ASME BPE-2014 Bioprocessing Equipment《生物加工设备》.pdf

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1、Bioprocessing EquipmentAN INTERNATIONAL STANDARDASME BPE-2014(Revision of ASME BPE-2012)ASME BPE-2014(Revision of ASME BPE-2012)BioprocessingEquipmentAN INTERNATIONAL STANDARDTwo Park Avenue New York, NY 10016 USADate of Issuance: October 10, 2014The next edition of this Standard is scheduled for pu

2、blication in 2016. 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 code or standard was developed under procedures accredited as meeting the criteria for American NationalStandards. The Stand

6、ards Committee that approved the code or standard was balanced to assure that individuals fromcompetent and concerned interests have had an opportunity to participate. The proposed code or standard was madeavailable for public review and comment that provides an opportunity for additional public inp

7、ut 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 patent rights asserted in connection with anyitems mention

8、ed 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 determination of the validity of any such patent rights, and the

9、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 standard.ASME accepts responsibility for only those interpret

10、ations 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 or otherwise,without the prior written permission of

11、the publisher.The American Society of Mechanical EngineersTwo Park Avenue, New York, NY 10016-5990Copyright 2014 byTHE AMERICAN SOCIETY OF MECHANICAL ENGINEERSAll rights reservedPrinted in U.S.A.CONTENTSForeword ixStatements of Policy . xiCommittee Roster . xiiSummary of Changes xviPart GR General R

12、equirements 1GR-1 Introduction 1GR-2 Scope of the ASME BPE Standard . 1GR-3 Manufacturers Quality Assurance Program . 1GR-4 Inspection 2GR-5 Documentation . 6GR-6 U.S. Customary and SI Units 8GR-7 References 8GR-8 Terms and Definitions 9Part SD Systems Design 17SD-1 Purpose and Scope . 17SD-2 Genera

13、l Guidelines . 17SD-3 Process Components 19SD-4 Process Utilities 59SD-5 Process Systems 64SD-6 Design Conformance Testing 89Part DT Dimensions and Tolerances for Process Components 90DT-1 Purpose and Scope . 90DT-2 Pressure Rating . 90DT-3 Wall Thickness . 90DT-4 Dimensions . 90DT-5 Materials . 91D

14、T-6 Tests . 91DT-7 Tolerances 91DT-8 Weld Ends . 91DT-9 Hygienic Clamp Unions 91DT-10 Minimum Examination Requirements . 91DT-11 Marking 92DT-12 Packaging 93Part MJ Materials Joining. 118MJ-1 Purpose and Scope . 118MJ-2 Materials . 118MJ-3 Joint Design and Preparation 119MJ-4 Joining Processes and P

15、rocedures . 119MJ-5 Procedure Qualifications 120MJ-6 Performance Qualifications 120MJ-7 Examination, Inspection, and Testing 121MJ-8 Acceptance Criteria . 122MJ-9 Joining of Polymeric Materials 123MJ-10 Documentation Requirements . 125MJ-11 Passivation . 125Part SF Process Contact Surface Finishes 1

16、40SF-1 Purpose and Scope . 140iiiSF-2 Metallic Applications . 140SF-3 Polymeric Applications . 143Part SG Sealing Components . 145SG-1 Purpose and Scope . 145SG-2 Sealing Component Types . 145SG-3 Sealing Components General Design Requirements (GeneralProvisions) . 161SG-4 Seal Performance Requireme

17、nts . 167SG-5 Seal Applications . 169Part PM Polymeric and Other Nonmetallic Materials 170PM-1 Purpose and Scope . 170PM-2 Materials . 170PM-3 Properties and Performance . 172PM-4 Applications 175Part CR Certification . 182CR-1 Purpose and Scope . 182CR-2 General 182Part MM Metallic Materials 187MM-

18、1 Purpose and Scope . 187MM-2 Alloy Designations . 187MM-3 Uses of Specifications . 187MM-4 Referenced Specifications . 190MM-5 Fabrication . 192MM-6 Mechanical Properties 197MM-7 Corrosion Resistance Requirements 198MM-8 Addition of New Alloys to Part MM 198Part PI Process Instrumentation 199PI-1 P

