{"id":169429,"date":"2024-10-19T10:24:40","date_gmt":"2024-10-19T10:24:40","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/asme-bpe-2016\/"},"modified":"2024-10-25T02:35:15","modified_gmt":"2024-10-25T02:35:15","slug":"asme-bpe-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/asme\/asme-bpe-2016\/","title":{"rendered":"ASME BPE 2016"},"content":{"rendered":"

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: \u2022 Compendial Water Applications \u2022 New Valve Seal Performance requirements \u2022 Thermal Treatment Systems (HTST\/UHT) \u2022 Process Waste Systems \u2022 Solution Prep Systems \u2022 Washers and Diaphragm Pumps \u2022 Particulates \u2022 Change Management \u2022 Filtration ASME-BPE is referenced in ASME\u2019s 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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
4<\/td>\nCONTENTS <\/td>\n<\/tr>\n
5<\/td>\nFigures <\/td>\n<\/tr>\n
8<\/td>\nTables <\/td>\n<\/tr>\n
11<\/td>\nFOREWORD <\/td>\n<\/tr>\n
13<\/td>\nSTATEMENT OF POLICY <\/td>\n<\/tr>\n
14<\/td>\nCOMMITTEE ROSTER <\/td>\n<\/tr>\n
18<\/td>\nSUMMARY OF CHANGES <\/td>\n<\/tr>\n
26<\/td>\nCHAPTER 1 INTRODUCTION, SCOPE, AND DEFINITIONS
Part GR General Requirements
GR-1 INTRODUCTION
GR-2 SCOPE OF THE ASME BPE STANDARD <\/td>\n<\/tr>\n
27<\/td>\nGR-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. <\/td>\n<\/tr>\n
28<\/td>\nTable GR-4.2-1 Inspector\u2019s Delegate Capabilities <\/td>\n<\/tr>\n
30<\/td>\nGR-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. <\/td>\n<\/tr>\n
31<\/td>\nGR-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 <\/td>\n<\/tr>\n
32<\/td>\nGR-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 <\/td>\n<\/tr>\n
33<\/td>\nGR-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 <\/td>\n<\/tr>\n
34<\/td>\nGR-8 TERMS AND DEFINITIONS <\/td>\n<\/tr>\n
43<\/td>\nCHAPTER 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. <\/td>\n<\/tr>\n
44<\/td>\nSD-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 <\/td>\n<\/tr>\n
45<\/td>\nSD-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 <\/td>\n<\/tr>\n
46<\/td>\nSD-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. <\/td>\n<\/tr>\n
47<\/td>\nFig. SD-3.1.1-1 Flat Gasket Applications <\/td>\n<\/tr>\n
48<\/td>\nTable SD-3.1.2.2-1 L\/D Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With Blind Cap <\/td>\n<\/tr>\n
49<\/td>\nTable SD-3.1.2.2-2 L\/D Dimensions for Flow-Through Tee: Short-Outlet Reducing Tee With Blind Cap <\/td>\n<\/tr>\n
51<\/td>\nFig. SD-3.1.2.2-1 Accepted Point-of-Use Designs <\/td>\n<\/tr>\n
52<\/td>\nSD-3.1.2.3 System Piping
Fig. SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly <\/td>\n<\/tr>\n
53<\/td>\nSD-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 <\/td>\n<\/tr>\n
54<\/td>\nSD-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 <\/td>\n<\/tr>\n
55<\/td>\nSD-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 <\/td>\n<\/tr>\n
56<\/td>\nFig. SD-3.3.2.2-2 Acceptable Impeller Attachments
