{"id":129657,"date":"2024-10-19T06:34:05","date_gmt":"2024-10-19T06:34:05","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/asme-bpe-2014\/"},"modified":"2024-10-24T23:36:19","modified_gmt":"2024-10-24T23:36:19","slug":"asme-bpe-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/asme\/asme-bpe-2014\/","title":{"rendered":"ASME BPE 2014"},"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: \u00e2\u20ac\u00a2 Testing procedures and acceptance criteria for valve diaphragms \u00e2\u20ac\u00a2 Chromatography requirements \u00e2\u20ac\u00a2 Polymeric Hygienic Unions \u00e2\u20ac\u00a2 Steam to\/through Connections \u00e2\u20ac\u00a2 Shelf-life, storage and expiration date requirements for single-use equipment \u00e2\u20ac\u00a2 Radar Level and Temperature Sensors \u00e2\u20ac\u00a2 Acceptance criteria for a variance in luster \u00e2\u20ac\u00a2 Adoption of the CA-1 Standard ASME-BPE is referenced in ASME\u00e2\u20ac\u2122s 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
5<\/td>\nCONTENTS <\/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
25<\/td>\nPart GR General Requirements
GR-1 INTRODUCTION
GR-2 SCOPE OF THE ASME BPE STANDARD
GR-3 MANUFACTURER\u00c5\u2019S QUALITY ASSURANCE PROGRAM <\/td>\n<\/tr>\n
26<\/td>\nGR-4 INSPECTION
GR-4.1 Inspector\/Examiner
GR-4.2 Inspector\u00c5\u2019s Delegate
GR-4.2.1 Levels of Qualification.
GR-4.2.2 Qualification Requirements. <\/td>\n<\/tr>\n
29<\/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.
GR-4.4 Access for Inspectors <\/td>\n<\/tr>\n
30<\/td>\nGR-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 Turn Over Package Documentation.
GR-5.2.1.1.2
GR-5.3 Material Test Reports\/Certificates of Compliance
GR-5.3.1 Metallic Materials. <\/td>\n<\/tr>\n
31<\/td>\nGR-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 Log <\/td>\n<\/tr>\n
32<\/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
33<\/td>\nGR-8 TERMS AND DEFINITIONS <\/td>\n<\/tr>\n
41<\/td>\nPart 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.
SD-2.4 Fabrication
SD-2.4.1 Materials of Construction
SD-2.4.1.1 General. <\/td>\n<\/tr>\n
42<\/td>\nSD-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
SD-2.4.3 Drainability
SD-2.4.3.1 General. <\/td>\n<\/tr>\n
43<\/td>\nSD-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.
SD-2.4.4.3 Surface Finishes.
SD-3 PROCESS COMPONENTS
SD-3.1 Connections, Fittings, and Piping
SD-3.1.1 General <\/td>\n<\/tr>\n
44<\/td>\nSD-3.1.2 System Design
SD-3.1.2.1 General
SD-3.1.2.2 Dead Legs.
SD-3.1.2.3 System Piping <\/td>\n<\/tr>\n
45<\/td>\nFigures
\n
Fig. SD-3.1.1-1 Flat Gasket Applications <\/td>\n<\/tr>\n
46<\/td>\nTables
Table 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
47<\/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
49<\/td>\nFig. SD-3.1.2.2-1 Accepted Point-of-Use Designs <\/td>\n<\/tr>\n
50<\/td>\nSD-3.1.2.4 Hygienic Support Systems
Fig. SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly <\/td>\n<\/tr>\n
51<\/td>\nSD-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
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 <\/td>\n<\/tr>\n
52<\/td>\nSD-3.3.2.2 Centrifugal Pumps
SD-3.3.2.3 Positive Displacement Pumps
SD-3.3.2.4 Rotary Lobe Pumps
Fig. SD-3.2.1-1 Flexible Hygienic Hose Design <\/td>\n<\/tr>\n
53<\/td>\nFig. SD-3.3.2.2-1 Pump Impeller Configurations
Fig. SD-3.3.2.2-2 Acceptable Impeller Attachments <\/td>\n<\/tr>\n
54<\/td>\nFig. SD-3.3.2.2-3 Casing Drain Configurations
Fig. SD-3.3.2.2-4 Casing Drain L\/D Ratios <\/td>\n<\/tr>\n
55<\/td>\nSD-3.4 Vessels
SD-3.4.1 General
