{"id":439753,"date":"2024-10-20T08:10:55","date_gmt":"2024-10-20T08:10:55","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/asme-bpe-2022-w-errata\/"},"modified":"2024-10-26T15:18:53","modified_gmt":"2024-10-26T15:18:53","slug":"asme-bpe-2022-w-errata","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/asme\/asme-bpe-2022-w-errata\/","title":{"rendered":"ASME BPE 2022 w ERRATA"},"content":{"rendered":"

The ASME Bioprocessing Equipment (BPE) Standard was developed to aid in the design and construction of new fluid processing equipment used in the manufacture of biopharmaceuticals, where a defined level of purity and bioburden control is required.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
5<\/td>\nCONTENTS <\/td>\n<\/tr>\n
15<\/td>\nFOREWORD <\/td>\n<\/tr>\n
17<\/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
18<\/td>\nASME BIOPROCESSING EQUIPMENT COMMITTEE <\/td>\n<\/tr>\n
23<\/td>\nCORRESPONDENCE WITH THE BPE COMMITTEE <\/td>\n<\/tr>\n
25<\/td>\nASME BPE-2022 SUMMARY OF CHANGES <\/td>\n<\/tr>\n
37<\/td>\nCHAPTER 1 INTRODUCTION, SCOPE, AND GENERAL REQUIREMENTS
PART GR GENERAL REQUIREMENTS
GR-1 INTRODUCTION
GR-2 SCOPE OF THE ASME BPE STANDARD <\/td>\n<\/tr>\n
38<\/td>\nGR-3 MANUFACTURER\u2019S QUALITY ASSURANCE PROGRAM
GR-4 EXAMINATION, INSPECTION, AND TESTING
GR-4.1 Inspector\/Examiner
GR-4.2 Quality Inspector\u2019s Delegate <\/td>\n<\/tr>\n
39<\/td>\nTables
Table GR-4.2-1 Quality Inspector\u2019s Delegate Capabilities <\/td>\n<\/tr>\n
42<\/td>\nGR-4.3 Responsibilities
GR-4.4 Access for Inspectors
GR-5 DOCUMENTATION
GR-5.1 General
GR-5.2 Document Requirements <\/td>\n<\/tr>\n
43<\/td>\nGR-5.3 Material Test Reports\/Certificates of Conformance <\/td>\n<\/tr>\n
44<\/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
46<\/td>\nGR-8 TERMS AND DEFINITIONS <\/td>\n<\/tr>\n
55<\/td>\nGR-9 NOMENCLATURE <\/td>\n<\/tr>\n
56<\/td>\nCHAPTER 2 CERTIFICATION
PART CR CERTIFICATION REQUIREMENTS
CR-1 PURPOSE AND SCOPE
CR-2 GENERAL
Figures
Figure CR-1-1 The ASME Single Certification Mark With the BPE Certification Designator
Table CR-1-1 Types of ASME BPE Certificates <\/td>\n<\/tr>\n
57<\/td>\nCR-2.1 ASME BPE Certificate Holders
CR-2.2 ASME BPE Certificate Holder\u2019s Responsibilities
CR-2.3 Certified Individual Requirements Under a Certificate of Authorization <\/td>\n<\/tr>\n
59<\/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 <\/td>\n<\/tr>\n
60<\/td>\nTable MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
61<\/td>\nTable MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
62<\/td>\nTable MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations <\/td>\n<\/tr>\n
63<\/td>\nMM-3.5 Reclaimed Materials
MM-3.6 Designation of Alloy and Fluid Services
MM-4 REFERENCED SPECIFICATIONS
MM-4.1 General
MM-4.2 Tubing, Piping, and Hollow Bar
Table MM-2.1-4 Wrought Copper: Nominal Compositions (wt. %) (Cleaned for Oxygen Service) <\/td>\n<\/tr>\n
64<\/td>\nMM-4.3 Castings
MM-4.4 Forgings
MM-4.5 Plate, Sheet, and Strip
MM-4.6 Shapes, Rods, and Bars <\/td>\n<\/tr>\n
65<\/td>\nMM-4.7 Copper Alloy Fittings
MM-5 BASE METALS AND FILLER MATERIALS
MM-5.1 General
MM-5.2 Base Metals
Table MM-5.2.1.1-1 Predicted Ferrite Number (FN) Ranges for Various Austenitic Stainless Steel Product Forms and Welds <\/td>\n<\/tr>\n
66<\/td>\nMM-5.3 Filler Materials
Table MM-5.2.5-1 Materials for OEM Equipment <\/td>\n<\/tr>\n
67<\/td>\nTable MM-5.3-1 Filler Metals for Austenitic Stainless Steels <\/td>\n<\/tr>\n
69<\/td>\nTable MM-5.3-2 Filler Metals for Superaustenitic Stainless Steels <\/td>\n<\/tr>\n
70<\/td>\nTable MM-5.3-3 Filler Metals for Duplex Stainless Steels <\/td>\n<\/tr>\n
71<\/td>\nTable MM-5.3-4 Filler Metals for Nickel Alloys <\/td>\n<\/tr>\n
72<\/td>\nTable MM-5.3-5 Consumable Inserts for Superaustenitic and Duplex Stainless Steels <\/td>\n<\/tr>\n
73<\/td>\nMM-5.4 Heat Treatment
MM-6 MECHANICAL PROPERTIES AND LEAK TESTING
MM-6.1 Tubing\/Piping
MM-6.2 Fittings and Valves
MM-6.3 Toughness
MM-6.4 Testing
MM-7 POSITIVE MATERIAL IDENTIFICATION
MM-8 CORROSION-RESISTANCE REQUIREMENTS
MM-8.1 General <\/td>\n<\/tr>\n
74<\/td>\nTable MM-5.3.4-1 Brazing Filler Metals for Copper <\/td>\n<\/tr>\n
75<\/td>\nMM-8.2 Corrosion Testing
MM-9 MINIMUM REQUIREMENTS FOR ALLOYS IN PART MM
MM-9.1 General
Table MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic and Duplex Stainless Steels <\/td>\n<\/tr>\n
