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Bioprocessing Equipment
A N I N T E R N A T I O N A L S T A N D A R D
ASME BPE-2016(Revision of ASME BPE-2014)
ASME BPE-2016(Revision of ASME BPE-2014)
BioprocessingEquipment
A N I N T E R N A T I O N A L S T A N D A R D
Two Park Avenue • New York, NY • 10016 USA
Date of Issuance: October 14, 2016
The next edition of this Standard is scheduled for publication in 2018. This Standard will becomeeffective 6 months after the Date of Issuance.
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 Cases.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.This option can be found on the appropriate Committee Page after selecting “Errata” in the “PublicationInformation” section.
ASME is the registered trademark of The American Society of Mechanical Engineers.
This international code or standard was developed under procedures accredited as meeting the criteria for AmericanNational Standards and it is an American National Standard. The Standards Committee that approved the code orstandard was balanced to assure that individuals from competent and concerned interests have had an opportunity toparticipate. The proposed code or standard was made available for public review and comment that provides anopportunity 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
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without the prior written permission of the publisher.
The American Society of Mechanical EngineersTwo Park Avenue, New York, NY 10016-5990
Copyright © 2016 byTHE AMERICAN SOCIETY OF MECHANICAL ENGINEERS
All rights reservedPrinted in U.S.A.
CONTENTS
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xStatements of Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiiCommittee Roster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiiiSummary of Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
CHAPTER 1 INTRODUCTION, SCOPE, AND DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Part GR General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1GR-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1GR-2 Scope of the ASME BPE Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1GR-3 Manufacturer’s Quality Assurance Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2GR-4 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2GR-5 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6GR-6 U.S. Customary and SI Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8GR-7 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8GR-8 Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
CHAPTER 2 DESIGN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Part SD Systems Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18SD-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18SD-2 General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18SD-3 Process Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21SD-4 Process Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59SD-5 Process Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65SD-6 Design Conformance Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
CHAPTER 3 MATERIALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Part MM Metallic Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101MM-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101MM-2 Alloy Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101MM-3 Uses of Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101MM-4 Referenced Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104MM-5 Base Metals and Filler Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106MM-6 Mechanical Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108MM-7 Corrosion-Resistance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113MM-8 Addition of New Alloys to Part MM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Part PM Polymeric and Other Nonmetallic Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114PM-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114PM-2 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114PM-3 Properties and Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117PM-4 Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
CHAPTER 4 PROCESS COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Part DT Dimensions and Tolerances for Process Components. . . . . . . . . . . . . . . . . . . . . . . . 128DT-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128DT-2 Pressure Rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128DT-3 Wall Thickness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128DT-4 Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128DT-5 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129DT-6 Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
iii
DT-7 Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129DT-8 Weld Ends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129DT-9 Hygienic Clamp Unions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129DT-10 Minimum Examination Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130DT-11 Marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130DT-12 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Part PI Process Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157PI-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157PI-2 Process Instrumentation General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 157PI-3 Instrument Receiving, Handling, and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158PI-4 Flowmeters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158PI-5 Level Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163PI-6 Pressure Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165PI-7 Temperature Sensors and Associated Components . . . . . . . . . . . . . . . . . . . . . . . 165PI-8 Analytical Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170PI-9 Optical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Part SG Sealing Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182SG-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182SG-2 Sealing Component Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182SG-3 Sealing Components General Design Requirements (General
Provisions) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198SG-4 Seal Performance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204SG-5 Seal Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
CHAPTER 5 FABRICATION, ASSEMBLY, AND ERECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
Part MJ Materials Joining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209MJ-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209MJ-2 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209MJ-3 Joint Design and Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210MJ-4 Joining Processes and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210MJ-5 Procedure Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211MJ-6 Performance Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211MJ-7 Examination, Inspection, and Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212MJ-8 Acceptance Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213MJ-9 Joining of Polymeric Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214MJ-10 Documentation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229MJ-11 Passivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
