1、AN INTERNATIONAL STANDARDBioprocessing EquipmentASME BPE-2005(Revision of ASME BPE-2002)Copyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ASME BPE-2005(Revision of ASME BPE-2002)BioprocessingEquipme
2、ntAN AMERICAN NATIONAL STANDARDThree Park Avenue New York, NY 10016Copyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-Date of Issuance: April 28, 2006The next edition of this Standard is scheduled fo
3、r publication in 2007. There will be no addendaissued to this edition.ASME issues written replies to inquiries concerning interpretations of technical aspects of thisStandard. Interpretations are published on the ASME website under the Committee Pages athttp:/www.asme.org/codes/ as they are issued.A
4、SME 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 Standards Committee that approved the code or standard was balanced to assure that individuals f
5、romcompetent 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 input from industry, academia,regulatory agencies, and the public-at-large.ASME does not “appr
6、ove,” “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 mentioned in this document, and does not undertake to insure anyone utilizing a standard against l
7、iability 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 risk of infringement of such rights, isentirely their own responsibility.Participation by f
8、ederal 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 interpretations of this document issued in accordance with the establishedASME procedures and polici
9、es, 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 the publisher.The American Society of Mechanical EngineersThree Park Avenue, New York, NY 1
10、0016-5990Copyright 2006 byTHE AMERICAN SOCIETY OF MECHANICAL ENGINEERSAll 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 viiStatements of Policy .
11、 viiiCommittee Roster . ixSummary of Changes xiiPart GR General RequirementsGR-1 Introduction . 1GR-2 Scope . 1GR-3 Inspection . 1GR-4 Inspector/Examiner 1GR-5 Responsibilities 1GR-6 Access for Inspectors 2GR-7 Manufacturers Quality Assurance Program 2GR-8 Metric . 2GR-9 References . 2GR-10 Terms an
12、d Definitions . 3Part SD Design for Sterility and CleanabilitySD-1 Introduction . 8SD-2 Scope and Purpose 8SD-3 General Guidelines 8SD-4 Specific Guidelines 19SD-5 Testing and Inspection . 44SD-6 Documentation 46SD-7 Responsibilities 46Part DT Dimensions and Tolerances for Stainless Steel Automatic
13、Welding and HygienicClamp Tube Fittings and Process ComponentsDT-1 Scope . 47DT-2 Pressure Rating 47DT-3 Marking . 47DT-4 Materials 47DT-5 Metal Thickness . 47DT-6 Fitting Dimensions 47DT-7 Tests 48DT-8 Tolerances . 48DT-9 Welding Ends . 48DT-10 Hygienic Clamp Ends 48DT-11 Heat Treatment 48DT-12 Sur
14、face Condition . 48DT-13 Packaging . 48DT-14 Minimum Examination Requirements 48Part MJ Material JoiningMJ-1 Scope . 66MJ-2 Materials 66MJ-3 Joining Processes and Procedures 66MJ-4 Weld Joint Design and Preparation . 67MJ-5 Filler Material . 67MJ-6 Weld Acceptance Criteria 67MJ-7 Inspection, Examina
15、tion, and Testing . 69MJ-8 Procedure Qualification 73iiiCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-MJ-9 Performance Qualification 73MJ-10 Documentation Requirements 73MJ-11 Passivation 74Part
16、 SF Stainless Steel and Higher Alloy Product Contact Surface FinishesSF-1 Scope . 75SF-2 Objective 75SF-3 Applications . 75SF-4 Material . 75SF-7 Inspection and Techniques Employed in the Classification of Product ContactSurface Finishes . 75SF-8 Description of Various Surfaces Available on Stainles
17、s Steel and HigherAlloys 75Part SG Equipment SealsSG-1 Scope and Purpose 82SG-2 Seal Classes . 82SG-3 General Provisions for Seals in Bioprocessing Service: User Basic DesignRequirement 82SG-4 Special Provisions for Seals in Bioprocessing Service 89Part PM Polymer-Based Materials 95PM-1 Introduction
