{"id":194343,"date":"2024-10-19T12:19:54","date_gmt":"2024-10-19T12:19:54","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/asme-bpe-2019\/"},"modified":"2024-10-25T04:50:59","modified_gmt":"2024-10-25T04:50:59","slug":"asme-bpe-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/asme\/asme-bpe-2019\/","title":{"rendered":"ASME BPE 2019"},"content":{"rendered":"

The ASME BPE Standard provides requirements for systems and components that are subject to cleaning and sanitization and\/or sterilization including systems that are cleaned in place (CIP’d) and\/or steamed in place (SIP’d) and\/or other suitable processes used in the manufacturing of biopharmaceuticals. This Standard also provides requirements for single-use systems and components used in the above listed systems and components. This Standard may be used, in whole or in part, for other systems and components where bioburden risk is a concern. This Standard applies to new system (and component) design and fabrication definition of system boundaries specific metallic, polymeric, and elastomeric (e.g., seals and gaskets) materials of construction component dimensions and tolerances surface finishes materials joining examinations, inspections, and testing certification This Standard is intended to apply to new fabrication and construction. If the provisions of this Standard are optionally applied by an owner\/user to existing, inservice equipment, other considerations may be necessary. For installations between new construction and an existing, in-service system, such as a retrofit, modification, or repair, the boundaries and requirements must be agreed to among the owner\/user, engineer, installation contractor, and inspection contractor. For a system or component to be BPE-compliant, adherence to all applicable parts of this Standard is required.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
4<\/td>\nCONTENTS <\/td>\n<\/tr>\n
13<\/td>\nFOREWORD <\/td>\n<\/tr>\n
14<\/td>\nSTATEMENT OF POLICY ON THE USE OF THE ASME SINGLE CERTIFICATION MARK AND CODE AUTHORIZATION IN ADVERTISING
STATEMENT OF POLICY ON THE USE OF ASME MARKING TO IDENTIFY MANUFACTURED ITEMS <\/td>\n<\/tr>\n
15<\/td>\nCOMMITTEE ROSTER <\/td>\n<\/tr>\n
19<\/td>\nCORRESPONDENCE WITH THE BPE COMMITTEE <\/td>\n<\/tr>\n
21<\/td>\nASME BPE-2019 SUMMARY 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\u2019S QUALITY ASSURANCE PROGRAM
GR-4 EXAMINATION, INSPECTION, AND TESTING
GR-4.1 Inspector\/Examiner
GR-4.2 Inspector\u2019s Delegate <\/td>\n<\/tr>\n
28<\/td>\nGR-4.3 Responsibilities <\/td>\n<\/tr>\n
29<\/td>\nTables
Table GR-4.2-1 Inspector\u2019s Delegate Capabilities <\/td>\n<\/tr>\n
31<\/td>\nGR-4.4 Access for Inspectors
GR-5 DOCUMENTATION
GR-5.1 General
GR-5.2 Document Requirements <\/td>\n<\/tr>\n
32<\/td>\nGR-5.3 Material Test Reports\/Certificates of Compliance <\/td>\n<\/tr>\n
33<\/td>\nGR-5.4 Weld and Examination\/Inspection Log
GR-5.5 Records Retention
GR-6 U.S. CUSTOMARY AND SI UNITS
GR-7 REFERENCES <\/td>\n<\/tr>\n
35<\/td>\nGR-8 TERMS AND DEFINITIONS <\/td>\n<\/tr>\n
43<\/td>\nGR-9 NOMENCLATURE <\/td>\n<\/tr>\n
44<\/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 <\/td>\n<\/tr>\n
45<\/td>\nSD-2.4 Fabrication <\/td>\n<\/tr>\n
46<\/td>\nTable SD-2.4.3.1-1 Slope Designations for Gravity-Drained Lines <\/td>\n<\/tr>\n
47<\/td>\nSD-2.5 Hygienic System Design <\/td>\n<\/tr>\n
48<\/td>\nSD-3 PROCESS COMPONENTS
SD-3.1 Connections, Fittings, and Piping <\/td>\n<\/tr>\n
49<\/td>\nFigures
Figure SD-3.1.1-1 Flat Gasket Applications <\/td>\n<\/tr>\n
50<\/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
51<\/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
53<\/td>\nFigure SD-3.1.2.2-1 Accepted Point-of-Use Designs <\/td>\n<\/tr>\n
54<\/td>\nFigure SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly <\/td>\n<\/tr>\n
55<\/td>\nSD-3.2 Hose Assemblies <\/td>\n<\/tr>\n
56<\/td>\nSD-3.3 Pumps
Figure SD-3.2.1-1 Flexible Hygienic Hose Design <\/td>\n<\/tr>\n
57<\/td>\nFigure SD-3.3.2.2-1 Pump Impeller Configurations <\/td>\n<\/tr>\n
58<\/td>\nFigure SD-3.3.2.2-3 Casing Drain Configurations <\/td>\n<\/tr>\n
59<\/td>\nSD-3.4 Vessels
Figure SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment <\/td>\n<\/tr>\n
60<\/td>\nFigure SD-3.4.2-1 Nozzle Design <\/td>\n<\/tr>\n
61<\/td>\nFigure SD-3.4.2-2 Side and Bottom Connections