Fig. SD-3.3.2.2-3 Casing Drain Configurations <\/td>\n<\/tr>\n
57<\/td>\nFig. SD-3.3.2.2-4 Casing Drain L\/D Ratios
Fig. SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment <\/td>\n<\/tr>\n
58<\/td>\nSD-3.4.2 Vessel Openings
SD-3.4.3 Internal Components
SD-3.4.4 Fabrication <\/td>\n<\/tr>\n
59<\/td>\nFig. SD-3.4.2-1 Nozzle Design <\/td>\n<\/tr>\n
60<\/td>\nFig. SD-3.4.2-2 Side and Bottom Connections
Fig. SD-3.4.2-3 Sidewall Instrument Ports <\/td>\n<\/tr>\n
61<\/td>\nFig. SD-3.4.2-4 Vessel Design Tangential Nozzles
Fig. SD-3.4.2-5 Typical Nozzle Detail <\/td>\n<\/tr>\n
62<\/td>\nFig. SD-3.4.3-1 Accepted Nozzle Penetrations
Table SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes <\/td>\n<\/tr>\n
63<\/td>\nFig. SD-3.4.3-2 Internal Support Members <\/td>\n<\/tr>\n
64<\/td>\nSD-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 <\/td>\n<\/tr>\n
65<\/td>\nFig. SD-3.4.6-1 Sight Glass Design (Accepted) <\/td>\n<\/tr>\n
66<\/td>\nSD-3.5.3 Shafts and Keyways
Fig. SD-3.5.1-1 Agitator Mounting Flanges <\/td>\n<\/tr>\n
67<\/td>\nFig. SD-3.5.2-1 Shaft Coupling Construction <\/td>\n<\/tr>\n
68<\/td>\nFig. SD-3.5.2-2 Shaft Coupling Seal Arrangements <\/td>\n<\/tr>\n
69<\/td>\nSD-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 <\/td>\n<\/tr>\n
70<\/td>\nFig. SD-3.5.5-1 Shaft-Steady Bearing <\/td>\n<\/tr>\n
71<\/td>\nSD-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) <\/td>\n<\/tr>\n
72<\/td>\nSD-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 <\/td>\n<\/tr>\n
73<\/td>\nFig. SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design <\/td>\n<\/tr>\n
74<\/td>\nFig. SD-3.7.1-1 Transfer Panel Looped Headers <\/td>\n<\/tr>\n
75<\/td>\nFig. SD-3.7.2-1 Transfer Panel Tolerances <\/td>\n<\/tr>\n
76<\/td>\nSD-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. <\/td>\n<\/tr>\n
77<\/td>\nFig. SD-3.7.4-1 Transfer Panel Jumpers <\/td>\n<\/tr>\n
78<\/td>\nSD-3.8.1.1 Design Features.
SD-3.8.1.2 Testing.
SD-3.9 Spray Devices
SD-3.9.1 General. <\/td>\n<\/tr>\n
79<\/td>\nFig. SD-3.9.1-1 Dynamic Spray Device: Single Axis
Fig. SD-3.9.1-2 Two Axes Dynamic Spray Device <\/td>\n<\/tr>\n
80<\/td>\nSD-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 <\/td>\n<\/tr>\n
81<\/td>\nFig. SD-3.9.2.1-1 Static Spray Device
Fig. SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels <\/td>\n<\/tr>\n
82<\/td>\nFig. SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels
Fig. SD-3.9.2.3-1 Impact Pattern Buildup <\/td>\n<\/tr>\n
83<\/td>\nSD-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 <\/td>\n<\/tr>\n
84<\/td>\nSD-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 <\/td>\n<\/tr>\n
85<\/td>\nSD-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 <\/td>\n<\/tr>\n
86<\/td>\nFig. SD-4.1.2.1-1 Point-of-Use Piping <\/td>\n<\/tr>\n
87<\/td>\nSD-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 <\/td>\n<\/tr>\n
88<\/td>\nFig. SD-4.2.2-1 Typical Clean Steam System Isometric <\/td>\n<\/tr>\n
89<\/td>\nSD-4.4 Process Waste Systems
SD-4.4.1 General.