SD-3.4.2 Vessel Openings
Fig. SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment <\/td>\n<\/tr>\n
56<\/td>\nFig. SD-3.4.2-1 Nozzle Design <\/td>\n<\/tr>\n
57<\/td>\nFig. SD-3.4.2-2 Side and Bottom Connections
Fig. SD-3.4.2-3 Sidewall Instrument Ports <\/td>\n<\/tr>\n
58<\/td>\nFig. SD-3.4.2-4 Accepted Nozzle Penetrations
Table SD-3.4.2-1 Annular SpacingRecommendations for Hygienic Dip Tubes <\/td>\n<\/tr>\n
59<\/td>\nFig. SD-3.4.2-5 Vessel Design Tangential Nozzles <\/td>\n<\/tr>\n
60<\/td>\nFig. SD-3.4.2-6 Sight Glass Design (Accepted) <\/td>\n<\/tr>\n
61<\/td>\nSD-3.4.3 Internal Components
SD-3.4.4 Fabrication
SD-3.4.5 Finishes
SD-3.4.6 Sight Glasses
Fig. SD-3.4.2-7 Typical Nozzle Detail <\/td>\n<\/tr>\n
62<\/td>\nFig. SD-3.4.3-1 Internal Support Members <\/td>\n<\/tr>\n
63<\/td>\nSD-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
64<\/td>\nSD-3.5.3 Shafts and Keyways
SD-3.5.4 Hubs and Impellers
Fig. SD-3.5.1-1 Agitator Mounting Flanges <\/td>\n<\/tr>\n
65<\/td>\nFig. SD-3.5.2-1 Shaft Coupling Construction <\/td>\n<\/tr>\n
66<\/td>\nFig. SD-3.5.2-2 Shaft Coupling Seal Arrangements <\/td>\n<\/tr>\n
67<\/td>\nSD-3.5.5 Impeller and Shaft Support Bearings
SD-3.5.6 Mechanical Seals
SD-3.6 Heat Exchange Equipment
SD-3.6.1 General
Fig. SD-3.5.2-3 Fastener Seal Arrangements <\/td>\n<\/tr>\n
68<\/td>\nFig. SD-3.5.5-1 Shaft Steady Bearing <\/td>\n<\/tr>\n
69<\/td>\nFig. SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) <\/td>\n<\/tr>\n
70<\/td>\nFig. SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design <\/td>\n<\/tr>\n
71<\/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
SD-3.7.3 Headers or Pre-piped Manifolds
SD-3.7.4 Jumpers or U-Bends <\/td>\n<\/tr>\n
72<\/td>\nFig. SD-3.7.1-1 Transfer Panel Looped Headers <\/td>\n<\/tr>\n
73<\/td>\nFig. SD-3.7.2-1 Transfer Panel Tolerances (Reference Table DT-7-2) <\/td>\n<\/tr>\n
74<\/td>\nFig. SD-3.7.4-1 Transfer Panel Jumpers <\/td>\n<\/tr>\n
75<\/td>\nSD-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.
SD-3.8.1.1 Design Features.
SD-3.8.1.2 Testing. <\/td>\n<\/tr>\n
76<\/td>\nSD-3.9 Spray Devices
SD-3.9.1 General.
Fig. SD-3.8.1.1-1 Tapered Locking Tab Retainer \u2014 Recessed <\/td>\n<\/tr>\n
77<\/td>\nSD-3.9.2 Spray Device Requirements
Fig. SD-3.8.1.1-2 Tapered Locking Tab Retainer \u2014 External <\/td>\n<\/tr>\n
78<\/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
79<\/td>\nSD-3.9.2.1 Static Spray Device Requirements
SD-3.9.2.2 Single Axis Dynamic Spray Device Requirements
SD-3.9.2.3 Multi-Axis Dynamic Spray Device Requirements <\/td>\n<\/tr>\n
80<\/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
81<\/td>\nFig. SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels
Fig. SD-3.9.2.3-1 Impact Pattern Build-Up <\/td>\n<\/tr>\n
82<\/td>\nSD-3.10 Disposables That Require Pre-Sterilization or Post-Sterilization
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 Non-Aseptic Sampling.
SD-3.12 Steam Traps
Fig. SD-3.12-1 Steam Traps for Clean Steam Systems <\/td>\n<\/tr>\n
83<\/td>\nSD-3.13 Check Valves
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
SD-4.1.1 Compendial Water Generation <\/td>\n<\/tr>\n
84<\/td>\nSD-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
SD-4.2.2 Clean\/Pure Steam Distribution System <\/td>\n<\/tr>\n
85<\/td>\nFig. SD-4.1.2.1-1 Point-of-Use Piping <\/td>\n<\/tr>\n
86<\/td>\nSD-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
87<\/td>\nFig. SD-4.2.2-1 Typical Clean Steam System Isometric <\/td>\n<\/tr>\n
88<\/td>\nSD-4.4 Process Waste Systems
SD-4.4.1 Bio-Kill Systems.
