SD-5.3.3.4 Design Guidelines for Cleaning Process Vessels SD-5.3.3.5 CIP Distribution Design SD-5.3.3.5.1 CIP Distribution Guidelines (Supply and Return)
111	SD-5.3.3.5.2 CIP Distribution Piping Fig. SD-5.3.3.5.1-1 CIP Looped Header (Supply or Return) Fig. SD-5.3.3.5.1-2 Zero-Static Chain
112	SD-5.3.3.5.3 CIP Return Pumps SD-5.3.3.5.4 CIP Return Eductors. SD-5.3.4 Thermal Treatment Systems SD-5.3.4.1 General. SD-5.3.4.1.1 Terminology. SD-5.3.4.2 Performance Requirements. SD-5.3.4.3 Thermal Treatment System Design SD-5.3.4.3.1 System Configuration Fig. SD-5.3.3.5.1-3 Swing Elbow Arrangement
113	Fig. SD-5.3.4.3.1-1 Example HTST Process Flow Schematic Diagram
114	SD-5.3.4.3.2 Heat Exchangers. Fig. SD-5.3.4.3.1-2 Example Direct Steam Injection UHT Process Flow Schematic Diagram
115	SD-5.3.4.3.3 Steam Injectors SD-5.3.4.3.4 Flash Chambers. SD-5.3.4.3.5 Pumps. SD-5.3.4.3.6 Retention Tube SD-5.3.4.3.7 Instrumentation. SD-5.3.4.3.8 Flow Control. SD-5.3.4.3.9 Back Pressure Control.
116	Fig. SD-5.3.4.3.6-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing
117	SD-5.3.4.3.10 Materials of Construction SD-5.3.4.3.11 System Interfaces SD-5.3.4.4 Operating Capabilities and System Function. SD-5.3.4.4.1 Drainability. SD-5.3.4.4.2 Cleaning. SD-5.3.4.4.3 Sterilization. SD-5.3.4.4.4 Priming. SD-5.3.4.4.5 Thermal Sanitization. SD-5.3.4.4.6 Temperature Stabilization. SD-5.3.4.4.7 Heat Treatment.
118	SD-5.3.4.4.8 Post-Use Sequence. SD-5.3.4.5 Product Impact Considerations (Degradation, Fouling, Precipitation). SD-5.3.4.6 Testing. SD-5.3.4.7 Maintenance. SD-5.3.5 Solution Preparation Systems. SD-5.3.5.1 Contamination Control.
119	SD-5.3.5.1.1 SD-5.3.5.1.2 SD-5.3.5.1.3 SD-5.4 Fill and Finish Systems SD-5.4.1 Lyophilizers/Freeze Dryers SD-5.4.1.1 General. SD-5.4.1.2 Components. SD-5.4.1.2.1 General SD-5.4.1.2.2 Lyophilizer Chamber SD-5.4.1.2.3 Condenser Vessel
120	Fig. SD-5.4.1.2-1 Typical Lyophilizer Component Assembly
121	SD-5.4.1.2.4 Lyophilizer Shelves SD-5.4.1.2.5 Vacuum Systems SD-5.4.1.2.6 Isolation Bellows SD-5.4.1.2.7 Internal Moving Parts. SD-5.4.1.2.8 Spray Devices
122	SD-5.4.1.2.9 Gas Filter Assemblies SD-5.4.1.2.10 Doors and Door Seals SD-5.4.1.2.11 Valves SD-5.4.1.2.12 Instruments SD-5.4.1.3 Sterile Boundary.
123	SD-5.4.1.4 Internal Connections and Fasteners SD-5.4.1.5 CIP of Lyophilizers Fig. SD-5.4.1.3-1 Lyophilizer Sterile Boundary
124	SD-5.4.1.6 Bioburden Reduction in Lyophilizers. SD-5.4.1.6.1 Steam-in-Place. SD-5.4.1.6.2 Hydrogen Peroxide Sterilization. SD-5.4.1.7 Leak Rate
125	SD-5.4.1.8 Branch Connections SD-6 DESIGN CONFORMANCE TESTING SD-6.1 Spray Device Coverage Test SD-6.2 Cleaning, Steaming, and Bioburden Control Testing SD-6.3 Fluid Requirements for Leak Testing SD-6.4 Vessel Drainability Test
126	CHAPTER 3 MATERIALS 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
127	Table MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %)
128	Table MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %)
129	MM-3.6 Designation of Alloy and Fluid Service MM-4 REFERENCED SPECIFICATIONS MM-4.1 General MM-4.2 Tubing/Piping Table MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations Table MM-2.1-4 Wrought Copper: Nominal Compositions (wt. %) (Cleaned for Oxygen Service)
130	MM-4.3 Castings MM-4.4 Forgings MM-4.5 Plate, Sheet, and Strip
131	MM-4.6 Hollow Products, Rod, and Bar Stock MM-4.7 Copper Alloy Fittings MM-5 BASE METALS AND FILLER MATERIALS MM-5.1 General MM-5.2 Base Metals MM-5.2.1 Austenitic Stainless Steels MM-5.2.1.1 Weld Ends. MM-5.2.1.2 Ferrite. MM-5.2.2 Superaustenitic Stainless Steels.