Fig. SD-4.2.2-2 Clean Steam Point-of-Use Design <\/td>\n<\/tr>\n
90<\/td>\nSD-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. <\/td>\n<\/tr>\n
91<\/td>\nFig. SD-5.1.1.1-1 Fermentor Sterile Envelope <\/td>\n<\/tr>\n
92<\/td>\nFig. SD-5.1.1.1-2 Bioreactor Sterile Envelope <\/td>\n<\/tr>\n
93<\/td>\nSD-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 <\/td>\n<\/tr>\n
94<\/td>\nFig. SD-5.1.1.2.3-1 Gas Sparging Assembly \u2014 Lance <\/td>\n<\/tr>\n
95<\/td>\nFig. SD-5.1.1.2.3-2 Gas Sparging Assembly \u2014 Sintered <\/td>\n<\/tr>\n
96<\/td>\nFig. SD-5.1.1.2.3-3 Gas Sparging Assembly \u2014 Ring <\/td>\n<\/tr>\n
97<\/td>\nFig. SD-5.1.1.2.3-4 Gas Sparging Assembly \u2014 Single Orifice <\/td>\n<\/tr>\n
98<\/td>\nFig. SD-5.1.1.3.1-1 Exhaust Gas Condenser
Fig. SD-5.1.1.3.1-2 Exhaust Gas Heater <\/td>\n<\/tr>\n
99<\/td>\nFig. SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing <\/td>\n<\/tr>\n
100<\/td>\nSD-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. <\/td>\n<\/tr>\n
101<\/td>\nSD-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. <\/td>\n<\/tr>\n
102<\/td>\nSD-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 <\/td>\n<\/tr>\n
103<\/td>\nSD-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 <\/td>\n<\/tr>\n
104<\/td>\nSD-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 <\/td>\n<\/tr>\n
105<\/td>\nSD-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. <\/td>\n<\/tr>\n
106<\/td>\nSD-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. <\/td>\n<\/tr>\n
107<\/td>\nSD-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. <\/td>\n<\/tr>\n
108<\/td>\nSD-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 <\/td>\n<\/tr>\n
109<\/td>\nSD-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) <\/td>\n<\/tr>\n
110<\/td>\nSD-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) <\/td>\n<\/tr>\n
111<\/td>\nSD-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 <\/td>\n<\/tr>\n
112<\/td>\nSD-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 <\/td>\n<\/tr>\n
113<\/td>\nFig. SD-5.3.4.3.1-1 Example HTST Process Flow Schematic Diagram <\/td>\n<\/tr>\n
114<\/td>\nSD-5.3.4.3.2 Heat Exchangers.
Fig. SD-5.3.4.3.1-2 Example Direct Steam Injection UHT Process Flow Schematic Diagram <\/td>\n<\/tr>\n
115<\/td>\nSD-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. <\/td>\n<\/tr>\n
116<\/td>\nFig. SD-5.3.4.3.6-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing <\/td>\n<\/tr>\n
117<\/td>\nSD-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. <\/td>\n<\/tr>\n
118<\/td>\nSD-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. <\/td>\n<\/tr>\n
119<\/td>\nSD-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 <\/td>\n<\/tr>\n
120<\/td>\nFig. SD-5.4.1.2-1 Typical Lyophilizer Component Assembly <\/td>\n<\/tr>\n
121<\/td>\nSD-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 <\/td>\n<\/tr>\n
122<\/td>\nSD-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. <\/td>\n<\/tr>\n
123<\/td>\nSD-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 <\/td>\n<\/tr>\n
124<\/td>\nSD-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 <\/td>\n<\/tr>\n
125<\/td>\nSD-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 <\/td>\n<\/tr>\n
126<\/td>\nCHAPTER 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 <\/td>\n<\/tr>\n
127<\/td>\nTable MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
128<\/td>\nTable MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