SD-5 PROCESS SYSTEMS
SD-5.1 Upstream Systems
SD-5.1.1 Bioreactors and Fermentors
SD-5.1.1.1 General
Fig. SD-4.2.2-2 Clean Steam Point-of-Use Design <\/td>\n<\/tr>\n
89<\/td>\nFig. SD-5.1.1.1-1 Fermentor Sterile Envelope <\/td>\n<\/tr>\n
90<\/td>\nFig. SD-5.1.1.1-2 Bioreactor Sterile Envelope <\/td>\n<\/tr>\n
91<\/td>\nSD-5.1.1.2 Inlet Gas Assembly.
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 <\/td>\n<\/tr>\n
92<\/td>\nFig. SD-5.1.1.2.3-1 Gas Sparging Assembly \u2014 Lance <\/td>\n<\/tr>\n
93<\/td>\nFig. SD-5.1.1.2.3-2 Gas Sparging Assembly \u2014 Sintered <\/td>\n<\/tr>\n
94<\/td>\nFig. SD-5.1.1.2.3-3 Gas Sparging Assembly \u2014 Ring <\/td>\n<\/tr>\n
95<\/td>\nFig. SD-5.1.1.2.3-4 Gas Sparging Assembly \u2014 Single Orifice <\/td>\n<\/tr>\n
96<\/td>\nSD-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
SD-5.1.1.3.3 Backpressure 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. <\/td>\n<\/tr>\n
97<\/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
98<\/td>\nFig. SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing <\/td>\n<\/tr>\n
99<\/td>\nSD-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.
SD-5.1.1.6 Instrumentation
SD-5.1.2 Cell Disrupters
SD-5.1.3 Centrifuges
SD-5.1.3.1 General <\/td>\n<\/tr>\n
100<\/td>\nSD-5.1.3.2 Process Contact Surface Finishes Wetted Surfaces
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
SD-5.2.1.3 Depth Filtration.
SD-5.2.1.4 Tangential\/Cross Flow Filtration.
SD-5.2.3 Chromatography. <\/td>\n<\/tr>\n
101<\/td>\nSD-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 Washers.
SD-5.3.2 Steam Sterilizers\/Autoclaves
SD-5.3.2.1 General.
SD-5.3.2.2 Cycle Types.
Fig. SD-5.2.1.1-1 Tank\/Vessel Vent Filters <\/td>\n<\/tr>\n
102<\/td>\nSD-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.
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. <\/td>\n<\/tr>\n
103<\/td>\nSD-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
104<\/td>\nSD-5.3.3.2 CIP Skid Design
SD-5.3.3.3 CIP Flow Rate Guidelines for Process Lines
SD-5.3.3.4 Design Guidelines for Cleaning Process Vessels
Table SD-5.3.3.3-1 Flow Rates to Achieve5 ft\/sec (1.52 m\/s) <\/td>\n<\/tr>\n
105<\/td>\nSD-5.3.3.5 CIP Distribution Design
SD-5.3.3.5.1 CIP Distribution Guidelines Supply and Return
SD-5.3.3.5.2 CIP Distribution Piping
SD-5.3.3.5.3 CIP Return Pumps
SD-5.3.3.5.4 CIP Return Eductors. <\/td>\n<\/tr>\n
106<\/td>\nFig. SD-5.3.3.5.1-1 CIP Looped Header (Supply or Return)
Fig. SD-5.3.3.5.1-2 Zero-Static Chain
Fig. SD-5.3.3.5.1-3 Swing Elbow Arrangement <\/td>\n<\/tr>\n
107<\/td>\nSD-5.3.4 Ultra High Temperature Sterilizers.
SD-5.3.5 Media Prep.
SD-5.4 Formulation 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
SD-5.4.1.2.4 Lyophilizer Shelves <\/td>\n<\/tr>\n
108<\/td>\nFig. SD-5.4.1.2-1 Typical Lyophilizer Component Assembly <\/td>\n<\/tr>\n
109<\/td>\nSD-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
SD-5.4.1.2.9 Gas Filter Assemblies <\/td>\n<\/tr>\n
110<\/td>\nSD-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.
SD-5.4.1.4 Internal Connections and Fasteners <\/td>\n<\/tr>\n
111<\/td>\nSD-5.4.1.5 CIP of Lyophilizers
Fig. SD-5.4.1.3-1 Lyophilizer Sterile Boundary <\/td>\n<\/tr>\n
112<\/td>\nSD-5.4.1.6 Bioburden Reduction in Lyophilizers.
SD-5.4.1.6.1 Steam-in-Place SIP.
SD-5.4.1.6.2 Hydrogen Peroxide Sterilization.
