{"id":463844,"date":"2024-10-20T10:31:04","date_gmt":"2024-10-20T10:31:04","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/asme-bpe-2024\/"},"modified":"2024-10-26T19:23:50","modified_gmt":"2024-10-26T19:23:50","slug":"asme-bpe-2024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/asme\/asme-bpe-2024\/","title":{"rendered":"ASME BPE 2024"},"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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
4<\/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 BPE COMMITTEE ROSTER <\/td>\n<\/tr>\n
23<\/td>\nCORRESPONDENCE WITH THE BPE COMMITTEE <\/td>\n<\/tr>\n
25<\/td>\nASME BPE-2024 SUMMARY OF CHANGES <\/td>\n<\/tr>\n
30<\/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
31<\/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
32<\/td>\nTables
Table GR-4.2-1 Quality Inspector\u2019s Delegate Capabilities <\/td>\n<\/tr>\n
35<\/td>\nGR-4.3 Responsibilities
GR-4.4 Access for Inspectors
GR-5 DOCUMENTATION
GR-5.1 General
GR-5.2 General List of Documents <\/td>\n<\/tr>\n
36<\/td>\nGR-5.3 Document Requirements for Metallic Materials <\/td>\n<\/tr>\n
37<\/td>\nGR-5.4 Records Retention
GR-5.5 Document Requirements for Polymeric and Other Nonmetallic Materials
GR-6 PRODUCT IDENTIFICATION AND PACKAGING
GR-6.1 Marking and Labeling
GR-6.2 Packaging <\/td>\n<\/tr>\n
38<\/td>\nGR-7 PROCESS COMPATIBILITY
GR-7.1 Materials
GR-7.2 Animal-Derived Ingredients
GR-8 CONTAMINATION CONTROL
GR-8.1 Closed Systems
GR-8.2 Open Systems
GR-9 U.S. CUSTOMARY AND SI UNITS
GR-10 REFERENCES <\/td>\n<\/tr>\n
40<\/td>\nGR-11 TERMS AND DEFINITIONS <\/td>\n<\/tr>\n
49<\/td>\nGR-12 NOMENCLATURE <\/td>\n<\/tr>\n
50<\/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
51<\/td>\nCR-2.1 ASME BPE Certificate Holders
CR-2.2 ASME BPE Certificate Holder\u2019s Responsibilities <\/td>\n<\/tr>\n
52<\/td>\nCR-2.3 Certified Individual Requirements Under a Certificate of Authorization <\/td>\n<\/tr>\n
53<\/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
54<\/td>\nTable MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
55<\/td>\nTable MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %) <\/td>\n<\/tr>\n
56<\/td>\nTable MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations <\/td>\n<\/tr>\n
57<\/td>\nMM-3.5 Reclaimed Materials
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
58<\/td>\nMM-4.3 Castings
MM-4.4 Forgings
MM-4.5 Plate, Sheet, and Strip <\/td>\n<\/tr>\n
59<\/td>\nMM-4.6 Shapes, Rods, and Bars
MM-5 BASE METALS AND FILLER MATERIALS
MM-5.1 General
MM-5.2 Base Metals <\/td>\n<\/tr>\n
60<\/td>\nTable MM-5.2.1.1-1 Predicted Ferrite Number (FN) Ranges for Various Austenitic Stainless Steel Product Forms and Welds <\/td>\n<\/tr>\n
61<\/td>\nMM-5.3 Filler Materials
MM-5.4 Heat Treatment
Table MM-5.2.5-1 Materials for OEM Equipment <\/td>\n<\/tr>\n
62<\/td>\nTable MM-5.3-1 Filler Metals for Austenitic Stainless Steels <\/td>\n<\/tr>\n
64<\/td>\nTable MM-5.3-2 Filler Metals for Superaustenitic Stainless Steels <\/td>\n<\/tr>\n
65<\/td>\nTable MM-5.3-3 Filler Metals for Duplex Stainless Steels <\/td>\n<\/tr>\n
66<\/td>\nTable MM-5.3-4 Filler Metals for Nickel Alloys <\/td>\n<\/tr>\n
67<\/td>\nTable MM-5.3-5 Consumable Inserts for Superaustenitic and Duplex Stainless Steels <\/td>\n<\/tr>\n
68<\/td>\nMM-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
Table MM-5.3.4-1 Brazing Filler Metals for Copper <\/td>\n<\/tr>\n
69<\/td>\nMM-7 POSITIVE MATERIAL IDENTIFICATION
MM-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
Table MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic and Duplex Stainless Steels <\/td>\n<\/tr>\n
71<\/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
72<\/td>\nPM-2.2 General Requirements <\/td>\n<\/tr>\n
73<\/td>\nTable PM-2.2.1-1 Content Required on the Certificate of Conformance <\/td>\n<\/tr>\n