19、urpose and Scope . 199PI-2 Process Instrumentation General Requirements 199PI-3 Instrument Receiving, Handling, and Storage 200PI-4 Flowmeters . 200PI-5 Level Instruments 204PI-6 Pressure Instruments 205PI-7 Temperature Sensors and Associated Components . 205PI-8 Analytical Instruments 211PI-9 Optic

20、al . 218FiguresSD-3.1.1-1 Flat Gasket Applications 21SD-3.1.2.2-1 Accepted Point-of-Use Designs 25SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly 26SD-3.2.1-1 Flexible Hygienic Hose Design 28SD-3.3.2.2-1 Pump Impeller Configurations 29SD-3.3.2.2-2 Acceptable Impeller Attachments . 29SD-3.3.2.2-3

21、Casing Drain Configurations 30SD-3.3.2.2-4 Casing Drain L/D Ratios . 30SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment . 31SD-3.4.2-1 Nozzle Design 32SD-3.4.2-2 Side and Bottom Connections . 33SD-3.4.2-3 Sidewall Instrument Ports . 33SD-3.4.2-4 Accepted Nozzle Penetrations . 34SD-3.4.2-5 Vessel Desig

22、n Tangential Nozzles . 35SD-3.4.2-6 Sight Glass Design (Accepted) 36SD-3.4.2-7 Typical Nozzle Detail . 37SD-3.4.3-1 Internal Support Members 38ivSD-3.5.1-1 Agitator Mounting Flanges . 40SD-3.5.2-1 Shaft Coupling Construction 41SD-3.5.2-2 Shaft Coupling Seal Arrangments . 42SD-3.5.2-3 Fastener Seal A

23、rrangements . 43SD-3.5.5-1 Shaft Steady Bearing 44SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) 45SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design . 46SD-3.7.1-1 Transfer Panel Looped Headers . 48SD-3.7.2-1 Transfer Panel Tolerances . 49SD-3.7.4-1 Transfer Panel Jumpers . 50SD

24、-3.8.1.1-1 Tapered Locking Tab Retainer Recessed 52SD-3.8.1.1-2 Tapered Locking Tab Retainer External . 53SD-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 Vesse

25、ls . 56SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels 57SD-3.9.2.3-1 Impact Pattern Build-Up 57SD-3.12-1 Steam Traps for Clean Steam Systems . 58SD-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 Isom

26、etric . 63SD-4.2.2-2 Clean Steam Point-of-Use Design 64SD-5.1.1.1-1 Fermentor Sterile Envelope . 65SD-5.1.1.1-2 Bioreactor Sterile Envelope 66SD-5.1.1.2.3-1 Gas Sparging Assembly Lance . 68SD-5.1.1.2.3-2 Gas Sparging Assembly Sintered . 69SD-5.1.1.2.3-3 Gas Sparging Assembly Ring . 70SD-5.1.1.2.3-4

27、Gas Sparging Assembly Single Orifice 71SD-5.1.1.3.1-1 Exhaust Gas Condenser . 73SD-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 77SD-5.3.3.5.1-1 CIP Looped Header (Supply or Return) . 82SD-5.3.3.5.1-2 Zero-Static Ch

28、ain . 82SD-5.3.3.5.1-3 Swing Elbow Arrangement . 82SD-5.4.1.2-1 Typical Lyophilizer Component Assembly . 84SD-5.4.1.3-1 Lyophilizer Sterile Boundary 87DT-2-1 Clamp Conditions at Installation 94MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Tube Welds 132MJ-8.4-2 Discoloration Acceptance Crit

29、eria for Weld Heat-Affected Zones onElectropolished 316L Tubing 133MJ-8.4-3 Discoloration Acceptance Criteria for Weld Heat-Affected Zones onMechanically Polished 316L Tubing . 134MJ-8.4-4 Acceptable and Unacceptable Weld Bend Width and Meander . 135MJ-8.5-1 Acceptable Weld Profiles for Tube-Attachm

