_BPE_2009.pdf

AN INTERNATIO NAL STANDARDASME BPE-2009(Revision of ASME BPE-2007)Bioprocessing EquipmentCopyright 2009 by the American Society of Mechanical Engineers.No reproduction may be made of this material without written consent of ASME.cCopyrighted material licensed to Stanford University by Thomson Scientific(),downloaded on Oct-05-2010 by Stanford University User.No further reproduction or distribution is permitted.Uncontrolled when printed.ASME BPE-2009(Revision of ASME BPE-2007)BioprocessingEquipmentAN INTERNATIONAL STANDARDCopyright 2009 by the American Society of Mechanical Engineers.No reproduction may be made of this material without written consent of ASME.cCopyrighted material licensed to Stanford University by Thomson Scientific(),downloaded on Oct-05-2010 by Stanford University User.No further reproduction or distribution is permitted.Uncontrolled when printed.Date of Issuance:October 20,2009The next edition of this Standard is scheduled for publication in 2012.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.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 2009 byTHE AMERICAN SOCIETY OF MECHANICAL ENGINEERSAll rights reservedPrinted in U.S.A.Copyright 2009 by the American Society of Mechanical Engineers.No reproduction may be made of this material without written consent of ASME.cCopyrighted material licensed to Stanford University by Thomson Scientific(),downloaded on Oct-05-2010 by Stanford University User.No further reproduction or distribution is permitted.Uncontrolled when printed.CONTENTSForeword.ixStatements of Policy.xCommittee Roster.xiSummary of Changes.xvPart GRGeneral Requirements.1GR-1Introduction.1GR-2Scope.1GR-3Inspection.1GR-4Inspector/Examiner.1GR-5Responsibilities.3GR-6Access for Inspectors.3GR-7Manufacturers Quality Assurance Program.3GR-8Metric.3GR-9References.3GR-10Terms and Definitions.7Part SDDesign for Sterility and Cleanability.14SD-1Introduction.14SD-2Scope and Purpose.14SD-3General Guidelines.14SD-4Specific Guidelines.18SD-5Testing.37SD-6Documentation.37SD-7Responsibilities.38Part DTDimensions and Tolerances for Stainless Steel Automatic Welding andHygienic Clamp Tube Fittings and Process Components.82DT-1Scope.82DT-2Pressure Rating.82DT-3Marking.82DT-4Materials.82DT-5Metal Thickness.82DT-6Fitting Dimensions.82DT-7Tests.83DT-8Tolerances.83DT-9Welding Ends.83DT-10Hygienic Clamp Unions.83DT-11Heat Treatment.83DT-12Surface Condition.84DT-13Packaging.84DT-14Minimum Examination Requirements.84DT-V-1Scope.84DT-V-2Pressure Rating.84DT-V-3Marking.84DT-V-4Materials.85DT-V-5Metal Thickness.85DT-V-6Valve Dimension.85DT-V-7Tests.85DT-V-8Tolerances.85DT-V-9Welding Ends.85iiiCopyright 2009 by the American Society of Mechanical Engineers.No reproduction may be made of this material without written consent of ASME.cCopyrighted material licensed to Stanford University by Thomson Scientific(),downloaded on Oct-05-2010 by Stanford University User.No further reprodu