74<\/td>\nTable PM-2.2.3.2-1 Change Levels and Minimum Change Notification Requirements <\/td>\n<\/tr>\n
75<\/td>\nPM-3 PROPERTIES AND PERFORMANCE
PM-3.1 Biocompatibility
PM-3.2 Extractables and Leachables <\/td>\n<\/tr>\n
76<\/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 <\/td>\n<\/tr>\n
77<\/td>\nPM-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
79<\/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
80<\/td>\nSD-2.4 Fabrication <\/td>\n<\/tr>\n
82<\/td>\nTable SD-2.4.3.1-1 Slope Designations for Drainable Lines <\/td>\n<\/tr>\n
83<\/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
84<\/td>\nFigure SD-3.1.1-1 Flat Gasket Applications <\/td>\n<\/tr>\n
85<\/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
86<\/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
88<\/td>\nFigure SD-3.1.2.2-1 Accepted Point-of-Use Designs <\/td>\n<\/tr>\n
89<\/td>\nFigure SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly <\/td>\n<\/tr>\n
90<\/td>\nSD-3.2 Hose Assemblies <\/td>\n<\/tr>\n
91<\/td>\nSD-3.3 Pumps
Figure SD-3.2.1-1 Flexible Hygienic Hose Design <\/td>\n<\/tr>\n
92<\/td>\nFigure SD-3.3.2.2-1 Pump Impeller Configurations <\/td>\n<\/tr>\n
93<\/td>\nFigure SD-3.3.2.2-2 Acceptable Impeller Attachments
Figure SD-3.3.2.2-3 Casing Drain Configurations <\/td>\n<\/tr>\n
94<\/td>\nFigure SD-3.3.2.2-4 Casing Drain L\/d Ratios <\/td>\n<\/tr>\n
95<\/td>\nSD-3.4 Metallic Vessels
Figure SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment <\/td>\n<\/tr>\n
96<\/td>\nFigure SD-3.4.2-1 Nozzle Design <\/td>\n<\/tr>\n
97<\/td>\nFigure SD-3.4.2-2 Side and Bottom Connections <\/td>\n<\/tr>\n
98<\/td>\nFigure SD-3.4.2-3 Sidewall Nozzles <\/td>\n<\/tr>\n
99<\/td>\nFigure SD-3.4.2-4 Vessel Design Tangential Nozzles
Figure SD-3.4.2-5 Typical Nozzle Detail <\/td>\n<\/tr>\n
100<\/td>\nTable SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes <\/td>\n<\/tr>\n
101<\/td>\nFigure SD-3.4.3-1 Accepted Nozzle Penetrations <\/td>\n<\/tr>\n
102<\/td>\nFigure SD-3.4.3-2 Internal Components <\/td>\n<\/tr>\n
103<\/td>\nFigure SD-3.4.6-1 Sight Glass Design (Accepted) <\/td>\n<\/tr>\n
104<\/td>\nSD-3.5 Agitators and Mixers <\/td>\n<\/tr>\n
105<\/td>\nFigure SD-3.5.1-1 Agitator Mounting Flanges <\/td>\n<\/tr>\n
106<\/td>\nFigure SD-3.5.2-1 Shaft Coupling Construction <\/td>\n<\/tr>\n
107<\/td>\nFigure SD-3.5.2-2 Shaft Coupling Seal Arrangements <\/td>\n<\/tr>\n
109<\/td>\nFigure SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs <\/td>\n<\/tr>\n
110<\/td>\nFigure SD-3.5.5-1 Shaft Steady Bearing <\/td>\n<\/tr>\n
111<\/td>\nSD-3.6 Heat Exchange Equipment
Figure SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) <\/td>\n<\/tr>\n
112<\/td>\nFigure SD-3.6.2-1 Double Tubesheet Heat Exchanger Bonnet Design <\/td>\n<\/tr>\n
113<\/td>\nSD-3.7 Transfer Panels <\/td>\n<\/tr>\n
114<\/td>\nFigure SD-3.7.1-1 Transfer Panel Looped Headers <\/td>\n<\/tr>\n
115<\/td>\nFigure SD-3.7.2-1 Transfer Panel Tolerances <\/td>\n<\/tr>\n
116<\/td>\nSD-3.8 Filtration Elements and Components <\/td>\n<\/tr>\n
117<\/td>\nFigure SD-3.7.4-1 Transfer Panel Jumpers <\/td>\n<\/tr>\n
119<\/td>\nSD-3.9 Spray Devices <\/td>\n<\/tr>\n
120<\/td>\nFigure SD-3.9.1-1 Dynamic Spray Device: Single Axis <\/td>\n<\/tr>\n
121<\/td>\nFigure SD-3.9.1-2 Two-Axis Dynamic Spray Device <\/td>\n<\/tr>\n
122<\/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
123<\/td>\nFigure SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels <\/td>\n<\/tr>\n
124<\/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
125<\/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
126<\/td>\nSD-3.16 Liquid Pressure Regulators
SD-3.17 Strainers
SD-3.18 Chromatography Columns <\/td>\n<\/tr>\n
127<\/td>\nFigure SD-3.17.1-1 Example Strainer Types <\/td>\n<\/tr>\n
128<\/td>\nSD-3.19 Multiuse Rigid Polymeric Vessels
SD-4 PROCESS UTILITY SYSTEMS
SD-4.1 Compendial Water Systems <\/td>\n<\/tr>\n
129<\/td>\nSD-4.2 Clean\/Pure Steam Systems <\/td>\n<\/tr>\n
