ASME BPE-2016 Bioprocessing Equipment《生物加工设备》.pdf

1、Bioprocessing EquipmentAN INTERNATIONAL STANDARDASME BPE-2016(Revision of ASME BPE-2014)ASME BPE-2016(Revision of ASME BPE-2014)BioprocessingEquipmentAN INTERNATIONAL STANDARDTwo Park Avenue New York, NY 10016 USADate of Issuance: October 14, 2016The next edition of this Standard is scheduled for pu

2、blication in 2018. This Standard will becomeeffective 6 months after the Date of Issuance.ASME issues written replies to inquiries concerning interpretations of technical aspects of thisStandard. Periodically, certain actions of the ASME BPE Committee may be published as Cases.Cases and interpretati

3、ons are published on the ASME Web site under the Committee Pages athttp:/cstools.asme.org/ as they are issued.Errata to codes and standards may be posted on the ASME Web site under the Committee Pages toprovide corrections to incorrectly published items, or to correct typographical or grammatical er

4、rorsin codes and standards. Such errata shall be used on the date posted.The Committee Pages can be found at http:/cstools.asme.org/. There is an option available toautomatically receive an e-mail notification when errata are posted to a particular code or standard.This option can be found on the ap

5、propriate Committee Page after selecting “Errata” in the “PublicationInformation” section.ASME is the registered trademark of The American Society of Mechanical Engineers.This international code or standard was developed under procedures accredited as meeting the criteria for AmericanNational Standa

6、rds and it is an American National Standard. The Standards Committee that approved the code orstandard was balanced to assure that individuals from competent and concerned interests have had an opportunity toparticipate. The proposed code or standard was made available for public review and comment

7、that provides anopportunity for additional public input from industry, academia, regulatory agencies, and the public-at-large.ASME does not “approve,” “rate,” or “endorse” any item, construction, proprietary device, or activity.ASME does not take any position with respect to the validity of any pate

8、nt rights asserted in connection with anyitems mentioned in this document, and does not undertake to insure anyone utilizing a standard against liability forinfringement of any applicable letters patent, nor assume any such liability. Users of a code or standard are expresslyadvised that determinati

9、on of the validity of any such patent rights, and the risk of infringement of such rights, isentirely their own responsibility.Participation by federal agency representative(s) or person(s) affiliated with industry is not to be interpreted asgovernment or industry endorsement of this code or standar

10、d.ASME accepts responsibility for only those interpretations of this document issued in accordance with the establishedASME procedures and policies, which precludes the issuance of interpretations by individuals.No part of this document may be reproduced in any form,in an electronic retrieval system

11、 or otherwise,without the prior written permission of the publisher.The American Society of Mechanical EngineersTwo Park Avenue, New York, NY 10016-5990Copyright 2016 byTHE AMERICAN SOCIETY OF MECHANICAL ENGINEERSAll rights reservedPrinted in U.S.A.CONTENTSForeword xStatements of Policy . xiiCommitt

12、ee Roster . xiiiSummary of Changes xviiCHAPTER 1 INTRODUCTION, SCOPE, AND DEFINITIONS . 1Part GR General Requirements 1GR-1 Introduction 1GR-2 Scope of the ASME BPE Standard . 1GR-3 Manufacturers Quality Assurance Program . 2GR-4 Inspection 2GR-5 Documentation . 6GR-6 U.S. Customary and SI Units 8GR

13、-7 References 8GR-8 Terms and Definitions 9CHAPTER 2 DESIGN 18Part SD Systems Design 18SD-1 Purpose and Scope . 18SD-2 General Guidelines . 18SD-3 Process Components 21SD-4 Process Utilities 59SD-5 Process Systems 65SD-6 Design Conformance Testing 100CHAPTER 3 MATERIALS 101Part MM Metallic Materials

14、 101MM-1 Purpose and Scope . 101MM-2 Alloy Designations . 101MM-3 Uses of Specifications . 101MM-4 Referenced Specifications . 104MM-5 Base Metals and Filler Materials 106MM-6 Mechanical Properties 108MM-7 Corrosion-Resistance Requirements 113MM-8 Addition of New Alloys to Part MM 113Part PM Polymer

15、ic and Other Nonmetallic Materials 114PM-1 Purpose and Scope . 114PM-2 Materials . 114PM-3 Properties and Performance . 117PM-4 Applications 119CHAPTER 4 PROCESS COMPONENTS 128Part DT Dimensions and Tolerances for Process Components 128DT-1 Purpose and Scope . 128DT-2 Pressure Rating . 128DT-3 Wall