Figure SD-3.4.2-3 Sidewall Instrument Ports <\/td>\n<\/tr>\n
62<\/td>\nFigure SD-3.4.2-4 Vessel Design Tangential Nozzles <\/td>\n<\/tr>\n
63<\/td>\nFigure SD-3.4.2-5 Typical Nozzle Detail
Table SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes <\/td>\n<\/tr>\n
64<\/td>\nFigure SD-3.4.3-1 Accepted Nozzle Penetrations <\/td>\n<\/tr>\n
65<\/td>\nFigure SD-3.4.3-2 Internal Support Members <\/td>\n<\/tr>\n
66<\/td>\nSD-3.5 Agitators and Mixers <\/td>\n<\/tr>\n
67<\/td>\nFigure SD-3.4.6-1 Sight Glass Design (Accepted) <\/td>\n<\/tr>\n
68<\/td>\nFigure SD-3.5.1-1 Agitator Mounting Flanges <\/td>\n<\/tr>\n
69<\/td>\nFigure SD-3.5.2-1 Shaft Coupling Construction <\/td>\n<\/tr>\n
70<\/td>\nFigure SD-3.5.2-2 Shaft Coupling Seal Arrangements <\/td>\n<\/tr>\n
71<\/td>\nFigure SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs <\/td>\n<\/tr>\n
72<\/td>\nFigure SD-3.5.5-1 Shaft-Steady Bearing <\/td>\n<\/tr>\n
73<\/td>\nSD-3.6 Heat Exchange Equipment
Figure SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) <\/td>\n<\/tr>\n
74<\/td>\nSD-3.7 Transfer Panels <\/td>\n<\/tr>\n
75<\/td>\nFigure SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design <\/td>\n<\/tr>\n
76<\/td>\nFigure SD-3.7.1-1 Transfer Panel Looped Headers <\/td>\n<\/tr>\n
77<\/td>\nFigure SD-3.7.2-1 Transfer Panel Tolerances (Reference Table DT-7-3) <\/td>\n<\/tr>\n
78<\/td>\nFigure SD-3.7.4-1 Transfer Panel Jumpers <\/td>\n<\/tr>\n
79<\/td>\nSD-3.8 Filters <\/td>\n<\/tr>\n
80<\/td>\nSD-3.9 Spray Devices
Figure SD-3.9.1-1 Dynamic Spray Device: Single Axis <\/td>\n<\/tr>\n
81<\/td>\nFigure SD-3.9.1-2 Two-Axis Dynamic Spray Device <\/td>\n<\/tr>\n
82<\/td>\nFigure SD-3.9.2.1-1 Static Spray Device <\/td>\n<\/tr>\n
83<\/td>\nFigure SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels <\/td>\n<\/tr>\n
84<\/td>\nSD-3.10 Disposables That Require Presterilization or Poststerilization
SD-3.11 Sampling Systems
SD-3.12 Steam Traps
Figure SD-3.9.2.3-1 Impact Pattern Buildup <\/td>\n<\/tr>\n
85<\/td>\nSD-3.13 Check Valves
SD-3.14 Orifice Plates
SD-3.15 Relief Devices
Figure SD-3.12-1 Steam Traps for Clean Steam Systems <\/td>\n<\/tr>\n
86<\/td>\nSD-3.16 Liquid Pressure Regulators
SD-4 PROCESS UTILITIES
SD-4.1 Compendial Water Systems <\/td>\n<\/tr>\n
87<\/td>\nFigure SD-4.1.2.1-1 Point-of-Use Piping <\/td>\n<\/tr>\n
88<\/td>\nSD-4.2 Clean\/Pure Steam Systems
Figure SD-4.1.2.2-1 Physical Break in Point-of-Use Piping <\/td>\n<\/tr>\n
89<\/td>\nFigure SD-4.2.2-1 Typical Clean Steam System Isometric <\/td>\n<\/tr>\n
90<\/td>\nSD-4.3 Process Gases
SD-4.4 Process Waste Systems
Figure SD-4.2.2-2 Clean Steam Point-of-Use Design <\/td>\n<\/tr>\n
91<\/td>\nSD-5 PROCESS SYSTEMS
SD-5.1 Bioreactors and Fermentors <\/td>\n<\/tr>\n
92<\/td>\nFigure SD-5.1.4.4-1 Gas Sparging Assembly \u2014 Lance <\/td>\n<\/tr>\n
93<\/td>\nFigure SD-5.1.4.4-2 Gas Sparging Assembly \u2014 Sintered <\/td>\n<\/tr>\n
94<\/td>\nFigure SD-5.1.4.4-3 Gas Sparging Assembly \u2014 Ring <\/td>\n<\/tr>\n
95<\/td>\nFigure SD-5.1.4.4-4 Gas Sparging Assembly \u2014 Single Orifice <\/td>\n<\/tr>\n
97<\/td>\nFigure SD-5.1.4.7-1 Exhaust Gas Condenser <\/td>\n<\/tr>\n
98<\/td>\nFigure SD-5.1.4.7-3 Electrically Heat Traced Filter Housing <\/td>\n<\/tr>\n
99<\/td>\nFigure SD-5.1.5-1 Fermentor Sterile Envelope <\/td>\n<\/tr>\n
100<\/td>\nFigure SD-5.1.5-2 Bioreactor Sterile Envelope <\/td>\n<\/tr>\n
101<\/td>\nSD-5.2 Cell Disrupters
SD-5.3 Centrifuges <\/td>\n<\/tr>\n
102<\/td>\nSD-5.4 Filtration Systems <\/td>\n<\/tr>\n
103<\/td>\nSD-5.5 Chromatography Systems
Figure SD-5.4.4-1 Tank\/Vessel Vent Fillers <\/td>\n<\/tr>\n
104<\/td>\nSD-5.6 Lyophilizers\/Freeze Dryers <\/td>\n<\/tr>\n
105<\/td>\nFigure SD-5.6.2-1 Typical Lyophilizer Component Assembly <\/td>\n<\/tr>\n
108<\/td>\nFigure SD-5.6.3-1 Lyophilizer Sterile Boundary <\/td>\n<\/tr>\n
110<\/td>\nSD-5.7 Solution Preparation Systems
SD-6 PROCESS SUPPORT SYSTEMS
SD-6.1 Cabinet Washers <\/td>\n<\/tr>\n
114<\/td>\nSD-6.2 Steam Sterilizers\/Autoclaves <\/td>\n<\/tr>\n
115<\/td>\nSD-6.3 CIP Systems <\/td>\n<\/tr>\n
117<\/td>\nFigure SD-6.3.4.6-1 CIP Looped Header (Supply or Return) <\/td>\n<\/tr>\n
118<\/td>\nFigure SD-6.3.4.6-2 Zero-Static Chain
Figure SD-6.3.4.6-3 Swing Elbow Arrangement
Table SD-6.3.5.2-1 Flow Rates to Achieve 5 ft\/sec (1.52 m\/s) <\/td>\n<\/tr>\n
119<\/td>\nSD-6.4 Thermal Treatment Systems <\/td>\n<\/tr>\n