130<\/td>\nFigure SD-4.1.2.1-1 Point-of-Use Piping <\/td>\n<\/tr>\n
131<\/td>\nSD-4.3 Process Gases
Figure SD-4.1.2.2-1 Physical Break in Point-of-Use Piping <\/td>\n<\/tr>\n
132<\/td>\nFigure SD-4.2.2-1 Typical Clean Steam System Isometric <\/td>\n<\/tr>\n
133<\/td>\nSD-4.4 Process Waste Systems
Figure SD-4.2.2-2 Clean Steam Point-of-Use Design <\/td>\n<\/tr>\n
134<\/td>\nSD-5 PROCESS SYSTEMS
SD-5.1 Bioreactors and Fermentors <\/td>\n<\/tr>\n
135<\/td>\nFigure SD-5.1.4.1.3-1 Gas Sparging Assembly \u2014 Lance <\/td>\n<\/tr>\n
136<\/td>\nFigure SD-5.1.4.1.3-2 Gas Sparging Assembly \u2014 Sintered <\/td>\n<\/tr>\n
137<\/td>\nFigure SD-5.1.4.1.3-3 Gas Sparging Assembly \u2014 Ring <\/td>\n<\/tr>\n
138<\/td>\nFigure SD-5.1.4.1.3-4 Gas Sparging Assembly \u2014 Single Orifice <\/td>\n<\/tr>\n
139<\/td>\nFigure SD-5.1.4.2.1-1 Exhaust Gas Condenser
Figure SD-5.1.4.2.1-2 Exhaust Gas Heater <\/td>\n<\/tr>\n
140<\/td>\nFigure SD-5.1.4.2.1-3 Electrically Heat Traced Filter Housing <\/td>\n<\/tr>\n
142<\/td>\nFigure SD-5.1.5-1 Fermentor Sterile Envelope <\/td>\n<\/tr>\n
143<\/td>\nFigure SD-5.1.5-2 Bioreactor Sterile Envelope <\/td>\n<\/tr>\n
144<\/td>\nSD-5.2 Cell Disruptors <\/td>\n<\/tr>\n
145<\/td>\nFigure SD-5.2.1-1 Cell Disruptor Process Flow Schematic Diagram <\/td>\n<\/tr>\n
146<\/td>\nSD-5.3 Centrifuges <\/td>\n<\/tr>\n
148<\/td>\nSD-5.4 Filtration <\/td>\n<\/tr>\n
149<\/td>\nFigure SD-5.4.5.1-1 Tank\/Vessel Vent Fillers <\/td>\n<\/tr>\n
150<\/td>\nSD-5.5 Chromatography Systems <\/td>\n<\/tr>\n
152<\/td>\nSD-5.6 Lyophilizers\/Freeze Dryers <\/td>\n<\/tr>\n
153<\/td>\nFigure SD-5.6.4-1 Typical Lyophilizer Component Assembly <\/td>\n<\/tr>\n
156<\/td>\nFigure SD-5.6.5-1 Lyophilizer Sterile Boundary <\/td>\n<\/tr>\n
158<\/td>\nSD-5.7 Solution Preparation Systems <\/td>\n<\/tr>\n
159<\/td>\nSD-6 PROCESS SUPPORT SYSTEMS
SD-6.1 Cabinet Washers <\/td>\n<\/tr>\n
162<\/td>\nSD-6.2 Steam Sterilizers\/Autoclaves <\/td>\n<\/tr>\n
163<\/td>\nSD-6.3 CIP Systems <\/td>\n<\/tr>\n
165<\/td>\nFigure SD-6.3.4.1.1-1 Conical Vessel With Reduced Bottom Outlet, or Tulip Tank <\/td>\n<\/tr>\n
167<\/td>\nFigure SD-6.3.4.2-1 CIP Looped Header (Supply or Return)
Figure SD-6.3.4.2-2 Zero-Static Chain
Figure SD-6.3.4.2-3 Swing Elbow Arrangement <\/td>\n<\/tr>\n
168<\/td>\nFigure SD-6.3.4.2-4 Mix-Proof Valve Array <\/td>\n<\/tr>\n
169<\/td>\nTable SD-6.3.5.2.1-1 Flow Rates to Achieve 5 ft\/sec (1.5 m\/s) <\/td>\n<\/tr>\n
170<\/td>\nSD-6.4 Thermal Treatment Systems <\/td>\n<\/tr>\n
171<\/td>\nFigure SD-6.4.1.1-1 Example of HTST Process Flow Schematic Diagram <\/td>\n<\/tr>\n
172<\/td>\nFigure SD-6.4.1.1-2 Example of Direct Steam Injection UHT Process Flow Schematic Diagram <\/td>\n<\/tr>\n
174<\/td>\nFigure SD-6.4.4.5-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing <\/td>\n<\/tr>\n
175<\/td>\nSD-6.5 Immersion Washers <\/td>\n<\/tr>\n
177<\/td>\nFigure SD-6.5.4.2-1 Immersion Tank Side Nozzle Design <\/td>\n<\/tr>\n
178<\/td>\nSD-6.6 Isolator Systems <\/td>\n<\/tr>\n
182<\/td>\nSD-7 DESIGN CONFORMANCE TESTING
SD-7.1 Spray Device Coverage Test <\/td>\n<\/tr>\n
183<\/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
184<\/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
185<\/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
DT-9.2 Hygienic Gaskets <\/td>\n<\/tr>\n
186<\/td>\nDT-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
DT-11 MARKING
DT-11.1 Fittings, Valves, and Instrumentation Marking Information <\/td>\n<\/tr>\n
187<\/td>\nDT-11.2 Modified Surfaces
DT-12 PACKAGING
Table DT-2-1 Metallic Fittings: Rated Internal Working Pressure <\/td>\n<\/tr>\n
188<\/td>\nTable DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components, Excluding Tube <\/td>\n<\/tr>\n
190<\/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
191<\/td>\nTable DT-4.1-1 Tangent Lengths