16、Thickness . 128DT-4 Dimensions . 128DT-5 Materials . 129DT-6 Tests . 129iiiDT-7 Tolerances 129DT-8 Weld Ends . 129DT-9 Hygienic Clamp Unions 129DT-10 Minimum Examination Requirements . 130DT-11 Marking 130DT-12 Packaging 131Part PI Process Instrumentation 157PI-1 Purpose and Scope . 157PI-2 Process

17、Instrumentation General Requirements 157PI-3 Instrument Receiving, Handling, and Storage 158PI-4 Flowmeters . 158PI-5 Level Instruments 163PI-6 Pressure Instruments 165PI-7 Temperature Sensors and Associated Components . 165PI-8 Analytical Instruments 170PI-9 Optical . 178Part SG Sealing Components

18、. 182SG-1 Purpose and Scope . 182SG-2 Sealing Component Types . 182SG-3 Sealing Components General Design Requirements (GeneralProvisions) . 198SG-4 Seal Performance Requirements . 204SG-5 Seal Applications . 206CHAPTER 5 FABRICATION, ASSEMBLY, AND ERECTION 209Part MJ Materials Joining. 209MJ-1 Purp

19、ose and Scope . 209MJ-2 Materials . 209MJ-3 Joint Design and Preparation 210MJ-4 Joining Processes and Procedures . 210MJ-5 Procedure Qualifications 211MJ-6 Performance Qualifications 211MJ-7 Examination, Inspection, and Testing 212MJ-8 Acceptance Criteria . 213MJ-9 Joining of Polymeric Materials 21

20、4MJ-10 Documentation Requirements . 229MJ-11 Passivation . 229Part SF Process Contact Surface Finishes 230SF-1 Purpose and Scope . 230SF-2 Metallic Applications . 230SF-3 Polymeric Applications . 234CHAPTER 6 CERTIFICATION . 235Part CR Certification Requirements 235CR-1 Purpose and Scope . 235CR-2 G

21、eneral 235FiguresSD-3.1.1-1 Flat Gasket Applications 22SD-3.1.2.2-1 Accepted Point-of-Use Designs 26SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly 27SD-3.2.1-1 Flexible Hygienic Hose Design 29SD-3.3.2.2-1 Pump Impeller Configurations 30SD-3.3.2.2-2 Acceptable Impeller Attachments . 31SD-3.3.2.2-

22、3 Casing Drain Configurations 31SD-3.3.2.2-4 Casing Drain L/D Ratios . 32ivSD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment . 32SD-3.4.2-1 Nozzle Design 34SD-3.4.2-2 Side and Bottom Connections . 35SD-3.4.2-3 Sidewall Instrument Ports . 35SD-3.4.2-4 Vessel Design Tangential Nozzles . 36SD-3.4.2-5 Typi

23、cal Nozzle Detail . 36SD-3.4.3-1 Accepted Nozzle Penetrations . 37SD-3.4.3-2 Internal Support Members 38SD-3.4.6-1 Sight Glass Design (Accepted) 40SD-3.5.1-1 Agitator Mounting Flanges . 41SD-3.5.2-1 Shaft Coupling Construction 42SD-3.5.2-2 Shaft Coupling Seal Arrangements 43SD-3.5.2-3 Fastener Seal

24、Arrangements: Alternative Bolting Designs 44SD-3.5.5-1 Shaft-Steady Bearing 45SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) 46SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design . 48SD-3.7.1-1 Transfer Panel Looped Headers . 49SD-3.7.2-1 Transfer Panel Tolerances . 50SD-3.7.4-1 T

25、ransfer Panel Jumpers . 52SD-3.9.1-1 Dynamic Spray Device: Single Axis . 54SD-3.9.1-2 Two Axes Dynamic Spray Device . 54SD-3.9.2.1-1 Static Spray Device . 56SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels . 56SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels 57SD-

26、3.9.2.3-1 Impact Pattern Buildup . 57SD-3.12-1 Steam Traps for Clean Steam Systems . 59SD-4.1.2.1-1 Point-of-Use Piping . 61SD-4.1.2.2-1 Physical Break in Point-of-Use Piping . 62SD-4.2.2-1 Typical Clean Steam System Isometric . 63SD-4.2.2-2 Clean Steam Point-of-Use Design 64SD-5.1.1.1-1 Fermentor S