129<\/td>\nMM-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) <\/td>\n<\/tr>\n
130<\/td>\nMM-4.3 Castings
MM-4.4 Forgings
MM-4.5 Plate, Sheet, and Strip <\/td>\n<\/tr>\n
131<\/td>\nMM-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. <\/td>\n<\/tr>\n
132<\/td>\nMM-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 <\/td>\n<\/tr>\n
133<\/td>\nMM-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 <\/td>\n<\/tr>\n
134<\/td>\nTable MM-5.3-1 Filler Metals <\/td>\n<\/tr>\n
136<\/td>\nTable MM-5.3-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels <\/td>\n<\/tr>\n
137<\/td>\nTable 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 <\/td>\n<\/tr>\n
138<\/td>\nMM-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 <\/td>\n<\/tr>\n
139<\/td>\nPart 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. <\/td>\n<\/tr>\n
140<\/td>\nPM-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 <\/td>\n<\/tr>\n
141<\/td>\nPM-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 <\/td>\n<\/tr>\n
142<\/td>\nPM-3 PROPERTIES AND PERFORMANCE
PM-3.1 Biocompatibility
Table PM-2.2.1-1 Content Required on the Certificate of Compliance <\/td>\n<\/tr>\n
143<\/td>\nPM-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 <\/td>\n<\/tr>\n
144<\/td>\nPM-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. <\/td>\n<\/tr>\n
145<\/td>\nPM-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. <\/td>\n<\/tr>\n
146<\/td>\nPM-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. <\/td>\n<\/tr>\n
147<\/td>\nTable PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards <\/td>\n<\/tr>\n
148<\/td>\nPM-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. <\/td>\n<\/tr>\n
149<\/td>\nPM-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. <\/td>\n<\/tr>\n
150<\/td>\nPM-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. <\/td>\n<\/tr>\n
151<\/td>\nPM-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. <\/td>\n<\/tr>\n
152<\/td>\nPM-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. <\/td>\n<\/tr>\n
153<\/td>\nCHAPTER 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 <\/td>\n<\/tr>\n
154<\/td>\nDT-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 <\/td>\n<\/tr>\n
155<\/td>\nDT-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 <\/td>\n<\/tr>\n
156<\/td>\nDT-11.1.1 Exceptions
DT-11.2 Valve Marking Information
DT-11.2.1 Exceptions
DT-11.3 Modified Surfaces
DT-12 PACKAGING <\/td>\n<\/tr>\n
157<\/td>\nFig. DT-2-1 Clamp Conditions at Installation
Table DT-2-1 Metallic Hygienic Unions: Rated Internal Working Pressure <\/td>\n<\/tr>\n
158<\/td>\nTable DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components <\/td>\n<\/tr>\n
159<\/td>\nTable 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 <\/td>\n<\/tr>\n
160<\/td>\nTable 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 <\/td>\n<\/tr>\n
161<\/td>\nTable DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Elbow
Table DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow <\/td>\n<\/tr>\n
162<\/td>\nTable 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 <\/td>\n<\/tr>\n
163<\/td>\nTable 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 <\/td>\n<\/tr>\n
164<\/td>\nTable 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 <\/td>\n<\/tr>\n
165<\/td>\nTable 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 <\/td>\n<\/tr>\n
166<\/td>\nTable DT-4.1.2-5 Hygienic Clamp Joint: Short-Outlet Tee
Table DT-4.1.2-6 Automatic Tube Weld: Reducing Tee <\/td>\n<\/tr>\n