Table DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow <\/td>\n<\/tr>\n
192<\/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
193<\/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
194<\/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
195<\/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
196<\/td>\nTable DT-4.1.1-10 Automatic Tube Weld: 92-deg Elbow
Table DT-4.1.2-1 Automatic Tube Weld: Straight Tee and Cross <\/td>\n<\/tr>\n
197<\/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
198<\/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
199<\/td>\nTable DT-4.1.2-6 Automatic Tube Weld: Reducing Tee <\/td>\n<\/tr>\n
200<\/td>\nTable DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee <\/td>\n<\/tr>\n
201<\/td>\nTable DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee <\/td>\n<\/tr>\n
202<\/td>\nTable DT-4.1.2-9 Hygienic Clamp Joint: Short-Outlet Reducing Tee <\/td>\n<\/tr>\n
203<\/td>\nTable DT-4.1.2-10 Automatic Tube Weld: Instrument Tee
Table 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
204<\/td>\nTable DT-4.1.2-13 Automatic Tube Weld: Standard Outlet Hygienic Clamp Joint Reducing Tee <\/td>\n<\/tr>\n
205<\/td>\nTable DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
206<\/td>\nTable DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
207<\/td>\nTable DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer <\/td>\n<\/tr>\n
208<\/td>\nTable DT-4.1.4-1 Automatic Tube Weld: Ferrule <\/td>\n<\/tr>\n
209<\/td>\nTable DT-4.1.5-1 Automatic Tube Weld: Cap <\/td>\n<\/tr>\n
210<\/td>\nTable DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap <\/td>\n<\/tr>\n
211<\/td>\nTable DT-4.4.1-1 Hygienic Clamp Joint: Two-Way, Weir-Style Diaphragm Valve <\/td>\n<\/tr>\n
212<\/td>\nTable DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed <\/td>\n<\/tr>\n
213<\/td>\nTable DT-4.5.2-1 Tapered Locking Tab Retainer: External <\/td>\n<\/tr>\n
214<\/td>\nTable DT-7.1-1 Metallic Hygienic Clamp Ferrule Standard Dimensions and Tolerances <\/td>\n<\/tr>\n
217<\/td>\nTable DT-7.1-2 Polymeric Hygienic Clamp Ferrule Standard Dimensions and Tolerances <\/td>\n<\/tr>\n
220<\/td>\nTable DT-7.2-1 Tubing End Square Cut Tolerances <\/td>\n<\/tr>\n
221<\/td>\nTable DT-7.3-1 Transfer Panel and Jumper Tolerances <\/td>\n<\/tr>\n
222<\/td>\nTable DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria <\/td>\n<\/tr>\n
223<\/td>\nFigure DT-9.4-1 Clamp Conditions at Installation <\/td>\n<\/tr>\n
224<\/td>\nTable DT-11.1.1-1 Minimum Required Marking Information <\/td>\n<\/tr>\n
225<\/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
226<\/td>\nFigure PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples <\/td>\n<\/tr>\n
227<\/td>\nFigure PI-2.2.2-1 Accepted Insertion Device Installation Examples <\/td>\n<\/tr>\n
228<\/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
229<\/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
231<\/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
232<\/td>\nFigure PI-4.2.2-1 Typical Turbine Flowmeters <\/td>\n<\/tr>\n
233<\/td>\nPI-5 LEVEL INSTRUMENTS
PI-5.1 Free-Space Radar Level Instruments <\/td>\n<\/tr>\n
234<\/td>\nFigure PI-5.1.2-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna
Figure PI-5.1.3.1-1 Dead Band, Measuring Range, and Mounting Location <\/td>\n<\/tr>\n
235<\/td>\nPI-6 PRESSURE INSTRUMENTS
PI-6.1 Pressure Sensors
PI-7 TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS
PI-7.1 General
PI-7.2 Components
PI-7.3 Installation <\/td>\n<\/tr>\n
236<\/td>\nFigure PI-6.1.2-1 Accepted Orientation and Flow <\/td>\n<\/tr>\n
237<\/td>\nFigure PI-7.3-1 Typical Installation Styles <\/td>\n<\/tr>\n
238<\/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
239<\/td>\nPI-7.4 Performance
PI-7.5 Selection <\/td>\n<\/tr>\n
240<\/td>\nFigure PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations <\/td>\n<\/tr>\n