120<\/td>\nFigure SD-6.4.1.1-1 Example of HTST Process Flow Schematic Diagram <\/td>\n<\/tr>\n
121<\/td>\nFigure SD-6.4.1.1-2 Example of Direct Steam Injection UHT Process Flow Schematic Diagram <\/td>\n<\/tr>\n
123<\/td>\nFigure SD-6.4.4.5-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing <\/td>\n<\/tr>\n
124<\/td>\nSD-6.5 Immersion Washers <\/td>\n<\/tr>\n
126<\/td>\nFigure SD-6.5.4.2-1 Immersion Tank Side Nozzle Design <\/td>\n<\/tr>\n
127<\/td>\nSD-6.6 Isolator Systems <\/td>\n<\/tr>\n
131<\/td>\nSD-7 DESIGN CONFORMANCE TESTING
SD-7.1 Spray Device Coverage Test <\/td>\n<\/tr>\n
132<\/td>\nSD-7.2 Cleaning, Steaming, and Bioburden Control Testing
SD-7.3 Fluid Requirements for Leak Testing
SD-7.4 Vessel Drainability Test <\/td>\n<\/tr>\n
133<\/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
134<\/td>\nTable MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
135<\/td>\nTable MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
136<\/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
137<\/td>\nMM-4.3 Castings
MM-4.4 Forgings
MM-4.5 Plate, Sheet, and Strip <\/td>\n<\/tr>\n
138<\/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 <\/td>\n<\/tr>\n
139<\/td>\nMM-5.3 Filler Materials
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
140<\/td>\nMM-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-7 POSITIVE MATERIAL IDENTIFICATION
Table MM-5.2.6-1 Materials for OEM Equipment <\/td>\n<\/tr>\n
141<\/td>\nTable MM-5.3-1 Filler Metals <\/td>\n<\/tr>\n
145<\/td>\nTable MM-5.3-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels <\/td>\n<\/tr>\n
146<\/td>\nTable MM-5.3.3-1 Brazing Filler Metals for Copper <\/td>\n<\/tr>\n
147<\/td>\nMM-8 CORROSION-RESISTANCE REQUIREMENTS
MM-8.1 General
MM-8.2 Corrosion Testing
MM-9 MINIMUM REQUIREMENTS FOR ALLOYS IN PART MM
MM-9.1 General
MM-9.1.1 Wrought, Cast, and Welded Fabricated Applications
MM-9.1.2 Specialty OEM Material Applications
Table MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic and Duplex Stainless Steels
Table MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic and Duplex Stainless Steels <\/td>\n<\/tr>\n
149<\/td>\nPART PM POLYMERIC AND OTHER NONMETALLIC MATERIALS
PM-1 PURPOSE AND SCOPE
PM-2 MATERIALS
PM-2.1 Materials of Construction <\/td>\n<\/tr>\n
150<\/td>\nPM-2.2 General Requirements
Table PM-2.1.1-1 Common Thermoplastic Polymers and Applications
Table PM-2.1.2-1 Common Thermoset Polymers and Applications <\/td>\n<\/tr>\n
151<\/td>\nTable PM-2.1.3-1 Examples of Nonmetallics <\/td>\n<\/tr>\n
152<\/td>\nTable PM-2.2.1-1 Content Required on the Certificate of Compliance <\/td>\n<\/tr>\n
153<\/td>\nPM-3 PROPERTIES AND PERFORMANCE
PM-3.1 Biocompatibility
Table PM-2.2.3.2-1 Change Levels and Minimum Change Notification Requirements <\/td>\n<\/tr>\n
154<\/td>\nPM-3.2 Extractables and Leachables
PM-3.3 Physical and Mechanical Properties of Thermoplastic Polymers <\/td>\n<\/tr>\n
155<\/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-4.2 Piping <\/td>\n<\/tr>\n
156<\/td>\nTable PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards <\/td>\n<\/tr>\n
157<\/td>\nPM-4.3 Hose Assemblies <\/td>\n<\/tr>\n
159<\/td>\nPM-4.4 Chromatography Columns <\/td>\n<\/tr>\n
160<\/td>\nPM-4.5 Filtration Elements and Components <\/td>\n<\/tr>\n
161<\/td>\nPM-4.6 Polymeric Hygienic Unions <\/td>\n<\/tr>\n
162<\/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-4.2 Nonstandard Fitting Dimensions <\/td>\n<\/tr>\n
163<\/td>\nDT-4.3 Special Angle Fittings Dimensions
DT-4.4 Valve Dimensions
DT-4.5 Filter Dimensions
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
164<\/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
165<\/td>\nDT-11.2 Valve Marking Information
DT-11.3 Modified Surfaces
DT-12 PACKAGING
Table DT-2-1 Metallic Hygienic Unions: Rated Internal Working Pressure <\/td>\n<\/tr>\n
166<\/td>\nFigure DT-2-1 Clamp Conditions at Installation <\/td>\n<\/tr>\n
167<\/td>\nTable DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components <\/td>\n<\/tr>\n
168<\/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
169<\/td>\nTable DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow <\/td>\n<\/tr>\n
170<\/td>\nTable DT-4.1.1-2 Automatic Tube Weld: Hygienic Clamp Joint, 90-deg Elbow
Table DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Elbow <\/td>\n<\/tr>\n