77<\/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
78<\/td>\nTable 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
79<\/td>\nPM-2.2 General Requirements
Table PM-2.1.3-1 Examples of Nonmetallics <\/td>\n<\/tr>\n
80<\/td>\nTable PM-2.2.1-1 Content Required on the Certificate of Conformance <\/td>\n<\/tr>\n
81<\/td>\nTable PM-2.2.3.2-1 Change Levels and Minimum Change Notification Requirements <\/td>\n<\/tr>\n
82<\/td>\nPM-3 PROPERTIES AND PERFORMANCE
PM-3.1 Biocompatibility
PM-3.2 Extractables and Leachables <\/td>\n<\/tr>\n
83<\/td>\nPM-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
PM-3.8 Chemical Compatibility of Nonmetallic Materials <\/td>\n<\/tr>\n
84<\/td>\nPM-3.9 Polymeric Surface Finish
PM-4 APPLICATIONS
PM-4.1 Single-Use Components and Assemblies
PM-4.2 Piping <\/td>\n<\/tr>\n
85<\/td>\nTable PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards <\/td>\n<\/tr>\n
86<\/td>\nPM-4.3 Hose Assemblies <\/td>\n<\/tr>\n
87<\/td>\nPM-4.4 Polymeric Hygienic Unions <\/td>\n<\/tr>\n
88<\/td>\nCHAPTER 4 DESIGN FOR MULTIUSE
PART SD SYSTEMS DESIGN FOR MULTIUSE
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
89<\/td>\nSD-2.4 Fabrication <\/td>\n<\/tr>\n
91<\/td>\nTable SD-2.4.3.1-1 Slope Designations for Drainable Lines <\/td>\n<\/tr>\n
92<\/td>\nSD-2.5 Hygienic System Design
SD-2.6 Animal-Derived Ingredients
SD-3 PROCESS COMPONENTS AND EQUIPMENT
SD-3.1 Connections, Fittings, and Piping <\/td>\n<\/tr>\n
93<\/td>\nFigure SD-3.1.1-1 Flat Gasket Applications <\/td>\n<\/tr>\n
94<\/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
95<\/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
97<\/td>\nFigure SD-3.1.2.2-1 Accepted Point-of-Use Designs <\/td>\n<\/tr>\n
98<\/td>\nFigure SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly <\/td>\n<\/tr>\n
99<\/td>\nSD-3.2 Hose Assemblies <\/td>\n<\/tr>\n
100<\/td>\nSD-3.3 Pumps
Figure SD-3.2.1-1 Flexible Hygienic Hose Design <\/td>\n<\/tr>\n
101<\/td>\nFigure SD-3.3.2.2-1 Pump Impeller Configurations <\/td>\n<\/tr>\n
102<\/td>\nFigure SD-3.3.2.2-2 Acceptable Impeller Attachments <\/td>\n<\/tr>\n
103<\/td>\nFigure SD-3.3.2.2-3 Casing Drain Configurations <\/td>\n<\/tr>\n
104<\/td>\nFigure SD-3.3.2.2-4 Casing Drain L\/d Ratios <\/td>\n<\/tr>\n
105<\/td>\nSD-3.4 Vessels
Figure SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment <\/td>\n<\/tr>\n
106<\/td>\nFigure SD-3.4.2-1 Nozzle Design <\/td>\n<\/tr>\n
107<\/td>\nFigure SD-3.4.2-2 Side and Bottom Connections <\/td>\n<\/tr>\n
108<\/td>\nFigure SD-3.4.2-3 Sidewall Nozzles <\/td>\n<\/tr>\n
109<\/td>\nFigure SD-3.4.2-4 Vessel Design Tangential Nozzles
Figure SD-3.4.2-5 Typical Nozzle Detail <\/td>\n<\/tr>\n
110<\/td>\nTable SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes <\/td>\n<\/tr>\n
111<\/td>\nFigure SD-3.4.3-1 Accepted Nozzle Penetrations <\/td>\n<\/tr>\n
112<\/td>\nFigure SD-3.4.3-2 Internal Components <\/td>\n<\/tr>\n
113<\/td>\nFigure SD-3.4.6-1 Sight Glass Design (Accepted) <\/td>\n<\/tr>\n
114<\/td>\nSD-3.5 Agitators and Mixers <\/td>\n<\/tr>\n
115<\/td>\nFigure SD-3.5.1-1 Agitator Mounting Flanges <\/td>\n<\/tr>\n
116<\/td>\nFigure SD-3.5.2-1 Shaft Coupling Construction <\/td>\n<\/tr>\n
117<\/td>\nFigure SD-3.5.2-2 Shaft Coupling Seal Arrangements <\/td>\n<\/tr>\n
119<\/td>\nFigure SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs <\/td>\n<\/tr>\n
120<\/td>\nFigure SD-3.5.5-1 Shaft-Steady Bearing <\/td>\n<\/tr>\n
121<\/td>\nSD-3.6 Heat Exchange Equipment
Figure SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) <\/td>\n<\/tr>\n
122<\/td>\nFigure SD-3.6.2-1 Double Tubesheet Heat Exchanger Bonnet Design <\/td>\n<\/tr>\n
123<\/td>\nSD-3.7 Transfer Panels <\/td>\n<\/tr>\n
124<\/td>\nFigure SD-3.7.1-1 Transfer Panel Looped Headers <\/td>\n<\/tr>\n
125<\/td>\nFigure SD-3.7.2-1 Transfer Panel Tolerances <\/td>\n<\/tr>\n
126<\/td>\nSD-3.8 Filtration Elements and Components <\/td>\n<\/tr>\n
127<\/td>\nFigure SD-3.7.4-1 Transfer Panel Jumpers <\/td>\n<\/tr>\n
129<\/td>\nSD-3.9 Spray Devices <\/td>\n<\/tr>\n
130<\/td>\nFigure SD-3.9.1-1 Dynamic Spray Device: Single Axis <\/td>\n<\/tr>\n
131<\/td>\nFigure SD-3.9.1-2 Two-Axis Dynamic Spray Device <\/td>\n<\/tr>\n
132<\/td>\nFigure SD-3.9.2.1-1 Static Spray Device
Figure SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels <\/td>\n<\/tr>\n
133<\/td>\nSD-3.10 Disposables That Require Presterilization or Poststerilization
SD-3.11 Sampling Systems