30、ent Fillet Welds 138MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds 139SG-2.2.2-1 Hygienic Union per Table DT-7-1 . 146SG-2.2.2-2 Hygienic Clamp Union per Table DT-7-1 146SG-2.2.2-3 Hygienic Union per DIN 11864 . 147SG-2.2.2-4 Hygienic Clamp Union per DIN 11864 147SG-2.2.2-5

31、Nonhygienic Connections . 148SG-2.3.1.2-1 Weir Valves . 149SG-2.3.1.2-2 Radial Valves . 150SG-2.3.1.2-3 Weirless Diaphragm Valve 150SG-2.3.1.2-4 Linear Control Valves . 151vSG-2.3.1.2-5 Regulator Valve 151SG-2.3.1.3-1 Ball Valves . 152SG-2.3.1.4-1 Rising Stem Single, Double Seat Mix Proof, and Needl

32、e Valves . 152SG-2.3.1.5-1 Butterfly Valve . 153SG-2.3.1.7-1 Back Pressure Control Valve 153SG-2.3.1.8-1 Pinch Valve 153SG-2.3.1.9-1 Pressure Relief and Check Valves . 154SG-2.3.1.10-1 Plug Valve . 155SG-2.3.2.2-1 Single Mechanical Seal 155SG-2.3.2.2-2 Single Seal for Top Entry Agitator . 156SG-2.3.

33、2.3-1 Dual Pressurized Mechanical Seal for Pumps 156SG-2.3.2.3-2 Dual Pressurized Mechanical Seal for Top Entry Agitator 156SG-2.3.2.3-3 Dual Unpressurized Mechanical Seal for Pumps . 157SG-2.3.2.4-1 Flush Plan 01 . 157SG-2.3.2.4-2 Flush Plan 02 . 157SG-2.3.2.4-3 Flush Plan 03 . 157SG-2.3.2.4-4 Flus

34、h Plan 11 . 158SG-2.3.2.4-5 Flush Plan 32 . 158SG-2.3.2.4-6 Flush Plan 52 for Pump . 158SG-2.3.2.4-7 Flush Plan 52 for Top Entry Agitator 158SG-2.3.2.4-8 Flush Plan BPE52 for Pump . 159SG-2.3.2.4-9 Flush Plan 53 for Pump . 159SG-2.3.2.4-10 Flush Plan 53 for Top Entry Agitator 159SG-2.3.2.4-11 Flush

35、Plan 54 for Pump . 159SG-2.3.2.4-12 Flush Plan 54 for Top Entry Agitator 160SG-2.3.2.4-13 Flush Plan 55 for Pump . 160SG-2.3.2.4-14 Flush Plan 55 for Top Entry Agitator 160SG-2.3.2.4-15 Flush Plan 74 for Pump . 160SG-2.3.2.4-16 Flush Plan 74 for Top Entry Agitator 160SG-3.3.2.2-1 Static O-Ring . 163

36、SG-3.3.2.3-1 Seals for Rising Stem Valves 165SG-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion 168CR-1-1 ASME Certification Mark With BPE Designator 182CR-2-1 Options for Certification of Organizations . 183PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples . 200PI-2.2.2

37、-1 Accepted Insertion Device Installation Examples 201PI-4.1.3.2-1 Manifold or Flow Splitter for Dual Tube Construction Flowmeters andPotential for Product Holdup . 202PI-4.1.3.3-1 Concentrically Reducing Process Connection . 203PI-4.1.4.3-1 Vertical Installation . 203PI-4.1.4.4-1 Minimum Angle of I

38、nclination, H9251 . 203PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod Style Antenna 205PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location 206PI-7.3-1 Typical Installation Styles . 207PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions . 208PI-7.3.4-2 Accepted Nonintrusive Orienta

39、tions and Flow Directions 208PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations 209PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations . 211PI-8.1.2-1 Conductivity Type Examples 212PI-8.1.3-1 Accepted Installations for Conductivity Sensors . 213PI-8.1.3.6-1 Installation Clearance Requ

