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ASME has established procedures to authorize qualified organizations to perform various activities in accordance with the requirements of the ASME Codes and Standards. It is the aim of the Society to provide recognition of organizations so authorized. An organization holding authorization to perform various activities in accordance with the requirements of the Codes and Standards may state this capability in its advertising literature.
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Bioprocessing
Equipment
AN INTERNATIONAL STANDARD
ASME BPE-2012
(Revision of ASME BPE-2009)
Copyright
2012 by the American Society of Mechanical Engineers.
No reproduction may be made of this material without written consent of ASME.
c
Copyright
2012 by the American Society of Mechanical Engineers.
No reproduction may be made of this material without written consent of ASME.
c
ASME BPE-2012
(Revision of ASME BPE-2009)
Bioprocessing
Equipment
AN INTERNATIONAL STANDARD
Three Park Avenue • New York, NY • 10016 USA
Copyright
2012 by the American Society of Mechanical Engineers.
No reproduction may be made of this material without written consent of ASME.
c
Date of Issuance: September 28, 2012
The next edition of this Standard is scheduled for publication in 2014. There will be no addenda
issued to this edition.
ASME issues written replies to inquirie s concerning inter pretat ions of te chnical aspects of this
Standard. 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 at
http://cstools.asme.org/ as they are issued.
Errata to codes and standards may be posted on the ASME Web site under the Committee Pages to
provide corrections to incorrectly published items, or to correct typographical or grammatical errors
in 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 to
automatically 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 “Publication
Information” 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 National
Standards. The Standards Committee that approved the code or standard was balanced to assure that individuals from
competent and concerned interests have had an opportunity to participate. The proposed code or standard was made
available 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 device, or activity.
ASME does not take any position with respect to the validity of any patent rights asserted in connection with any
items mentioned in this document, and does not undertake to insure anyone utilizing a standard against liability for
infringement of any applicable letters patent, nor assume any such liability. Users of a code or standard are expressly
advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, is
entirely their own responsibility.
Participation by federal agency representative(s) or person(s) affiliated with industry is not to be interpreted as
government or industry endorsement of this code or standard.
ASME accepts responsibility for only those interpretations of this document issued in accordance with the established
ASME 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 Engineers
Three Park Avenue, New York, NY 10016-5990
Copyright © 2012 by
THE AMERICAN SOCIETY OF MECHANICAL ENGINEERS
All rights reserved
Printed in U.S.A.
Copyright
2012 by the American Society of Mechanical Engineers.
No reproduction may be made of this material without written consent of ASME.
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CONTENTS
Foreword .............................................................................. ix
Statements of Policy ................................................................... x
Committee Roster ..................................................................... xi
Summary of Changes .................................................................. xv
Part GR General Requirements .................................................... 1
GR-1 Introduction ............................................................ 1
GR-2 Scope of the ASME BPE Standard ....................................... 1
GR-3 Manufacturer’s Quality Assurance Program ............................. 1
GR-4 Inspection .............................................................. 2
GR-5 Documentation Requirements ........................................... 5
GR-6 Metric .................................................................. 8
GR-7 References .............................................................. 8
GR-8 Terms and Definitions .................................................. 10
Part SD Systems Design.......................................................... 17
SD-1 Purpose and Scope ..................................................... 17
SD-2 General Guidelines ..................................................... 17
SD-3 Process Components .................................................... 20
SD-4 Process Utilities ........................................................ 56
SD-5 Process Systems ........................................................ 61
SD-6 Testing ................................................................. 79
Part DT Dimensions and Tolerances for Process Components........................ 81
DT-1 Purpose and Scope ..................................................... 81
DT-2 Pressure Rating ......................................................... 81
DT-3 Wall Thickness ......................................................... 81
DT-4 Dimensions ............................................................. 81
DT-5 Materials ............................................................... 82
DT-6 Tests ................................................................... 82
DT-7 Tolerances .............................................................. 82
DT-8 Weld Ends ............................................................. 82
DT-9 Hygienic Clamp Unions ................................................ 82
DT-10 Minimum Examination Requirements ................................... 82
DT-11 Marking ................................................................ 83
DT-12 Packaging .............................................................. 83
Part MJ Material Joining .......................................................... 110
MJ-1 Purpose and Scope ..................................................... 110
MJ-2 Materials ............................................................... 110
MJ-3 Weld Joint Design and Preparation ...................................... 110
MJ-4 Joining Processes and Procedures ....................................... 111
MJ-5 Procedure Qualifications ................................................ 112
MJ-6 Performance Qualifications .............................................. 112
MJ-7 Examination, Inspection, and Testing .................................... 112
MJ-8 Weld Acceptance Criteria ............................................... 114
MJ-9 Documentation Requirements ........................................... 114
MJ-10 Passivation ............................................................. 114
Part SF Product Contact Surface Finishes.......................................... 123
SF-1 Purpose and Scope ..................................................... 123
SF-2 Metallic Applications ................................................... 123
iii
Copyright
2012 by the American Society of Mechanical Engineers.
No reproduction may be made of this material without written consent of ASME.
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