171<\/td>\nTable DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow <\/td>\n<\/tr>\n
172<\/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
173<\/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
174<\/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
175<\/td>\nTable DT-4.1.2-3 Hygienic Mechanical Joint: Short-Outlet Run Tee <\/td>\n<\/tr>\n
176<\/td>\nTable DT-4.1.2-4 Hygienic Clamp Joint: Straight Tee and Cross
Table DT-4.1.2-5 Hygienic Clamp Joint: Short-Outlet Tee <\/td>\n<\/tr>\n
177<\/td>\nTable DT-4.1.2-6 Automatic Tube Weld: Reducing Tee <\/td>\n<\/tr>\n
178<\/td>\nTable DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee <\/td>\n<\/tr>\n
179<\/td>\nTable DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee <\/td>\n<\/tr>\n
180<\/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 <\/td>\n<\/tr>\n
181<\/td>\nTable DT-4.1.2-11 Hygienic Clamp Joint: Instrument Tee <\/td>\n<\/tr>\n
182<\/td>\nTable DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
183<\/td>\nTable DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
184<\/td>\nTable DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
185<\/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
186<\/td>\nTable DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap <\/td>\n<\/tr>\n
187<\/td>\nTable DT-4.4.1-1 Hygienic Clamp Joint: Weir-Style Diaphragm Valve <\/td>\n<\/tr>\n
188<\/td>\nTable DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed <\/td>\n<\/tr>\n
189<\/td>\nTable DT-4.5.2-1 Tapered Locking Tab Retainer: External <\/td>\n<\/tr>\n
190<\/td>\nTable DT-7-1 Metallic Hygienic Clamp Ferrule Standard Dimensions and Tolerances <\/td>\n<\/tr>\n
193<\/td>\nTable DT-7-2 Polymeric Hygienic Clamp Ferrule Standard Dimensions and Tolerances <\/td>\n<\/tr>\n
196<\/td>\nTable DT-7-3 Transfer Panel and Jumper Tolerances <\/td>\n<\/tr>\n
197<\/td>\nTable DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria <\/td>\n<\/tr>\n
198<\/td>\nPART PI PROCESS INSTRUMENTATION
PI-1 PURPOSE AND SCOPE
PI-2 PROCESS INSTRUMENTATION GENERAL REQUIREMENTS
PI-2.1 General Considerations
PI-2.2 Instrumentation Categories <\/td>\n<\/tr>\n
199<\/td>\nPI-3 INSTRUMENT RECEIVING, HANDLING, AND STORAGE
PI-3.1 Introduction
PI-3.2 Instrument Receiving
PI-3.3 Instrument Handling: Protection of Process Connections and Surface Finish
PI-3.4 Instrument Storage
PI-4 FLOWMETERS
PI-4.1 Coriolis Flowmeter
Figure PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples <\/td>\n<\/tr>\n
200<\/td>\nFigure PI-2.2.2-1 Accepted Insertion Device Installation Examples <\/td>\n<\/tr>\n
201<\/td>\nFigure PI-4.1.3.2-1 Manifold or Flow Splitter for Dual-Tube Construction Flowmeters and Potential for Product Holdup <\/td>\n<\/tr>\n
202<\/td>\nFigure PI-4.1.3.3-1 Concentrically Reducing Process Connection
Figure PI-4.1.4.3-1 Vertical Installation <\/td>\n<\/tr>\n
203<\/td>\nPI-4.2 Turbine Flowmeter
Figure PI-4.1.4.4-1 Minimum Angle of Inclination, \u03b1 <\/td>\n<\/tr>\n
204<\/td>\nFigure PI-4.2.2-1 Typical Turbine Flowmeters <\/td>\n<\/tr>\n
205<\/td>\nPI-5 LEVEL INSTRUMENTS
PI-5.1 Radar Level Instruments <\/td>\n<\/tr>\n
206<\/td>\nPI-6 PRESSURE INSTRUMENTS
PI-6.1 Pressure Sensors
Figure PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna <\/td>\n<\/tr>\n
207<\/td>\nFigure PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location <\/td>\n<\/tr>\n
208<\/td>\nFigure PI-6.1.2-1 Accepted Orientation and Flow <\/td>\n<\/tr>\n
209<\/td>\nPI-7 TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS
PI-7.1 General
PI-7.2 Components
PI-7.3 Installation <\/td>\n<\/tr>\n
210<\/td>\nPI-7.4 Performance
Figure PI-7.3-1 Typical Installation Styles <\/td>\n<\/tr>\n
211<\/td>\nFigure PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions
Figure PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions <\/td>\n<\/tr>\n
212<\/td>\nFigure PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations <\/td>\n<\/tr>\n
213<\/td>\nFigure PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations <\/td>\n<\/tr>\n
214<\/td>\nPI-7.5 Selection
PI-7.6 Sensor Calibration Verification
PI-8 ANALYTICAL INSTRUMENTS
PI-8.1 Conductivity <\/td>\n<\/tr>\n
215<\/td>\nFigure PI-8.1.2-1 Conductivity-Type Examples <\/td>\n<\/tr>\n
216<\/td>\nPI-8.2 pH \u2014 Glass Measuring Electrode
Figure PI-8.1.3-1 Accepted Installations for Conductivity Sensors