Figure SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels <\/td>\n<\/tr>\n
134<\/td>\nSD-3.12 Steam Traps
SD-3.13 Check Valves
Figure SD-3.9.2.3-1 Impact Pattern Buildup <\/td>\n<\/tr>\n
135<\/td>\nSD-3.14 Orifice Plates
SD-3.15 Relief Devices
SD-3.16 Liquid Pressure Regulators
Figure SD-3.12-1 Steam Traps for Clean Steam Systems <\/td>\n<\/tr>\n
136<\/td>\nSD-3.17 Strainers
Figure SD-3.17.1-1 Example Strainer Types <\/td>\n<\/tr>\n
137<\/td>\nSD-3.18 Chromatography Columns <\/td>\n<\/tr>\n
138<\/td>\nSD-4 PROCESS UTILITY SYSTEMS
SD-4.1 Compendial Water Systems
SD-4.2 Clean\/Pure Steam Systems <\/td>\n<\/tr>\n
139<\/td>\nFigure SD-4.1.2.1-1 Point-of-Use Piping <\/td>\n<\/tr>\n
140<\/td>\nSD-4.3 Process Gases
Figure SD-4.1.2.2-1 Physical Break in Point-of-Use Piping <\/td>\n<\/tr>\n
141<\/td>\nFigure SD-4.2.2-1 Typical Clean Steam System Isometric <\/td>\n<\/tr>\n
142<\/td>\nSD-4.4 Process Waste Systems
Figure SD-4.2.2-2 Clean Steam Point-of-Use Design <\/td>\n<\/tr>\n
143<\/td>\nSD-5 PROCESS SYSTEMS
SD-5.1 Bioreactors and Fermentors <\/td>\n<\/tr>\n
144<\/td>\nFigure SD-5.1.4.4-1 Gas Sparging Assembly \u2014 Lance <\/td>\n<\/tr>\n
145<\/td>\nFigure SD-5.1.4.4-2 Gas Sparging Assembly \u2014 Sintered <\/td>\n<\/tr>\n
146<\/td>\nFigure SD-5.1.4.4-3 Gas Sparging Assembly \u2014 Ring <\/td>\n<\/tr>\n
147<\/td>\nFigure SD-5.1.4.4-4 Gas Sparging Assembly \u2014 Single Orifice <\/td>\n<\/tr>\n
149<\/td>\nFigure SD-5.1.4.7-1 Exhaust Gas Condenser
Figure SD-5.1.4.7-2 Exhaust Gas Heater <\/td>\n<\/tr>\n
150<\/td>\nFigure SD-5.1.4.7-3 Electrically Heat Traced Filter Housing <\/td>\n<\/tr>\n
151<\/td>\nFigure SD-5.1.5-1 Fermentor Sterile Envelope <\/td>\n<\/tr>\n
152<\/td>\nFigure SD-5.1.5-2 Bioreactor Sterile Envelope <\/td>\n<\/tr>\n
153<\/td>\nSD-5.2 Cell Disruptors <\/td>\n<\/tr>\n
154<\/td>\nFigure SD-5.2.1-1 Cell Disruptor Process Flow Schematic Diagram <\/td>\n<\/tr>\n
155<\/td>\nSD-5.3 Centrifuges <\/td>\n<\/tr>\n
157<\/td>\nSD-5.4 Filtration <\/td>\n<\/tr>\n
159<\/td>\nSD-5.5 Chromatography Systems
Figure SD-5.4.5.1-1 Tank\/Vessel Vent Fillers <\/td>\n<\/tr>\n
160<\/td>\nSD-5.6 Lyophilizers\/Freeze Dryers <\/td>\n<\/tr>\n
161<\/td>\nFigure SD-5.6.4-1 Typical Lyophilizer Component Assembly <\/td>\n<\/tr>\n
165<\/td>\nFigure SD-5.6.5-1 Lyophilizer Sterile Boundary <\/td>\n<\/tr>\n
166<\/td>\nSD-5.7 Solution Preparation Systems <\/td>\n<\/tr>\n
167<\/td>\nSD-6 PROCESS SUPPORT SYSTEMS
SD-6.1 Cabinet Washers <\/td>\n<\/tr>\n
170<\/td>\nSD-6.2 Steam Sterilizers\/Autoclaves <\/td>\n<\/tr>\n
171<\/td>\nSD-6.3 CIP Systems <\/td>\n<\/tr>\n
173<\/td>\nFigure SD-6.3.4.1.1-1 Conical Vessel With Reduced Bottom Outlet, or Tulip Tank <\/td>\n<\/tr>\n
174<\/td>\nFigure SD-6.3.4.2-1 CIP Looped Header (Supply or Return) <\/td>\n<\/tr>\n
175<\/td>\nFigure SD-6.3.4.2-2 Zero-Static Chain
Figure SD-6.3.4.2-3 Swing Elbow Arrangement <\/td>\n<\/tr>\n
176<\/td>\nFigure SD-6.3.4.2-4 Mix-Proof Valve Array <\/td>\n<\/tr>\n
177<\/td>\nTable SD-6.3.5.2.1-1 Flow Rates to Achieve 5 ft\/sec (1.5 m\/s) <\/td>\n<\/tr>\n
178<\/td>\nSD-6.4 Thermal Treatment Systems <\/td>\n<\/tr>\n
179<\/td>\nFigure SD-6.4.1.1-1 Example of HTST Process Flow Schematic Diagram <\/td>\n<\/tr>\n
180<\/td>\nFigure SD-6.4.1.1-2 Example of Direct Steam Injection UHT Process Flow Schematic Diagram <\/td>\n<\/tr>\n
182<\/td>\nFigure SD-6.4.4.5-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing <\/td>\n<\/tr>\n
183<\/td>\nSD-6.5 Immersion Washers <\/td>\n<\/tr>\n
185<\/td>\nFigure SD-6.5.4.2-1 Immersion Tank Side Nozzle Design <\/td>\n<\/tr>\n
186<\/td>\nSD-6.6 Isolator Systems <\/td>\n<\/tr>\n
190<\/td>\nSD-7 DESIGN CONFORMANCE TESTING
SD-7.1 Spray Device Coverage Test <\/td>\n<\/tr>\n
191<\/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
192<\/td>\nCHAPTER 5 PROCESS COMPONENTS FOR MULTIUSE
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
193<\/td>\nDT-4.3 Special Angle Fittings Dimensions
DT-4.4 Valve Dimensions
DT-4.5 Filter Dimensions
DT-4.6 Tube Dimensions
DT-5 MATERIALS
DT-6 TESTS
DT-7 TOLERANCES
DT-7.1 Fitting and Process Component Tolerances
DT-7.2 Tubing Tolerances
DT-7.3 Transfer Panel Nozzle and Jumper Tolerances
DT-8 WELD ENDS
DT-9 HYGIENIC CLAMP UNIONS
DT-9.1 Typical Hygienic Clamp Unions <\/td>\n<\/tr>\n
194<\/td>\nDT-9.2 Hygienic Gaskets
DT-9.3 Connections
DT-9.4 Hygienic Clamps
DT-10 MINIMUM EXAMINATION REQUIREMENTS
DT-10.1 Visual Inspection