241<\/td>\nFigure PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations <\/td>\n<\/tr>\n
242<\/td>\nPI-7.6 Sensor Calibration Verification
PI-8 ANALYTICAL INSTRUMENTS
PI-8.1 Conductivity
Figure PI-8.1.2-1 Conductivity Sensor Components <\/td>\n<\/tr>\n
243<\/td>\nPI-8.2 pH Sensors <\/td>\n<\/tr>\n
244<\/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
245<\/td>\nFigure PI-8.2.2-1 pH Sensor Components
Figure PI-8.2.3.3-1 Accepted Mounting Orientations <\/td>\n<\/tr>\n
246<\/td>\nPI-8.4 Total Organic Carbon Instruments
PI-9 OPTICAL
PI-9.1 Optical Devices <\/td>\n<\/tr>\n
247<\/td>\nFigure PI-8.4.3-1 Accepted Installation for a TOC Instrument <\/td>\n<\/tr>\n
248<\/td>\nFigure PI-9.1.3.2-1 Vessel Light Glass Design and Mounting <\/td>\n<\/tr>\n
249<\/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
250<\/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
251<\/td>\nFigure MC-2.2.2-1 Hygienic Union, Ferrules per Table DT-7.1-1 or Table DT-7.1-2
Figure MC-2.2.2-2 Hygienic Clamp Union, Ferrules per Table DT-7.1-1 or Table DT-7.1-2 <\/td>\n<\/tr>\n
252<\/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
253<\/td>\nFigure MC-2.2.2-5 Nonhygienic Connections <\/td>\n<\/tr>\n
254<\/td>\nMC-2.3 Dynamic Seals <\/td>\n<\/tr>\n
255<\/td>\nFigure MC-2.3.1.2-1 Weir Valves
Figure MC-2.3.1.2-2 Radial Valves <\/td>\n<\/tr>\n
256<\/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
257<\/td>\nFigure MC-2.3.1.2-5 Regulator Valve
Figure MC-2.3.1.3-1 Ball Valves <\/td>\n<\/tr>\n
258<\/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
259<\/td>\nFigure MC-2.3.1.8-1 Pinch Valve <\/td>\n<\/tr>\n
260<\/td>\nFigure MC-2.3.1.9-1 Check Valves <\/td>\n<\/tr>\n
261<\/td>\nFigure MC-2.3.1.10-1 Plug Valve <\/td>\n<\/tr>\n
262<\/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
263<\/td>\nMC-2.3.2.4 Seal Support System Plans.
Figure MC-2.3.2.3-3 Dual Mechanical Seal\u2013Unpressurized for Pumps <\/td>\n<\/tr>\n
264<\/td>\nFigure MC-2.3.2.4-1 Plan 01
Figure MC-2.3.2.4-2 Plan 02 <\/td>\n<\/tr>\n
265<\/td>\nFigure MC-2.3.2.4-3 Plan 03
Figure MC-2.3.2.4-4 Plan 11
Figure MC-2.3.2.4-5 Plan 32
Figure MC-2.3.2.4-6 Plan 52 for Pump <\/td>\n<\/tr>\n
266<\/td>\nFigure MC-2.3.2.4-7 Plan 52 for Top-Entry Agitator
Figure MC-2.3.2.4-8 Plan 53 for Pump
Figure MC-2.3.2.4-9 Plan 53 for Top-Entry Agitator
Figure MC-2.3.2.4-10 Plan 54 for Pump <\/td>\n<\/tr>\n
267<\/td>\nFigure MC-2.3.2.4-11 Plan 54 for Top-Entry Agitator
Figure MC-2.3.2.4-12 Plan 55 for Pump
Figure MC-2.3.2.4-13 Plan 55 With Buffer Fluid From Pump Discharge
Figure MC-2.3.2.4-14 Plan 55 for Top-Entry Agitator <\/td>\n<\/tr>\n
268<\/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 Plan 74 for Pump
Figure MC-2.3.2.4-16 Plan 74 for Top-Entry Agitator <\/td>\n<\/tr>\n
270<\/td>\nFigure MC-3.3.2.2-1 Examples of Static O-Ring Grooves <\/td>\n<\/tr>\n
272<\/td>\nFigure MC-3.3.2.3-1 Seals for Rising Stem Valves <\/td>\n<\/tr>\n
273<\/td>\nMC-3.4 Conformance Requirements for Sealing Elements <\/td>\n<\/tr>\n
274<\/td>\nMC-3.5 Seal Identification
MC-4 SEAL PERFORMANCE REQUIREMENTS
MC-4.1 General Requirements
MC-4.2 Static Seal Performance <\/td>\n<\/tr>\n
275<\/td>\nMC-4.3 Dynamic Seal Performance
Figure MC-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion <\/td>\n<\/tr>\n
276<\/td>\nMC-5 HOSE ASSEMBLIES
MC-5.1 General
MC-5.2 Hose Construction <\/td>\n<\/tr>\n
277<\/td>\nMC-5.3 Hose Assembly Performance
MC-5.4 Hose Assembly Installation
MC-5.5 Conformance Requirements for Hose Assemblies <\/td>\n<\/tr>\n
278<\/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
279<\/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 and Fittings
MJ-3.5 Tube-Attachment Welds <\/td>\n<\/tr>\n
280<\/td>\nFigure MJ-3.1-1 Vent Hole Examples <\/td>\n<\/tr>\n
281<\/td>\nFigure MJ-3.2-1 Unacceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations <\/td>\n<\/tr>\n
282<\/td>\nFigure MJ-3.2-2 Acceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations <\/td>\n<\/tr>\n
