ASMEBPE-2022 (RevisionofASMEBPE-2019) Bioprocessing Equipment ANINTERNATIONAL STANDARD Mechanical Engineers TheAmericanSocietyof
(Revision ofASMEBPE-2019) ASMEBPE-2022 Bioprocessing Equipment AN INTERNATIONALSTANDARD Mechanical Engineers The American Societyof Two Park Avenue New York NY 10016 USA
Date of Issuance: April 29 2022 The next edition of this Standard is scheduled for publication in 2024. This Standard will bee effective 6 months after the Date of Issuance. ASME issues written replies to inquiries concerning interpretations of technical aspects of this Standard. Periodically certain actions of the ASME BPE Committee may be published as Cases. Cases and interpretations are published on the ASME website under the Committee Pages at as they are issued. incorrectly published items or to correct typographical or grammatical errors in codes and standards. Such errata shall be used on the date posted. e ae euoe suoseod pn qe s notifiation when errataare posted to a particular code orstandard. 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 intenational code or standard was developed under procedures accredited as meeting the criteriafor American National Standards anditisanAmerican NationalStandard. The standards mittee that approved the code orstandardwas balanced toensure that individuals from petent and concened interestshad an opportunity to participateThe proposed code orstandard was made available for public reviewandcmment which providedanopportunity fradditionalpublicinpt fromindustry academia egulatoryagencies andthepuli- at-large. ASME does notaprove rate orendorse anyitem construction proprietary device oractivity ASME does not takeany positin 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 tilizinga standard against liability fornfringement of anyapplicable leterspatent nor doesASM assume any suhliability. Users of a code orstandard are expresslyadvised that determination of the validity of any such patent rights and the risk ofinfringement of such rights is entirely their own responsibility. Participation by federal agency representatives or persons 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 isued 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 permisson of the publisher. The American Society of Mechanical Engineers Two Park Avenue New York NY 10016-5990 Copyright @ 2022 by THE AMERICAN SOCIETY OF MECHANICAL ENGINEERS All rights reserved Printed in U.5.A.
CONTENTS Foreword . xii Statement of Policy on the Use of the ASME Single Certification Mark and Code Authorization in Advertising X Statement of Policy on the Use of ASME Marking to Identify Manufactured Items xv Committee Roster . xvi Correspondence With the BPE Committee xxi Summary of Changes xxdi Chapter 1 Introduction Scope and General Requirements . 1 Part GR General Requirements 1 GR-1 Introduction.. 1 GR-2 Scope of the ASME BPE Standard 1 GR-3 Manufacturer's Qualty Assurance Program . N GR-4 Examination Inspection and Testing 2 GR-5 Documentation. GR-6 U.S. Customary and SI Units ... 8 GR-7 References. 8 GR-8 sa e s 10 GR-9 Nomendlature.. 19 Chapter 2 Certification... 20 Part CR Certification Requirements 20 CR-1 Purpose and Scope 20 CR-2 General 20 Chapter 3 Materials 23 W Metallic Materials 23 MM-1 Purpose and Scope MM-2 Alloy Designations 7 MM-3 Uses of Specifications . MM-4 Referenced Specifications 27 MM-5 Base Metals and Filler Materials 29 MM-6 Mechanical Properties and Leak Testing .. 37 MM-7 Positive Material Identification . 37 MM-8 Corrosion-Resistance Requirements 37 MM-9 Minimum Requirements for Alloys in Part MM 39 Part PM Polymeric and Other Nonmetallic Materials 41 PM-1 Purpose and Scope - 41 PM-2 Materials 41 -Nd Properties and Performance . 46 PM-4 Applications . 48 Chapter 4 Design for Multiuse 52
Part SD Systems Design for Multiuse ... 52 SD-1 Purpose and Scope . 52 SD-2 General Guidelines .. . 52 SD-3 Process Components and Equipment ........... 56 SD-4 102 SD-5 Process Systems ... 107 SD-6 s d ss 131 SD-7 154 Chapter.5 Process Components for Multiuse...... 156 Dimensions and Tolerances for Process Components............ 156 DT-1 Purpose and Scope .. 156 DT-2 Pressure Rating .... 156 DT-3 156 DT-4 Dimensions ...... 156 DT-5 Materials ..... 157 DT-6 Tests. 157 DT-7 Tolerances 157 DT-8 Weld Ends 157 DT-9 Hygienic Clamp Unions 157 DT-10 Minimum Examination Requirements . ... 158 DT-11 Marking - 159 DT-12 Packaging 159 Part PI 194 PI-1 Purpose and Scope 194 PI-2 Process Instrumentation General Requirements ................... 194 PI-3 Instrument Receiving Handling and Storage .................... 197 PI-4 Flowmeters. 197 PI-5 Level Instruments 202 PI-6 Pressure Instruments . 203 PI-7 Temperature Sensors and Associated Components ........... 206 PI-8 Analytical Instruments . 211 PI-9 Optical 215 Part MC Components for Multiuse 219 MC-1 Purpose and Scope 219 MC-2 Sealing Component Types 219 MC-3 Sealing Components General Design Requirements (General Provisions) ......... 237 MC-4 Seal Performance Requirements .... 243 MC-5 Seal Applications . 245 Chapter 6 Fabrication Assembly and Erection for Multiuse ............ 248 Part MJ Materials Joining for Multiuse . . 248 MJ-1 Purpose and Scope 248 MI-2 Materials . . 248 MJ-3 Joint Design and Preparation . 249 MJ-4 252 S- Procedure Qualifications........ 252 AI
ASME BPE-2022生物加工设备(437页英文版).pdf