DT-10.2 Documentation Verification
DT-10.3 Physical Examination <\/td>\n<\/tr>\n
195<\/td>\nDT-11 MARKING
DT-11.1 Fittings, Valves, and Instrumentation Marking Information
DT-11.2 Modified Surfaces
DT-12 PACKAGING
Table DT-2-1 Metallic Fittings: Rated Internal Working Pressure <\/td>\n<\/tr>\n
196<\/td>\nTable DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components, Excluding Tube <\/td>\n<\/tr>\n
197<\/td>\nTable DT-3-2 Final Tolerances for Electropolished Fittings and Process Components, Excluding Tube
Table DT-4-1 Nominal O.D. Tubing Sizes <\/td>\n<\/tr>\n
198<\/td>\nTable DT-4.1-1 Tangent Lengths
Table DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow <\/td>\n<\/tr>\n
199<\/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
200<\/td>\nTable DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow
Table DT-4.1.1-5 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow <\/td>\n<\/tr>\n
201<\/td>\nTable DT-4.1.1-6 Hygienic Clamp Joint: 45-deg Elbow
Table DT-4.1.1-7 Automatic Tube Weld: 180-deg Return Bend <\/td>\n<\/tr>\n
202<\/td>\nTable DT-4.1.1-8 Hygienic Clamp Joint: 180-deg Return Bend
Table DT-4.1.1-9 Automatic Tube Weld: 88-deg Elbow <\/td>\n<\/tr>\n
203<\/td>\nTable DT-4.1.1-1 Automatic Tube Weld: 92-deg Elbow
Table DT-4.1.2-1 Automatic Tube Weld: Straight Tee and Cross <\/td>\n<\/tr>\n
204<\/td>\nTable DT-4.1.2-2 Automatic Tube Weld:Short-Outlet Hygienic Clamp Joint Tee
Table DT-4.1.2-3 Hygienic Mechanical Joint: Short-Outlet Run Tee <\/td>\n<\/tr>\n
205<\/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
206<\/td>\nTable DT-4.1.2-6 Automatic Tube Weld: Reducing Tee <\/td>\n<\/tr>\n
207<\/td>\nTable DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee <\/td>\n<\/tr>\n
208<\/td>\nTable DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee <\/td>\n<\/tr>\n
209<\/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
210<\/td>\nTable DT-4.1.2-11 Hygienic Clamp Joint: Instrument Tee
Table DT-4.1.2-12 Automatic Tube Weld: Standard Outlet Hygienic Clamp Joint Tee <\/td>\n<\/tr>\n
211<\/td>\nTable DT-4.1.2-13 Automatic Tube Weld: Standard Outlet Hygienic Clamp Joint Reducing Tee <\/td>\n<\/tr>\n
212<\/td>\nTable DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
213<\/td>\nTable DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
214<\/td>\nTable DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
215<\/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
216<\/td>\nTable DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap <\/td>\n<\/tr>\n
217<\/td>\nTable DT-4.4.1-1 Hygienic Clamp Joint: Two-Way, Weir-Style Diaphragm Valve <\/td>\n<\/tr>\n
218<\/td>\nTable DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed <\/td>\n<\/tr>\n
219<\/td>\nTable DT-4.5.2-1 Tapered Locking Tab Retainer: External <\/td>\n<\/tr>\n
220<\/td>\nTable DT-7.1-1 Metallic Hygienic Clamp Ferrule Standard Dimensions and Tolerances <\/td>\n<\/tr>\n
223<\/td>\nTable DT-7.1-2 Polymeric Hygienic Clamp Ferrule Standard Dimensions and Tolerances <\/td>\n<\/tr>\n
226<\/td>\nTable DT-7.3-1 Transfer Panel and Jumper Tolerances <\/td>\n<\/tr>\n
227<\/td>\nTable DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria <\/td>\n<\/tr>\n
228<\/td>\nFigure DT-9.4-1 Clamp Conditions at Installation <\/td>\n<\/tr>\n
229<\/td>\nTable DT-11.1.1-1 Minimum Required Marking Information <\/td>\n<\/tr>\n
230<\/td>\nPART PI PROCESS INSTRUMENTATION FOR MULTIUSE
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
231<\/td>\nFigure PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples <\/td>\n<\/tr>\n
232<\/td>\nFigure PI-2.2.2-1 Accepted Insertion Device Installation Examples <\/td>\n<\/tr>\n
233<\/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 <\/td>\n<\/tr>\n
234<\/td>\nFigure PI-4.1.3.2-1 Manifold or Flow Splitter for Dual-Tube Construction Flowmeters and Potential for Product Holdup
Figure PI-4.1.3.3-1 Concentrically Reducing Process Connection <\/td>\n<\/tr>\n
236<\/td>\nPI-4.2 Turbine Flowmeter
Figure PI-4.1.4.3-1 Vertical Installation
Figure PI-4.1.4.4-1 Minimum Angle of Inclination, \u03b1 <\/td>\n<\/tr>\n
237<\/td>\nFigure PI-4.2.2-1 Typical Turbine Flowmeters <\/td>\n<\/tr>\n
238<\/td>\nPI-5 LEVEL INSTRUMENTS
PI-5.1 Radar Level Instruments <\/td>\n<\/tr>\n
239<\/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
240<\/td>\nFigure PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location <\/td>\n<\/tr>\n