132	MM-5.2.3 Duplex Stainless Steels. MM-5.2.4 Castings. MM-5.2.5 Copper Alloys. MM-5.2.6 Special Alloys. MM-5.2.7 Unlisted Alloys. MM-5.3 Filler Materials MM-5.3.1 Austenitic Stainless Steels. Table MM-5.2.1.2-1 Predicted Ferrite Number (FN) Ranges for Various Austenitic Stainless Steel Product Forms and Welds
133	MM-5.3.2 Superaustenitic and Duplex Stainless Steels. MM-5.3.3 Copper Alloys. MM-5.4 Heat Treatment MM-6 MECHANICAL PROPERTIES MM-6.1 General MM-6.2 Tubing/Piping MM-6.3 Fittings and Valves MM-6.4 Toughness MM-6.5 Testing MM-6.6 Positive Material Identification (PMI) Table MM-5.2.6-1 Materials for OEM Equipment
134	Table MM-5.3-1 Filler Metals
136	Table MM-5.3-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels
137	Table MM-5.3.3-1 Brazing Filler Metals for Copper Table MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic and Duplex Stainless Steels
138	MM-7 CORROSION-RESISTANCE REQUIREMENTS MM-7.1 General MM-7.2 Corrosion Testing MM-8 ADDITION OF NEW ALLOYS TO PART MM MM-8.1 General
139	Part PM Polymeric and Other Nonmetallic Materials PM-1 PURPOSE AND SCOPE PM-2 MATERIALS PM-2.1 Materials of Construction PM-2.1.1 Thermoplastic Polymers. PM-2.1.2 Thermoset Polymers.
140	PM-2.1.3 Other Nonmetallic Materials. PM-2.2 General Requirements PM-2.2.1 Certificate of Compliance. Table PM-2.1.1-1 Common Thermoplastic Polymers and Applications Table PM-2.1.2-1 Common Thermoset Polymers and Applications
141	PM-2.2.2 Labeling and Marking. PM-2.2.3 Change Management PM-2.2.3.1 General. PM-2.2.3.2 Change Classifications PM-2.2.3.3 Owner/User Notification. PM-2.2.3.4 Supplier Responsibilities. PM-2.2.3.5 Owner/User Responsibilities. Table PM-2.1.3-1 Examples of Nonmetallics
142	PM-3 PROPERTIES AND PERFORMANCE PM-3.1 Biocompatibility Table PM-2.2.1-1 Content Required on the Certificate of Compliance
143	PM-3.2 Extractables and Leachables PM-3.2.1 General. PM-3.2.2 Extractables. PM-3.2.2.1 Polymeric Material Specific Extraction Study. PM-3.2.2.2 Extraction Study in Bioprocess Model Solutions. PM-3.2.3 Leachables. PM-3.2.4 Sample Preparation. PM-3.2.5 Documentation. PM-3.2.6 Risk Assessment. PM-3.3 Physical and Mechanical Properties of Thermoplastic Polymers
144	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 Physical and Mechanical Properties of Other Nonmetallic Materials PM-3.8 Chemical Compatibility of Nonmetallic Materials PM-3.9 Polymeric Surface Finish PM-4 APPLICATIONS PM-4.1 Single-Use Components and Assemblies PM-4.1.1 Identification. PM-4.1.1.1 Labeling. PM-4.1.1.2 Certificate of Compliance.
145	PM-4.1.2 Inspection and Packaging. PM-4.1.2.1 Inspection. PM-4.1.2.2 Packaging. PM-4.1.3 Joining Methods. PM-4.1.4 Biocompatibility. PM-4.1.5 Sterilization (Bioburden Control). PM-4.1.5.1 Gamma Irradiation. PM-4.1.6 Shelf Life, Storage, and Expiration Date.
146	PM-4.1.7 Particulates. PM-4.1.7.1 General. PM-4.1.7.2 Mitigation Techniques. PM-4.1.7.2.1 Suppliers. PM-4.1.7.2.2 Owner/User. PM-4.2 Piping PM-4.2.1 Sizing Comparisons. PM-4.2.2 Pressure Ratings. PM-4.2.3 Thermal Expansion.
147	Table PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards
148	PM-4.2.4 System Support Criteria PM-4.2.4.1 Support Distances. PM-4.2.4.2 Hanger and Clamp Types. PM-4.2.5 Connections and Fittings. PM-4.3 Hose Assemblies PM-4.3.1 General. PM-4.3.2 Hose Construction PM-4.3.2.1 Flexible Elements. PM-4.3.2.2 Mechanically Affixed and Reusable End Connections. PM-4.3.2.3 Flare-Through End Connections. PM-4.3.2.4 Molded-in-Place End Connections. PM-4.3.2.5 Hose Materials.
149	PM-4.3.3 Hose Assembly Performance. PM-4.3.3.1 Service Temperatures and Pressures. PM-4.3.3.2 Nonroutine Events. PM-4.3.3.3 Cleaning Systems PM-4.3.3.4 Sterilizing Systems. PM-4.3.4 Hose Assembly Installation. PM-4.3.5 Compliance Requirements PM-4.3.5.1 General Requirements. PM-4.3.5.2 Certificate of Compliance. PM-4.3.5.3 Test Requirements. PM-4.4 Chromatography Columns PM-4.4.1 General. PM-4.4.2 Pressure-Retaining Parts.
150	PM-4.4.3 Design for Cleaning and Sanitization PM-4.4.3.1 Cleaning. PM-4.4.3.1.1 Seals. PM-4.4.3.1.2 Exterior Surfaces. PM-4.4.3.1.3 Hygienic Connections. PM-4.4.3.2 Sanitization PM-4.4.3.2.1 Chemical Sanitization. PM-4.4.3.2.2 Thermal Sanitization. PM-4.4.4 Column Materials. PM-4.4.5 Column Performance. PM-4.4.5.1 Service Temperature and Pressure. PM-4.4.5.2 Routine Maintenance. PM-4.4.6 Compliance Requirements PM-4.4.6.1 General Requirements. PM-4.4.6.2 Certificate of Compliance. PM-4.5 Filtration Elements and Components PM-4.5.1 General. PM-4.5.2 Filtration Formats. PM-4.5.3 Housing and Encapsulation. PM-4.5.3.1 Housings. PM-4.5.3.2 Encapsulation.