18、 . 95PM-2 Design Considerations for Polymeric Piping, Tubing, Fittings, Valve Bodies,and Other Components 95PM-3 Polymer Material Joining 97PM-4 Polymer Interior Product Contact Surfaces of Piping, Tubing, Fittings, ValveBodies, and Coated or Lined Vessels . 101PM-5 Materials of Construction 101Figu
19、resSD-1 Hygienic Connections 10SD-2 Non-Hygienic Connections . 12SD-3 Flat Gasket Applications . 13SD-4 Recommended and Preferred Drop Designs 17SD-5 Double Block-and-Bleed Valve Assembly . 18SD-6 Instrument Location Detail: Hygienic Design . 19SD-7 Flexible Hygienic Hose Design . 20SD-8 Tank/Vessel
20、 Vent Filters . 22SD-9 Nozzle Design . 24SD-10 Sidewall Instrument Ports 25SD-11 Dip Tube 26SD-12 Vessel Design Tangential Nozzles 26SD-13 Vessel Sight Glass Design 27SD-14 Side and Bottom Connections 28SD-15 Dip Tube Nozzles: Removable Designs . 29SD-16 Sight Glass Design . 30SD-17 Internal Support
21、 Members . 31SD-18 Mitered Fittings . 32SD-19 Typical Nozzle Detail 32SD-20 Double Tubesheet Heat Exchanger Bonnet Design 33SD-21 In-Tank Couplings . 34SD-22 Removable Agitator Impeller Design . 36SD-23 Point-of-Use Piping 38SD-24 Transfer Panel Tolerances 42SD-25 Transfer Panel Looped Headers 43SD-
22、26 Transfer Panel Jumpers 45MJ-1 Acceptable and Unacceptable Weld Profiles for Tube Welds . 71SG-1 Basic Components of a Seal 85ivCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-SG-2 Single Dry Ru
23、nning Contacting Seal 86SG-3 Internally Mounted, Process Lubricated Contact Seal 86SG-4 Externally Mounted, Process Lubricated Contact Seal . 87SG-5 Double Seal Installation 87SG-6 Tandem Seal Installation . 88SG-7 Seal Piping and Lubrication Plans 89SG-8 Gas Lubricated Noncontacting Double Seal . 9
24、0SG-9 Tandem Seal With Barrier System 90SG-10 Typical Packing Installation 91SG-11 V-Ring Packing for Reciprocating Applications . 91SG-12 Open Cross-Sectional Lip Seal 91SG-13 Labyrinth Seal . 91SG-14 Typical Angle Valve With Rolling Diaphragm and Orifice . 92SG-15 Example of Sampling Valve With Un
25、iformly Loaded Sliding Seal . 93SG-16 Typical In-Line Diaphragm Valve With Weir 93SG-17 Typical Ball Valve Configuration . 94PM-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds . 100TablesSD-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee WithBlind Cap . 14SD-2 L
26、/D Dimensions for Flow-Through Tee: Short Outlet Reducing Tee With BlindCap . 15SD-3 Annular Spacing Recommendations for Hygienic Dip Tubes 25SD-4 Recommended Flow Rates to Achieve 5 fps (1.52 mps) . 40SD-5 Recommended Flow Rates for Cleaning Vertical Cylindrical VesselsHaving Dished Heads . 40SD-6
27、Transfer Panel and Jumper Tolerances 44DT-1 Nominal OD Tubing Sizes . 50DT-2 Hygienic Unions . 51DT-3 Chemical Composition for Automatic Weld Ends, % 51DT-4 Tangent Lengths . 51DT-5 Final Tolerances for Mechanically Polished Fittings and ProcessComponents 52DT-5.1 Hygienic Clamp Ferrule Standard Dim
28、ensions and Tolerances 53DT-6 Final Tolerances for Electropolished Fittings and Process Components . 54DT-7 Automatic Tube Weld: 90 deg Elbow . 54DT-8 Automatic Tube Weld: 45 deg Elbow . 54DT-9 Automatic Tube Weld: Straight Tee and Cross 55DT-10 Automatic Tube Weld: Reducing Tee . 55DT-11 Automatic
29、Tube Weld: Concentric and Eccentric Reducer 56DT-12 Automatic Tube Weld: Hygienic Clamp Joint, 90 deg Elbow . 56DT-13 Automatic Tube Weld: Hygienic Clamp Joint, 45 deg Elbow . 57DT-14 Automatic Tube Weld: Short Outlet Hygienic Clamp JointReducing Tee 57DT-15 Automatic Tube Weld: Short Outlet Hygieni
30、c Clamp Joint Tee . 58DT-16 Hygienic Clamp Joint: 90 deg Elbow . 58DT-17 Hygienic Clamp Joint: 45 deg Elbow . 59DT-18 Hygienic Clamp Joint: Straight Tee and Cross . 59DT-19 Hygienic Clamp Joint: Reducing Tee 60DT-20 Hygienic Clamp Joint: Short Outlet Reducing Tee . 60DT-21 Hygienic Clamp Joint: Conc
31、entric and Eccentric Reducer 61DT-22 Automatic Tube Weld: Ferrule . 62DT-23 Automatic Tube Weld: 180 deg Return Bend 63DT-24 Hygienic Clamp Joint: 180 deg Return Bend 63DT-25 Hygienic Mechanical Joint: Short Outlet Run Tee . 64DT-26 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer .
32、64vCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-DT-27 Hygienic Clamp Joint: Short Outlet Tee . 65DT-28 Automatic Tube Weld: Instrument Tee 65DT-29 Hygienic Clamp Joint: Instrument Tee 65DT-30 A
33、utomatic Tube Weld: Cap 65MJ-1 Acceptance Criteria for Welds on Pressure Vessels and Tanks . 68MJ-2 Acceptance Criteria for Welds on Pipe 69MJ-3 Acceptance Criteria for Welds on Tube . 70SF-1 Acceptance Criteria for Product Contact Surface Finishes of Tubing . 77SF-2 RaReadings for Tubing 77SF-3 Acc
34、eptance Criteria for Product Contact Surface Finishes of Fittings . 78SF-4 RaReadings for Fittings 78SF-5 Acceptance Criteria for Product Contact Surface Finishes of Valve Bodies 79SF-6 RaReadings for Valves . 79SF-7 Acceptance Criteria for Product Contact Surface Finishes of Vessels . 80SF-8 RaRead
35、ings for Vessels 80SF-9 Acceptance Criteria for Product Contact Surface Finishes of Other ProcessComponents 81SF-10 RaReadings for Other Process Components . 81SG-1 Common Rotary Seal Materials for Biochemical and Sterile Service 88PM-1 Size Comparison of Common Thermoplastic Sizing Standards 96Nonm
36、andatory AppendicesA Commentary: Slag . 103B Material Examination Log and Weld Log . 104Index 109viCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-FOREWORDAt the 1988 ASME Winter Annual Meeting (W
37、AM), many individuals expressed interest indeveloping standards for the design of equipment and components for use in the biopharmaceuti-cal industry. As a result of this interest, the ASME Council on Codes and Standards (CCS) waspetitioned to approve this as a project. The initial scope was approve
38、d by the CCS on June 20,1989, with a directive to the Board on Pressure Technology to initiate this project with the followinginitial scope:This standard is intended for design, materials, construction, inspection, and testing of vessels,piping, and related accessories such as pumps, valves, and fit
39、tings for use in the biopharmaceuticalindustry. The rules provide for the adoption of other ASME and related national standards, andwhen so referenced become part of the standard.At the 1989 WAM, an ad hoc committee was formed to assess the need to develop further thescope and action plan. The commi
40、ttee met in 1990 and there was consensus concerning the needto develop standards that would meet the requirements of operational bioprocessing, including:(a) the need for equipment designs that are both cleanable and sterilizable;(b) the need for special emphasis on the quality of weld surfaces once
41、 the required strengthis present;(c) the need for standardized definitions that can be used by material suppliers, designers/fabricators, and users; and(d) the need to integrate existing standards covering vessels, piping, appurtenances, and otherequipment necessary for the biopharmaceutical industr
42、y without infringing on the scopes ofthose standards.The BPE Main Committee was structured with six functioning subcommittees and an executivecommittee comprising the main committee chair and the subcommittee chairs. The subcommit-tees are:(a) General Requirements;(b) Design Relating to Sterility an
43、d Cleanability of Equipment;(c) Dimensions and Tolerances;(d) Material Joining;(e) Surface Finishes; and(f) Seals.Throughout the development of the Standard, close liaison was made with the European CEN,ASTM, and the AAA Dairy Standards. The purpose was to develop an ASME standard thatwould be disti
44、nctive, germane, and not in conflict with other industry standards. Whereverpossible, the Committee strived to reference existing standards that are applicable to biopharma-ceutical equipment design and fabrication.This Standard represents the work of the BPE Standards Committee and includes the fol
45、low-ing Parts:(a) General Requirements;(b) Design for Sterility and Cleanability;(c) Dimensions and Tolerances for Stainless Steel Automatic Welding and Hygienic ClampTube Fittings;(d) Material Joining;(e) Stainless Steel and Higher Alloy Interior Surface Finishes;(f) Equipment Seals; and(g) Polymer
46、-Based Materials.This edition was approved as an American National Standard on December 22, 2005.Requests for interpretations or suggestions for revision should be sent to Secretary, BPE Commit-tee, The American Society of Mechanical Engineers, Three Park Avenue, New York, NY 10016.vii(05)Copyright
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