Figure PI-8.1.3.6-1 Installation Clearance Requirements <\/td>\n<\/tr>\n
217<\/td>\nFigure PI-8.2.2-1 pH Sensor Components <\/td>\n<\/tr>\n
218<\/td>\nFigure PI-8.2.3-1 Accepted pH Sensor Installations <\/td>\n<\/tr>\n
219<\/td>\nFigure PI-8.2.3.4-1 Accepted Mounting Orientations <\/td>\n<\/tr>\n
220<\/td>\nPI-9 OPTICAL
PI-9.1 Optical Devices
Figure PI-8.2.3.5-1 Insertion Length or Depth <\/td>\n<\/tr>\n
222<\/td>\nFigure PI-9.1.3.3-1 Vessel Light Glass Design and Mounting <\/td>\n<\/tr>\n
223<\/td>\nFigure PI-9.1.3.5-1 In-Line Insertion Length
Figure PI-9.1.3.5-2 Insertion Probe Length <\/td>\n<\/tr>\n
224<\/td>\nPART SG SEALING COMPONENTS
SG-1 PURPOSE AND SCOPE
SG-2 SEALING COMPONENT TYPES
SG-2.1 General
SG-2.2 Static Seals <\/td>\n<\/tr>\n
225<\/td>\nFigure SG-2.2.2-1 Hygienic Union per Table DT-7-1
Figure SG-2.2.2-2 Hygienic Clamp Union per Table DT-7-1
Figure SG-2.2.2-3 Hygienic Union per DIN 11864 <\/td>\n<\/tr>\n
226<\/td>\nFigure SG-2.2.2-4 Hygienic Clamp Union per DIN 11864 <\/td>\n<\/tr>\n
227<\/td>\nFigure SG-2.2.2-5 Nonhygienic Connections <\/td>\n<\/tr>\n
228<\/td>\nSG-2.3 Dynamic Seals <\/td>\n<\/tr>\n
229<\/td>\nFigure SG-2.3.1.2-1 Weir Valves
Figure SG-2.3.1.2-2 Radial Valves <\/td>\n<\/tr>\n
230<\/td>\nFigure SG-2.3.1.2-3 Weirless Diaphragm Valve
Figure SG-2.3.1.2-4 Linear Control Valves <\/td>\n<\/tr>\n
231<\/td>\nFigure SG-2.3.1.2-5 Regulator Valve
Figure SG-2.3.1.3-1 Ball Valves <\/td>\n<\/tr>\n
232<\/td>\nFigure SG-2.3.1.4-1 Rising Stem Single, Double-Seat Mix-Proof, and Needle Valves
Figure SG-2.3.1.5-1 Butterfly Valve
Figure SG-2.3.1.7-1 Back Pressure Control Valve <\/td>\n<\/tr>\n
233<\/td>\nFigure SG-2.3.1.8-1 Pinch Valve <\/td>\n<\/tr>\n
234<\/td>\nFigure SG-2.3.1.9-1 Pressure Relief and Check Valves <\/td>\n<\/tr>\n
236<\/td>\nFigure SG-2.3.1.10-1 Plug Valve
Figure SG-2.3.2.2-1 Single Mechanical Seal
Figure SG-2.3.2.2-2 Single Seal for Top-Entry Agitator
Figure SG-2.3.2.3-1 Dual Pressurized Mechanical Seal for Pumps
Figure SG-2.3.2.3-2 Dual Pressurized Mechanical Seal for Top-Entry Agitator
Figure SG-2.3.2.3-3 Dual Unpressurized Mechanical Seal for Pumps <\/td>\n<\/tr>\n
238<\/td>\nFigure SG-2.3.2.4-1 Flush Plan 01
Figure SG-2.3.2.4-2 Flush Plan 02
Figure SG-2.3.2.4-3 Flush Plan 03
Figure SG-2.3.2.4-4 Flush Plan 11
Figure SG-2.3.2.4-5 Flush Plan 32 <\/td>\n<\/tr>\n
239<\/td>\nFigure SG-2.3.2.4-6 Flush Plan 52 for Pump
Figure SG-2.3.2.4-7 Flush Plan 52 for Top-Entry Agitator
Figure SG-2.3.2.4-8 Flush Plan BPE52 for Pump
Figure SG-2.3.2.4-9 Flush Plan 53 for Pump
Figure SG-2.3.2.4-10 Flush Plan 53 for Top-Entry Agitator <\/td>\n<\/tr>\n
240<\/td>\nFigure SG-2.3.2.4-11 Flush Plan 54 for Pump
Figure SG-2.3.2.4-12 Flush Plan 54 for Top-Entry Agitator
Figure SG-2.3.2.4-13 Flush Plan 55 for Pump
Figure SG-2.3.2.4-14 Flush Plan 55 for Top-Entry Agitator
Figure SG-2.3.2.4-15 Flush Plan 74 for Pump
Figure SG-2.3.2.4-16 Flush Plan 74 for Top-Entry Agitator <\/td>\n<\/tr>\n
241<\/td>\nSG-3 SEALING COMPONENTS GENERAL DESIGN REQUIREMENTS (GENERAL PROVISIONS)
SG-3.1 Seal Design Conditions
SG-3.2 System Requirements
SG-3.3 Seal Construction <\/td>\n<\/tr>\n
243<\/td>\nFigure SG-3.3.2.2-1 Examples of Static O-Ring Grooves <\/td>\n<\/tr>\n
245<\/td>\nFigure SG-3.3.2.3-1 Seals for Rising Stem Valves <\/td>\n<\/tr>\n
246<\/td>\nSG-3.4 Compliance Requirements for Sealing Elements <\/td>\n<\/tr>\n
247<\/td>\nSG-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
248<\/td>\nSG-4.3 Dynamic Seal Performance
Figure SG-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion <\/td>\n<\/tr>\n
249<\/td>\nSG-5 SEAL APPLICATIONS
SG-5.1 General Considerations
SG-5.1.1 Static Seals. <\/td>\n<\/tr>\n
250<\/td>\nSG-5.2 Process Systems
SG-5.3 Compendial Ambient\/Hot-Water Distribution Systems
SG-5.3.1 Valves for Compendial Water
SG-5.3.1.1 Seals for Compendial Water.
SG-5.3.1.2 Valve Types for Compendial Water
SG-5.3.2 Single Mechanical Seals for Compendial Water per SG-3.3.2.4(a) and SG-3.3.2.4(b)
SG-5.3.2.1 Additional Application Conditions Relevant to Mechanical Seals.
SG-5.3.2.2 Additional Equipment Characteristics Relevant to Mechanical Seals.
SG-5.3.2.3 Materials of Construction.
SG-5.3.2.4 Flush Plans.
SG-5.4 Pure Steam Distribution Systems <\/td>\n<\/tr>\n
251<\/td>\nSG-5.4.1 Static Seal Recommendations for Pure Steam Distribution Systems.