151	PM-4.5.3.2.1 Holders. PM-4.5.4 Design for Cleaning and Sanitization PM-4.5.4.1 Cleaning. PM-4.5.4.1.1 Seals. PM-4.5.4.1.2 Exterior Surfaces. PM-4.5.4.2 Sanitization PM-4.5.4.2.1 Chemical Sanitization. PM-4.5.4.2.2 Thermal Sanitization. PM-4.5.5 Filtration Performance. PM-4.5.5.1 Service Temperature and Pressure. PM-4.5.5.2 Routine Maintenance. PM-4.5.5.2.1 Integrity Testing and Permeability PM-4.5.6 Installation. PM-4.5.7 Compliance Requirements PM-4.5.7.1 General Requirements. PM-4.5.7.2 Certificate of Compliance. PM-4.6 Polymeric Hygienic Unions PM-4.6.1 Multiuse PM-4.6.1.1 Installation. PM-4.6.1.2 Performance.
152	PM-4.6.1.3 Cleaning. PM-4.6.1.4 Bioburden Control. PM-4.6.1.5 Seals. PM-4.6.2 Single-Use. PM-4.6.2.1 Installation. PM-4.6.2.2 Performance. PM-4.6.2.3 Seals. PM-4.7 Steam-Through and Steam-to Connections PM-4.7.1 General Requirements.
153	CHAPTER 4 PROCESS COMPONENTS 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-4.1.1 Elbows/Bends. DT-4.1.2 Tees/Crosses. DT-4.1.3 Reducers. DT-4.1.4 Ferrules. DT-4.1.5 Caps. DT-4.2 Nonstandard Fitting Dimensions
154	DT-4.3 Special Angle Fittings Dimensions DT-4.4 Valve Dimensions DT-4.4.1 Diaphragm Valves. DT-4.5 Filter Dimensions DT-4.5.1 Code 7 Tapered Locking Tab Retainer: Recessed. DT-4.5.2 Code 7 Tapered Locking Tab Retainer: External. 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
155	DT-9.4 Hygienic Clamps DT-10 MINIMUM EXAMINATION REQUIREMENTS DT-10.1 Visual Inspection DT-10.2 Documentation Verification DT-10.3 Physical Examination DT-11 MARKING DT-11.1 Fitting Marking Information
156	DT-11.1.1 Exceptions DT-11.2 Valve Marking Information DT-11.2.1 Exceptions DT-11.3 Modified Surfaces DT-12 PACKAGING
157	Fig. DT-2-1 Clamp Conditions at Installation Table DT-2-1 Metallic Hygienic Unions: Rated Internal Working Pressure
158	Table DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components
159	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
160	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
161	Table DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Elbow Table DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow
162	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
163	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
164	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
165	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
166	Table DT-4.1.2-5 Hygienic Clamp Joint: Short-Outlet Tee Table DT-4.1.2-6 Automatic Tube Weld: Reducing Tee
167	Table DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee
168	Table DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee
169	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
170	Table DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer
171	Table DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
172	Table DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer
173	Table DT-4.1.4-1 Automatic Tube Weld: Ferrule Table DT-4.1.5-1 Automatic Tube Weld: Cap
174	Table DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap
175	Table DT-4.4.1-1 Hygienic Clamp Joint: Weir-Style Diaphragm Valve
176	Table DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed
177	Table DT-4.5.2-1 Tapered Locking Tab Retainer: External
178	Table DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances
180	Table DT-7-2 Transfer Panel and Jumper Tolerances
181	Table DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria
182	Part PI Process Instrumentation PI-1 PURPOSE AND SCOPE PI-2 PROCESS INSTRUMENTATION GENERAL REQUIREMENTS PI-2.1 General Considerations PI-2.1.1 Installation. PI-2.1.2 Internal Design and Process Connections PI-2.1.3 Exterior Design. PI-2.2 Instrumentation Categories PI-2.2.1 In-Line Devices. PI-2.2.2 Insertion Devices.