167<\/td>\nTable DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee <\/td>\n<\/tr>\n
168<\/td>\nTable DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee <\/td>\n<\/tr>\n
169<\/td>\nTable 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 <\/td>\n<\/tr>\n
170<\/td>\nTable DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
171<\/td>\nTable DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
172<\/td>\nTable DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
173<\/td>\nTable DT-4.1.4-1 Automatic Tube Weld: Ferrule
Table DT-4.1.5-1 Automatic Tube Weld: Cap <\/td>\n<\/tr>\n
174<\/td>\nTable DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap <\/td>\n<\/tr>\n
175<\/td>\nTable DT-4.4.1-1 Hygienic Clamp Joint: Weir-Style Diaphragm Valve <\/td>\n<\/tr>\n
176<\/td>\nTable DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed <\/td>\n<\/tr>\n
177<\/td>\nTable DT-4.5.2-1 Tapered Locking Tab Retainer: External <\/td>\n<\/tr>\n
178<\/td>\nTable DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances <\/td>\n<\/tr>\n
180<\/td>\nTable DT-7-2 Transfer Panel and Jumper Tolerances <\/td>\n<\/tr>\n
181<\/td>\nTable DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria <\/td>\n<\/tr>\n
182<\/td>\nPart 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. <\/td>\n<\/tr>\n
183<\/td>\nPI-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 <\/td>\n<\/tr>\n
184<\/td>\nFig. PI-2.2.2-1 Accepted Insertion Device Installation Examples <\/td>\n<\/tr>\n
185<\/td>\nPI-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 <\/td>\n<\/tr>\n
186<\/td>\nFig. PI-4.1.3.3-1 Concentrically Reducing Process Connection
Fig. PI-4.1.4.3-1 Vertical Installation <\/td>\n<\/tr>\n
187<\/td>\nPI-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 <\/td>\n<\/tr>\n
188<\/td>\nPI-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 <\/td>\n<\/tr>\n
189<\/td>\nFig. PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location <\/td>\n<\/tr>\n
190<\/td>\nPI-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 <\/td>\n<\/tr>\n
191<\/td>\nPI-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 <\/td>\n<\/tr>\n
192<\/td>\nFig. PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions
Fig. PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions <\/td>\n<\/tr>\n
193<\/td>\nFig. PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations <\/td>\n<\/tr>\n
194<\/td>\nFig. PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations <\/td>\n<\/tr>\n
195<\/td>\nPI-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. <\/td>\n<\/tr>\n
196<\/td>\nPI-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 <\/td>\n<\/tr>\n
197<\/td>\nFig. PI-8.1.3-1 Accepted Installations for Conductivity Sensors <\/td>\n<\/tr>\n
198<\/td>\nPI-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 <\/td>\n<\/tr>\n
199<\/td>\nPI-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 <\/td>\n<\/tr>\n
200<\/td>\nFig. PI-8.2.3-1 Accepted pH Sensor Installations <\/td>\n<\/tr>\n
201<\/td>\nFig. PI-8.2.3.4-1 Accepted Mounting Orientations <\/td>\n<\/tr>\n
202<\/td>\nPI-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 <\/td>\n<\/tr>\n
203<\/td>\nPI-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. <\/td>\n<\/tr>\n
204<\/td>\nFig. PI-9.1.3.3-1 Vessel Light Glass Design and Mounting <\/td>\n<\/tr>\n
205<\/td>\nFig. PI-9.1.3.5-1 In-Line Insertion Length
Fig. PI-9.1.3.5-2 Insertion Probe Length <\/td>\n<\/tr>\n
206<\/td>\nPI-9.1.4.3 Process Influences.
PI-9.1.4.4 Ambient Influences.