SG-5.4.2 Valves for Pure Steam Distribution Systems
SG-5.4.2.1 Valve Seals.
SG-5.4.2.2 Valve Types
SG-5.5 CIP <\/td>\n<\/tr>\n
252<\/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-2.2 Filler Metals <\/td>\n<\/tr>\n
253<\/td>\nMJ-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 <\/td>\n<\/tr>\n
254<\/td>\nMJ-4 JOINING PROCESSES AND PROCEDURES
MJ-4.1 Introduction
MJ-4.2 Welds Finished After Welding
MJ-4.3 Welds Used in the As-Welded Condition
MJ-4.4 Brazing
MJ-5 PROCEDURE QUALIFICATIONS
MJ-5.1 Pressure Vessels and Tanks
MJ-5.2 Piping
MJ-5.3 Tubing
MJ-5.4 Duplex Stainless Steels
MJ-5.5 Brazing
MJ-6 PERFORMANCE QUALIFICATIONS
MJ-6.1 Pressure Vessels and Tanks
MJ-6.2 Piping
MJ-6.3 Tubing <\/td>\n<\/tr>\n
255<\/td>\nMJ-6.4 Brazing
MJ-7 EXAMINATION, INSPECTION, AND TESTING
MJ-7.1 Examination Procedures
MJ-7.2 Personnel Requirements
Table MJ-6.3-1 Metallic Tube\/Pipe Diameter Limits for Orbital GTAW Performance Qualification
Table MJ-6.3-2 Metallic Weld Thickness Limits for Orbital GTAW Performance Qualification <\/td>\n<\/tr>\n
256<\/td>\nMJ-7.3 Examination, Inspection, and Testing Requirements
MJ-7.4 Records
MJ-8 ACCEPTANCE CRITERIA
MJ-8.1 General <\/td>\n<\/tr>\n
257<\/td>\nMJ-8.2 Pressure Vessel and Tank Welds
MJ-8.3 Piping Welds
MJ-8.4 Tubing Welds
MJ-8.5 Tube-Attachment Welds
MJ-8.6 Brazed Joints
MJ-9 JOINING OF POLYMERIC MATERIALS
MJ-9.1 General
MJ-9.2 Weld Joint Design and Preparation <\/td>\n<\/tr>\n
258<\/td>\nTable MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks <\/td>\n<\/tr>\n
259<\/td>\nTable MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe <\/td>\n<\/tr>\n
260<\/td>\nTable MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints <\/td>\n<\/tr>\n
262<\/td>\nMJ-9.3 Joining Processes and Procedures
MJ-9.4 Procedure Qualifications
MJ-9.5 Performance Qualifications
MJ-9.6 Examination, Inspection, and Testing <\/td>\n<\/tr>\n
263<\/td>\nFigure MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube-to-Tube Butt Joints <\/td>\n<\/tr>\n
264<\/td>\nFigure MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on ElectropolishedUNS S31603 Tubing <\/td>\n<\/tr>\n
265<\/td>\nFigure MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically PolishedUNS S31603 Tubing <\/td>\n<\/tr>\n
266<\/td>\nFigure 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
267<\/td>\nTable MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds <\/td>\n<\/tr>\n
269<\/td>\nMJ-9.7 Weld Acceptance Criteria
Figure MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds <\/td>\n<\/tr>\n
270<\/td>\nFigure MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds <\/td>\n<\/tr>\n
271<\/td>\nMJ-9.8 Documentation Requirements
MJ-10 DOCUMENTATION REQUIREMENTS
MJ-11 PASSIVATION <\/td>\n<\/tr>\n
272<\/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 <\/td>\n<\/tr>\n
273<\/td>\nTable SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes <\/td>\n<\/tr>\n
274<\/td>\nSF-2.5 Electropolishing Procedure Qualification
SF-2.6 Passivation Procedure
SF-2.7 Normative References
Table SF-2.2-2 Additional Acceptance Criteria for Electropolished Metallic Process Contact SurfaceFinishes
Table SF-2.4.1-1 Ra Readings for Metallic Process Contact Surfaces <\/td>\n<\/tr>\n
275<\/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
276<\/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
277<\/td>\nCHAPTER 6 CERTIFICATION
PART CR CERTIFICATION REQUIREMENTS
CR-1 PURPOSE AND SCOPE
CR-2 GENERAL
CR-2.1 ASME BPE Certificate Holders
CR-2.2 ASME BPE Certificate Holder\u2019s Responsibilities
Figure CR-1-1 ASME Certification Mark With BPE Designator <\/td>\n<\/tr>\n
278<\/td>\nCR-2.3 Certification Designator
CR-2.4 Quality Management System <\/td>\n<\/tr>\n
279<\/td>\nMANDATORY APPENDICES
MANDATORY APPENDIX I SUBMITTAL OF TECHNICAL INQUIRIES TO THE BIOPROCESSING EQUIPMENT (BPE) COMMITTEE <\/td>\n<\/tr>\n
280<\/td>\nTable II-1 Standard Units
MANDATORY APPENDIX II STANDARD UNITS <\/td>\n<\/tr>\n
281<\/td>\nMANDATORY APPENDIX III SINGLE-USE COMPONENTS AND ASSEMBLIES
III-1 GENERAL
III-2 GENERAL GUIDELINES
III-3 MATERIALS
III-4 BIOCOMPATIBILITY
III-5 EXTRACTABLES AND LEACHABLES
III-6 COMPONENTS <\/td>\n<\/tr>\n