183	PI-2.2.3 At-Line Devices. PI-2.2.4 Off-Line Devices. PI-3 INSTRUMENT RECEIVING, HANDLING, AND STORAGE PI-3.1 Introduction PI-3.2 Instrument Receiving PI-3.2.1 Original Packaging. PI-3.3 Instrument Handling: Protection of Process Connections and Surface Finish PI-3.4 Instrument Storage PI-3.4.1 Special Considerations. PI-3.4.2 Instrument Shelf Life and Environmental Requirements. PI-4 FLOWMETERS PI-4.1 Coriolis Flowmeter PI-4.1.1 General Considerations. Fig. PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples
184	Fig. PI-2.2.2-1 Accepted Insertion Device Installation Examples
185	PI-4.1.2 Essential Components. PI-4.1.3 Components PI-4.1.3.1 Flow Tube(s). PI-4.1.3.2 Manifold or Flow Splitter. PI-4.1.3.3 Process Connections. PI-4.1.4 Installation. PI-4.1.4.1 Drainability. PI-4.1.4.2 Cleanability. PI-4.1.4.3 Mounting Location. PI-4.1.4.4 Orientation. Fig. PI-4.1.3.2-1 Manifold or Flow Splitter for Dual-Tube Construction Flowmeters and Potential for Product Holdup
186	Fig. PI-4.1.3.3-1 Concentrically Reducing Process Connection Fig. PI-4.1.4.3-1 Vertical Installation
187	PI-4.1.4.5 Special Considerations for Passivation of Coriolis Flowmeters. PI-4.1.5 Performance. PI-4.1.5.1 Accuracy. PI-4.1.5.2 Process Influences. PI-4.1.5.3 Ambient Influences. PI-4.1.6 Selection. PI-4.1.7 Maintenance. PI-4.1.7.1 Seals/Gaskets. PI-4.1.7.2 Recalibration/Verification Schedule. Fig. PI-4.1.4.4-1 Minimum Angle of Inclination, a
188	PI-5 LEVEL INSTRUMENTS PI-5.1 Radar Level Instruments PI-5.1.1 General. PI-5.1.2 Essential Components. PI-5.1.2.1 Antenna. PI-5.1.2.2 Process Connection. PI-5.1.3 Installation. PI-5.1.3.1 Drainability. PI-5.1.3.2 Cleanability. PI-5.1.3.3 Mounting Location. PI-5.1.3.4 Orientation. PI-5.1.3.5 Insertion Length/Depth. PI-5.1.3.6 Special Considerations. Fig. PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna
189	Fig. PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location
190	PI-5.1.4 Performance. PI-5.1.4.1 Accuracy. PI-5.1.4.2 Process Influences. PI-5.1.4.3 Ambient Influences. PI-5.1.5 Selection. PI-6 PRESSURE INSTRUMENTS PI-7 TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS PI-7.1 General PI-7.2 Components PI-7.2.1 Sensors. PI-7.2.2 Thermowells. PI-7.3 Installation Fig. PI-7.3-1 Typical Installation Styles
191	PI-7.3.1 Drainability. PI-7.3.2 Cleanability. PI-7.3.3 Mounting Location. PI-7.3.4 Orientation PI-7.3.5 Insertion Length/Depth PI-7.3.6 Special Considerations
192	Fig. PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions Fig. PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions
193	Fig. PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations
194	Fig. PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations
195	PI-7.4 Performance PI-7.4.1 Accuracy. PI-7.4.2 Response Time. PI-7.4.3 Process Influences. PI-7.4.4 Ambient Influences. PI-7.5 Selection PI-7.5.1 Sensor Selection. PI-7.5.2 Thermowell Selection. PI-7.6 Sensor Calibration Verification PI-8 ANALYTICAL INSTRUMENTS PI-8.1 Conductivity PI-8.1.1 General. PI-8.1.2 Essential Components.
196	PI-8.1.2.1 Sensor Types. PI-8.1.3 Installation. PI-8.1.3.1 Drainability. PI-8.1.3.2 Cleanability. PI-8.1.3.3 Mounting Location. PI-8.1.3.4 Orientation. Fig. PI-8.1.2-1 Conductivity-Type Examples
197	Fig. PI-8.1.3-1 Accepted Installations for Conductivity Sensors
198	PI-8.1.3.5 Immersion Length/Depth. PI-8.1.3.6 Special Consideration. PI-8.1.4 Performance. PI-8.1.4.1 Accuracy. PI-8.1.4.2 Response Time. PI-8.1.4.3 Process Influences. PI-8.1.4.4 Ambient Influences. PI-8.1.5 Selection. PI-8.1.6 Maintenance PI-8.1.6.1 Calibration/Verification Schedule. PI-8.2 pH — Glass Measuring Electrode PI-8.2.1 General. PI-8.2.2 Components. Fig. PI-8.1.3.6-1 Installation Clearance Requirements
199	PI-8.2.3 Installation. PI-8.2.3.1 Drainability. PI-8.2.3.2 Cleanability. PI-8.2.3.3 Mounting Location. PI-8.2.3.4 Orientation. PI-8.2.3.5 Insertion Length/Depth. PI-8.2.3.6 Special Considerations. PI-8.2.4 Performance. Fig. PI-8.2.2-1 pH Sensor Components
200	Fig. PI-8.2.3-1 Accepted pH Sensor Installations
201	Fig. PI-8.2.3.4-1 Accepted Mounting Orientations
202	PI-8.2.4.1 Accuracy. PI-8.2.4.2 Response Time. PI-8.2.4.3 Process Influences. PI-8.2.4.4 Ambient Influences. PI-8.2.5 Selection. PI-8.2.6 Maintenance. PI-8.2.6.1 Calibration/Verification Schedule. Fig. PI-8.2.3.5-1 Insertion Length or Depth
203	PI-9 OPTICAL PI-9.1 Optical Devices PI-9.1.1 General. PI-9.1.2 Components PI-9.1.2.1 Light Source(s). PI-9.1.2.2 Sensor. PI-9.1.2.3 Sight Glass. PI-9.1.3 Installation. PI-9.1.3.1 Drainability. PI-9.1.3.2 Cleanability. PI-9.1.3.3 Mounting Location. PI-9.1.3.4 Orientation. PI-9.1.3.5 Insertion Length. PI-9.1.3.6 Special Considerations. PI-9.1.4 Performance. PI-9.1.4.1 Accuracy. PI-9.1.4.2 Response Time.