27、terile Envelope . 66SD-5.1.1.1-2 Bioreactor Sterile Envelope 67SD-5.1.1.2.3-1 Gas Sparging Assembly Lance . 69SD-5.1.1.2.3-2 Gas Sparging Assembly Sintered . 70SD-5.1.1.2.3-3 Gas Sparging Assembly Ring . 71SD-5.1.1.2.3-4 Gas Sparging Assembly Single Orifice 72SD-5.1.1.3.1-1 Exhaust Gas Condenser . 7

28、3SD-5.1.1.3.1-2 Exhaust Gas Heater . 73SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing 74SD-5.2.1.1-1 Tank/Vessel Vent Filters 78SD-5.3.3.5.1-1 CIP Looped Header (Supply or Return) . 86SD-5.3.3.5.1-2 Zero-Static Chain . 86SD-5.3.3.5.1-3 Swing Elbow Arrangement . 87SD-5.3.4.3.1-1 Example HTST

29、Process Flow Schematic Diagram 88SD-5.3.4.3.1-2 Example Direct Steam Injection UHT Process Flow SchematicDiagram . 89SD-5.3.4.3.6-1 Example of Additional Retention Tube Length Required to Account forAxial Mixing . 91SD-5.4.1.2-1 Typical Lyophilizer Component Assembly . 95SD-5.4.1.3-1 Lyophilizer Ste

30、rile Boundary 98DT-2-1 Clamp Conditions at Installation 132PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples . 158PI-2.2.2-1 Accepted Insertion Device Installation Examples 159PI-4.1.3.2-1 Manifold or Flow Splitter for Dual-Tube Construction Flowmeters andPotentialforProductHoldup . 16

31、0PI-4.1.3.3-1 Concentrically Reducing Process Connection . 161vPI-4.1.4.3-1 Vertical Installation . 161PI-4.1.4.4-1 Minimum Angle of Inclination, H9251 . 162PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna 163PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location 164PI-7.3-1 Typ

32、ical Installation Styles . 165PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions . 167PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions 167PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations 168PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations . 169PI-8.1.2-1

33、Conductivity-Type Examples 171PI-8.1.3-1 Accepted Installations for Conductivity Sensors . 172PI-8.1.3.6-1 Installation Clearance Requirements . 173PI-8.2.2-1 pH Sensor Components . 174PI-8.2.3-1 Accepted pH Sensor Installations . 175PI-8.2.3.4-1 Accepted Mounting Orientations 176PI-8.2.3.5-1 Insert

34、ion Length or Depth 177PI-9.1.3.3-1 Vessel Light Glass Design and Mounting 179PI-9.1.3.5-1 In-Line Insertion Length 180PI-9.1.3.5-2 Insertion Probe Length 180SG-2.2.2-1 Hygienic Union per Table DT-7-1 . 183SG-2.2.2-2 Hygienic Clamp Union per Table DT-7-1 183SG-2.2.2-3 Hygienic Union per DIN 11864 .

35、184SG-2.2.2-4 Hygienic Clamp Union per DIN 11864 184SG-2.2.2-5 Nonhygienic Connections . 185SG-2.3.1.2-1 Weir Valves . 186SG-2.3.1.2-2 Radial Valves . 187SG-2.3.1.2-3 Weirless Diaphragm Valve 187SG-2.3.1.2-4 Linear Control Valves . 188SG-2.3.1.2-5 Regulator Valve 188SG-2.3.1.3-1 Ball Valves . 189SG-

36、2.3.1.4-1 Rising Stem Single, Double-Seat Mix-Proof, and Needle Valves . 189SG-2.3.1.5-1 Butterfly Valve . 190SG-2.3.1.7-1 Back Pressure Control Valve 190SG-2.3.1.8-1 Pinch Valve 190SG-2.3.1.9-1 Pressure Relief and Check Valves . 191SG-2.3.1.10-1 Plug Valve . 192SG-2.3.2.2-1 Single Mechanical Seal 1

37、93SG-2.3.2.2-2 Single Seal for Top-Entry Agitator . 193SG-2.3.2.3-1 Dual Pressurized Mechanical Seal for Pumps 193SG-2.3.2.3-2 Dual Pressurized Mechanical Seal for Top-Entry Agitator 194SG-2.3.2.3-3 Dual Unpressurized Mechanical Seal for Pumps . 194SG-2.3.2.4-1 Flush Plan 01 . 195SG-2.3.2.4-2 Flush

