ASME BPE-2012 BPE - 2012 Bioprocessing Equipment with Errata《生物加工设备》.pdf

1、Bioprocessing EquipmentAN INTERNATIONAL STANDARDASME BPE-2012(Revision of ASME BPE-2009)Copyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-Copyright ASME International Provided by IHS under license w

2、ith ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ASME BPE-2012(Revision of ASME BPE-2009)BioprocessingEquipmentAN INTERNATIONAL STANDARDThree Park Avenue New York, NY 10016 USACopyright ASME International Provided by IHS under license with ASME Not for Resa

3、leNo reproduction or networking permitted without license from IHS-,-,-Date of Issuance: September 28, 2012The next edition of this Standard is scheduled for publication in 2014. There will be no addendaissued to this edition.ASME issues written replies to inquiries concerning interpretations of tec

4、hnical aspects of thisStandard. Periodically, certain actions of the ASME BPE Committee may be published as Code Cases.Code Cases and interpretations 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

5、on the ASME Web site under the Committee Pages toprovide corrections to incorrectly published items, or to correct typographical or grammatical errorsin 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 a

6、vailable toautomatically receive an e-mail notification when errata are posted to a particular code or standard.This option can be found on the appropriate Committee Page after selecting “Errata” in the “PublicationInformation” section.ASME is the registered trademark of The American Society of Mech

7、anical Engineers.This code or standard was developed under procedures accredited as meeting the criteria for American NationalStandards. The Standards Committee that approved the code or standard was balanced to assure that individuals fromcompetent and concerned interests have had an opportunity to

8、 participate. The proposed code or standard was madeavailable for public review and comment that provides an opportunity 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

9、device, or activity.ASME does not take any position with respect to the validity of any patent 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

10、assume any such liability. Users of a code or standard are expresslyadvised that determination 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 in

11、dustry is not to be interpreted asgovernment or industry endorsement of this code or standard.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 individu

12、als.No part of this document may be reproduced in any form,in an electronic retrieval system or otherwise,without the prior written permission of the publisher.The American Society of Mechanical EngineersThree Park Avenue, New York, NY 10016-5990Copyright 2012 byTHE AMERICAN SOCIETY OF MECHANICAL EN

13、GINEERSAll rights reservedPrinted in U.S.A.Copyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-CONTENTSForeword ixStatements of Policy . xCommittee Roster . xiSummary of Changes xvPart GR General Requ

14、irements 1GR-1 Introduction 1GR-2 Scope of the ASME BPE Standard . 1GR-3 Manufacturers Quality Assurance Program . 1GR-4 Inspection 2GR-5 Documentation Requirements . 5GR-6 Metric 8GR-7 References 8GR-8 Terms and Definitions 10Part SD Systems Design 17SD-1 Purpose and Scope . 17SD-2 General Guidelin

15、es . 17SD-3 Process Components 20SD-4 Process Utilities 56SD-5 Process Systems 61SD-6 Testing . 79Part DT Dimensions and Tolerances for Process Components 81DT-1 Purpose and Scope . 81DT-2 Pressure Rating . 81DT-3 Wall Thickness . 81DT-4 Dimensions . 81DT-5 Materials . 82DT-6 Tests . 82DT-7 Toleranc

16、es 82DT-8 Weld Ends . 82DT-9 Hygienic Clamp Unions 82DT-10 Minimum Examination Requirements . 82DT-11 Marking 83DT-12 Packaging 83Part MJ Material Joining 110MJ-1 Purpose and Scope . 110MJ-2 Materials . 110MJ-3 Weld Joint Design and Preparation 110MJ-4 Joining Processes and Procedures . 111MJ-5 Proc

17、edure Qualifications 112MJ-6 Performance Qualifications 112MJ-7 Examination, Inspection, and Testing 112MJ-8 Weld Acceptance Criteria . 114MJ-9 Documentation Requirements . 114MJ-10 Passivation . 114Part SF Product Contact Surface Finishes 123SF-1 Purpose and Scope . 123SF-2 Metallic Applications .