Part SF Process Contact Surface Finishes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230SF-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230SF-2 Metallic Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230SF-3 Polymeric Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
CHAPTER 6 CERTIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Part CR Certification Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235CR-1 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235CR-2 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
FiguresSD-3.1.1-1 Flat Gasket Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22SD-3.1.2.2-1 Accepted Point-of-Use Designs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27SD-3.2.1-1 Flexible Hygienic Hose Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29SD-3.3.2.2-1 Pump Impeller Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30SD-3.3.2.2-2 Acceptable Impeller Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31SD-3.3.2.2-3 Casing Drain Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31SD-3.3.2.2-4 Casing Drain L/D Ratios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
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SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32SD-3.4.2-1 Nozzle Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34SD-3.4.2-2 Side and Bottom Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35SD-3.4.2-3 Sidewall Instrument Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35SD-3.4.2-4 Vessel Design Tangential Nozzles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36SD-3.4.2-5 Typical Nozzle Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36SD-3.4.3-1 Accepted Nozzle Penetrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37SD-3.4.3-2 Internal Support Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38SD-3.4.6-1 Sight Glass Design (Accepted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40SD-3.5.1-1 Agitator Mounting Flanges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41SD-3.5.2-1 Shaft Coupling Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42SD-3.5.2-2 Shaft Coupling Seal Arrangements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs . . . . . . . . . . . . . . . . 44SD-3.5.5-1 Shaft-Steady Bearing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) . . . . . . . . . . . . . . . . . . . . 46SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design . . . . . . . . . . . . . . . . . . . . . . . 48SD-3.7.1-1 Transfer Panel Looped Headers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49SD-3.7.2-1 Transfer Panel Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50SD-3.7.4-1 Transfer Panel Jumpers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52SD-3.9.1-1 Dynamic Spray Device: Single Axis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54SD-3.9.1-2 Two Axes Dynamic Spray Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54SD-3.9.2.1-1 Static Spray Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels . . . . . . . . . . . . . . . . . . . . . 56SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels . . . . . . . . . . . . . . . . . . 57SD-3.9.2.3-1 Impact Pattern Buildup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57SD-3.12-1 Steam Traps for Clean Steam Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59SD-4.1.2.1-1 Point-of-Use Piping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61SD-4.1.2.2-1 Physical Break in Point-of-Use Piping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62SD-4.2.2-1 Typical Clean Steam System Isometric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63SD-4.2.2-2 Clean Steam Point-of-Use Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64SD-5.1.1.1-1 Fermentor Sterile Envelope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66SD-5.1.1.1-2 Bioreactor Sterile Envelope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67SD-5.1.1.2.3-1 Gas Sparging Assembly — Lance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69SD-5.1.1.2.3-2 Gas Sparging Assembly — Sintered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70SD-5.1.1.2.3-3 Gas Sparging Assembly — Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71SD-5.1.1.2.3-4 Gas Sparging Assembly — Single Orifice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72SD-5.1.1.3.1-1 Exhaust Gas Condenser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73SD-5.1.1.3.1-2 Exhaust Gas Heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74SD-5.2.1.1-1 Tank/Vessel Vent Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78SD-5.3.3.5.1-1 CIP Looped Header (Supply or Return) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86SD-5.3.3.5.1-2 Zero-Static Chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86SD-5.3.3.5.1-3 Swing Elbow Arrangement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87SD-5.3.4.3.1-1 Example HTST Process Flow Schematic Diagram . . . . . . . . . . . . . . . . . . . . . . . . 88SD-5.3.4.3.1-2 Example Direct Steam Injection UHT Process Flow Schematic
Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89SD-5.3.4.3.6-1 Example of Additional Retention Tube Length Required to Account for
Axial Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91SD-5.4.1.2-1 Typical Lyophilizer Component Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95SD-5.4.1.3-1 Lyophilizer Sterile Boundary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98DT-2-1 Clamp Conditions at Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples . . . . . . . . . . . . . . . . . . . 158PI-2.2.2-1 Accepted Insertion Device Installation Examples . . . . . . . . . . . . . . . . . . . . . . . . 159PI-4.1.3.2-1 Manifold or Flow Splitter for Dual-Tube Construction Flowmeters and
Potential for Product Holdup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160PI-4.1.3.3-1 Concentrically Reducing Process Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