283<\/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 <\/td>\n<\/tr>\n
284<\/td>\nMJ-6.3 Tubing
MJ-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
285<\/td>\nMJ-7.3 Examination, Inspection, and Testing Requirements <\/td>\n<\/tr>\n
286<\/td>\nMJ-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
MJ-8.5 Tube-Attachment Welds
MJ-8.6 Brazed Joints
MJ-9 JOINING OF POLYMERIC MATERIALS
MJ-9.1 General <\/td>\n<\/tr>\n
287<\/td>\nTable MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks <\/td>\n<\/tr>\n
289<\/td>\nTable MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe <\/td>\n<\/tr>\n
291<\/td>\nTable MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints <\/td>\n<\/tr>\n
293<\/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
294<\/td>\nFigure MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Electropolished UNS S31603 Tubing <\/td>\n<\/tr>\n
295<\/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
296<\/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
297<\/td>\nTable MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds <\/td>\n<\/tr>\n
299<\/td>\nMJ-9.2 Weld Joint Design and Preparation
MJ-9.3 Joining Processes and Procedures
MJ-9.4 Procedure Qualifications
Figure MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds <\/td>\n<\/tr>\n
300<\/td>\nMJ-9.5 Performance Qualifications
MJ-9.6 Examination, Inspection, and Testing
MJ-9.7 Weld Acceptance Criteria <\/td>\n<\/tr>\n
301<\/td>\nMJ-9.8 Documentation Requirements
MJ-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
302<\/td>\nFigure MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds <\/td>\n<\/tr>\n
303<\/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
304<\/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
305<\/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
306<\/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
307<\/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
308<\/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 Integrity Versus Leak Testing and Correlation to Maximum Allowable Leakage Limit
SU-3.3 Common Leak and Integrity Test Methods <\/td>\n<\/tr>\n
309<\/td>\nSU-4 BIOCOMPATIBILITY
SU-5 EXTRACTABLES AND LEACHABLES
SU-5.1 General
SU-6 IDENTIFICATION
SU-6.1 Labeling
SU-7 CERTIFICATE OF CONFORMANCE
SU-8 INSPECTION AND PACKAGING
SU-8.1 Inspection
SU-8.2 Packaging <\/td>\n<\/tr>\n
310<\/td>\nSU-9 STERILIZATION AND BIOBURDEN REDUCTION
SU-9.1 Ionizing Radiation
SU-9.2 Steam Sterilization
SU-9.3 Chemical Sterilization
SU-10 SHELF LIFE, STORAGE, AND EXPIRATION DATE <\/td>\n<\/tr>\n
311<\/td>\nSU-11 PARTICULATES
SU-11.1 General
SU-11.2 Particulate-Monitoring Program
SU-11.3 Mitigation Techniques
SU-12 DESIGN CONFORMANCE
Table SU-12-1 Single-Use Design Aspects <\/td>\n<\/tr>\n
312<\/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
313<\/td>\nSC-3.1 Materials
SC-3.2 Qualifications
SC-4 POLYMERIC HYGIENIC UNIONS
SC-5 VALVES
SC-5.1 General
SC-5.2 Pinch Clamps
SC-5.3 Pinch Valves <\/td>\n<\/tr>\n
314<\/td>\nFigure SC-5.2-1 Typical Pinch Clamps <\/td>\n<\/tr>\n
315<\/td>\nSC-5.4 Diaphragm Valves
SC-5.5 Material Requirements
Figure SC-5.3-1 Typical Pinch Valves <\/td>\n<\/tr>\n
316<\/td>\nFigure SC-5.4-1 Typical Diaphragm Valve <\/td>\n<\/tr>\n
317<\/td>\nSC-5.6 Valve Performance
SC-5.7 Identification Requirements <\/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>\nPART SI SINGLE-USE PROCESS INSTRUMENTATION
SI-1 PURPOSE AND SCOPE
SI-2 SINGLE-USE PROCESS INSTRUMENTATION GENERAL REQUIREMENTS <\/td>\n<\/tr>\n
321<\/td>\nTable II-1 Standard Units
MANDATORY APPENDICES
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 SLAG AND OXIDE ISLAND FORMATION IN WELDS <\/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
E-4 PASSIVATION QUALITY CONTROL <\/td>\n<\/tr>\n
341<\/td>\nE-5 EVALUATION OF CLEANED AND PASSIVATED SURFACES <\/td>\n<\/tr>\n
