ASME BPE-2009 Bioprocessing Equipment (BPE - 2009)《生物加工设备》.pdf

1、AN INTERNATIONAL STANDARDASME BPE-2009(Revision of ASME BPE-2007)Bioprocessing EquipmentCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ASME BPE-2009(Revision of ASME BPE-2007)BioprocessingEquipme

2、ntAN INTERNATIONAL STANDARDCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-Date of Issuance: October 20, 2009The next edition of this Standard is scheduled for publication in 2012. There will be n

3、o addendaissued to this edition.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 Code Cases.Code Cases and interpretations are published on the ASME Web site under the

4、 Committee Pages athttp:/cstools.asme.org as they are issued.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 Standards Committee that approved

5、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 input from industry, academia,re

6、gulatory 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 mentioned in this document, and does

7、 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 risk of infringement of such

8、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 interpretations of this document issue

9、d 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 the publisher.The American So

10、ciety of Mechanical EngineersThree Park Avenue, New York, NY 10016-5990Copyright 2009 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 l

11、icense from IHS-,-,-CONTENTSForeword ixStatements of Policy . xCommittee Roster . xiSummary of Changes xvPart GR General Requirements 1GR-1 Introduction 1GR-2 Scope 1GR-3 Inspection 1GR-4 Inspector/Examiner 1GR-5 Responsibilities . 3GR-6 Access for Inspectors . 3GR-7 Manufacturers Quality Assurance

12、Program . 3GR-8 Metric 3GR-9 References . 3GR-10 Terms and Definitions 7Part SD Design for Sterility and Cleanability. 14SD-1 Introduction 14SD-2 Scope and Purpose . 14SD-3 General Guidelines . 14SD-4 Specific Guidelines . 18SD-5 Testing . 37SD-6 Documentation . 37SD-7 Responsibilities . 38Part DT D

13、imensions and Tolerances for Stainless Steel Automatic Welding andHygienic Clamp Tube Fittings and Process Components 82DT-1 Scope 82DT-2 Pressure Rating 82DT-3 Marking . 82DT-4 Materials . 82DT-5 Metal Thickness 82DT-6 Fitting Dimensions . 82DT-7 Tests . 83DT-8 Tolerances 83DT-9 Welding Ends 83DT-1

14、0 Hygienic Clamp Unions 83DT-11 Heat Treatment . 83DT-12 Surface Condition 84DT-13 Packaging 84DT-14 Minimum Examination Requirements . 84DT-V-1 Scope 84DT-V-2 Pressure Rating 84DT-V-3 Marking . 84DT-V-4 Materials . 85DT-V-5 Metal Thickness 85DT-V-6 Valve Dimension . 85DT-V-7 Tests . 85DT-V-8 Tolera

15、nces 85DT-V-9 Welding Ends 85iiiCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-DT-V-10 Hygienic Clamp Ends 85DT-V-11 Surface Condition 85Part MJ Material Joining 108MJ-1 Scope 108MJ-2 Materials .

16、 108MJ-3 Joining Processes and Procedures . 108MJ-4 Weld Joint Design and Preparation 109MJ-5 Filler Material 110MJ-6 Weld Acceptance Criteria . 110MJ-7 Inspection, Examination, and Testing 110MJ-8 Procedure Qualification . 117MJ-9 Performance Qualification 117MJ-10 Documentation Requirements . 118M

17、J-11 Passivation . 119Part SF Stainless Steel and Higher Alloy Product Contact Surface Finishes 120SF-1 Scope 120SF-2 Objective . 120SF-3 Applications . 120SF-4 Material 120SF-5 Inspection and Techniques Employed in the Classification of ProductContact Surface Finishes 120SF-6 Surface Condition 120S

18、F-7 Electropolishing Procedure Qualification 120SF-8 Passivation Procedure 123SF-9 Normative References 123SF-10 Rouge and Stainless Steel . 123SF-P-1 Scope 124SF-P-2 Objective . 124SF-P-3 Applications . 124SF-P-4 Materials . 124SF-P-5 Inspection and Techniques Employed in the Classification of Prod