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PI-4.1.4.3-1 Vertical Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161PI-4.1.4.4-1 Minimum Angle of Inclination, ! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna . . . . . . . . . . . . . . . . . . . . . . 163PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location . . . . . . . . . . . . . . . . . . 164PI-7.3-1 Typical Installation Styles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions . . . . . . . . . . . . . . . . . . . . . . . 167PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions . . . . . . . . . . . . . . . . 167PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations . . . . . . . . . . . . . . . . . . . . . . . . . 169PI-8.1.2-1 Conductivity-Type Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171PI-8.1.3-1 Accepted Installations for Conductivity Sensors . . . . . . . . . . . . . . . . . . . . . . . . . 172PI-8.1.3.6-1 Installation Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173PI-8.2.2-1 pH Sensor Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174PI-8.2.3-1 Accepted pH Sensor Installations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175PI-8.2.3.4-1 Accepted Mounting Orientations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176PI-8.2.3.5-1 Insertion Length or Depth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177PI-9.1.3.3-1 Vessel Light Glass Design and Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179PI-9.1.3.5-1 In-Line Insertion Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180PI-9.1.3.5-2 Insertion Probe Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180SG-2.2.2-1 Hygienic Union per Table DT-7-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183SG-2.2.2-2 Hygienic Clamp Union per Table DT-7-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183SG-2.2.2-3 Hygienic Union per DIN 11864 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184SG-2.2.2-4 Hygienic Clamp Union per DIN 11864 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184SG-2.2.2-5 Nonhygienic Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185SG-2.3.1.2-1 Weir Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186SG-2.3.1.2-2 Radial Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187SG-2.3.1.2-3 Weirless Diaphragm Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187SG-2.3.1.2-4 Linear Control Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188SG-2.3.1.2-5 Regulator Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188SG-2.3.1.3-1 Ball Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189SG-2.3.1.4-1 Rising Stem Single, Double-Seat Mix-Proof, and Needle Valves . . . . . . . . . . . 189SG-2.3.1.5-1 Butterfly Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190SG-2.3.1.7-1 Back Pressure Control Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190SG-2.3.1.8-1 Pinch Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190SG-2.3.1.9-1 Pressure Relief and Check Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191SG-2.3.1.10-1 Plug Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192SG-2.3.2.2-1 Single Mechanical Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193SG-2.3.2.2-2 Single Seal for Top-Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193SG-2.3.2.3-1 Dual Pressurized Mechanical Seal for Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193SG-2.3.2.3-2 Dual Pressurized Mechanical Seal for Top-Entry Agitator . . . . . . . . . . . . . . . . 194SG-2.3.2.3-3 Dual Unpressurized Mechanical Seal for Pumps . . . . . . . . . . . . . . . . . . . . . . . . . 194SG-2.3.2.4-1 Flush Plan 01 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195SG-2.3.2.4-2 Flush Plan 02 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195SG-2.3.2.4-3 Flush Plan 03 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195SG-2.3.2.4-4 Flush Plan 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195SG-2.3.2.4-5 Flush Plan 32 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195SG-2.3.2.4-6 Flush Plan 52 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196SG-2.3.2.4-7 Flush Plan 52 for Top-Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196SG-2.3.2.4-8 Flush Plan BPE52 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196SG-2.3.2.4-9 Flush Plan 53 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196SG-2.3.2.4-10 Flush Plan 53 for Top-Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197SG-2.3.2.4-11 Flush Plan 54 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197SG-2.3.2.4-12 Flush Plan 54 for Top-Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197SG-2.3.2.4-13 Flush Plan 55 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197SG-2.3.2.4-14 Flush Plan 55 for Top-Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197SG-2.3.2.4-15 Flush Plan 74 for Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
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SG-2.3.2.4-16 Flush Plan 74 for Top-Entry Agitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198SG-3.3.2.2-1 Examples of Static O-Ring Grooves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200SG-3.3.2.3-1 Seals for Rising Stem Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202SG-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion . . . . . . . . . . . . . . 205MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds on
Metallic Tube-to-Tube Butt Joints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones
on Electropolished UNS S31603 Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones
on Mechanically Polished UNS S31603 Tubing . . . . . . . . . . . . . . . . . . . . . . . . . 222MJ-8.4-4 Acceptable and Unacceptable Metallic Weld Bend Width and Meander on
Non–Process Contact Surfaces of Groove Welds on Tube-to-Tube ButtJoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds . . . . . . 226MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless
Welds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229CR-1-1 ASME Certification Mark With BPE Designator . . . . . . . . . . . . . . . . . . . . . . . . . . 235CR-2-1 Options for Certification of Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
TablesGR-4.2-1 Inspector’s Delegate Capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3SD-2.4.3.1-1 Slope Designations for Gravity-Drained Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . 20SD-3.1.2.2-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight
Tee With Blind Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23SD-3.1.2.2-2 L/D Dimensions for Flow-Through Tee: Short-Outlet Reducing Tee With
Blind Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes . . . . . . . . . . . . . 37SD-5.3.3.3-1 Flow Rates to Achieve 5 ft/sec (1.52 m/s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %) . . . . . . . . . . . . . . . . 102MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %) . . . . . . . . . . . . . . . . . . 103MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations . . . . . . . . . . . . . . . . . . . . . . 104MM-2.1-4 Wrought Copper: Nominal Compositions (wt. %) (Cleaned for Oxygen
Service) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104MM-5.2.1.2-1 Predicted Ferrite Number (FN) Ranges for Various Austenitic
Stainless Steel Product Forms and Welds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107MM-5.2.6-1 Materials for OEM Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108MM-5.3-1 Filler Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109MM-5.3-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels . . . . . . 111MM-5.3.3-1 Brazing Filler Metals for Copper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic
and Duplex Stainless Steels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112PM-2.1.1-1 Common Thermoplastic Polymers and Applications . . . . . . . . . . . . . . . . . . . . . 115PM-2.1.2-1 Common Thermoset Polymers and Applications . . . . . . . . . . . . . . . . . . . . . . . . . 115PM-2.1.3-1 Examples of Nonmetallics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116PM-2.2.1-1 Content Required on the Certificate of Compliance . . . . . . . . . . . . . . . . . . . . . . 117PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards . . . . . . . . . . . 122DT-2-1 Metallic Hygienic Unions: Rated Internal Working Pressure . . . . . . . . . . . . . . 132DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133DT-3-2 Final Tolerances for Electropolished Fittings and Process Components . . . . 134DT-4-1 Nominal O.D. Tubing Sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134DT-4.1-1 Tangent Lengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135DT-4.1.1-2 Automatic Tube Weld: Hygienic Clamp Joint, 90-deg Elbow . . . . . . . . . . . . . . 135DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136DT-4.1.1-5 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow . . . . . . . . . . . . . . 137
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DT-4.1.1-6 Hygienic Clamp Joint: 45-deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137DT-4.1.1-7 Automatic Tube Weld: 180-deg Return Bend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138DT-4.1.1-8 Hygienic Clamp Joint: 180-deg Return Bend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138DT-4.1.2-1 Automatic Tube Weld: Straight Tee and Cross . . . . . . . . . . . . . . . . . . . . . . . . . . . 139DT-4.1.2-2 Automatic Tube Weld: Short-Outlet Hygienic Clamp Joint Tee . . . . . . . . . . . . 139DT-4.1.2-3 Hygienic Mechanical Joint: Short-Outlet Run Tee . . . . . . . . . . . . . . . . . . . . . . . . 140DT-4.1.2-4 Hygienic Clamp Joint: Straight Tee and Cross . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140DT-4.1.2-5 Hygienic Clamp Joint: Short-Outlet Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141DT-4.1.2-6 Automatic Tube Weld: Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint
Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143DT-4.1.2-9 Hygienic Clamp Joint: Short-Outlet Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . 144DT-4.1.2-10 Automatic Tube Weld: Instrument Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144DT-4.1.2-11 Hygienic Clamp Joint: Instrument Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer . . . . . . . . . . . . . . . . . 145DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer . . . . . . 146DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer . . . . . . . . . . . . . . . . . 147DT-4.1.4-1 Automatic Tube Weld: Ferrule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148DT-4.1.5-1 Automatic Tube Weld: Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149DT-4.4.1-1 Hygienic Clamp Joint: Weir-Style Diaphragm Valve . . . . . . . . . . . . . . . . . . . . . . 150DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151DT-4.5.2-1 Tapered Locking Tab Retainer: External . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances . . . . . . . . . . . 153DT-7-2 Transfer Panel and Jumper Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156MJ-6.3-1 Metallic Tube/Pipe Diameter Limits for Orbital GTAW Performance
Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211MJ-6.3-2 Metallic Weld Thickness Limits for Orbital GTAW Performance
Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic
Pressure Vessels and Tanks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe . . . . . . 216MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic
Tube-to-Tube Butt Joints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment
Welds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes . . . . . . . . 231SF-2.2-2 Additional Acceptance Criteria for Electropolished Metallic Process
Contact Surface Finishes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232SF-2.4-1 Ra Readings for Metallic Process Contact Surfaces . . . . . . . . . . . . . . . . . . . . . . . 232SF-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact Surface
Finishes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233SF-3.3-1 Acceptance Criteria for Polymeric Process Contact Surface Finishes . . . . . . 234SF-3.4-1 Ra Readings for Polymeric Process Contact Surfaces . . . . . . . . . . . . . . . . . . . . . . 234
Mandatory AppendicesI Submittal of Technical Inquiries to the Bioprocessing Equipment
(BPE) Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241II Standard Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Nonmandatory AppendicesA Commentary: Slag and Oxide Islands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244B Material and Weld Examination/Inspection Documentation . . . . . . . . . . . . . . 245C Slope Measurement and Joint Misalignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249D Rouge and Stainless Steel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250E Passivation Procedure Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
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F Corrosion Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269G Ferrite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272H Electropolishing Procedure Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273I Vendor Documentation Requirements for New Instruments . . . . . . . . . . . . . . 275J Standard Process Test Conditions (SPTC) for Seal Performance
Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279K Standard Test Methods for Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290L Spray Device Coverage Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293M Commentary: UNS S31603 Weld Heat-Affected Zone Discoloration
Acceptance Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295N Guidance When Choosing Polymeric and Nonmetallic Materials . . . . . . . . . 296O General Background/Useful Information for Extractables and
Leachables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297P Temperature Sensors and Associated Components . . . . . . . . . . . . . . . . . . . . . . . 300Q Instrument Receiving, Handling, and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 302R Application Data Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303S Guidance on Polymer Applications: Chromatography Columns and
Filtration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306T Guidance for the Use of U.S. Customary and SI Units . . . . . . . . . . . . . . . . . . . 309U Positive Material Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311V Procurement Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315
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FOREWORD
At the 1988 ASME Winter Annual Meeting (WAM), many individuals expressed interest indeveloping standards for the design of equipment and components for use in the biopharmaceuti-cal industry. As a result of this interest, the ASME Council on Codes and Standards (CCS) waspetitioned to approve this as a project. The initial scope was approved by the CCS on June 20,1989, with a directive to the Board on Pressure Technology to initiate this project with the followinginitial scope:
This standard is intended for design, materials, construction, inspection, and testingof vessels, piping, and related accessories such as pumps, valves, and fittings for use inthe biopharmaceutical industry. The rules provide for the adoption of other ASME andrelated national standards, and when so referenced become part of the standard.