PI-9.1.5 Selection. <\/td>\n<\/tr>\n
207<\/td>\nPart 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. <\/td>\n<\/tr>\n
208<\/td>\nFig. 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 <\/td>\n<\/tr>\n
209<\/td>\nFig. SG-2.2.2-3 Hygienic Union per DIN 11864
Fig. SG-2.2.2-4 Hygienic Clamp Union per DIN 11864 <\/td>\n<\/tr>\n
210<\/td>\nFig. SG-2.2.2-5 Nonhygienic Connections <\/td>\n<\/tr>\n
211<\/td>\nSG-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 <\/td>\n<\/tr>\n
212<\/td>\nFig. SG-2.3.1.2-2 Radial Valves
Fig. SG-2.3.1.2-3 Weirless Diaphragm Valve <\/td>\n<\/tr>\n
213<\/td>\nFig. SG-2.3.1.2-4 Linear Control Valves
Fig. SG-2.3.1.2-5 Regulator Valve <\/td>\n<\/tr>\n
214<\/td>\nFig. 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 <\/td>\n<\/tr>\n
215<\/td>\nFig. 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 <\/td>\n<\/tr>\n
216<\/td>\nFig. SG-2.3.1.9-1 Pressure Relief and Check Valves <\/td>\n<\/tr>\n
217<\/td>\nSG-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 <\/td>\n<\/tr>\n
218<\/td>\nSG-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 <\/td>\n<\/tr>\n
219<\/td>\nFig. 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 <\/td>\n<\/tr>\n
220<\/td>\nFig. 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 <\/td>\n<\/tr>\n
221<\/td>\nFig. 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 <\/td>\n<\/tr>\n
222<\/td>\nFig. 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 <\/td>\n<\/tr>\n
223<\/td>\nSG-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 <\/td>\n<\/tr>\n
224<\/td>\nSG-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 <\/td>\n<\/tr>\n
225<\/td>\nFig. SG-3.3.2.2-1 Examples of Static O-Ring Grooves <\/td>\n<\/tr>\n
226<\/td>\nSG-3.3.2.3 Valves <\/td>\n<\/tr>\n
227<\/td>\nFig. SG-3.3.2.3-1 Seals for Rising Stem Valves <\/td>\n<\/tr>\n
228<\/td>\nSG-3.3.2.4 End Face Mechanical Seal General Design Requirements <\/td>\n<\/tr>\n
229<\/td>\nSG-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 <\/td>\n<\/tr>\n
230<\/td>\nSG-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 <\/td>\n<\/tr>\n
231<\/td>\nSG-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 <\/td>\n<\/tr>\n
232<\/td>\nSG-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. <\/td>\n<\/tr>\n
233<\/td>\nSG-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 <\/td>\n<\/tr>\n
234<\/td>\nCHAPTER 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. <\/td>\n<\/tr>\n
235<\/td>\nMJ-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 <\/td>\n<\/tr>\n
236<\/td>\nMJ-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 <\/td>\n<\/tr>\n
237<\/td>\nMJ-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 <\/td>\n<\/tr>\n
238<\/td>\nMJ-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 <\/td>\n<\/tr>\n
239<\/td>\nMJ-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 <\/td>\n<\/tr>\n
240<\/td>\nTable MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks <\/td>\n<\/tr>\n
241<\/td>\nTable MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe <\/td>\n<\/tr>\n
243<\/td>\nTable MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints <\/td>\n<\/tr>\n
245<\/td>\nFig. MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube-to-Tube Butt Joints <\/td>\n<\/tr>\n
246<\/td>\nFig. MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Electropolished UNS S31603 Tubing <\/td>\n<\/tr>\n
247<\/td>\nFig. MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically Polished UNS S31603 Tubing <\/td>\n<\/tr>\n
248<\/td>\nFig. MJ-8.4-4 Acceptable and Unacceptable Metallic Weld Bead Width and Meander on Non\u2013Process Contact Surfaces of Groove Welds on Tube-to-Tube Butt Joints <\/td>\n<\/tr>\n
249<\/td>\nTable MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds <\/td>\n<\/tr>\n
251<\/td>\nFig. MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds <\/td>\n<\/tr>\n
252<\/td>\nMJ-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. <\/td>\n<\/tr>\n
253<\/td>\nMJ-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 <\/td>\n<\/tr>\n
254<\/td>\nMJ-10 DOCUMENTATION REQUIREMENTS
MJ-11 PASSIVATION
Fig. MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds <\/td>\n<\/tr>\n
255<\/td>\nPart 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 <\/td>\n<\/tr>\n
256<\/td>\nTable SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes <\/td>\n<\/tr>\n
257<\/td>\nTable 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 <\/td>\n<\/tr>\n
258<\/td>\nSF-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 <\/td>\n<\/tr>\n
259<\/td>\nSF-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 <\/td>\n<\/tr>\n
260<\/td>\nCHAPTER 6 CERTIFICATION
Part CR Certification Requirements
CR-1 PURPOSE AND SCOPE
CR-2 GENERAL
Fig. CR-1-1 ASME Certification Mark With BPE Designator <\/td>\n<\/tr>\n
261<\/td>\nCR-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 <\/td>\n<\/tr>\n
262<\/td>\nCR-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 <\/td>\n<\/tr>\n
263<\/td>\nCR-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 <\/td>\n<\/tr>\n
264<\/td>\nCR-2.5.8 Internal Audits.