19、uctContact Surface Finishes 124SF-P-6 Surface Condition 124Part SG Equipment Seals. 126SG-1 Scope and Purpose . 126SG-2 Seal Classes 126SG-3 General Provisions for Seals in Bioprocessing Service: User Basic DesignRequirement . 127SG-4 Special Provisions for Seals in Bioprocessing Service . 131Part P

20、M Polymer-Based Materials . 144PM-1 Introduction 144PM-2 Design Considerations for Polymeric Piping, Tubing, Fittings, ValveBodies, and Other Components . 144PM-3 Polymer Material Joining . 146PM-4 Polymer Interior Product Contact Surfaces of Piping, Tubing, Fittings,Valve Bodies, and Coated or Line

21、d Vessels 150PM-5 Materials of Construction . 150PM-6 Elastomer Performance Properties . 151PM-7 Single-Use Components and Assemblies 151PM-8 Hose Assemblies . 153Part CR Certification . 155CR-1 Introduction 155CR-2 General 155CR-3 Acquiring an ASME BPE Certificate . 157ivCopyright ASME Internationa

22、l Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-CR-4 Requirements Subject to Change 158Part MMOC Metallic Materials of Construction 159MMOC-1 General 159MMOC-2 Alloy Designations . 159MMOC-3 Uses of Specifications . 159MMOC

23、-4 Referenced Specifications . 161MMOC-5 Fabrication . 163MMOC-6 Mechanical Properties 166MMOC-7 Corrosion Resistance Requirements . 166MMOC-8 Surface Finish Requirements 167MMOC-9 Unlisted Alloys . 167FiguresSD-1 Hygienic Connections 39SD-2 Nonhygienic Connections . 40SD-3 Flat Gasket Applications

24、41SD-4 Recommended and Preferred Drop Designs . 42SD-5 Double Block-and-Bleed Valve Assembly 43SD-6 Instrument Location Detail: Hygienic Design 44SD-7-1 Flexible Hygienic Hose Design 45SD-7-2 Pump Impeller Configurations 45SD-7-3 Acceptable Impeller Attachments . 46SD-7-4 Casing Drain Configurations

25、 46SD-7-5 Casing Drain L/D Ratios . 47SD-8 Tank/Vessel Vent Filters 47SD-9 Nozzle Design . 48SD-10 Sidewall Instrument Ports . 49SD-11 Dip Tube . 49SD-12 Vessel Design Tangential Nozzles . 50SD-13 Vessel Sight Glass Design . 51SD-14 Side and Bottom Connections . 52SD-15 Agitator Mounting Flanges . 5

26、3SD-16 Sight Glass Design . 54SD-17 Internal Support Members 55SD-18 Mitered Fittings 56SD-19 Typical Nozzle Detail . 56SD-20 Double Tubesheet Heat Exchanger Bonnet Design . 57SD-21-1 Shaft Coupling Construction 58SD-21-2 Shaft Coupling Seal Arrangements 59SD-21-3 Fastener Seal Arrangements 60SD-21-

27、4 Shaft Steady Bearing . 61SD-21-5 Magnetically Coupled Mixer (Typical Bottom-Mount) 62SD-21-6 Double Mechanical Cartridge Seal With Debris Well . 63SD-22-1 Typical Clean Steam System Isometric 64SD-22-2 Clean Steam Point-of-Use Design . 65SD-22-3 Steam Traps for Clean Steam Systems . 65SD-23-1 Poin

28、t-of-Use Piping . 66SD-23-2 Physical Break in Point-of-Use Piping . 67SD-23-3 Static Spray Device . 67SD-23-4 CIP Looped Header (Supply or Return) . 68SD-23-5 Zero-Static Chain . 68SD-23-6 Swing Elbow Arrangement . 69SD-24 Transfer Panel Tolerances . 70SD-25 Transfer Panel Looped Headers . 71SD-26 T