(a) At the 1989 WAM, an ad hoc committee was formed to assess the need to develop furtherthe scope and action plan. The committee met in 1990 and there was consensus concerningthe need to develop standards that would meet the requirements of operational bioprocessing,including
(1) the need for equipment designs that are both cleanable and sterilizable(2) the need for special emphasis on the quality of weld surfaces once the required strength
is present(3) the need for standardized definitions that can be used by material suppliers, designers/
fabricators, and users(4) the need to integrate existing standards covering vessels, piping, appurtenances, and
other equipment necessary for the biopharmaceutical industry without infringing on the scopesof those standards
(b) The BPE Main Committee was structured with six functioning subcommittees and anexecutive committee comprising the main committee chair and the subcommittee chairs. Theinitial subcommittees were
(1) General Requirements(2) Design Relating to Sterility and Cleanability of Equipment(3) Dimensions and Tolerances(4) Material Joining(5) Surface Finishes(6) Seals
(c) Throughout the development of the Standard, close liaison was made with the EuropeanCEN, ASTM, and the 3-A Dairy Standards. The purpose was to develop an ASME standard thatwould be distinctive, germane, and not in conflict with other industry standards. Whereverpossible, the Committee strived to reference existing standards that are applicable to biopharma-ceutical equipment design and fabrication.
This Standard represents the work of the BPE Standards Committee, and this edition includesthe following Parts:
(1) General Requirements(2) Systems Design(3) Metallic Materials(4) Polymeric and Other Nonmetallic Materials(5) Dimensions and Tolerances for Process Components(6) Process Instrumentation(7) Sealing Components(8) Materials Joining(9) Process Contact Surface Finishes(10) Certification Requirements
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The first edition of this Standard was approved as an American National Standard onMay 20, 1997. This edition was approved by ANSI on June 27, 2016.
Requests for interpretations or suggestions for revision should be sent to Secretary,BPE Committee, The American Society of Mechanical Engineers, Two Park Avenue,New York, NY 10016.
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STATEMENT OF POLICY ON THE USE OFCERTIFICATION MARKS AND CODE AUTHORIZATION
IN ADVERTISING
ASME has established procedures to authorize qualified organizations to perform variousactivities in accordance with the requirements of the ASME Codes and Standards. It is the aimof the Society to provide recognition of organizations so authorized. An organization holdingauthorization to perform various activities in accordance with the requirements of the Codes andStandards may state this capability in its advertising literature.
Organizations that are authorized to use the Certification Mark for marking items or construc-tions that have been constructed and inspected in compliance with ASME Codes and Standardsare issued Certificates of Authorization. It is the aim of the Society to maintain the standing ofthe Certification Mark for the benefit of the users, the enforcement jurisdictions, and the holdersof the Certification Mark who comply with all requirements.
Based on these objectives, the following policy has been established on the usage in advertisingof facsimiles of the symbols, Certificates of Authorization, and references to Codes or Standardsconstruction. The American Society of Mechanical Engineers does not “approve,” “certify,” “rate,”or “endorse” any item, construction, or activity and there shall be no statements or implicationsthat might so indicate. An organization holding a Certification Mark and/or a Certificate ofAuthorization may state in advertising literature that items, constructions, or activities “are built(produced or performed) or activities conducted in accordance with the requirements of theapplicable ASME Code or Standard.” An ASME corporate logo shall not be used by any organiza-tion other than ASME.
The Certification Mark shall be used only for stamping and nameplates as specifically providedin the Code or Standard. However, facsimiles may be used for the purpose of fostering the useof such construction. Such usage may be by an association or a society, or by a holder of aCertification Mark who may also use the facsimile in advertising to show that clearly specifieditems will carry the Certification Mark. General usage is permitted only when all of a manufactur-er’s items are constructed under the rules of the applicable Code or Standard.
STATEMENT OF POLICY ON THE USE OF ASMEMARKING TO IDENTIFY MANUFACTURED ITEMS
The ASME Codes and Standards provide rules for the construction of various items. Theseinclude requirements for materials, design, fabrication, examination, inspection, and stamping.Items constructed in accordance with all of the applicable rules of ASME are identified with theofficial Certification Mark described in the governing Code or Standard.
Markings such as “ASME” and “ASME Standard” or any other marking including “ASME”or the Certification Mark shall not be used on any item that is not constructed in accordancewith all of the applicable requirements of the Code or Standard.
Items shall not be described on ASME Data Report Forms nor on similar forms referring toASME which tend to imply that all requirements have been met when in fact they have not been.Data Report Forms covering items not fully complying with ASME requirements should not referto ASME or they should clearly identify all exceptions to the ASME requirements.
ASME’s certification related to products means that the capability by the supplier to fulfillrequirements in the applicable standard has been reviewed and accepted by ASME. The supplieris responsible for ensuring that products meet, and if applicable continue to meet, the requirements.
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ASME BIOPROCESSING EQUIPMENT COMMITTEE(The following is the roster of the Committee at the time of approval of this Standard.)