18、123iiiCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-SF-3 Polymeric Applications . 126Part SG Sealing Components . 128SG-1 Purpose and Scope . 128SG-2 Sealing Component Types . 128SG-3 Sealing Co

19、mponents General Design Requirements (GeneralProvisions) . 144SG-4 Seal Performance Requirements . 150SG-5 Seal Applications . 152Part PM Polymeric and Other Nonmetallic Materials 153PM-1 Purpose and Scope . 153PM-2 Materials . 153PM-3 Properties and Performance . 155PM-4 Applications 157Part CR Cer

20、tification . 166CR-1 Purpose and Scope . 166CR-2 General 166CR-3 Acquiring an ASME BPE Certificate . 169CR-4 Requirements Subject to Change 171Part MM Metallic Materials 172MM-1 Purpose and Scope . 172MM-2 Alloy Designations . 172MM-3 Uses of Specifications . 172MM-4 Referenced Specifications . 173M

21、M-5 Fabrication . 176MM-6 Mechanical Properties 180MM-7 Corrosion Resistance Requirements 181MM-8 Unlisted Alloys . 181Part PI Process Instrumentation 182PI-1 Purpose and Scope . 182PI-2 Process Instrumentation General Requirements 182PI-3 Instrument Receiving, Handling, and Storage 183PI-4 Flowmete

22、rs . 183PI-5 Level Instruments 187PI-6 Pressure Instruments 187PI-7 Temperature Instruments . 187PI-8 Analytical Instruments 187PI-9 Optical . 194FiguresSD-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

23、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 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 Si

24、de and Bottom Connections . 33SD-3.4.2-3 Sidewall Instrument Ports . 33SD-3.2.4-4 Accepted Nozzle Penetrations . 34SD-3.4.2-5 Vessel Design Tangential Nozzles . 35SD-3.4.2-6 Sight Glass Design (Accepted) 36SD-3.4.2-7 Typical Nozzle Detail . 37ivCopyright ASME International Provided by IHS under lice

25、nse with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-SD-3.4.3-1 Internal Support Members 38SD-3.5.1-1 Agitator Mounting Flanges . 40SD-3.5.2-1 Shaft Coupling Construction 41SD-3.5.2-2 Shaft Coupling Seal Arrangments . 41SD-3.5.2-3 Fastener Seal Arrangement

26、s . 42SD-3.5.5-1 Shaft Steady Bearing 43SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) 44SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design . 46SD-3.7.1-1 Transfer Panel Looped Headers . 47SD-3.7.2-1 Transfer Panel Tolerances . 48SD-3.7.4-1 Transfer Panel Jumpers . 50SD-3.9.1-1 D

27、ynamic Spray Device: Single Axis . 51SD-3.9.1-2 Two Axes Dynamic Spray Device . 51SD-3.9.2.1-1 Static Spray Device . 53SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels . 53SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels 54SD-3.9.2.3-1 Impact Pattern Build-Up 54SD

28、-3.12-1 Steam Traps for Clean Steam Systems . 56SD-4.1.2.1-1 Point-of-Use Piping . 57SD-4.1.2.2-1 Physical Break in Point-of-Use Piping . 58SD-4.2.2-1 Typical Clean Steam System Isometric . 59SD-4.2.2-2 Clean Steam Point-of-Use Design 60SD-5.1.1.1-1 Fermentor Sterile Envelope . 62SD-5.1.1.1-2 Biorea

29、ctor Sterile Envelope 63SD-5.1.1.2.3-1 Gas Sparging Assembly Lance . 65SD-5.1.1.2.3-2 Gas Sparging Assembly Sintered . 66SD-5.1.1.2.3-3 Gas Sparging Assembly Ring . 67SD-5.1.1.2.3-4 Gas Sparging Assembly Single Orifice 68SD-5.1.1.3.1-1 Exhaust Gas Condenser . 69SD-5.1.1.3.1-2 Exhaust Gas Heater . 69