342<\/td>\nTable E-3.2-2 Passivation Processes <\/td>\n<\/tr>\n
344<\/td>\nTable E-5-1 Test Matrix for Evaluation of Cleaned and Passivated Surfaces <\/td>\n<\/tr>\n
348<\/td>\nNONMANDATORY APPENDIX F CORROSION TESTING
F-1 GENERAL
F-2 CORROSION TESTS
F-3 PITTING RESISTANCE EQUIVALENT (PRE) NUMBER <\/td>\n<\/tr>\n
349<\/td>\nTable F-1-1 Corrosion Tests <\/td>\n<\/tr>\n
351<\/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
352<\/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
353<\/td>\nNONMANDATORY APPENDIX H ELECTROPOLISHING PROCEDURE QUALIFICATION
H-1 SCOPE
H-2 PURPOSE
H-3 ELECTROPOLISHING PROCESS
H-4 ELECTROPOLISHING PROCEDURE QUALIFICATION <\/td>\n<\/tr>\n
354<\/td>\nForm EPPS-1 Suggested Format for Electropolishing Procedure Specification (EPPS) <\/td>\n<\/tr>\n
355<\/td>\nForm EPQR-1 Suggested Format for Electropolishing Procedure Qualification Record (EPQR) <\/td>\n<\/tr>\n
356<\/td>\nTable H-4.3-1 Procedure Qualification Acceptance Criteria for Test Coupons <\/td>\n<\/tr>\n
357<\/td>\nNONMANDATORY APPENDIX J VENDOR DOCUMENTATION REQUIREMENTS FOR NEW INSTRUMENTS
J-1 OVERVIEW
J-2 INSTRUCTIONS FOR USE <\/td>\n<\/tr>\n
358<\/td>\nTable J-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions <\/td>\n<\/tr>\n
359<\/td>\nTable J-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents <\/td>\n<\/tr>\n
360<\/td>\nNONMANDATORY APPENDIX K STANDARD PROCESS TEST CONDITIONS (SPTC) FOR SEAL PERFORMANCE EVALUATION
K-1 SEALING COMPONENT PERFORMANCE EVALUATION <\/td>\n<\/tr>\n
362<\/td>\nFigure K-1.3.2.1-1 Weir-Style Diaphragm <\/td>\n<\/tr>\n
365<\/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
366<\/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
370<\/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 <\/td>\n<\/tr>\n
371<\/td>\nTable L-3-1 Thermoset Polymer Test Properties
L-5 TESTING PROTOCOLS FOR THERMOSET POLYMERS <\/td>\n<\/tr>\n
372<\/td>\nTable L-4-1 Interpretation of Thermoset Material Property Changes <\/td>\n<\/tr>\n
373<\/td>\nNONMANDATORY APPENDIX M SPRAY DEVICE COVERAGE TESTING
M-1 SCOPE
M-2 PURPOSE
M-3 MATERIALS
M-4 PROCEDURE <\/td>\n<\/tr>\n
374<\/td>\nM-5 ACCEPTANCE CRITERIA
M-6 RECOMMENDED DOCUMENTATION <\/td>\n<\/tr>\n
375<\/td>\nNONMANDATORY APPENDIX N EXPLANATION OF WELD BEAD AND HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA ON UNS S31603 <\/td>\n<\/tr>\n
376<\/td>\nNONMANDATORY APPENDIX O GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS
O-1 GENERAL <\/td>\n<\/tr>\n
377<\/td>\nTable O-1.1-1 Common Thermoplastic Polymers and Applications
Table O-1.2-1 Common Thermoset Polymers and Applications
O-2 PARTICULATES <\/td>\n<\/tr>\n
378<\/td>\nTable O-1.3-1 Examples of Nonmetallics <\/td>\n<\/tr>\n
379<\/td>\nNONMANDATORY APPENDIX P GENERAL BACKGROUND\/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES
P-1 REFERENCES
P-2 RECOMMENDED CONDITIONS FOR A POLYMERIC MATERIAL-SPECIFIC EXTRACTION <\/td>\n<\/tr>\n
380<\/td>\nP-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
381<\/td>\nFigure P-4-1 Flowchart of Bioprocessing Equipment\/Component Evaluation Related to Extractables and Leachables Characterization <\/td>\n<\/tr>\n
382<\/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
383<\/td>\nQ-4 SELECTION
Q-5 MAINTENANCE <\/td>\n<\/tr>\n
384<\/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
385<\/td>\nNONMANDATORY APPENDIX S APPLICATION DATA SHEET <\/td>\n<\/tr>\n
386<\/td>\nForm S-1 Application Data Sheet <\/td>\n<\/tr>\n
387<\/td>\nNONMANDATORY APPENDIX T GUIDANCE ON POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS AND FILTRATION
T-1 CHROMATOGRAPHY COLUMNS
T-2 FILTRATION <\/td>\n<\/tr>\n
390<\/td>\nNONMANDATORY APPENDIX U GUIDANCE FOR THE USE OF U.S. CUSTOMARY AND SI UNITS
U-2 GUIDELINES USED TO DEVELOP SIEQUIVALENTS <\/td>\n<\/tr>\n
391<\/td>\nU-3 CHECKING EQUATIONS
U-4 SOFT CONVERSION FACTORS <\/td>\n<\/tr>\n