STANDARDS COMMITTEE OFFICERSJ. Ankers, Chair
M. Pelletier, Vice ChairP. D. Stumpf, Secretary
STANDARDS COMMITTEE PERSONNEL
J. Ankers, Ocean Alloys, LLCM. L. Balmer, Sanofi PasteurD. D. Baram, Contributing Member, Clifton EnterprisesE. A. Benway, Contributing Member, Ironwood SpecialistB. A. Billmyer, Central States Industrial EquipmentW. H. Cagney, Johnson & JohnsonR. D. Campbell, BechtelA. P. Cirillo, Cirillo Consulting Services, LLCR. A. Cotter, Cotter Brothers Corp.J. Dvorscek, Abbott LaboratoriesM. Embury, ASEPCOE. B. Fisher, Fisher EngineeringM. M. Gonzalez, Contributing Member, BioPharm Engineering
ConsultantZ. Gu, Shanghai MorimatsuR. Hanselka, CRB EngineersB. K. Henon, Contributing Member, MagnatechM. A. Hohmann, Quality CoalescenceL. T. Hutton, Plasticwelding, LLCC. Johnson, Genentech, Inc.C. E. Kettermann, RathGibson
EXECUTIVE COMMITTEE
M. Pelletier, Chair, CRBJ. Ankers, Vice Chair, Ocean Alloys, LLCW. H. Cagney, Johnson & JohnsonR. D. Campbell, BechtelA. P. Cirillo, Cirillo Consulting Services, LLCM. Embury, ASEPCOC. E. Kettermann, RathGibsonK. D. Kimbrel, UltraClean Electropolish
SUBCOMMITTEE ON GENERAL REQUIREMENTS AND EDITORIAL REVIEW
M. Embury, Chair, ASEPCOT. J. Winter, Vice Chair, Winter TechnologiesT. Fridman, Secretary, VanasylE. A. Benway, Contributing Member, Ironwood SpecialistJ. L. Bradley, Contributing Member, Eli Lilly and Co.W. P. Burg, DECCOW. H. Cagney, JSG, LLCR. D. Campbell, BechtelA. P. Cirillo, Contributing Member, Cirillo Consulting Services, LLCR. B. Fitts, Spraying Systems Co.
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K. D. Kimbrel, UltraClean ElectropolishD. T. Klees, Magnetrol InternationalG. Kroehnert, NeumoI. Lisboa, ConsultantJ. T. Mahar, 3M PurificationF. J. Manning, VNE Corp.D. M. Marks, DMED. J. Mathien, Behringer Corp.M. McFeeters, SteridoseR. A. Michalak, Eli Lilly and Co.S. Murakami, Hitachi Ltd.C. N. Pacheco, AmgenM. Pelletier, CRBL. J. Peterman, United Industries, Inc.W. L. Roth, Procter & GambleR. Snow, Sanofi GlobalP. D. Stumpf, The American Society of Mechanical EngineersP. L. Sturgill, SWCCC. A. Trumbull, Paul Mueller Co.J. D. Vogel, The BioProcess InstituteR. J. Zinkowski, RJZ Alliances, LLCM. A. Zumbrum, Sartorius Stedim
D. T. Klees, Magnetrol InternationalD. M. Marks, DMED. J. Mathien, Behringer Corp.M. McFeeters, SteridoseP. L. Sturgill, SWCCR. J. Zinkowski, RJZ Alliances, LLCM. A. Zumbrum, Sartorius Stedim
L. Harper, WIKA InstrumentB. K. Henon, MagnatechM. A. Hohmann, Quality CoalescenceW. M. Huitt, W. M. Huitt Co.D. Kwilosz, Elanco Global EngineeringJ. W. Minor, Paul Mueller Co.V. Norton, T & C StainlessW. Ortiz, Contributing Member, Eli Lilly and Co.M. Pelletier, CRBK. Seibert, ABECP. L. Sturgill, SWCC
SUBCOMMITTEE ON SYSTEMS DESIGN
D. M. Marks, Chair, DMEM. L. Balmer, Vice Chair, Sanofi PasteurA. Dyrness, Vice Chair, ADVENT Engineering ServicesB. Jensen, Vice Chair, Alfa LavalR. A. Michalak, Secretary, Eli Lilly and Co.J. Ankers, Ocean Alloys, LLCR. Berk, Hyde-EcB. A. Billmyer, Central States Industrial EquipmentJ. L. Bradley, Eli Lilly and Co.T. M. Canty, Contributing Member, JM Canty Associates, Inc.C. Chapman, GEMU ValvesI. Conley, DPS EngineeringR. A. Cotter, Cotter Brothers Corp.J. Crawley, Jacobs EngineeringJ. Daly, BSI EngineeringJ. Dvorscek, Contributing Member, Abbott LaboratoriesM. Embury, ASEPCOJ. Feldman, Yula Corp.E. B. Fisher, Fisher EngineeringG. P. Foley, Sr., PBMR. F. Foley, DPS EngineeringJ. Fortin, LonzaJ. W. Franks, Electrol Specialties Co.D. George, Hallam-ICSR. Gerra, Shire PharmaceuticalsZ. Gu, Shanghai MorimatsuM. Guttzeit, GEA
SUBCOMMITTEE ON DIMENSIONS AND TOLERANCES