SD-5.4.1.7 Leak Rate
SD-5.4.1.8 Branch Connections <\/td>\n<\/tr>\n
113<\/td>\nSD-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
114<\/td>\nPart 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
DT-4.3 Special Angle Fittings Dimensions
DT-4.4 Valve Dimensions <\/td>\n<\/tr>\n
115<\/td>\nDT-4.4.1 Diaphragm Valves.
DT-5 MATERIALS
DT-6 TESTS
DT-7 TOLERANCES
DT-8 WELD ENDS
DT-9 HYGIENIC CLAMP UNIONS
DT-9.1 Typical Hygienic Clamp Unions
DT-9.2 Hygienic Gaskets
DT-9.3 Connections
DT-9.4 Hygienic Clamps
DT-10 MINIMUM EXAMINATION REQUIREMENTS
DT-10.1 Visual Inspection <\/td>\n<\/tr>\n
116<\/td>\nDT-10.2 Documentation Verification
DT-10.3 Physical Examination
DT-11 MARKING
DT-11.1 Fitting Marking Information
DT-11.1.1 Exceptions
DT-11.2 Valve Marking Information <\/td>\n<\/tr>\n
117<\/td>\nDT-11.2.1 Exceptions
DT-11.3 Modified Surfaces
DT-12 PACKAGING <\/td>\n<\/tr>\n
118<\/td>\nFig. DT-2-1 Clamp Conditions at Installation <\/td>\n<\/tr>\n
119<\/td>\nTable DT-2-1 Hygienic Unions: Rated Internal Working Pressure <\/td>\n<\/tr>\n
120<\/td>\nTable DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components <\/td>\n<\/tr>\n
121<\/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
122<\/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
123<\/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
124<\/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
125<\/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
126<\/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
127<\/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
128<\/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
129<\/td>\nTable DT-4.1.2-7 Automatic Tube Weld: Short Outlet Hygienic Clamp, Joint Reducing Tee <\/td>\n<\/tr>\n
130<\/td>\nTable DT-4.1.2-8 Hygienic Clamp Joint: Reducing <\/td>\n<\/tr>\n
131<\/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
132<\/td>\nTable DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
133<\/td>\nTable DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
134<\/td>\nTable DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
135<\/td>\nTable DT-4.1.4-1 Automatic Tube Weld: Ferrule <\/td>\n<\/tr>\n
136<\/td>\nTable DT-4.1.5-1 Automatic Tube Weld: Cap
Table DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap <\/td>\n<\/tr>\n
137<\/td>\nTable DT-4.4.1-1 Hygienic Clamp Joint: Weir Style Diaphragm Valve <\/td>\n<\/tr>\n
138<\/td>\nTable DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances <\/td>\n<\/tr>\n
140<\/td>\nTable DT-7-2 Transfer Panel and Jumper Tolerances <\/td>\n<\/tr>\n
141<\/td>\nTable DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria <\/td>\n<\/tr>\n
142<\/td>\nPart 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.
MJ-2.2.2 Nickel Alloys.
MJ-2.2.3 Copper Alloys.
MJ-2.3 Nonmetallics <\/td>\n<\/tr>\n
143<\/td>\nMJ-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 Welds Finished After Welding
MJ-4.2 Welds Used in the As-Welded Condition <\/td>\n<\/tr>\n
144<\/td>\nMJ-4.3 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 Tube\/Pipe Diameter Limits for Orbital GTAW Performance Qualification
Table MJ-6.3-2 Weld Thickness Limits for Orbital GTAW Performance Qualification <\/td>\n<\/tr>\n
145<\/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
MJ-7.3.2 Piping <\/td>\n<\/tr>\n
146<\/td>\nMJ-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
MJ-8.2 Pressure Vessel and Tank Welds
MJ-8.3 Piping Welds
MJ-8.4 Tubing Welds <\/td>\n<\/tr>\n
147<\/td>\nMJ-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
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. <\/td>\n<\/tr>\n
148<\/td>\nMJ-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.