204	Fig. PI-9.1.3.3-1 Vessel Light Glass Design and Mounting
205	Fig. PI-9.1.3.5-1 In-Line Insertion Length Fig. PI-9.1.3.5-2 Insertion Probe Length
206	PI-9.1.4.3 Process Influences. PI-9.1.4.4 Ambient Influences. PI-9.1.5 Selection.
207	Part SG Sealing Components SG-1 PURPOSE AND SCOPE SG-2 SEALING COMPONENT TYPES SG-2.1 General SG-2.2 Static Seals SG-2.2.1 General. SG-2.2.2 Hygienic Unions. SG-2.2.3 O-Ring Seals. SG-2.2.4 Other Static Seals. SG-2.3 Dynamic Seals SG-2.3.1 Valves SG-2.3.1.1 General.
208	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
209	Fig. SG-2.2.2-3 Hygienic Union per DIN 11864 Fig. SG-2.2.2-4 Hygienic Clamp Union per DIN 11864
210	Fig. SG-2.2.2-5 Nonhygienic Connections
211	SG-2.3.1.2 Diaphragm Valves SG-2.3.1.3 Ball Valve and Ball Tank Bottom Valve. SG-2.3.1.4 Rising Stem Single, Double-Seat Mix-Proof, and Needle Valves. SG-2.3.1.5 Butterfly Valves. SG-2.3.1.6 Thermostatic Steam Trap. SG-2.3.1.7 Back Pressure Control Valve. SG-2.3.1.8 Pinch Valve. SG-2.3.1.9 Check, Pressure Relief, and Safety Pressure Relief Valves Fig. SG-2.3.1.2-1 Weir Valves
212	Fig. SG-2.3.1.2-2 Radial Valves Fig. SG-2.3.1.2-3 Weirless Diaphragm Valve
213	Fig. SG-2.3.1.2-4 Linear Control Valves Fig. SG-2.3.1.2-5 Regulator Valve
214	Fig. SG-2.3.1.3-1 Ball Valves Fig. SG-2.3.1.4-1 Rising Stem Single, Double-Seat Mix-Proof, and Needle Valves
215	Fig. SG-2.3.1.5-1 Butterfly Valve Fig. SG-2.3.1.7-1 Back Pressure Control Valve Fig. SG-2.3.1.8-1 Pinch Valve
216	Fig. SG-2.3.1.9-1 Pressure Relief and Check Valves
217	SG-2.3.1.10 Plug Valves. SG-2.3.2 Mechanical Seals SG-2.3.2.1 General SG-2.3.2.2 Single Mechanical Seals SG-2.3.2.3 Dual Mechanical Seals Fig. SG-2.3.1.10-1 Plug Valve
218	SG-2.3.2.4 Flush Plans. Fig. SG-2.3.2.2-1 Single Mechanical Seal Fig. SG-2.3.2.2-2 Single Seal for Top-Entry Agitator Fig. SG-2.3.2.3-1 Dual Pressurized Mechanical Seal for Pumps
219	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
220	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 03 Fig. SG-2.3.2.4-4 Flush Plan 11 Fig. SG-2.3.2.4-5 Flush Plan 32
221	Fig. SG-2.3.2.4-6 Flush Plan 52 for Pump Fig. SG-2.3.2.4-7 Flush Plan 52 for Top-Entry Agitator Fig. SG-2.3.2.4-8 Flush Plan BPE52 for Pump Fig. SG-2.3.2.4-9 Flush Plan 53 for Pump
222	Fig. SG-2.3.2.4-10 Flush Plan 53 for Top-Entry Agitator Fig. SG-2.3.2.4-11 Flush Plan 54 for Pump Fig. SG-2.3.2.4-12 Flush Plan 54 for Top-Entry Agitator Fig. SG-2.3.2.4-13 Flush Plan 55 for Pump Fig. SG-2.3.2.4-14 Flush Plan 55 for Top-Entry Agitator
223	SG-2.3.3 Other Dynamic Seals SG-2.3.3.1 Reciprocating Seals. SG-2.3.3.2 Oscillating Seals. SG-3 SEALING COMPONENTS GENERAL DESIGN REQUIREMENTS (GENERAL PROVISIONS) SG-3.1 Seal Design Conditions SG-3.1.1 Service Temperature. SG-3.1.2 Service Pressure. SG-3.1.3 Bioburden. SG-3.1.4 Cavitation Resistance. SG-3.1.5 Sterilization. SG-3.1.6 Cleaning. SG-3.1.7 Passivation. SG-3.2 System Requirements SG-3.2.1 Cleaning Systems Fig. SG-2.3.2.4-15 Flush Plan 74 for Pump Fig. SG-2.3.2.4-16 Flush Plan 74 for Top-Entry Agitator
224	SG-3.2.2 Sterilizing Systems. SG-3.2.3 Passivation Systems. SG-3.3 Seal Construction SG-3.3.1 Materials SG-3.3.2 Design SG-3.3.2.1 General SG-3.3.2.2 Static Seals
225	Fig. SG-3.3.2.2-1 Examples of Static O-Ring Grooves
226	SG-3.3.2.3 Valves
227	Fig. SG-3.3.2.3-1 Seals for Rising Stem Valves
228	SG-3.3.2.4 End Face Mechanical Seal General Design Requirements
229	SG-3.4 Compliance Requirements for Sealing Elements SG-3.4.1 General Requirements. SG-3.4.2 Certificate of Compliance. SG-3.4.3 Test Requirements. SG-3.4.4 Additional Requirements. SG-3.5 Seal Identification SG-3.6 Other Seal Requirements SG-4 SEAL PERFORMANCE REQUIREMENTS SG-4.1 General Requirements
230	SG-4.2 Static Seal Performance SG-4.3 Dynamic Seal Performance SG-4.3.1 Valve Seal Performance. Fig. SG-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion
231	SG-4.3.1.1 New Valve Seal Performance. SG-4.3.2 Mechanical Seal Performance. SG-4.3.2.1 New Mechanical Seal Performance. SG-4.3.2.2 Installed Seals. SG-5 SEAL APPLICATIONS SG-5.1 General Considerations
232	SG-5.2 Process Systems SG-5.3 Compendial Ambient/Hot-Water Distribution Systems SG-5.3.1 Static Seal Recommendations for Compendial Water SG-5.3.1.1 Additional Considerations SG-5.3.2 Valves for Compendial Water SG-5.3.2.1 Seals for Compendial Water. SG-5.3.2.2 Valve Types for Compendial Water SG-5.3.3 Single Mechanical Seals for Compendial Water per Paras. SG-3.3.2.4(a) and (b) SG-5.3.3.1 Additional Application Conditions Relevant to Mechanical Seals.