241<\/td>\nFigure PI-6.1.2-1 Accepted Orientation and Flow <\/td>\n<\/tr>\n
242<\/td>\nPI-7 TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS
PI-7.1 General
PI-7.2 Components
PI-7.3 Installation
Figure PI-7.3-1 Typical Installation Styles <\/td>\n<\/tr>\n
243<\/td>\nFigure PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions <\/td>\n<\/tr>\n
244<\/td>\nFigure PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions <\/td>\n<\/tr>\n
245<\/td>\nFigure PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations <\/td>\n<\/tr>\n
246<\/td>\nFigure PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations <\/td>\n<\/tr>\n
247<\/td>\nPI-7.4 Performance
PI-7.5 Selection
PI-7.6 Sensor Calibration Verification
PI-8 ANALYTICAL INSTRUMENTS
PI-8.1 Conductivity <\/td>\n<\/tr>\n
248<\/td>\nFigure PI-8.1.2-1 Conductivity Sensor Components <\/td>\n<\/tr>\n
249<\/td>\nFigure PI-8.1.3.2-1 Acceptable Orientations for Conductivity Sensors
Figure PI-8.1.3.4-1 Installation Clearance Requirements <\/td>\n<\/tr>\n
250<\/td>\nPI-8.2 pH Sensors
Figure PI-8.2.2-1 pH Sensor Components <\/td>\n<\/tr>\n
251<\/td>\nPI-9 OPTICAL
PI-9.1 Optical Devices
Figure PI-8.2.3.3-1 Accepted Mounting Orientations <\/td>\n<\/tr>\n
253<\/td>\nFigure PI-9.1.3.2-1 Vessel Light Glass Design and Mounting <\/td>\n<\/tr>\n
254<\/td>\nFigure PI-9.1.3.4-1 In-Line Insertion Length
Figure PI-9.1.3.4-2 Insertion Probe Length <\/td>\n<\/tr>\n
255<\/td>\nPART MC COMPONENTS FOR MULTIUSE
MC-1 PURPOSE AND SCOPE
MC-2 SEALING COMPONENT TYPES
MC-2.1 General
MC-2.2 Static Seals <\/td>\n<\/tr>\n
256<\/td>\nFigure MC-2.2.2-1 Hygienic Union per Table DT-7.1-1
Figure MC-2.2.2-2 Hygienic Clamp Union per Table DT-7.1-1 <\/td>\n<\/tr>\n
257<\/td>\nFigure MC-2.2.2-3 Hygienic Union per DIN 11864
Figure MC-2.2.2-4 Hygienic Clamp Union per DIN 11864 <\/td>\n<\/tr>\n
258<\/td>\nFigure MC-2.2.2-5 Nonhygienic Connections <\/td>\n<\/tr>\n
259<\/td>\nMC-2.3 Dynamic Seals <\/td>\n<\/tr>\n
260<\/td>\nFigure MC-2.3.1.2-1 Weir Valves
Figure MC-2.3.1.2-2 Radial Valves <\/td>\n<\/tr>\n
261<\/td>\nFigure MC-2.3.1.2-3 Weirless Diaphragm Valve
Figure MC-2.3.1.2-4 Linear Control Valves <\/td>\n<\/tr>\n
262<\/td>\nFigure MC-2.3.1.2-5 Regulator Valve
Figure MC-2.3.1.3-1 Ball Valves <\/td>\n<\/tr>\n
263<\/td>\nFigure MC-2.3.1.4-1 Rising Stem Single, Double-Seat Mix-Proof, and Needle Valves
Figure MC-2.3.1.5-1 Butterfly Valve
Figure MC-2.3.1.7-1 Back Pressure Control Valve <\/td>\n<\/tr>\n
264<\/td>\nFigure MC-2.3.1.8-1 Pinch Valve <\/td>\n<\/tr>\n
265<\/td>\nFigure MC-2.3.1.9-1 Pressure Relief and Check Valves <\/td>\n<\/tr>\n
266<\/td>\nFigure MC-2.3.1.10-1 Plug Valve <\/td>\n<\/tr>\n
267<\/td>\nFigure MC-2.3.2.2-1 Single Mechanical Seal
Figure MC-2.3.2.2-2 Single Seal for Top-Entry Agitator
Figure MC-2.3.2.3-1 Dual Mechanical Seal\u2013Pressurized for Pumps
Figure MC-2.3.2.3-2 Dual Mechanical Seal\u2013Pressurized for Top-Entry Agitator <\/td>\n<\/tr>\n
268<\/td>\nFigure MC-2.3.2.3-3 Dual Mechanical Seal\u2013Unpressurized for Pumps <\/td>\n<\/tr>\n
269<\/td>\nFigure MC-2.3.2.4-1 Flush Plan 01
Figure MC-2.3.2.4-2 Flush Plan 02
Figure MC-2.3.2.4-3 Flush Plan 03 <\/td>\n<\/tr>\n
270<\/td>\nFigure MC-2.3.2.4-4 Flush Plan 11
Figure MC-2.3.2.4-5 Flush Plan 32
Figure MC-2.3.2.4-6 Flush Plan 52 for Pump <\/td>\n<\/tr>\n
271<\/td>\nFigure MC-2.3.2.4-7 Flush Plan 52 for Top-Entry Agitator
Figure MC-2.3.2.4-8 Flush Plan BPE52 for Pump
Figure MC-2.3.2.4-9 Flush Plan 53 for Pump
Figure MC-2.3.2.4-10 Flush Plan 53 for Top-Entry Agitator <\/td>\n<\/tr>\n
272<\/td>\nFigure MC-2.3.2.4-11 Flush Plan 54 for Pump
Figure MC-2.3.2.4-12 Flush Plan 54 for Top-Entry Agitator
Figure MC-2.3.2.4-13 Flush Plan 55 for Pump
Figure MC-2.3.2.4-14 Flush Plan 55 for Top-Entry Agitator <\/td>\n<\/tr>\n
273<\/td>\nMC-3 SEALING COMPONENTS GENERAL DESIGN REQUIREMENTS (GENERAL PROVISIONS)
MC-3.1 Process Conditions
MC-3.2 System Requirements
MC-3.3 Seal Construction
Figure MC-2.3.2.4-15 Flush Plan 74 for Pump
Figure MC-2.3.2.4-16 Flush Plan 74 for Top-Entry Agitator <\/td>\n<\/tr>\n
275<\/td>\nFigure MC-3.3.2.2-1 Examples of Static O-Ring Grooves <\/td>\n<\/tr>\n
277<\/td>\nFigure MC-3.3.2.3-1 Seals for Rising Stem Valves <\/td>\n<\/tr>\n
278<\/td>\nMC-3.4 Conformance Requirements for Sealing Elements <\/td>\n<\/tr>\n
279<\/td>\nMC-3.5 Seal Identification
MC-3.6 Other Seal Requirements
MC-4 SEAL PERFORMANCE REQUIREMENTS