30、SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing 71SD-5.2.1-1 Tank/Vessel Vent Filters 72SD-5.3.3.5.1-1 CIP Looped Header (Supply or Return) . 77SD-5.3.3.5.1-2 Zero-Static Chain . 78SD-5.3.3.5.1-3 Swing Elbow Arrangement . 78DT-2-1 Clamp Conditions at Installation 85MJ-8.4-1 Acceptable and Una

31、cceptable Weld Profiles for Tube Welds 119MJ-8.4-2 Discoloration Acceptance Criteria for Weld Heat-Affected Zones onElectropolished 316L Tubing 120MJ-8.4-3 Discoloration Acceptance Criteria for Weld Heat-Affected Zones onMechanically Polished 316L Tubing . 121SG-2.2.2-1 Hygienic Union per Table DT-7

32、-1 . 129SG-2.2.2-2 Hygienic Clamp Union per Table DT-7-1 129SG-2.2.2-3 Hygienic Union per DIN 11864 . 130SG-2.2.2-4 Hygienic Clamp Union per DIN 11864 130SG-2.2.2-5 Nonhygienic Connections . 131SG-2.3.1.2-1 Weir Valves . 132SG-2.3.1.2-2 Radial Valves . 133SG-2.3.1.2-3 Weirless Diaphragm Valve 133SG-

33、2.3.1.2-4 Linear Control Valves . 134SG-2.3.1.2-5 Regulator Valve 134SG-2.3.1.3-1 Ball Valves . 135SG-2.3.1.4-1 Rising Stem Single, Double Seat Mix Proof, and Needle Valves . 135SG-2.3.1.5-1 Butterfly Valve . 136SG-2.3.1.7-1 Back Pressure Control Valve 136SG-2.3.1.8-1 Pinch Valve 137vCopyright ASME

34、International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-SG-2.3.1.9-1 Pressure Relief and Check Valves . 137SG-2.3.1.10-1 Plug Valve . 137SG-2.3.2.2-1 Single Mechanical Seal 138SG-2.3.2.2-2 Single Seal for Top Entry Agit

35、ator . 138SG-2.3.2.3-1 Dual Pressurized Mechanical Seal for Pumps 139SG-2.3.2.3-2 Dual Pressurized Mechanical Seal for Top Entry Agitator 139SG-2.3.2.3-3 Dual Unpressurized Mechanical Seal for Pumps . 139SG-2.3.2.4-1 Flush Plan 01 . 140SG-2.3.2.4-2 Flush Plan 02 . 140SG-2.3.2.4-3 Flush Plan 11 . 140

36、SG-2.3.2.4-4 Flush Plan 32 . 141SG-2.3.2.4-5 Flush Plan 52 for Pump . 141SG-2.3.2.4-6 Flush Plan 52 for Top Entry Agitator 142SG-2.3.2.4-7 Flush Plan BPE52 for Pump . 142SG-2.3.2.4-8 Flush Plan 53 for Pump . 142SG-2.3.2.4-9 Flush Plan 53 for Top Entry Agitator 142SG-2.3.2.4-10 Flush Plan 54 for Pump

37、 . 143SG-2.3.2.4-11 Flush Plan 54 for Top Entry Agitator 143SG-2.3.2.4-12 Flush Plan 74 for Pump . 143SG-2.3.2.4-13 Flush Plan 74 for Top Entry Agitator 143SG-3.3.2.2-1 Static O-Ring . 146SG-3.3.2.3-1 Seals for Rising Stem Valves 148SG-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion 1

38、51PM-4.2.8.1-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds 163CR-2.3.1-1 ASME Mark With BPE Designator 166CR-2.3.2-1 Options for Certification of Organizations . 167PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples . 183PI-2.2.2-1 Accepted Insertion Device Installation

39、 Examples 184PI-4.1.3.2-1 Manifold or Flow Splitter for Dual Tube Construction Flowmeters andPotentialforProductHoldup . 185PI-4.1.3.3-1 Concentrically Reducing Process Connection . 186PI-4.1.4.3-1 Vertical Installation . 186PI-4.1.4.4-1 Minimum Angle of Inclination, H9251 . 186PI-8.1.2-1 Conductivi