29、ransfer Panel Jumpers . 72SD-27-1 Fermentor Sterile Envelope . 73SD-27-2 Bioreactor Sterile Envelope . 74vCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-SD-28-1 Gas Sparging Assembly Lance . 74SD

30、-28-2 Gas Sparging Assembly Sintered . 75SD-28-3 Gas Sparging Assembly Ring 76SD-28-4 Gas Sparging Assembly Single Orifice 76SD-29-1 Exhaust Gas Condenser 77SD-29-2 Exhaust Gas Heater 77SD-30 Electrically Heat Traced Filter Housing 77DT-1 Clamp Conditions at Installation 86MJ-1 Acceptable and Unacce

31、ptable Weld Profiles for Tube Welds 115SG-1 Basic Components of a Seal . 133SG-2 Single Dry Running Contacting Seal 134SG-3 Internally Mounted, Process Lubricated Contact Seal 134SG-4 Externally Mounted, Process Lubricated Contact Seal 135SG-5 Double Seal Installation 135SG-6 Tandem Seal Installatio

32、n 136SG-7 Seal Piping and Lubrication Plans 137SG-8 Gas Lubricated Noncontacting Double Seal . 138SG-9 Tandem Seal With Barrier System . 138SG-10 Typical Packing Installation . 139SG-11 V-Ring Packing for Reciprocating Applications 139SG-12 Open Cross-Sectional Lip Seal 139SG-13 Labyrinth Seal 139SG

33、-14 Typical Angle Valve With Rolling Diaphragm and Orifice 140SG-15 Example of Sampling Valve With Uniformly Loaded Sliding Seal 141SG-16 Typical In-Line Diaphragm Valve With Weir . 141SG-17 Typical Ball Valve Configuration 142SG-18 Example of Secondary Seal Design 142PM-1 Acceptable and Unacceptabl

34、e Weld Profiles for Beadless Welds 149CR-1 Options for Certification of Organizations . 156TablesGR-1 Inspectors Delegate Capabilities 4SD-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight TeeWith Blind Cap 78SD-2 L/D Dimensions for Flow-Through Tee: Short Outlet Reducing Tee WithBl

35、ind Cap 79SD-3 Slope Designations for Gravity-Drained Lines . 80SD-4 Annular Spacing Recommendations for Hygienic Dip Tubes . 80SD-5 Recommended Flow Rates to Achieve 5 ft/sec (1.52 m/s) . 80SD-6 Recommended Flow Rates to Static Spray Devices to Ensure Coverageof Vertical Process Vessels 81SD-7 Tran

36、sfer Panel and Jumper Tolerances . 81DT-1 Nominal O.D. Tubing Sizes . 87DT-2 Hygienic Unions: Rated Internal Working Pressure 87DT-3 Chemical Composition for Automatic Weld Ends, % . 88DT-4 Tangent Lengths 88DT-5-1 Final Tolerances for Mechanically Polished Fittings and ProcessComponents . 89DT-5-2

37、Hygienic Clamp Ferrule Standard Dimensions and Tolerances . 90DT-5-3 Hygienic Clamp Ferrule: Design Criteria 92DT-6 Final Tolerances for Electropolished Fittings and Process Components 93DT-7 Automatic Tube Weld: 90-deg Elbow 93DT-8 Automatic Tube Weld: 45-deg Elbow 93DT-9 Automatic Tube Weld: Strai

38、ght Tee and Cross . 94DT-10 Automatic Tube Weld: Reducing Tee 94DT-11 Automatic Tube Weld: Concentric and Eccentric Reducer 95DT-12 Automatic Tube Weld: Hygienic Clamp Joint, 90-deg Elbow . 95viCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or netw