MC-4.1 General Requirements
MC-4.2 Static Seal Performance <\/td>\n<\/tr>\n
280<\/td>\nMC-4.3 Dynamic Seal Performance
Figure MC-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion <\/td>\n<\/tr>\n
281<\/td>\nMC-5 SEAL APPLICATIONS
MC-5.1 General Considerations <\/td>\n<\/tr>\n
282<\/td>\nMC-5.2 Process Systems
MC-5.3 Compendial Ambient\/Hot-Water Distribution Systems
MC-5.4 Pure Steam Distribution Systems <\/td>\n<\/tr>\n
283<\/td>\nMC-5.5 CIP <\/td>\n<\/tr>\n
284<\/td>\nCHAPTER 6 FABRICATION, ASSEMBLY, AND ERECTION FOR MULTIUSE
PART MJ MATERIALS JOINING FOR MULTIUSE
MJ-1 PURPOSE AND SCOPE
MJ-2 MATERIALS
MJ-2.1 Base Metals
MJ-2.2 Filler Metals <\/td>\n<\/tr>\n
285<\/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 <\/td>\n<\/tr>\n
286<\/td>\nFigure MJ-3.2-1 Unacceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations <\/td>\n<\/tr>\n
287<\/td>\nFigure MJ-3.2-2 Acceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations <\/td>\n<\/tr>\n
288<\/td>\nMJ-3.6 Brazed Joints
MJ-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
289<\/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
290<\/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
291<\/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
292<\/td>\nTable MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks <\/td>\n<\/tr>\n
294<\/td>\nTable MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe <\/td>\n<\/tr>\n
296<\/td>\nTable MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints <\/td>\n<\/tr>\n
298<\/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
299<\/td>\nFigure MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Electropolished UNS S31603 Tubing <\/td>\n<\/tr>\n
300<\/td>\nFigure MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically Polished UNS S31603 Tubing <\/td>\n<\/tr>\n
301<\/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
302<\/td>\nTable MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds <\/td>\n<\/tr>\n
304<\/td>\nMJ-9.3 Joining Processes and Procedures
MJ-9.4 Procedure Qualifications
MJ-9.5 Performance Qualifications
Figure MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds <\/td>\n<\/tr>\n
305<\/td>\nMJ-9.6 Examination, Inspection, and Testing
MJ-9.7 Weld Acceptance Criteria
MJ-9.8 Documentation Requirements <\/td>\n<\/tr>\n
306<\/td>\nMJ-10 DOCUMENTATION REQUIREMENTS
MJ-11 PASSIVATION
Table MJ-9.7.1-1 Visual Examination Acceptance Criteria for Polymeric Pipe Beadless Welds <\/td>\n<\/tr>\n
307<\/td>\nFigure MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds <\/td>\n<\/tr>\n
308<\/td>\nPART SF PROCESS CONTACT SURFACE FINISHES FOR MULTIUSE
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 <\/td>\n<\/tr>\n
309<\/td>\nSF-2.4 Surface Condition
Table SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes
Table SF-2.2-2 Additional Acceptance Criteria for Electropolished Metallic Process Contact Surface Finishes <\/td>\n<\/tr>\n
310<\/td>\nSF-2.5 Electropolishing Procedure Qualification
SF-2.6 Passivation Procedure
SF-2.7 Normative References
SF-2.8 Rouge and Stainless Steel
Table SF-2.4.1-1 Ra Readings for Metallic Process Contact Surfaces <\/td>\n<\/tr>\n
311<\/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-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes <\/td>\n<\/tr>\n
312<\/td>\nTable 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
313<\/td>\nCHAPTER 7 DESIGN FOR SINGLE-USE
PART SU SYSTEMS DESIGN FOR SINGLE-USE
SU-1 GENERAL
SU-2 GENERAL GUIDELINES
SU-3 INTEGRITY
SU-3.1 Maintenance of Integrity
SU-3.2 Common Leak Test Methods
SU-4 BIOCOMPATIBILITY
SU-5 EXTRACTABLES AND LEACHABLES
SU-5.1 General <\/td>\n<\/tr>\n
314<\/td>\nSU-6 IDENTIFICATION
SU-6.1 Labeling
SU-7 CERTIFICATE OF CONFORMANCE
SU-8 INSPECTION AND PACKAGING
SU-8.1 Inspection
SU-8.2 Packaging
SU-9 STERILIZATION (BIOBURDEN CONTROL)
SU-9.1 Gamma Irradiation
SU-10 SHELF LIFE, STORAGE, AND EXPIRATION DATE <\/td>\n<\/tr>\n
315<\/td>\nSU-11 PARTICULATES
SU-11.1 General
SU-11.2 Particulate-Monitoring Program
SU-11.3 Mitigation Techniques <\/td>\n<\/tr>\n
316<\/td>\nCHAPTER 8 PROCESS COMPONENTS FOR SINGLE-USE
PART SC COMPONENTS FOR SINGLE-USE
SC-1 STEAM-THROUGH AND STEAM-TO CONNECTORS
SC-2 ASEPTIC CONNECTORS
SC-2.1 Manufacturer Responsibilities
SC-2.2 Owner\/User Responsibilities
SC-3 FLEXIBLE BIOPROCESS CONTAINERS (BAGS) <\/td>\n<\/tr>\n
317<\/td>\nSC-3.1 Materials
SC-3.2 Qualifications