40、ty Type Examples 188PI-8.1.3-1 Accepted Installations for Conductivity Sensors . 189PI-8.1.3.6-1 Installation Clearance Requirements . 190PI-8.2.2-1 pH Sensor Components . 191PI-8.2.3-1 Accepted pH Sensor Installations . 192PI-8.2.3.4-1 Accepted Mounting Orientations 193PI-8.2.3.5-1 Insertion Length

41、 or Depth 194PI-9.1.3.3-1 Vessel Light Glass Design and Mounting 196PI-9.1.3.5-1 In-Line Insertion Length 197PI-9.1.3.5-2 Insertion Probe Length 197TablesGR-4.2-1 Inspectors Delegate Capabilities 3SD-2.4.3.1-1 Slope Designations for Gravity-Drained Lines . 19SD-3.1.2.2-1 L/D Dimensions for Flow-Thro

42、ugh Tee: Full-Size Standard StraightTee With Blind Cap . 22SD-3.1.2.2-2 L/D Dimensions for Flow-Through Tee: Short Outlet 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) . 76DT-2-1 Hygienic Unio

43、ns: Rated Internal Working Pressure 84DT-3-1 Final Tolerances for Mechanically Polished Fittings and ProcessComponents . 86DT-3-2 Final Tolerances for Electropolished Fittings and Process Components 87viCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproductio

44、n or networking permitted without license from IHS-,-,-DT-4-1 Nominal O.D. Tubing Sizes . 87DT-4.1-1 Tangent Lengths 87DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow 88DT-4.1.1-2 Automatic Tube Weld: Hygienic Clamp Joint, 90-deg Elbow 88DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Elbow 89DT-4.1.1-4 Automa

45、tic Tube Weld: 45-deg Elbow 89DT-4.1.1-5 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow 90DT-4.1.1-6 Hygienic Clamp Joint: 45-deg Elbow 90DT-4.1.1-7 Automatic Tube Weld: 180-deg Return Bend . 91DT-4.1.1-8 Hygienic Clamp Joint: 180-deg Return Bend . 91DT-4.1.2-1 Automatic Tube Weld: Straight

46、 Tee and Cross . 92DT-4.1.2-2 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee 92DT-4.1.2-3 Hygienic Mechanical Joint: Short Outlet Run Tee 93DT-4.1.2-4 Hygienic Clamp Joint: Straight Tee and Cross 93DT-4.1.2-5 Hygienic Clamp Joint: Short Outlet Tee 94DT-4.1.2-6 Automatic Tube Weld: Reduci

47、ng Tee 94DT-4.1.2-7 Automatic Tube Weld: Short Outlet Hygienic Clamp, JointReducing Tee . 95DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee . 96DT-4.1.2-9 Hygienic Clamp Joint: Short Outlet Reducing Tee 97DT-4.1.2-10 Automatic Tube Weld: Instrument Tee . 97DT-4.1.2-11 Hygienic Clamp Joint: Instrument

48、Tee . 97DT-4.1.3-1(a) Automatic Tube Weld: Concentric and Eccentric Reducer . 98DT-4.1.3-1(b) Automatic Tube Weld: Concentric and Eccentric Reducer . 99DT-4.1.3-2(a) Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer 100DT-4.1.3-2(b) Hygienic Clamp Joint: Tube Weld Concentric and Eccen

49、tric Reducer 101DT-4.1.3-3(a) Hygienic Clamp Joint: Concentric and Eccentric Reducer . 102DT-4.1.3-3(b) Hygienic Clamp Joint: Concentric and Eccentric Reducer . 103DT-4.1.4-1 Automatic Tube Weld: Ferrule 104DT-4.1.5-1 Automatic Tube Weld: Cap . 105DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap . 105DT-4.4.1-1 Hygienic Clamp Joint: Weir Style Diaphr