_BPE_2012.pdf

Bioprocessing EquipmentAN INTE R NAT IO NAL STANDARDASME BPE-2012(Revision of ASME BPE-2009)-,-,-ASME BPE-2012(Revision of ASME BPE-2009)BioprocessingEquipmentAN INTERNATIONAL STANDARDThree Park Avenue New York,NY 10016 USA-,-,-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 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 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 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 available toautomatically receive an e-mail notification when errata are posted to a particular code or standard.ThisoptioncanbefoundontheappropriateCommitteePageafterselecting“Errata”inthe“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 Standards 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 forpublic review andcomment thatprovides an opportunityfor additional publicinput 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 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 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 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 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 Society of Mechanical EngineersThree Park Avenue,New York,NY 10016-5990Copyright 2012 byTHE AMERICAN SOCIETY OF MECHANICAL ENGINEERSAll rights reservedPrinted in U.S.A.CONTENTSForeword.ixStatements of Policy.xCommittee Roster.xiSummary of Changes.xvPart GRGeneral Requirements.1GR-1Introduction.1GR-2Scope of the ASME BPE Standard.1GR-3Manufacturers Quality Assurance Program.1GR-4Inspection.2GR-5Documentation Requirements.5GR-6Metric.8GR-7References.8GR-8Terms and Definitions.10Part SDSystems Design.17SD-1Purpose and Scope.17SD-2General Guidelines.17SD-3Process Components.20SD-4Process Utilities.56SD-5Process Systems.61SD-6Testing.79Part DTDimensions and Tolerances for Process Components.81DT-1Purpose and Scope.81DT-2Pressure Rating.81DT-3Wall Thickness.81DT-4Dimensions.81DT-5Materials.82DT-6Tests.82DT-7Tolerances.82DT-8Weld Ends.82DT-9Hygienic Clamp Unions.82DT-10Minimum Examination Requirements.82DT-11Marking.83DT-12Packaging.83Part MJMaterial Joining.110MJ-1Purpose and Scope.110MJ-2Materials.110MJ-3Weld Joint Design and Preparation.110MJ-4Joining Processes and Procedures.111MJ-5Procedure Qualifications.112MJ-6Performance Qualifications.112MJ-7Examination,Inspection,and Testing.112MJ-8Weld Acceptance Criteria.114MJ-9Documentation Requirements.114MJ-10Passivation.114Part SFProduct Contact Surface Finishes.123SF-1Purpose and Scope.123SF-2Metallic Applications.123iii-,-,-SF-3Polymeric Applications.126Part SGSealing Components.128SG-1Purpose and Scope.128SG-2Sealing Component Types.128SG-3Sealing Components General Design Requirements(GeneralProvisions).144SG-4Seal Performance Requirements.150SG-5Seal Applications.152Part PMPolymeric and Other Nonmetallic Materials.153PM-1Purpose and Scope.153PM-2Materials.153PM-3Properties and Performance.155PM-4Applications.157Part CRCertification.166CR-1Purpose and Scope.166CR-2General.166CR-3Acquiring an ASME BPE Certificate.169CR-4Requirements Subject to Change.171Part MMMetallic Materials.172MM-1Purpose and Scope.172MM-2Alloy Designations.172MM-3Uses