SC-4 POLYMERIC HYGIENIC UNIONS <\/td>\n<\/tr>\n
318<\/td>\nCHAPTER 9 FABRICATION, ASSEMBLY, AND ERECTION FOR SINGLE-USE
PART SJ JOINING METHODS FOR SINGLE-USE
SJ-1 GENERAL
SJ-2 MECHANICAL HOSE BARB CONNECTIONS
SJ-2.1 Operating Conditions
SJ-2.2 Assembly
SJ-2.3 Qualification
SJ-3 THERMAL WELDING OF THERMOPLASTIC ELASTOMER TUBING
SJ-3.1 Specifications
SJ-3.2 Design Parameters <\/td>\n<\/tr>\n
319<\/td>\nSJ-3.3 Acceptance Criteria <\/td>\n<\/tr>\n
320<\/td>\nMANDATORY APPENDICES
MANDATORY APPENDIX I SUBMITTAL OF TECHNICAL INQUIRIES TO THE BIOPROCESSING EQUIPMENT (BPE) COMMITTEE <\/td>\n<\/tr>\n
321<\/td>\nTable II-1 Standard Units
MANDATORY APPENDIX II STANDARD UNITS <\/td>\n<\/tr>\n
322<\/td>\nMANDATORY APPENDIX III SINGLE-USE COMPONENTS AND ASSEMBLIES <\/td>\n<\/tr>\n
323<\/td>\nMANDATORY APPENDIX IV NOMENCLATURE <\/td>\n<\/tr>\n
325<\/td>\nNONMANDATORY APPENDICES
NONMANDATORY APPENDIX A COMMENTARY: SLAG AND OXIDE ISLANDS <\/td>\n<\/tr>\n
326<\/td>\nNONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION\/INSPECTION DOCUMENTATION <\/td>\n<\/tr>\n
327<\/td>\nForms
Form MEL-1 Material Examination Log <\/td>\n<\/tr>\n
328<\/td>\nForm MER-1 Material Examination Record <\/td>\n<\/tr>\n
329<\/td>\nForm WEL-1 Weld and Examination\/Inspection Log <\/td>\n<\/tr>\n
330<\/td>\nNONMANDATORY APPENDIX C SLOPE MEASUREMENT AND JOINT MISALIGNMENT
C-1 GENERAL
C-2 JOINT MISALIGNMENT <\/td>\n<\/tr>\n
331<\/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
333<\/td>\nTable D-2-1 Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System <\/td>\n<\/tr>\n
334<\/td>\nTable D-2-2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System <\/td>\n<\/tr>\n
335<\/td>\nTable D-3.1-1 Process Fluid Analyses for the Identification of Mobile Constituents of Rouge <\/td>\n<\/tr>\n
336<\/td>\nTable D-3.2-1 Solid Surface Analyses for the Identification of Surface Layers Composition <\/td>\n<\/tr>\n
337<\/td>\nTable D-4.1-1 Rouge Remediation Processes Summary <\/td>\n<\/tr>\n
339<\/td>\nNONMANDATORY APPENDIX E PASSIVATION PROCEDURE QUALIFICATION
E-1 GENERAL
E-2 PURPOSE OF PASSIVATION TREATMENTS <\/td>\n<\/tr>\n
340<\/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
341<\/td>\nTable E-3.2-2 Passivation Processes <\/td>\n<\/tr>\n
342<\/td>\nE-5 EVALUATION OF CLEANED AND PASSIVATED SURFACES <\/td>\n<\/tr>\n
343<\/td>\nTable E-5-1 Test Matrix for Evaluation of Cleaned and Passivated Surfaces <\/td>\n<\/tr>\n
347<\/td>\nNONMANDATORY APPENDIX F CORROSION TESTING
F-1 GENERAL
F-2 CORROSION TESTS
F-3 PITTING RESISTANCE EQUIVALENT (PRE) NUMBER <\/td>\n<\/tr>\n
348<\/td>\nTable F-1-1 ASTM Corrosion Tests <\/td>\n<\/tr>\n
349<\/td>\nTable F-3-1 PRE Numbers for Stainless Steels per Table MM-2.1-1 and for Nickel Alloys per Table MM-2.1-2 <\/td>\n<\/tr>\n
350<\/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
351<\/td>\nNONMANDATORY APPENDIX H ELECTROPOLISHING PROCEDURE QUALIFICATION
H-1 SCOPE
H-2 PURPOSE
H-3 ELECTROPOLISH PROCEDURE QUALIFICATION <\/td>\n<\/tr>\n
352<\/td>\nTable H-3.3-1 Minimum Surface Requirements for Process Qualification Samples <\/td>\n<\/tr>\n
353<\/td>\nNONMANDATORY APPENDIX J VENDOR DOCUMENTATION REQUIREMENTS FOR NEW INSTRUMENTS
J-1 OVERVIEW
J-2 INSTRUCTIONS FOR USE <\/td>\n<\/tr>\n
354<\/td>\nTable J-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions <\/td>\n<\/tr>\n
355<\/td>\nTable J-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents <\/td>\n<\/tr>\n
356<\/td>\nNONMANDATORY APPENDIX K STANDARD PROCESS TEST CONDITIONS (SPTC) FOR SEAL PERFORMANCE EVALUATION
K-1 SEALING COMPONENT PERFORMANCE EVALUATION <\/td>\n<\/tr>\n
358<\/td>\nFigure K-1.3.2.1-1 Weir-Style Diaphragm <\/td>\n<\/tr>\n
361<\/td>\nFigure K-1.3.2.1-2 Weir-Style Body
Figure K-1.3.2.1-3 Radial-Style Body <\/td>\n<\/tr>\n
362<\/td>\nFigure K-1.3.2.1-4 Manual Bonnet
Figure K-1.3.2.1-5 Pneumatic
K-2 MECHANICAL SEAL PERFORMANCE EVALUATION <\/td>\n<\/tr>\n
366<\/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
367<\/td>\nTable L-3-1 Thermoset Polymer Test Properties <\/td>\n<\/tr>\n
368<\/td>\nTable L-4-1 Interpretation of Thermoset Material Property Changes <\/td>\n<\/tr>\n
369<\/td>\nNONMANDATORY APPENDIX M SPRAY DEVICE COVERAGE TESTING
M-1 SCOPE
M-2 PURPOSE
M-3 MATERIALS
M-4 PROCEDURE <\/td>\n<\/tr>\n
370<\/td>\nM-5 ACCEPTANCE CRITERIA
M-6 RECOMMENDED DOCUMENTATION <\/td>\n<\/tr>\n