38、Plan 02 . 195SG-2.3.2.4-3 Flush Plan 03 . 195SG-2.3.2.4-4 Flush Plan 11 . 195SG-2.3.2.4-5 Flush Plan 32 . 195SG-2.3.2.4-6 Flush Plan 52 for Pump . 196SG-2.3.2.4-7 Flush Plan 52 for Top-Entry Agitator 196SG-2.3.2.4-8 Flush Plan BPE52 for Pump . 196SG-2.3.2.4-9 Flush Plan 53 for Pump . 196SG-2.3.2.4-1

39、0 Flush Plan 53 for Top-Entry Agitator 197SG-2.3.2.4-11 Flush Plan 54 for Pump . 197SG-2.3.2.4-12 Flush Plan 54 for Top-Entry Agitator 197SG-2.3.2.4-13 Flush Plan 55 for Pump . 197SG-2.3.2.4-14 Flush Plan 55 for Top-Entry Agitator 197SG-2.3.2.4-15 Flush Plan 74 for Pump . 198viSG-2.3.2.4-16 Flush Pl

40、an 74 for Top-Entry Agitator 198SG-3.3.2.2-1 Examples of Static O-Ring Grooves 200SG-3.3.2.3-1 Seals for Rising Stem Valves 202SG-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion 205MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds onMetallic Tube-to-Tube Butt Joints

41、220MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zoneson Electropolished UNS S31603 Tubing . 221MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zoneson Mechanically Polished UNS S31603 Tubing . 222MJ-8.4-4 Acceptable and Unacceptable Metallic Weld Bend

42、 Width and Meander onNonProcess Contact Surfaces of Groove Welds on Tube-to-Tube ButtJoints 223MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds 226MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric BeadlessWelds 229CR-1-1 ASME Certification Mark With BPE De

43、signator 235CR-2-1 Options for Certification of Organizations . 236TablesGR-4.2-1 Inspectors Delegate Capabilities 3SD-2.4.3.1-1 Slope Designations for Gravity-Drained Lines . 20SD-3.1.2.2-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard StraightTee With Blind Cap . 23SD-3.1.2.2-2 L/D Dimen

44、sions for Flow-Through Tee: Short-Outlet Reducing Tee WithBlind Cap 24SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes . 37SD-5.3.3.3-1 Flow Rates to Achieve 5 ft/sec (1.52 m/s) . 84MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %) 102MM-2.1-2 Wrought Nickel Alloys: No

45、minal Compositions (wt. %) 103MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations 104MM-2.1-4 Wrought Copper: Nominal Compositions (wt. %) (Cleaned for OxygenService) 104MM-5.2.1.2-1 Predicted Ferrite Number (FN) Ranges for Various AusteniticStainless Steel Product Forms and Welds 107MM-5.2.

46、6-1 Materials for OEM Equipment 108MM-5.3-1 Filler Metals 109MM-5.3-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels 111MM-5.3.3-1 Brazing Filler Metals for Copper 112MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superausteniticand Duplex Stainless Steels . 112PM-2.1.1

47、-1 Common Thermoplastic Polymers and Applications . 115PM-2.1.2-1 Common Thermoset Polymers and Applications . 115PM-2.1.3-1 Examples of Nonmetallics 116PM-2.2.1-1 Content Required on the Certificate of Compliance 117PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards . 122DT-2-1 Met

48、allic Hygienic Unions: Rated Internal Working Pressure 132DT-3-1 Final Tolerances for Mechanically Polished Fittings and ProcessComponents . 133DT-3-2 Final Tolerances for Electropolished Fittings and Process Components 134DT-4-1 Nominal O.D. Tubing Sizes . 134DT-4.1-1 Tangent Lengths 134DT-4.1.1-1

49、Automatic Tube Weld: 90-deg Elbow 135DT-4.1.1-2 Automatic Tube Weld: Hygienic Clamp Joint, 90-deg Elbow 135DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Elbow 136DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow 136DT-4.1.1-5 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow 137viiDT-4.1.1-6 Hygienic Clamp Joint: 45-deg Elbow 137DT-4.1.1-7 Automatic Tube Weld: 180-deg Return Bend . 138DT-4.1.1-8 Hygienic Clamp Joint: 180-deg Return Bend . 138DT-4.1.2-1 Automatic Tube Weld: Straight Tee and Cross . 139DT-4.1.2-2 Automatic Tube Weld: Short-Outlet Hygienic Clamp Joint Tee 139DT-4.1.