282<\/td>\nIII-7 JOINING METHODS
III-8 IDENTIFICATION
III-9 CERTIFICATE OF COMPLIANCE
III-10 INSPECTION AND PACKAGING <\/td>\n<\/tr>\n
283<\/td>\nIII-11 STERILIZATION (BIOBURDEN CONTROL)
III-12 SHELF LIFE, STORAGE, AND EXPIRATION DATE
III-13 PARTICULATES <\/td>\n<\/tr>\n
285<\/td>\nMANDATORY APPENDIX IV NOMENCLATURE <\/td>\n<\/tr>\n
287<\/td>\nNONMANDATORY APPENDICES
NONMANDATORY APPENDIX A COMMENTARY: SLAG AND OXIDE ISLANDS <\/td>\n<\/tr>\n
288<\/td>\nNONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION\/INSPECTION DOCUMENTATION <\/td>\n<\/tr>\n
289<\/td>\nForms
Form MEL-1 Material Examination Log <\/td>\n<\/tr>\n
290<\/td>\nForm MER-1 Material Examination Record <\/td>\n<\/tr>\n
291<\/td>\nForm WEL-1 Weld and Examination\/Inspection Log <\/td>\n<\/tr>\n
292<\/td>\nNONMANDATORY APPENDIX C SLOPE MEASUREMENT AND JOINT MISALIGNMENT
C-1 GENERAL
C-2 JOINT MISALIGNMENT <\/td>\n<\/tr>\n
293<\/td>\nNONMANDATORY APPENDIX D ROUGE AND STAINLESS STEEL
D-1 GENERAL
D-2 CONSIDERATIONS FOR REDUCING ROUGE FORMATION
D-3 EVALUATION METHODS TO MEASURE ROUGE
D-4 METHODS TO REMEDIATE THE PRESENCE OF ROUGE IN A SYSTEM <\/td>\n<\/tr>\n
295<\/td>\nTable D-2-1 Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System <\/td>\n<\/tr>\n
296<\/td>\nTable D-2-2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System <\/td>\n<\/tr>\n
297<\/td>\nTable D-3.1-1 Process Fluid Analyses for the Identification of Mobile Constituents of Rouge <\/td>\n<\/tr>\n
298<\/td>\nTable D-3.2-1 Solid Surface Analyses for the Identification of Surface Layers Composition <\/td>\n<\/tr>\n
299<\/td>\nTable D-4.1-1 Rouge Remediation Processes Summary <\/td>\n<\/tr>\n
301<\/td>\nNONMANDATORY APPENDIX E PASSIVATION PROCEDURE QUALIFICATION
E-1 GENERAL
E-2 PURPOSE OF PASSIVATION TREATMENTS <\/td>\n<\/tr>\n
302<\/td>\nTable E-3.2-1 Minimum Surface Requirements for Process Qualification Samples
E-3 PASSIVATION PROCEDURE (SEE SF-2.6)
E-4 PASSIVATION QUALITY CONTROL <\/td>\n<\/tr>\n
303<\/td>\nTable E-3.2-2 Passivation Processes <\/td>\n<\/tr>\n
304<\/td>\nE-5 EVALUATION OF CLEANED AND PASSIVATED SURFACES <\/td>\n<\/tr>\n
305<\/td>\nTable E-5-1 Test Matrix for Evaluation of Cleaned and\/or Passivated Surfaces <\/td>\n<\/tr>\n
309<\/td>\nNONMANDATORY APPENDIX F CORROSION TESTING
F-1 GENERAL
F-2 CORROSION TESTS
F-3 PITTING RESISTANCE EQUIVALENT (PRE) NUMBER <\/td>\n<\/tr>\n
310<\/td>\nTable F-1-1 ASTM Corrosion Tests <\/td>\n<\/tr>\n
311<\/td>\nTable F-3-1 PRE Numbers for Some Alloys <\/td>\n<\/tr>\n
312<\/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
313<\/td>\nNONMANDATORY APPENDIX H ELECTROPOLISHING PROCEDURE QUALIFICATION
H-1 SCOPE
H-2 PURPOSE
H-3 ELECTROPOLISH PROCEDURE QUALIFICATION <\/td>\n<\/tr>\n
314<\/td>\nTable H-3.3-1 Minimum Surface Requirements for Process Qualification Samples <\/td>\n<\/tr>\n
315<\/td>\nNONMANDATORY APPENDIX J VENDOR DOCUMENTATION REQUIREMENTS FOR NEW INSTRUMENTS
J-1 OVERVIEW
J-2 INSTRUCTIONS FOR USE <\/td>\n<\/tr>\n
316<\/td>\nTable J-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions <\/td>\n<\/tr>\n
317<\/td>\nTable J-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents <\/td>\n<\/tr>\n
318<\/td>\nNONMANDATORY APPENDIX K STANDARD PROCESS TEST CONDITIONS (SPTC) FOR SEAL PERFORMANCE EVALUATION
K-1 SEALING COMPONENT PERFORMANCE EVALUATION <\/td>\n<\/tr>\n
320<\/td>\nK-2 MECHANICAL SEAL PERFORMANCE EVALUATION <\/td>\n<\/tr>\n
321<\/td>\nFigure K-1.3.2.1-1 Weir-Style Diaphragm <\/td>\n<\/tr>\n
324<\/td>\nFigure K-1.3.2.1-2 Weir-Style Body
Figure K-1.3.2.1-3 Radial-Style Body
Figure K-1.3.2.1-4 Manual Bonnet
Figure K-1.3.2.1-5 Pneumatic <\/td>\n<\/tr>\n
328<\/td>\nNONMANDATORY APPENDIX L STANDARD TEST METHODS FOR POLYMERS
L-1 STANDARD TEST METHODS FOR THERMOPLASTIC POLYMERS
L-2 STANDARD TEST METHODS FOR THERMOSET POLYMERS
L-3 THERMOSET POLYMER TEST PROPERTIES
L-4 INTERPRETATION OF THERMOSET MATERIAL PROPERTY CHANGES
L-5 TESTING PROTOCOLS FOR THERMOSET POLYMERS <\/td>\n<\/tr>\n
329<\/td>\nTable L-3-1 Thermoset Polymer Test Properties <\/td>\n<\/tr>\n
330<\/td>\nTable L-4-1 Interpretation of Thermoset Material Property Changes <\/td>\n<\/tr>\n
331<\/td>\nNONMANDATORY APPENDIX M SPRAY DEVICE COVERAGE TESTING
M-1 SCOPE