392<\/td>\nNONMANDATORY APPENDIX W POSITIVE MATERIAL IDENTIFICATION
W-1 GENERAL
W-2 GENERAL REQUIREMENTS <\/td>\n<\/tr>\n
393<\/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
395<\/td>\nNONMANDATORY APPENDIX Y PROCUREMENT SOURCES <\/td>\n<\/tr>\n
396<\/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
400<\/td>\nNONMANDATORY APPENDIX AA SEAL APPLICATION MATERIAL SELECTION GUIDE
AA-1 GENERAL
AA-2 MATERIAL CLASS DESCRIPTIONS <\/td>\n<\/tr>\n
401<\/td>\nAA-3 COMPENDIAL AMBIENT AND HOT-WATER DISTRIBUTION SYSTEMS <\/td>\n<\/tr>\n
402<\/td>\nAA-4 PURE STEAM <\/td>\n<\/tr>\n
403<\/td>\nFigure AA-3.2.1-1 Polymeric Static and Dynamic Seal Selection for Use in Compendial Water Systems <\/td>\n<\/tr>\n
405<\/td>\nFigure AA-3.2.3-1 Mechanical Seal Face Material Selection for Compendial Water Pumps <\/td>\n<\/tr>\n
406<\/td>\nNONMANDATORY APPENDIX BB MECHANICAL SEAL FACE MATERIAL SELECTION FOR COMPENDIAL WATER PUMPS <\/td>\n<\/tr>\n
407<\/td>\nNONMANDATORY APPENDIX CC EXAMINATION, INSPECTION, AND TESTING CROSS-REFERENCES <\/td>\n<\/tr>\n
410<\/td>\nNONMANDATORY APPENDIX DD CONDUCTIVITY SENSOR SELECTION GUIDE
DD-1 PURPOSE
DD-2 GENERAL CONSIDERATIONS OF COMMON SENSOR TECHNOLOGIES <\/td>\n<\/tr>\n
411<\/td>\nFigure DD-2.1.1-1 Conductivity Scale
Table DD-2.6-1 Technological Considerations <\/td>\n<\/tr>\n
412<\/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
413<\/td>\nFigure EE-3-1 Direct-Mount Agitator <\/td>\n<\/tr>\n
414<\/td>\nFigure EE-3-2 Pedestal-Mount Agitator <\/td>\n<\/tr>\n
415<\/td>\nFigure EE-3.1-1 Registered Fit to Ensure Concentricity: Seal Housing-to-Drive Pilot <\/td>\n<\/tr>\n
416<\/td>\nFigure EE-3.2-1 Dual Mechanical Seal Assembly <\/td>\n<\/tr>\n
417<\/td>\nFigure EE-3.2-2 Seal Assembly to Flange O-Ring Detail <\/td>\n<\/tr>\n
418<\/td>\nTable EE-3.3-1 Vessel Flange Bore per Shaft Diameter <\/td>\n<\/tr>\n
419<\/td>\nFigure EE-3.3-1 Vessel Flange With Piloted Bore <\/td>\n<\/tr>\n
420<\/td>\nFigure EE-3.3-2 Vessel Flange Tolerance Parameters <\/td>\n<\/tr>\n
421<\/td>\nTable EE-3.3-2 Vessel Flange Fabrication Tolerance Guidelines <\/td>\n<\/tr>\n
422<\/td>\nNONMANDATORY APPENDIX FF LEAK AND INTEGRITY TEST METHODS FOR SINGLE-USE SYSTEMS
FF-1 CONCEPT OF MAXIMUM ALLOWABLE LEAKAGE LIMIT (MALL) FOR SINGLE-USE SYSTEMS <\/td>\n<\/tr>\n
423<\/td>\nTable FF-1-1 Leak and Integrity Test, Nondestructive Methods <\/td>\n<\/tr>\n
425<\/td>\nTable FF-1-2 Leak and Integrity Test, Destructive Methods <\/td>\n<\/tr>\n
428<\/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
429<\/td>\nTable GG-2-1 Typical Retention Devices by Tubing Type and Operating Pressure
GG-2 DESIGN GUIDANCE <\/td>\n<\/tr>\n
430<\/td>\nNONMANDATORY APPENDIX HH PHYSICAL AND FUNCTIONAL TESTING REFERENCES USED TO CHARACTERIZE SINGLE-USE BAGS <\/td>\n<\/tr>\n
431<\/td>\nTable HH-1 Physical Testing References Used to Characterize Single-Use Bags <\/td>\n<\/tr>\n
432<\/td>\nTable HH-2 Functional Testing References Used to Characterize Single-Use Bags <\/td>\n<\/tr>\n
433<\/td>\nNONMANDATORY APPENDIX JJ SIZE COMPARISON OF COMMON THERMOPLASTIC SIZING STANDARDS <\/td>\n<\/tr>\n
434<\/td>\nTable JJ-1 Size Comparison of Common Thermoplastic Sizing Standards <\/td>\n<\/tr>\n
435<\/td>\nINDEX \u00a0 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ASME BPE-2024 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>\n2024<\/td>\n453<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":463849,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2643],"product_tag":[],"class_list":{"0":"post-463844","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\/463844","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\/463849"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=463844"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=463844"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=463844"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}