D. J. Mathien, Chair, Behringer Corp.F. J. Manning, Vice Chair, VNE Corp.B. A. Billmyer, Secretary, Central States Industrial EquipmentD. Brockman, United Industries, Inc.C. Chapman, GEMU ValvesR. Cosentino, GILTECK. R. Davis, Nordson MedicalP. M. Dunbar, VNE Corp.R. J. Elbich, Exigo ManufacturingR. B. Fitts, Spraying Systems Co.R. F. Foley, DPS Engineering
SUBCOMMITTEE ON MATERIALS JOINING
J. Dvorscek, Chair, Abbott LaboratoriesK. Bhaila, Vice Chair, ITT Engineered ValvesW. L. Roth, Vice Chair, Procter & GambleW. P. Burg, Secretary, DECCOE. A. Benway, Contributing Member, Ironwood SpecialistN. K. Bickel, Genentech/RocheJ. L. Bradley, Contributing Member, Eli Lilly and Co.R. D. Campbell, Past Chair, BechtelT. J. Cook, T & C StainlessR. A. Cotter, Cotter Brothers Corp.C. W. Elkins, Central States Industrial EquipmentJ. D. Fritz, TMR StainlessE. L. Gayer, Holloway AmericaD. A. Gillespie, BMWC ConstructorsR. Hanselka, CRB Engineers
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R. Hanselka, CRB EngineersS. M. Hartner, BaxaltaT. L. Hobick, Holland Applied TechnologiesD. Hogensen, AmgenM. Inoue, FujikinJ. Janousek, Abbott LaboratoriesC. Johnson, Genentech, Inc.C. Kelleher, Janssen BiologicsL. Klitgaard, NNE PharmaplanP. M. Kubera, ABECJ. D. Larson, DCIJ. T. Mahar, 3M PurificationJ. Manachello, SP IndustriesR. Manser, DCID. P. McCune, Allegheny BradfordJ. W. Minor, Paul Mueller Co.M. Mortensen, NNE PharmaplanS. Muller, GE HealthcareA. R. Obertanec, Clark-RelianceW. Ortiz, Contributing Member, Eli Lilly and Co.C. N. Pacheco, AmgenM. Pelletier, CRBA. Powell, ConsultantS. Sharon, Genentech/RocheR. Snow, Sanofi GlobalR. Warn, Commissioning AgentsK. J. Westin, Roplan SteridoseR. J. Zinkowski, RJZ Alliances, LLC
G. Kroehnert, NeumoI. Lisboa, ConsultantM. Manfredi, ZDL Componentes de ProcessoP. McClune, ITT Engineered ValvesH. P. G. Montgomery, Tank Components IndustriesJ. Paulsen, Alfa LavalL. J. Peterman, United Industries, Inc.F. G. Villela, Stockval Tecno ComercialT. G. Wilson, Contributing Member, Top Line Process Equipment
Co.T. J. Winter, Winter Technologies
B. K. Henon, Contributing Member, MagnatechM. A. Hohmann, Quality CoalescenceW. M. Huitt, W. M. Huitt Co.L. T. Hutton, Plasticwelding, LLCD. Juritsch, Zeta BiopharmaC. E. Kettermann, RathGibsonK. J. Matheis, Sr., Complete AutomationN. S. McCauley, A & B Process SystemsT. M. O’Connor, Central States Industrial EquipmentH. A. Reinhold, AM Technical SolutionsD. P. Sisto, Purity SystemsM. S. Solamon, Feldmeier EquipmentP. L. Sturgill, SWCCG. R. Tabor, Eli Lilly and Co.C. A. Trumbull, Past Chair, Paul Mueller Co.C. Weeks, CRB
SUBCOMMITTEE ON SURFACE FINISH
K. D. Kimbrel, Chair, UltraClean ElectropolishP. H. Banes, Vice Chair, Astro PakJ. Hamilton, Vice Chair, RathGibsonR. E. Avery, Contributing Member, Nickel InstituteN. K. Bickel, Genentech/RocheM. Bosley, L. J. StarD. Brockmann, United Industries, Inc.D. K. Cohen, Contributing Member, Michigan MetrologyC. Conn, Top Line Process Equipment Co.T. J. Cook, T & C StainlessM. D. Cooper, United Industries, Inc.J. R. Daniels, ITT Engineered ValvesC. W. Elkins, Central States Industrial EquipmentE. L. Gayer, Holloway AmericaJ. Giffen, PBMM. M. Gonzalez, Contributing Member, BioPharm Engineering
Consultant
SUBCOMMITTEE ON SEALING COMPONENTS
M. McFeeters, Chair, SteridoseJ. D. Vogel, Vice Chair, The BioProcess InstituteK. J. Westin, Secretary, Roplan SteridoseD. D. Baram, Clifton EnterprisesJ. Blumenthal, Perceptual FocusJ. R. Daniels, ITT Engineered ValvesP. Day, Fisher ControlsS. J. DeFusco, Integra CompaniesD. Donnelly, James Walker Sealing Products & ServicesR. Dubiel, Parker HannifinP. Esbensen, Alfa Laval Kolding A/SG. P. Foley, Sr., PBMJ. Giffen, PBMB. Gregg, Top Line Process EquipmentS. Haman, FristamL. Harper, WIKA InstrumentT. Harvey, Gemu ValvesD. Helmke, Flow ProductsM. Inoue, FujikinD. Irish, Carten ControlsC. Johnson, Genentech, Inc.