233	SG-5.3.3.2 Additional Equipment Characteristics Relevant to Mechanical Seals. SG-5.3.3.3 Materials of Construction. SG-5.3.3.4 Flush Plans. SG-5.4 Clean/USP Pure Steam SG-5.5 CIP
234	CHAPTER 5 FABRICATION, ASSEMBLY, AND ERECTION Part MJ Materials Joining MJ-1 PURPOSE AND SCOPE MJ-2 MATERIALS MJ-2.1 Base Metals MJ-2.1.1 Stainless Steels MJ-2.1.2 Nickel Alloys. MJ-2.1.3 Copper Alloys. MJ-2.1.4 Other Metals. MJ-2.2 Filler Metals MJ-2.2.1 Stainless Steels.
235	MJ-2.2.2 Nickel Alloys. MJ-2.2.3 Copper Alloys. MJ-2.3 Nonmetallics MJ-3 JOINT DESIGN AND PREPARATION MJ-3.1 General MJ-3.2 Pressure Vessels and Tanks MJ-3.3 Piping MJ-3.4 Tubing MJ-3.5 Tube-Attachment Welds MJ-3.6 Brazed Joints MJ-4 JOINING PROCESSES AND PROCEDURES MJ-4.1 Introduction
236	MJ-4.2 Welds Finished After Welding MJ-4.3 Welds Used in the As-Welded Condition MJ-4.4 Brazing 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-5.5 Brazing MJ-6 PERFORMANCE QUALIFICATIONS MJ-6.1 Pressure Vessels and Tanks MJ-6.2 Piping MJ-6.3 Tubing Table MJ-6.3-1 Metallic Tube/Pipe Diameter Limits for Orbital GTAW Performance Qualification
237	MJ-6.4 Brazing MJ-7 EXAMINATION, INSPECTION, AND TESTING MJ-7.1 Examination Procedures MJ-7.1.1 Pressure Vessels and Tanks. MJ-7.1.2 Piping. MJ-7.1.3 Tubing. MJ-7.1.4 Tube Attachments. MJ-7.1.5 Brazing. MJ-7.2 Personnel Requirements MJ-7.2.1 Pressure Vessels and Tanks. MJ-7.2.2 Piping. MJ-7.2.3 Tubing. MJ-7.2.4 Tube Attachments. MJ-7.2.5 Copper Tubing/Piping. MJ-7.2.6 Examination Personnel Eye Examination Requirements. MJ-7.3 Examination, Inspection, and Testing Requirements MJ-7.3.1 Pressure Vessels and Tanks Table MJ-6.3-2 Metallic Weld Thickness Limits for Orbital GTAW Performance Qualification
238	MJ-7.3.2 Piping MJ-7.3.3 Tubing MJ-7.3.4 Tube Attachments MJ-7.3.5 Brazing MJ-7.4 Records MJ-8 ACCEPTANCE CRITERIA MJ-8.1 General
239	MJ-8.2 Pressure Vessel and Tank Welds MJ-8.3 Piping Welds MJ-8.4 Tubing Welds MJ-8.4.1 Sample Welds. MJ-8.4.2 Rewelding. MJ-8.5 Tube-Attachment Welds MJ-8.5.1 Sample Welds. MJ-8.5.2 Rewelding. MJ-8.6 Brazed Joints MJ-9 JOINING OF POLYMERIC MATERIALS MJ-9.1 General MJ-9.2 Weld Joint Design and Preparation MJ-9.2.1 Tubing and Piping. MJ-9.3 Joining Processes and Procedures
240	Table MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks
241	Table MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe
243	Table MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints
245	Fig. MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube-to-Tube Butt Joints
246	Fig. MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Electropolished UNS S31603 Tubing
247	Fig. MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically Polished UNS S31603 Tubing
248	Fig. MJ-8.4-4 Acceptable and Unacceptable Metallic Weld Bead Width and Meander on Non–Process Contact Surfaces of Groove Welds on Tube-to-Tube Butt Joints
249	Table MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds
251	Fig. MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds
252	MJ-9.3.1 Beadless Welding. MJ-9.3.1.1 Records. MJ-9.3.2 Noncontact IR and Contact Butt Fusion Welding. MJ-9.3.3 Socket Fusion Welding. MJ-9.4 Procedure Qualifications MJ-9.5 Performance Qualifications MJ-9.6 Examination, Inspection, and Testing MJ-9.6.1 Examination Procedures. MJ-9.6.2 Personnel Requirements MJ-9.6.2.1 Personnel Qualifications. MJ-9.6.2.2 Examination Personnel Eye Examination Requirements. MJ-9.6.3 Examination, Inspection, and Testing Requirements MJ-9.6.3.1 Examination.