MJ-9.6.3.2 Inspection. <\/td>\n<\/tr>\n
149<\/td>\nMJ-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
MJ-10 DOCUMENTATION REQUIREMENTS
MJ-11 PASSIVATION <\/td>\n<\/tr>\n
150<\/td>\nTable MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Pressure Vessels and Tanks <\/td>\n<\/tr>\n
152<\/td>\nTable MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Pipe <\/td>\n<\/tr>\n
154<\/td>\nTable MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Tube-to-Tube Butt Joints <\/td>\n<\/tr>\n
156<\/td>\nFig. MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Tube Welds <\/td>\n<\/tr>\n
157<\/td>\nFig. MJ-8.4-2 Discoloration Acceptance Criteria for Weld Heat Affected Zones on Electropolished 316L Tubing <\/td>\n<\/tr>\n
158<\/td>\nFig. MJ-8.4-3 Discoloration Acceptance Criteria for Weld Heat Affected Zones on MechanicallyPolished 316L Tubing <\/td>\n<\/tr>\n
159<\/td>\nFig. MJ-8.4-4 Acceptable and Unacceptable Weld Bead Width and Meander <\/td>\n<\/tr>\n
160<\/td>\nTable MJ-8.5-1 Visual Examination Acceptance Criteria for Tube-Attachment Welds <\/td>\n<\/tr>\n
162<\/td>\nFig. MJ-8.5-1 Acceptable Weld Profiles for Tube-Attachment Fillet Welds <\/td>\n<\/tr>\n
163<\/td>\nFig. MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds <\/td>\n<\/tr>\n
164<\/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
165<\/td>\nTable SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes <\/td>\n<\/tr>\n
166<\/td>\nSF-2.7 Normative References
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 <\/td>\n<\/tr>\n
167<\/td>\nSF-2.8 Rouge and Stainless Steel
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
Table SF-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes <\/td>\n<\/tr>\n
168<\/td>\nSF-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
169<\/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
170<\/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
171<\/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
172<\/td>\nFig. SG-2.2.2-5 Nonhygienic Connections <\/td>\n<\/tr>\n
173<\/td>\nSG-2.3.1.2 Diaphragm Valves
SG-2.3.1.3 Ball Valve, Ball Tank Bottom Valve.
SG-2.3.1.4 Rising Stem Single, Double Seat Mix Proof, 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
174<\/td>\nFig. SG-2.3.1.2-2 Radial Valves
Fig. SG-2.3.1.2-3 Weirless Diaphragm Valve <\/td>\n<\/tr>\n
175<\/td>\nFig. SG-2.3.1.2-4 Linear Control Valves
Fig. SG-2.3.1.2-5 Regulator Valve <\/td>\n<\/tr>\n
176<\/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
177<\/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
178<\/td>\nFig. SG-2.3.1.9-1 Pressure Relief and Check Valves <\/td>\n<\/tr>\n
179<\/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
Fig. SG-2.3.2.2-1 Single Mechanical Seal <\/td>\n<\/tr>\n
180<\/td>\nFig. 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
Fig. SG-2.3.2.3-2 Dual Pressurized Mechanical Seal for Top Entry Agitator <\/td>\n<\/tr>\n
181<\/td>\nSG-2.3.2.4 Flush Plans.
Fig. SG-2.3.2.3-3 Dual Unpressurized Mechanical Seal for Pumps
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 <\/td>\n<\/tr>\n
182<\/td>\nFig. SG-2.3.2.4-4 Flush Plan 11
Fig. SG-2.3.2.4-5 Flush Plan 32
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 <\/td>\n<\/tr>\n
183<\/td>\nSG-2.3.3 Other Dynamic Seals
SG-2.3.3.1 Reciprocating Seals.
SG-2.3.3.2 Oscillating Seals.
Fig. SG-2.3.2.4-8 Flush Plan BPE52 for Pump
Fig. SG-2.3.2.4-9 Flush Plan 53 for Pump
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 <\/td>\n<\/tr>\n
184<\/td>\nFig. 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
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
185<\/td>\nSG-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
SG-3.2.2 Sterilizing Systems.
SG-3.2.3 Passivation Systems.
SG-3.3 Seal Construction
SG-3.3.1 Materials <\/td>\n<\/tr>\n
186<\/td>\nSG-3.3.2 Design
SG-3.3.2.1 General
SG-3.3.2.2 Static Seals <\/td>\n<\/tr>\n
187<\/td>\nSG-3.3.2.3 Valves
Fig. SG-3.3.2.2-1 Static O-Ring <\/td>\n<\/tr>\n
189<\/td>\nSG-3.3.2.4 End Face Mechanical Seal General Design Requirements
Fig. SG-3.3.2.3-1 Seals for Rising Stem Valves <\/td>\n<\/tr>\n
190<\/td>\nSG-3.4 Compliance Requirements for Sealing Elements
SG-3.4.1 General Requirements. <\/td>\n<\/tr>\n
191<\/td>\nSG-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
SG-4.2 Static Seal Performance <\/td>\n<\/tr>\n
192<\/td>\nSG-4.3 Dynamic Seal Performance
SG-4.3.1 Valve Seal Performance.
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.
Fig. SG-4.2-1 Typical Hygienic Clamp Union:Allowable Gasket Intrusion <\/td>\n<\/tr>\n
193<\/td>\nSG-4.3.2.2 Installed Seals.