M-2 PURPOSE
M-3 MATERIALS
M-4 PROCEDURE
M-4.2 Application of Fluorescent Solution <\/td>\n<\/tr>\n
332<\/td>\nM-4.3 Execute Rinse
M-4.4 Inspection
M-5 ACCEPTANCE CRITERIA
M-6 RECOMMENDED DOCUMENTATION <\/td>\n<\/tr>\n
333<\/td>\nNONMANDATORY APPENDIX N COMMENTARY: UNS S31603 WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA <\/td>\n<\/tr>\n
334<\/td>\nNONMANDATORY APPENDIX O GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS
O-1 GENERAL
O-2 PARTICULATES <\/td>\n<\/tr>\n
335<\/td>\nNONMANDATORY APPENDIX P GENERAL BACKGROUND\/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES
P-1 REFERENCES <\/td>\n<\/tr>\n
336<\/td>\nP-2 RECOMMENDED CONDITIONS FOR A POLYMERIC MATERIAL-SPECIFIC EXTRACTION
P-3 RECOMMENDED CONDITIONS FOR AN EXTRACTION STUDY IN BIOPROCESS MODEL SOLUTIONS
P-4 OVERVIEW OF BIOPROCESSING EQUIPMENT\/COMPONENT EVALUATION RELATED TO EXTRACTABLES AND LEACHABLES CHARACTERIZATION <\/td>\n<\/tr>\n
337<\/td>\nFigure P-4-1 Flowchart of Bioprocessing Equipment\/Component Evaluation Related to Extractables and Leachables Characterization <\/td>\n<\/tr>\n
338<\/td>\nNONMANDATORY APPENDIX Q TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS
Q-1 GENERAL
Q-2 EXTERNAL SUPPORT COMPONENTS
Q-3 MEASUREMENT ACCURACY <\/td>\n<\/tr>\n
339<\/td>\nQ-4 SELECTION
Q-5 MAINTENANCE <\/td>\n<\/tr>\n
340<\/td>\nNONMANDATORY APPENDIX R INSTRUMENT RECEIVING, HANDLING, AND STORAGE
R-1 INTRODUCTION
R-2 INSTRUMENT RECEIVING
R-3 INSTRUMENT HANDLING
R-4 STORAGE <\/td>\n<\/tr>\n
341<\/td>\nNONMANDATORY APPENDIX S APPLICATION DATA SHEET <\/td>\n<\/tr>\n
342<\/td>\nForm S-1 Application Data Sheet <\/td>\n<\/tr>\n
343<\/td>\nNONMANDATORY APPENDIX T GUIDANCE ON POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS AND FILTRATION
T-1 CHROMATOGRAPHY COLUMNS
T-2 FILTRATION <\/td>\n<\/tr>\n
346<\/td>\nNONMANDATORY APPENDIX U GUIDANCE FOR THE USE OF U.S. CUSTOMARY AND SI UNITS
U-2 GUIDELINES USED TO DEVELOP SI EQUIVALENTS <\/td>\n<\/tr>\n
347<\/td>\nU-3 CHECKING EQUATIONS
U-4 SOFT CONVERSION FACTORS <\/td>\n<\/tr>\n
348<\/td>\nNONMANDATORY APPENDIX W POSITIVE MATERIAL IDENTIFICATION
W-1 GENERAL
W-2 GENERAL REQUIREMENTS <\/td>\n<\/tr>\n
349<\/td>\nW-3 CALIBRATION
W-4 PROCEDURE
W-5 PERSONNEL TRAINING AND QUALIFICATION
W-6 ACCEPTANCE\/REJECTION
W-7 PMI REFEREE METHODS
W-8 PMI SPECIAL CONDITIONS <\/td>\n<\/tr>\n
351<\/td>\nNONMANDATORY APPENDIX Y PROCUREMENT SOURCES <\/td>\n<\/tr>\n
352<\/td>\nNONMANDATORY APPENDIX Z QUALITY MANAGEMENT SYSTEM
Z-1 SCOPE AND PURPOSE
Z-2 GENERAL
Z-3 QUALITY MANAGEMENT SYSTEM MANUAL <\/td>\n<\/tr>\n
356<\/td>\nNONMANDATORY APPENDIX AA STATIC SEALS APPLICATION GUIDE FOR COMPENDIAL WATER SYSTEMS
AA-1 GENERAL
AA-2 MATERIAL CLASS DESCRIPTIONS1Reference ASTM D1418, Standard Practice for Rubber and Rubber Latices \u2014 Nomenclature. <\/td>\n<\/tr>\n
357<\/td>\nTable AA-1-1 Static Seals for Use in Compendial Water Systems (SG-2.2.1) <\/td>\n<\/tr>\n
359<\/td>\nFigure BB-1-1 Mechanical Seal Face Material Selection for Compendial Water Pumps
NONMANDATORY APPENDIX BB MECHANICAL SEAL FACE MATERIAL SELECTION FOR COMPENDIAL WATER PUMPS
BB-1 GENERAL <\/td>\n<\/tr>\n
361<\/td>\nNONMANDATORY APPENDIX CC EXAMINATION, INSPECTION, AND CROSS REFERENCES <\/td>\n<\/tr>\n
364<\/td>\nNONMANDATORY APPENDIX DD CONDUCTIVITY SENSOR SELECTION GUIDE
DD-1 PURPOSE
DD-2 GENERAL CONSIDERATIONS OF COMMON SENSE TECHNOLOGIES <\/td>\n<\/tr>\n
365<\/td>\nFigure DD-2.1.1-1 Conductivity Scale
Table DD-2.6-1 Technological Considerations <\/td>\n<\/tr>\n
366<\/td>\nINDEX \u00a0 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ASME BPE-2019: 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>\n2019<\/td>\n381<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":194345,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2643],"product_tag":[],"class_list":{"0":"post-194343","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\/194343","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\/194345"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=194343"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=194343"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=194343"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}