253	MJ-9.6.3.2 Inspection. MJ-9.6.3.3 Testing. MJ-9.6.4 Records. MJ-9.7 Weld Acceptance Criteria MJ-9.7.1 Acceptance Criteria for Beadless Welds. MJ-9.7.2 Acceptance Criteria for Nonbeadless Welds. MJ-9.7.3 Acceptance Criteria for Sample Welds. MJ-9.7.4 Rewelding. MJ-9.8 Documentation Requirements
254	MJ-10 DOCUMENTATION REQUIREMENTS MJ-11 PASSIVATION Fig. MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds
255	Part SF Process 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 Examination Techniques Employed in the Classification of Process Contact Surface Finishes SF-2.4 Surface Condition SF-2.5 Electropolishing Procedure Qualification SF-2.6 Passivation Procedure
256	Table SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes
257	Table SF-2.2-2 Additional Acceptance Criteria for Electropolished Metallic Process Contact Surface Finishes Table SF-2.4-1 Ra Readings for Metallic Process Contact Surfaces
258	SF-2.7 Normative References SF-2.8 Rouge and Stainless Steel Table SF-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes
259	SF-3 POLYMERIC APPLICATIONS SF-3.1 Applicable Systems SF-3.2 Materials SF-3.3 Examination Techniques Employed in the Classification of Process Contact Surface Finishes SF-3.4 Surface Condition Table SF-3.3-1 Acceptance Criteria for Polymeric Process Contact Surface Finishes Table SF-3.4-1 Ra Readings for Polymeric Process Contact Surfaces
260	CHAPTER 6 CERTIFICATION Part CR Certification Requirements CR-1 PURPOSE AND SCOPE CR-2 GENERAL Fig. CR-1-1 ASME Certification Mark With BPE Designator
261	CR-2.1 ASME BPE Certificate Holders CR-2.2 ASME BPE Certificate Holder’s Responsibilities CR-2.3 Certification Designator Fig. CR-2-1 Options for Certification of Organizations
262	CR-2.4 Subcontracting CR-2.5 Quality Management System CR-2.5.1 Quality Management System Control. CR-2.5.1.1 CR-2.5.1.2 CR-2.5.2 Requirements for Designated Oversight. CR-2.5.2.1 Duties of the Certified Individual. CR-2.5.2.2 Requirements for the Certified Individual
263	CR-2.5.3 Evaluation of the Quality Management System. CR-2.5.4 Applicant’s Facilities and Equipment. CR-2.5.5 Personnel. CR-2.5.6 Monitoring of Quality Control Measuring and Testing Devices CR-2.5.7 Discrepancies With Measuring and Testing Devices
264	CR-2.5.8 Internal Audits. CR-2.5.9 Corrective Action.
266	MANDATORY APPENDICES 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
267	I-4 CODE CASES I-5 INTERPRETATIONS I-6 SUBMITTALS
268	Table II-1 Standard Units MANDATORY APPENDIX II STANDARD UNITS
269	NONMANDATORY APPENDICES NONMANDATORY APPENDIX A COMMENTARY: SLAG AND OXIDE ISLANDS
270	NONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION/INSPECTION DOCUMENTATION
271	Forms Form MEL-1 Material Examination Log
272	Form MER-1 Material Examination Record
273	Form WEL-1 Weld and Examination/Inspection Log
274	NONMANDATORY APPENDIX C SLOPE MEASUREMENT AND JOINT MISALIGNMENT C-1 GENERAL C-2 JOINT MISALIGNMENT
275	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
276	D-4.2 Class II Rouge Remediation D-4.3 Class III Rouge Remediation D-4.4 Remediation Variables
277	Table D-2-1 Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System
278	Table D-2-2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System
280	Table D-3.1-1 Process Fluid Analyses for the Identification of Mobile Constituents of Rouge
281	Table D-3.2-1 Solid Surface Analyses for the Identification of Surface Layers Composition
282	Table D-4.1-1 Rouge Remediation Processes Summary
284	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 E-3 PASSIVATION PROCEDURE (SEE SF-2.6) E-3.1 Procedure Description
285	Table E-3.2-1 Minimum Surface Requirements for Process Qualification Samples E-3.2 Procedure Qualification E-3.3 Procedure Documentation Requirements E-4 PASSIVATION QUALITY CONTROL E-4.1 Quality Control Surveillance
286	Table E-3.2-2 Passivation Processes
288	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 Process Contact Surfaces (See Table SF-2.6-1)
290	Table E-5-1 Test Matrix for Evaluation of Cleaned and/or Passivated Surfaces
294	NONMANDATORY APPENDIX F CORROSION TESTING F-1 GENERAL F-2 CORROSION TESTS F-3 PITTING RESISISTANCE EQUIVALENT (PRE) NUMBER
295	Table F-1-1 ASTM Corrosion Tests
296	Table F-3-1 PRE Numbers for Some Alloys
297	NONMANDATORY APPENDIX G FERRITE G-1 GENERAL G-2 INFLUENCE OF FERRITE IN BIOPHARMACEUTICAL SERVICE G-3 CONTROL OF FERRITE CONTENT IN WELDS OF AUSTENITIC STAINLESS STEELS
298	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
299	Table H-3.3-1 Minimum Surface Requirements for Process Qualification Samples
300	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
301	Table I-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions
303	Table I-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents
304	NONMANDATORY APPENDIX J STANDARD PROCESS TEST CONDITIONS (SPTC) FOR SEAL PERFORMANCE EVALUATION J-1 SEALING COMPONENT PERFORMANCE EVALUATION J-1.1 Material and Component Testing J-1.1.1 Test Article Requirements J-1.2 Exposure Testing J-1.2.1 Simulated Steam-in-Place Testing.