40、irements . 214PI-8.2.2-1 pH Sensor Components . 214PI-8.2.3-1 Accepted pH Sensor Installations . 216PI-8.2.3.4-1 Accepted Mounting Orientations 217PI-8.2.3.5-1 Insertion Length or Depth 218PI-9.1.3.3-1 Vessel Light Glass Design and Mounting 220viPI-9.1.3.5-1 In-Line Insertion Length 221PI-9.1.3.5-2

41、Insertion Probe Length 221TablesGR-4.2-1 Inspectors Delegate Capabilities 3SD-2.4.3.1-1 Slope Designations for Gravity-Drained Lines . 18SD-3.1.2.2-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard StraightTee With Blind Cap . 22SD-3.1.2.2-2 L/D Dimensions for Flow-Through Tee: Short Outlet

42、Reducing Tee WithBlind Cap 23SD-3.4.2-1 Annular Spacing Recommendations for Hygienic Dip Tubes . 34SD-5.3.3.3-1 Flow Rates to Achieve 5 ft/sec (1.52 m/s) . 80DT-2-1 Hygienic Unions: Rated Internal Working Pressure 95DT-3-1 Final Tolerances for Mechanically Polished Fittings and ProcessComponents . 9

43、6DT-3-2 Final Tolerances for Electropolished Fittings and Process Components 97DT-4-1 Nominal O.D. Tubing Sizes . 97DT-4.1-1 Tangent Lengths 97DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow 98DT-4.1.1-2 Automatic Tube Weld: Hygienic Clamp Joint, 90-deg Elbow 98DT-4.1.1-3 Hygienic Clamp Joint: 90-deg E

44、lbow 99DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow 99DT-4.1.1-5 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow 100DT-4.1.1-6 Hygienic Clamp Joint: 45-deg Elbow 100DT-4.1.1-7 Automatic Tube Weld: 180-deg Return Bend . 101DT-4.1.1-8 Hygienic Clamp Joint: 180-deg Return Bend . 101DT-4.1.2-1 A

45、utomatic Tube Weld: Straight Tee and Cross . 102DT-4.1.2-2 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee 102DT-4.1.2-3 Hygienic Mechanical Joint: Short Outlet Run Tee 103DT-4.1.2-4 Hygienic Clamp Joint: Straight Tee and Cross 103DT-4.1.2-5 Hygienic Clamp Joint: Short Outlet Tee 104DT-4.

46、1.2-6 Automatic Tube Weld: Reducing Tee 104DT-4.1.2-7 Automatic Tube Weld: Short Outlet Hygienic Clamp, JointReducing Tee . 105DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee . 106DT-4.1.2-9 Hygienic Clamp Joint: Short Outlet Reducing Tee 107DT-4.1.2-10 Automatic Tube Weld: Instrument Tee . 107DT-4.1.

47、2-11 Hygienic Clamp Joint: Instrument Tee . 107DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer . 108DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer 109DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer . 110DT-4.1.4-1 Automatic Tube Weld: F

48、errule 111DT-4.1.5-1 Automatic Tube Weld: Cap . 112DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap . 112DT-4.4.1-1 Hygienic Clamp Joint: Weir Style Diaphragm Valve 113DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances . 114DT-7-2 Transfer Panel and Jumper Tolerances . 116DT-9.3-1 Hygien

49、ic Clamp Ferrule: Design Criteria 117MJ-6.3-1 Tube/Pipe Diameter Limits for Orbital GTAW PerformanceQualification . 120MJ-6.3-2 Weld Thickness Limits for Orbital GTAW Performance Qualification . 120MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Pressure Vesselsand Tanks 126MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Pipe . 128MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds onTube-to-Tube Butt Joints 130MJ-8.5-1 Visual Examination Acceptance Criteria for Tube-Attachment Welds . 136viiSF-2.2-1 Acceptance Criteria for Metallic