CR-2.5.9 Corrective Action. <\/td>\n<\/tr>\n
266<\/td>\nMANDATORY 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 <\/td>\n<\/tr>\n
267<\/td>\nI-4 CODE CASES
I-5 INTERPRETATIONS
I-6 SUBMITTALS <\/td>\n<\/tr>\n
268<\/td>\nTable II-1 Standard Units
MANDATORY APPENDIX II STANDARD UNITS <\/td>\n<\/tr>\n
269<\/td>\nNONMANDATORY APPENDICES
NONMANDATORY APPENDIX A COMMENTARY: SLAG AND OXIDE ISLANDS <\/td>\n<\/tr>\n
270<\/td>\nNONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION\/INSPECTION DOCUMENTATION <\/td>\n<\/tr>\n
271<\/td>\nForms
Form MEL-1 Material Examination Log <\/td>\n<\/tr>\n
272<\/td>\nForm MER-1 Material Examination Record <\/td>\n<\/tr>\n
273<\/td>\nForm WEL-1 Weld and Examination\/Inspection Log <\/td>\n<\/tr>\n
274<\/td>\nNONMANDATORY APPENDIX C SLOPE MEASUREMENT AND JOINT MISALIGNMENT
C-1 GENERAL
C-2 JOINT MISALIGNMENT <\/td>\n<\/tr>\n
275<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
276<\/td>\nD-4.2 Class II Rouge Remediation
D-4.3 Class III Rouge Remediation
D-4.4 Remediation Variables <\/td>\n<\/tr>\n
277<\/td>\nTable D-2-1 Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System <\/td>\n<\/tr>\n
278<\/td>\nTable D-2-2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System <\/td>\n<\/tr>\n
280<\/td>\nTable D-3.1-1 Process Fluid Analyses for the Identification of Mobile Constituents of Rouge <\/td>\n<\/tr>\n
281<\/td>\nTable D-3.2-1 Solid Surface Analyses for the Identification of Surface Layers Composition <\/td>\n<\/tr>\n
282<\/td>\nTable D-4.1-1 Rouge Remediation Processes Summary <\/td>\n<\/tr>\n
284<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
285<\/td>\nTable 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 <\/td>\n<\/tr>\n
286<\/td>\nTable E-3.2-2 Passivation Processes <\/td>\n<\/tr>\n
288<\/td>\nE-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) <\/td>\n<\/tr>\n
290<\/td>\nTable E-5-1 Test Matrix for Evaluation of Cleaned and\/or Passivated Surfaces <\/td>\n<\/tr>\n
294<\/td>\nNONMANDATORY APPENDIX F CORROSION TESTING
F-1 GENERAL
F-2 CORROSION TESTS
F-3 PITTING RESISISTANCE EQUIVALENT (PRE) NUMBER <\/td>\n<\/tr>\n
295<\/td>\nTable F-1-1 ASTM Corrosion Tests <\/td>\n<\/tr>\n
296<\/td>\nTable F-3-1 PRE Numbers for Some Alloys <\/td>\n<\/tr>\n
297<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
298<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
299<\/td>\nTable H-3.3-1 Minimum Surface Requirements for Process Qualification Samples <\/td>\n<\/tr>\n
300<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
301<\/td>\nTable I-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions <\/td>\n<\/tr>\n
303<\/td>\nTable I-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents <\/td>\n<\/tr>\n
304<\/td>\nNONMANDATORY 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. <\/td>\n<\/tr>\n
305<\/td>\nJ-1.2.2 Simulated Combined CIP and SIP Testing.