371<\/td>\nNONMANDATORY APPENDIX N COMMENTARY: UNS S31603 WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA <\/td>\n<\/tr>\n
372<\/td>\nNONMANDATORY APPENDIX O GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS
O-1 GENERAL
O-2 PARTICULATES <\/td>\n<\/tr>\n
373<\/td>\nNONMANDATORY APPENDIX P GENERAL BACKGROUND\/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES
P-1 REFERENCES <\/td>\n<\/tr>\n
374<\/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
375<\/td>\nFigure P-4-1 Flowchart of Bioprocessing Equipment\/Component Evaluation Related to Extractables and Leachables Characterization <\/td>\n<\/tr>\n
376<\/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
377<\/td>\nQ-4 SELECTION
Q-5 MAINTENANCE <\/td>\n<\/tr>\n
378<\/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
379<\/td>\nNONMANDATORY APPENDIX S APPLICATION DATA SHEET <\/td>\n<\/tr>\n
380<\/td>\nForm S-1 Application Data Sheet <\/td>\n<\/tr>\n
381<\/td>\nNONMANDATORY APPENDIX T GUIDANCE ON POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS AND FILTRATION
T-1 CHROMATOGRAPHY COLUMNS
T-2 FILTRATION <\/td>\n<\/tr>\n
384<\/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
385<\/td>\nU-3 CHECKING EQUATIONS
U-4 SOFT CONVERSION FACTORS <\/td>\n<\/tr>\n
386<\/td>\nNONMANDATORY APPENDIX W POSITIVE MATERIAL IDENTIFICATION
W-1 GENERAL
W-2 GENERAL REQUIREMENTS <\/td>\n<\/tr>\n
387<\/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
389<\/td>\nNONMANDATORY APPENDIX Y PROCUREMENT SOURCES <\/td>\n<\/tr>\n
390<\/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
394<\/td>\nNONMANDATORY APPENDIX AA STATIC SEALS APPLICATION GUIDE FOR COMPENDIAL WATER SYSTEMS
AA-1 GENERAL
AA-2 MATERIAL CLASS DESCRIPTIONS <\/td>\n<\/tr>\n
395<\/td>\nTable AA-1-1 Static Seals for Use in Compendial Water Systems (MC-2.2.1) <\/td>\n<\/tr>\n
397<\/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
399<\/td>\nNONMANDATORY APPENDIX CC EXAMINATION, INSPECTION, AND TESTING CROSS-REFERENCES <\/td>\n<\/tr>\n
402<\/td>\nNONMANDATORY APPENDIX DD CONDUCTIVITY SENSOR SELECTION GUIDE
DD-1 PURPOSE
DD-2 GENERAL CONSIDERATIONS OF COMMON SENSOR TECHNOLOGIES <\/td>\n<\/tr>\n
403<\/td>\nFigure DD-2.1.1-1 Conductivity Scale
Table DD-2.6-1 Technological Considerations <\/td>\n<\/tr>\n
404<\/td>\nNONMANDATORY APPENDIX EE VESSEL FLANGE, AGITATOR, AND MECHANICAL SEAL DESIGN FOR BOTTOM-MOUNT AGITATORS
EE-1 PURPOSE
EE-2 SCOPE
EE-3 COMPONENT DESIGN <\/td>\n<\/tr>\n
405<\/td>\nFigure EE-3-1 Direct-Mount Agitator <\/td>\n<\/tr>\n
406<\/td>\nFigure EE-3-2 Pedestal-Mount Agitator <\/td>\n<\/tr>\n
407<\/td>\nFigure EE-3.1-1 Registered Fit to Ensure Concentricity: Seal Housing-to-Drive Pilot <\/td>\n<\/tr>\n
408<\/td>\nFigure EE-3.2-1 Dual Mechanical Seal Assembly <\/td>\n<\/tr>\n
409<\/td>\nFigure EE-3.2-2 Seal Assembly to Flange O-Ring Detail <\/td>\n<\/tr>\n
410<\/td>\nTable EE-3.3-1 Vessel Flange Bore per Shaft Diameter <\/td>\n<\/tr>\n
411<\/td>\nFigure EE-3.3-1 Vessel Flange With Piloted Bore <\/td>\n<\/tr>\n
412<\/td>\nFigure EE-3.3-2 Vessel Flange Tolerance Parameters <\/td>\n<\/tr>\n
413<\/td>\nTable EE-3.3-2 Vessel Flange Fabrication Tolerance Guidelines <\/td>\n<\/tr>\n
414<\/td>\nNONMANDATORY APPENDIX FF LEAK TEST METHODS FOR SINGLE-USE COMPONENTS AND ASSEMBLIES <\/td>\n<\/tr>\n
415<\/td>\nTable FF-1 Leak Test, Nondestructive Methods <\/td>\n<\/tr>\n
417<\/td>\nTable FF-2 Leak Test, Destructive Methods <\/td>\n<\/tr>\n
419<\/td>\nFigure GG-1.2-1 Typical Polymeric Single-Use Hose Barb Featuring Mono-Barb Design
NONMANDATORY APPENDIX GG SINGLE-USE MECHANICAL HOSE BARB DESIGN RECOMMENDATIONS
GG-1 TERMINOLOGY <\/td>\n<\/tr>\n
420<\/td>\nTable GG-2-1 Typical Retention Devices by Tubing Type and Operating Pressure
GG-2 DESIGN GUIDANCE <\/td>\n<\/tr>\n
421<\/td>\nINDEX \u00a0 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ASME BPE-2022 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>\n2022<\/td>\n438<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":439759,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2643],"product_tag":[],"class_list":{"0":"post-439753","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\/439753","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\/439759"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=439753"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=439753"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=439753"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}