SG-5 SEAL APPLICATIONS
SG-5.1 General Considerations
SG-5.2 Process Systems
SG-5.3 Compendial Water Systems
SG-5.3.1 Seals for Centrifugal Compendial Water Pumps
SG-5.4 Clean\/USP Pure Steam
SG-5.5 CIP <\/td>\n<\/tr>\n
194<\/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
195<\/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
196<\/td>\nPM-2.2.2 Labeling and Marking.
PM-3 PROPERTIES AND PERFORMANCE
PM-3.1 Biocompatibility
Table PM-2.1.3-1 Examples of Nonmetallics <\/td>\n<\/tr>\n
197<\/td>\nPM-3.2 Extractables and Leachables
PM-3.2.1 General.
PM-3.2.2 Terminology.
PM-3.2.3 Extractables
PM-3.2.3.1 Sample Preparation.
PM-3.2.3.2 Extract Analysis.
Table PM-2.2.1-1 Content Required on the Certificate of Compliance <\/td>\n<\/tr>\n
198<\/td>\nPM-3.2.3.3 Risk Assessment.
PM-3.2.4 Leachables
PM-3.2.4.1 Sample Preparation.
PM-3.2.4.2 Leachable Fluid Analysis.
PM-3.2.4.3 Risk Assessment.
PM-3.2.4.4 Bracketed Leachable Testing.
PM-3.3 Physical and Mechanical Properties of Thermoplastic Polymers
PM-3.4 Chemical Compatibility of Thermoplastic Polymers
PM-3.5 Physical and Mechanical Properties of Thermoset Polymers
PM-3.6 Chemical Compatibility of Thermoset Elastomers
PM-3.7 Physical and Mechanical Properties of Other Nonmetallic Materials <\/td>\n<\/tr>\n
199<\/td>\nPM-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.
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. <\/td>\n<\/tr>\n
200<\/td>\nPM-4.1.5 Sterilization Bioburden Control.
PM-4.1.5.1 Gamma Irradiation.
PM-4.1.6 Shelf Life, Storage, and Expiration Date.
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
201<\/td>\nTable PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards <\/td>\n<\/tr>\n
202<\/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
203<\/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.
PM-4.4.3 Design for Cleaning and Sanitization
PM-4.4.3.1 Cleaning. <\/td>\n<\/tr>\n
204<\/td>\nPM-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 Requirementsnts.
PM-4.4.6.2 Certificate of Compliance.
PM-4.5 Filtration Elements and Components
PM-4.6 Polymeric Hygienic Unions
PM-4.6.1 Multi-Use
PM-4.6.1.1 Installation.
PM-4.6.1.2 Performance.
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. <\/td>\n<\/tr>\n
206<\/td>\nPart CR Certification
CR-1 PURPOSE AND SCOPE
CR-2 GENERAL
CR-2.1 ASME BPE Certificate Holders
Fig. CR-1-1 ASME Certification Mark With BPE Designator <\/td>\n<\/tr>\n
207<\/td>\nCR-2.2 ASME BPE Certificate Holder\u00c5\u2019s Responsibilities
CR-2.3 Certification Designator
CR-2.4 Subcontracting
Fig. CR-2-1 Options for Certification of Organizations <\/td>\n<\/tr>\n
208<\/td>\nCR-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
209<\/td>\nCR-2.5.3 Evaluation of the Quality Management System.
CR-2.5.4 Applicant\u00c5\u2019s 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
CR-2.5.8 Internal Audits. <\/td>\n<\/tr>\n
210<\/td>\nCR-2.5.9 Corrective Action. <\/td>\n<\/tr>\n
211<\/td>\nPart MM Metallic Materials
MM-1 PURPOSE AND SCOPE
MM-2 ALLOY DESIGNATIONS
MM-2.1 General
MM-3 USES OF SPECIFICATIONS
MM-3.1 General
MM-3.2 Listed Specifications
MM-3.3 Unlisted Specifications
MM-3.4 Unknown Materials
MM-3.5 Reclaimed Materials
MM-3.6 Designation of Alloy and Fluid Service <\/td>\n<\/tr>\n
212<\/td>\nTable MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
213<\/td>\nTable MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
214<\/td>\nMM-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
215<\/td>\nMM-4.3 Castings
MM-4.4 Forgings
MM-4.5 Plate, Sheet, and Strip <\/td>\n<\/tr>\n
216<\/td>\nMM-4.6 Hollow Products, Rod, and Bar Stock
MM-4.7 Copper Alloy Fittings
MM-5 FABRICATION
MM-5.1 General
MM-5.1.1 Austenitic Stainless Steel Weld Ends. <\/td>\n<\/tr>\n
217<\/td>\nMM-5.1.2 Superaustenitic and Duplex Stainless Steels.