J-1.2.3 Other Process Testing Considerations
J-1.2.3.1 Vacuum. <\/td>\n<\/tr>\n
306<\/td>\nJ-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 <\/td>\n<\/tr>\n
307<\/td>\nFig. J-1.3.2.1-1 Weir-Style Diaphragm <\/td>\n<\/tr>\n
310<\/td>\nFig. 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 <\/td>\n<\/tr>\n
311<\/td>\nJ-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 <\/td>\n<\/tr>\n
312<\/td>\nJ-2.3.2 Dual Mechanical Seals: Liquid Lubricated by Barrier Fluid (Dual Pressurized) or by Process and Buffer Fluid (Dual Unpressurized) <\/td>\n<\/tr>\n
313<\/td>\nJ-2.4 Mechanical Seal Testing Notes <\/td>\n<\/tr>\n
315<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
316<\/td>\nTable K-3-1 Thermoset Polymer Test Properties <\/td>\n<\/tr>\n
317<\/td>\nTable K-4-1 Interpretation of Thermoset Material Property Changes <\/td>\n<\/tr>\n
318<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
319<\/td>\n L-4.4 Inspection
L-5 ACCEPTANCE CRITERIA
L-6 RECOMMENDED DOCUMENTATION <\/td>\n<\/tr>\n
320<\/td>\nNONMANDATORY APPENDIX M COMMENTARY: UNS S31603 WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA <\/td>\n<\/tr>\n
321<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
322<\/td>\nNONMANDATORY APPENDIX O GENERAL BACKGROUND\/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES
O-1 REFERENCES
O-2 RECOMMENDED CONDITIONS FOR A POLYMERIC MATERIAL-SPECIFIC EXTRACTION <\/td>\n<\/tr>\n
323<\/td>\nO-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 <\/td>\n<\/tr>\n
324<\/td>\nFig. O-4-1 Flowchart of Bioprocessing Equipment\/Component Evaluation Related to Extractables and Leachables Characterization <\/td>\n<\/tr>\n
325<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
326<\/td>\nP-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 <\/td>\n<\/tr>\n
327<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
328<\/td>\nNONMANDATORY APPENDIX R APPLICATION DATA SHEET <\/td>\n<\/tr>\n
329<\/td>\nForm R-1 Application Data Sheet <\/td>\n<\/tr>\n
331<\/td>\nNONMANDATORY 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. <\/td>\n<\/tr>\n
332<\/td>\nS-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. <\/td>\n<\/tr>\n
333<\/td>\nS-2.5 Normalized Water Permeability (NWP) Testing
S-2-5.1 <\/td>\n<\/tr>\n
334<\/td>\nNONMANDATORY 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 <\/td>\n<\/tr>\n
335<\/td>\nT-3 CHECKING EQUATIONS
T-4 SOFT CONVERSION FACTORS <\/td>\n<\/tr>\n
336<\/td>\nNONMANDATORY APPENDIX U POSITIVE MATERIAL IDENTIFICATION
U-1 POSITIVE MATERIAL IDENTIFICATION
U-2 GENERAL REQUIREMENTS
U-3 CALIBRATION <\/td>\n<\/tr>\n
337<\/td>\nU-4 PROCEDURE
U-5 PERSONNEL TRAINING AND QUALIFICATION
U-6 ACCEPTANCE\/REJECTION
U-7 PMI REFEREE METHODS
U-8 PMI SPECIAL CONDITIONS <\/td>\n<\/tr>\n
338<\/td>\nNONMANDATORY APPENDIX V PROCUREMENT SOURCES <\/td>\n<\/tr>\n
340<\/td>\nINDEX <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ASME BPE Bioprocessing Equipment<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ASME<\/b><\/a><\/td>\n2016<\/td>\n354<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":169434,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2643],"product_tag":[],"class_list":{"0":"post-169429","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-asme","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/169429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/169434"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=169429"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=169429"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=169429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}