305	J-1.2.2 Simulated Combined CIP and SIP Testing. J-1.2.3 Other Process Testing Considerations J-1.2.3.1 Vacuum.
306	J-1.2.3.2 Additional Cleaning Chemicals. J-1.3 Test Acceptance Criteria J-1.3.1 Hygienic Fittings. J-1.3.2 Valve Diaphragms. J-1.3.2.1 General Requirements for Performance Evaluation Test for Valve Diaphragms, per This Nonmandatory Appendix. J-1.3.2.2 Test Acceptance Criteria — Required Criteria for Hygienic Performance of Diaphragms J-2 MECHANICAL SEAL PERFORMANCE EVALUATION J-2.1 Mechanical Seal Performance Evaluation
307	Fig. J-1.3.2.1-1 Weir-Style Diaphragm
310	Fig. J-1.3.2.1-2 Weir-Style Body Fig. J-1.3.2.1-3 Radial-Style Body Fig. J-1.3.2.1-4 Manual Bonnet Fig. J-1.3.2.1-5 Pneumatic
311	J-2.1.1 Factors Affecting Seal Performance. J-2.1.2 Design Parameters. J-2.2 Exceptions to Normal Seal Performance J-2.2.1 Event-Based Operational Failures. J-2.2.2 Design- and Application-Based Failures. J-2.2.3 Equipment-Based Failures. J-2.3 Mechanical Seal Integrity Tests J-2.3.1 Single Mechanical Seals: Liquid Lubricated by Process
312	J-2.3.2 Dual Mechanical Seals: Liquid Lubricated by Barrier Fluid (Dual Pressurized) or by Process and Buffer Fluid (Dual Unpressurized)
313	J-2.4 Mechanical Seal Testing Notes
315	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
316	Table K-3-1 Thermoset Polymer Test Properties
317	Table K-4-1 Interpretation of Thermoset Material Property Changes
318	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
319	L-4.4 Inspection L-5 ACCEPTANCE CRITERIA L-6 RECOMMENDED DOCUMENTATION
320	NONMANDATORY APPENDIX M COMMENTARY: UNS S31603 WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA
321	NONMANDATORY APPENDIX N GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS N-1 GENERAL N-1.1 Gamma Irradiation N-2 PARTICULATES N-2.1 Characterization N-2.2 Levels of Acceptance
322	NONMANDATORY APPENDIX O GENERAL BACKGROUND/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES O-1 REFERENCES O-2 RECOMMENDED CONDITIONS FOR A POLYMERIC MATERIAL-SPECIFIC EXTRACTION
323	O-3 RECOMMENDED CONDITIONS FOR AN EXTRACTION STUDY IN BIOPROCESS MODEL SOLUTIONS O-4 OVERVIEW OF BIOPROCESSING EQUIPMENT/COMPONENT EVALUATION RELATED TO EXTRACTABLES AND LEACHABLES CHARACTERIZATION
324	Fig. O-4-1 Flowchart of Bioprocessing Equipment/Component Evaluation Related to Extractables and Leachables Characterization
325	NONMANDATORY APPENDIX P TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS P-1 GENERAL P-1.1 General Considerations P-2 EXTERNAL SUPPORT COMPONENTS P-3 MEASUREMENT ACCURACY P-3.1 Sensor Accuracy P-3.2 Wiring and Cabling P-3.3 Electronics P-3.4 Process Influences P-3.5 Ambient Influences
326	P-4 SELECTION P-4.1 Sensor Selection P-4.2 Transmitter Selection P-5 MAINTENANCE P-5.1 Sensor Calibration Verification P-5.2 Sensor Inspection
327	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
328	NONMANDATORY APPENDIX R APPLICATION DATA SHEET
329	Form R-1 Application Data Sheet
331	NONMANDATORY APPENDIX S GUIDANCE ON POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS AND FILTRATION S-1 CHROMATOGRAPHY COLUMNS S-1.1 General S-1.2 Column Construction S-1.3 Cleaning S-1.4 Sanitization S-2 FILTRATION S-2.1 General S-2.2 Filtration Formats S-2.2.1 Direct Flow Filtration. S-2.2.1.1 Filtration Elements.
332	S-2.2.2 Tangential Flow Filtration. S-2.2.2.1 Filtration Elements. S-2.3 Housings and Encapsulation S-2.3.1 Holders. S-2.4 Design for Cleaning S-2.4.1 Cleaning.
333	S-2.5 Normalized Water Permeability (NWP) Testing S-2-5.1
334	NONMANDATORY APPENDIX T GUIDANCE FOR THE USE OF U.S. CUSTOMARY AND SI UNITS T-1 USE OF UNITS IN THE STANDARD T-2 GUIDELINES USED TO DEVELOP SI EQUIVALENTS
335	T-3 CHECKING EQUATIONS T-4 SOFT CONVERSION FACTORS
336	NONMANDATORY APPENDIX U POSITIVE MATERIAL IDENTIFICATION U-1 POSITIVE MATERIAL IDENTIFICATION U-2 GENERAL REQUIREMENTS U-3 CALIBRATION
337	U-4 PROCEDURE U-5 PERSONNEL TRAINING AND QUALIFICATION U-6 ACCEPTANCE/REJECTION U-7 PMI REFEREE METHODS U-8 PMI SPECIAL CONDITIONS
338	NONMANDATORY APPENDIX V PROCUREMENT SOURCES
340	INDEX

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ASME	2016	354


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Standard Title	ASME BPE Bioprocessing Equipment
Published Code	ASME
Publication Date	2016
Pages Count	354

ASME BPE 2016

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