MM-5.1.3 Castings.
MM-5.1.4 Ferrite.
MM-5.1.5 Special Materials.
MM-5.1.6 Copper Alloy Tubing Systems.
MM-5.2 Filler Metals and Consumable Inserts
MM-5.2.1 Austenitic Stainless Steels.
MM-5.2.2 Superaustenitic Stainless Steels.
MM-5.2.3 Consumable Inserts for Orbital Welding of Listed Alloys.
MM-5.2.4 Duplex Stainless Steels. <\/td>\n<\/tr>\n
218<\/td>\nTable MM-5.1.2-1 Filler Metals <\/td>\n<\/tr>\n
220<\/td>\nTable MM-5.1.2-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels
Table MM-5.1.4-1 Predicted Ferrite Number (FN) Ranges for Various 316 Product Forms and Welds
Table MM-5.1.5-1 Materials for OEM Equipment <\/td>\n<\/tr>\n
221<\/td>\nMM-5.2.5 Copper Alloys.
MM-5.3 Field Bending of Tubing
MM-5.4 Heat Treatment
MM-6 MECHANICAL PROPERTIES
MM-6.1 General
MM-6.2 Tubing\/Piping
MM-6.3 Fittings and Valves
MM-6.4 Toughness
Table MM-5.2.5-1 Brazing Filler Metals for Copper <\/td>\n<\/tr>\n
222<\/td>\nMM-6.5 Testing
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 <\/td>\n<\/tr>\n
223<\/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 Additional Considerations
PI-2.1.2 Exterior Design.
PI-2.2 Instrumentation Categories
PI-2.2.1 In-Line Devices.
PI-2.2.2 Insertion Devices.
PI-2.2.3 At-Line Devices. <\/td>\n<\/tr>\n
224<\/td>\nPI-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
225<\/td>\nFig. PI-2.2.2-1 Accepted Insertion Device Installation Examples <\/td>\n<\/tr>\n
226<\/td>\nPI-4.1.2 Essential Components.
PI-4.1.3 Components
PI-4.1.3.1 Flow Tubes.
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
227<\/td>\nFig. PI-4.1.3.3-1 Concentrically Reducing Process Connection
Fig. PI-4.1.4.3-1 Vertical Installation
Fig. PI-4.1.4.4-1 Minimum Angle of Inclination, a <\/td>\n<\/tr>\n
228<\/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.
PI-5 LEVEL INSTRUMENTS
PI-5.1 Radar Level Instruments
PI-5.1.1 General.
PI-5.1.2 Essential Components. <\/td>\n<\/tr>\n
229<\/td>\nPI-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.
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
Fig. PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod Style Antenna <\/td>\n<\/tr>\n
230<\/td>\nPI-7.2 Components
PI-7.2.1 Sensors.
PI-7.2.2 Thermowells.
PI-7.3 Installation
Fig. PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location <\/td>\n<\/tr>\n
231<\/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
Fig. PI-7.3-1 Typical Installation Styles <\/td>\n<\/tr>\n
232<\/td>\nFig. PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions
Fig. PI-7.3.4-2 Accepted Nonintrusive Orientation and Flow Directions <\/td>\n<\/tr>\n
233<\/td>\nFig. PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations <\/td>\n<\/tr>\n
234<\/td>\nPI-7.3.6 Special Considerations
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. <\/td>\n<\/tr>\n
235<\/td>\nPI-7.6 Sensor Calibration Verification
PI-7.6.1 Methods.
PI-8 ANALYTICAL INSTRUMENTS
PI-8.1 Conductivity
PI-8.1.1 General.
Fig. PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations <\/td>\n<\/tr>\n
236<\/td>\nPI-8.1.2 Essential Components.
PI-8.1.2.1 Sensor Types.
PI-8.1.3 Installation.
Fig. PI-8.1.2-1 Conductivity Type Examples <\/td>\n<\/tr>\n
237<\/td>\nPI-8.1.3.1 Drainability.
PI-8.1.3.2 Cleanability.
PI-8.1.3.3 Mounting Location.
PI-8.1.3.4 Orientation.
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.
Fig. PI-8.1.3-1 Accepted Installations for Conductivity Sensors <\/td>\n<\/tr>\n
238<\/td>\nPI-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.
PI-8.2.3 Installation.
Fig. PI-8.1.3.6-1 Installation Clearance Requirements
Fig. PI-8.2.2-1 pH Sensor Components <\/td>\n<\/tr>\n
239<\/td>\nPI-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.
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. <\/td>\n<\/tr>\n
240<\/td>\nFig. PI-8.2.3-1 Accepted pH Sensor Installations <\/td>\n<\/tr>\n
241<\/td>\nFig. PI-8.2.3.4-1 Accepted Mounting Orientations <\/td>\n<\/tr>\n
242<\/td>\nPI-8.2.5 Selection.