39、orking permitted without license from IHS-,-,-DT-13 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow . 96DT-14 Automatic Tube Weld: Short Outlet Hygienic Clamp JointReducing Tee 96DT-15 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee . 97DT-16 Hygienic Clamp Joint: 90-deg Elbow 97D

40、T-17 Hygienic Clamp Joint: 45-deg Elbow 98DT-18 Hygienic Clamp Joint: Straight Tee and Cross . 98DT-19 Hygienic Clamp Joint: Reducing Tee 99DT-20 Hygienic Clamp Joint: Short Outlet Reducing Tee 100DT-21 Hygienic Clamp Joint: Concentric and Eccentric Reducer 101DT-22 Automatic Tube Weld: Ferrule 102D

41、T-23 Automatic Tube Weld: 180-deg Return Bend . 103DT-24 Hygienic Clamp Joint: 180-deg Return Bend . 103DT-25 Hygienic Mechanical Joint: Short Outlet Run Tee 104DT-26 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer . 104DT-27 Hygienic Clamp Joint: Short Outlet Tee . 105DT-28 Automat

42、ic Tube Weld: Instrument Tee . 105DT-29 Hygienic Clamp Joint: Instrument Tee . 105DT-30 Automatic Tube Weld: Cap . 105DT-31 Hygienic Clamp Joint: Solid End Cap . 106DT-V-1 Hygienic Clamp Joint: Weir Style Diaphragm Valve 107MJ-1 Acceptance Criteria for Welds on Pressure Vessels and Tanks 111MJ-2 Acc

43、eptance Criteria for Welds on Pipe 112MJ-3 Acceptance Criteria for Welds on Tube 113MJ-4 Acceptance Criteria for Tube-Attachment Welds . 114MJ-5 Tube/Pipe Diameter Limits for Orbital GTAW PerformanceQualification . 117MJ-6 Weld Thickness Limits for Orbital GTAW Performance Qualification . 117SF-1 Ac

44、ceptance Criteria for Stainless Steel and Higher Alloy MechanicallyPolished Product Contact Surface Finishes 121SF-2 Acceptance Criteria for Mechanically Polished and ElectropolishedProduct Contact Surface Finishes . 122SF-3 RaReadings for Product Contact Surfaces . 122SF-4 Acceptance Criteria for P

45、assivated Product Contact Surface Finishes . 123SF-P-1 Acceptance Criteria for Polymer Product Contact Surface Finishes . 125SF-P-2 RaReadings for Product Contact Surfaces . 125SG-1 Common Rotary Seal Materials for Biochemical and Sterile Service 143PM-1 Size Comparison of Common Thermoplastic Sizin

46、g Standards . 145PM-2 Thermoset Elastomers Test Properties . 152MMOC-1 Wrought Stainless Steels: Nominal Compositions p (wt. %) . 160MMOC-2 Wrought Nickel Alloys: Nominal Compositions p (wt. %) . 160MMOC-3 Stainless Steel and Nickel Alloy Cast Designations 161MMOC-4 Chemical Composition for 316L Aut

47、omatic Weld Ends 164MMOC-5 Filler Metals 165MMOC-6 Consumable Inserts for Super-Austenitic and Duplex Stainless Steels 165MMOC-7 Predicted Ferrite Number (FN) Ranges forVarious 316 Product Forms and Welds 166Nonmandatory AppendicesA Commentary: Slag 169B Material Examination Log and Weld Log 170C Sl

48、ope Measurement . 175D Rouge and Stainless Steel . 176E Passivation Procedure Qualification . 185F Corrosion Testing . 195G Ferrite . 198H Electropolishing Procedure Qualification 199viiCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networking p

49、ermitted without license from IHS-,-,-I Vendor Documentation Requirements for New Instruments 201J Standard Process Test Conditions (SPTC) for Seal PerformanceEvaluation . 205K Interpretation of Elastomer Material Property Changes 209Index 211viiiCopyright ASME International Provided by IHS under license with ASME Not for ResaleNo reproduction or networ