PI-8.2.6 Maintenance.
PI-8.2.6.1 Calibration\/Verification Schedule.
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.
PI-9.1.2.2 Sensor.
PI-9.1.2.3 Sight Glass.
PI-9.1.3 Installation.
Fig. PI-8.2.3.5-1 Insertion Length or Depth <\/td>\n<\/tr>\n
243<\/td>\nPI-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.
PI-9.1.4.3 Process Influences.
PI-9.1.4.4 Ambient Influences.
PI-9.1.5 Selection.
PI-9.1.6 Maintenance.
PI-9.1.6.1 Calibration\/Verification. <\/td>\n<\/tr>\n
244<\/td>\nFig. PI-9.1.3.3-1 Vessel Light Glass Design and Mounting <\/td>\n<\/tr>\n
245<\/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
247<\/td>\nMANDATORY 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
248<\/td>\nI-4 CODE CASES
I-5 INTERPRETATIONS
I-6 SUBMITTALS <\/td>\n<\/tr>\n
249<\/td>\nMANDATORY APPENDIX II STANDARD UNITS
II-1 GENERAL <\/td>\n<\/tr>\n
250<\/td>\nNONMANDATORY APPENDICES
NONMANDATORY APPENDIX A COMMENTARY: SLAG
A-1 GENERAL <\/td>\n<\/tr>\n
251<\/td>\nNONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION\/INSPECTION DOCUMENTATION <\/td>\n<\/tr>\n
255<\/td>\nNONMANDATORY APPENDIX C SLOPE MEASUREMENT
C-1 GENERAL <\/td>\n<\/tr>\n
256<\/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
257<\/td>\nD-4.2 Class II Rouge Remediation
D-4.3 Class III Rouge Remediation
D-4.4 Remediation Variables <\/td>\n<\/tr>\n
265<\/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
266<\/td>\nE-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
269<\/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
275<\/td>\nNONMANDATORY APPENDIX F CORROSION TESTING
F-1 GENERAL
F-2 CORROSION TESTS
F-3 PITTING RESISISTANCE EQUIVALENT PRE NUMBER <\/td>\n<\/tr>\n
278<\/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 316 STAINLESS STEELS <\/td>\n<\/tr>\n
279<\/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
281<\/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
285<\/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 SIP Testing. <\/td>\n<\/tr>\n
286<\/td>\nJ-1.2.2 Other Process Testing Considerations
J-1.2.2.1 Vacuum.
J-1.2.2.2 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 <\/td>\n<\/tr>\n
291<\/td>\nJ-2 MECHANICAL SEAL PERFORMANCE EVALUATION
J-2.1 Mechanical Seal Performance Evaluation
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. <\/td>\n<\/tr>\n
292<\/td>\nJ-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
293<\/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
294<\/td>\nJ-2.4 Mechanical Seal Testing Notes <\/td>\n<\/tr>\n
295<\/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
298<\/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
299<\/td>\n L-4.4 Inspection
L-5 ACCEPTANCE CRITERIA
L-6 RECOMMENDED DOCUMENTATION <\/td>\n<\/tr>\n
300<\/td>\nNONMANDATORY APPENDIX M COMMENTARY: 316L WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA
M-1 GENERAL <\/td>\n<\/tr>\n
301<\/td>\nNONMANDATORY APPENDIX N GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS
N-1 GENERAL
N-2 PARTICULATES <\/td>\n<\/tr>\n
302<\/td>\nNONMANDATORY APPENDIX O GENERAL BACKGROUND\/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES
O-1 REFERENCES
O-2 RECOMMENDED CONDITIONS FOR AN EXTRACTABLES STUDY
O-3 RECOMMENDED MODEL PROCESS CONDITIONS FOR A BRACKETED STUDY <\/td>\n<\/tr>\n
303<\/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
304<\/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
305<\/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
306<\/td>\nNONMANDATORY APPENDIX R APPLICATION DATA SHEET <\/td>\n<\/tr>\n
309<\/td>\nNONMANDATORY APPENDIX S POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS
S-1 GENERAL
S-2 COLUMN CONSTRUCTION
S-2.1 Cleaning
S-2.2 Sanitization <\/td>\n<\/tr>\n
310<\/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
311<\/td>\nT-3 CHECKING EQUATIONS
T-4 SOFT CONVERSION FACTORS <\/td>\n<\/tr>\n
313<\/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>\n2014<\/td>\n328<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":129659,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2643],"product_tag":[],"class_list":{"0":"post-129657","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\/129657","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\/129659"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=129657"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=129657"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=129657"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}