SUBCOMMITTEE ON POLYMERS AND OTHER NONMETALLIC MATERIALS
M. W. Johnson, Chair, EntegrisP. G. Galvin, Vice Chair, George FischerM. Knox, Vice Chair, W. L. Gore & AssociatesM. Allard, NewAge Industries, Inc./AdvantapureJ. Anant, MilliporeSigmaJ. Andrews, Saint-Gobain Performance PlasticsT. Andrews, CPCG. E. Carpenter, Saint-Gobain Performance PlasticsA. Cobb, W. L. Gore & AssociatesK. R. Davis, Nordson MedicalS. J. DeFusco, Integra CompaniesD. Donnelly, James Walker Sealing Products & ServicesG. Evans, Ace SanitaryT. Fridman, VanasylL. T. Hutton, Plasticwelding, LLC
xv
S. T. Harrison, Harrison ElectropolishingB. K. Henon, Contributing Member, MagnatechG. Kroehnert, NeumoC. F. Kuo, King Lai Hygienic Material Co.F. J. Manning, Contributing Member, VNE Corp.R. McGonigle, Contributing Member, ConsultantM. Mondello, MECOA. Navabi, GenzymeL. J. Peterman, United Industries, Inc.P. A. Petrillo, Millennium Facilities ResourcesR. K. Raney, UltraClean ElectropolishJ. Rau, Dockweiler AGP. D. Sedivy, Past Chair, RathGibsonM. S. Solamon, Feldmeier EquipmentC. A. Trumbull, Paul Mueller Co.T. Winter, Elkhorn Electropolish
C. Kelleher, Janssen BiologicsP. M. Kubera, ABECJ. Marshall, PerrigoR. A. Michalak, Eli Lilly and Co.R. Mogul, R&I Material Solutions Ltd.A. R. Obertanec, Clark-RelianceC. N. Pacheco, AmgenG. Page, Jr., Page SolutionsA. K. Parker, Jr., W. L. Gore & AssociatesS. Pitolaj, Garlock Sealing TechnologiesJ. Pouliot, AmgenA. Powell, ConsultantR. Rieger, John CraneW. Sams, SteriflowR. W. Schnell, DuPont Performance PolymersR. P. Schroder, Newman Sanitary Gasket Co.R. A. Smith, FlowserveS. Tanner, Garlock Sealing TechnologiesJ. Vitti, Crane ChemPharma Flow SolutionsD. Wise, Genentech/RocheR. J. Zinkowski, RJZ Alliances, LLCM. A. Zumbrum, Sartorius Stedim
M. Jain, W. L. Gore & AssociatesC. Kollar, Dow Corning Co.T. Larkin, AmgenJ. T. Mahar, 3M PurificationM. McFeeters, SteridoseR. Mogul, R&I Material Solutions Ltd.E. Pitchford, Parker HannifinP. Priebe, Sartorius StedimR. W. Schnell, DuPont Performance ElastomersR. P. Schroder, Newman Sanitary Gasket Co.D. A. Seiler, ArkemaR. Snow, Sanofi GlobalJ. Stover, NewAge Industries, Inc./AdvantaPureJ. D. Vogel, The BioProcess InstituteM. A. Zumbrum, Past Chair, Sartorius Stedim
SUBCOMMITTEE ON METALLIC MATERIALS
P. L. Sturgill, Chair, SWCCJ. Rau, Vice Chair, Dockweiler AGN. A. Schmidt, Secretary, Boccard Life SciencesP. Anderson, Northland StainlessR. E. Avery, Nickel InstituteR. D. Campbell, BechtelJ. W. Franks, Electrol Specialties Co.J. D. Fritz, TMR Stainless
SUBCOMMITTEE ON CERTIFICATION REQUIREMENTS
C. E. Kettermann, Chair, RathGibsonT. L. Hobick, Vice Chair, Holland Applied TechnologiesW. M. Huitt, Secretary, W. M. Huitt Co.B. A. Billmyer, Central States Industrial EquipmentD. Brockmann, United Industries, Inc.R. D. Campbell, BechtelT. J. Cook, T & C StainlessP. M. Dunbar, VNE Corp.J. Dvorscek, Abbott LaboratoriesR. J. Elbich, Exigo Manufacturing
SUBCOMMITTEE ON PROCESS INSTRUMENTATION
D. T. Klees, Chair, Magnetrol InternationalT. M. Canty, Vice Chair, JM Canty Associates, Inc.V. Gorbis, Vice Chair, Genentech/RocheD. Kwilosz, Secretary, Elanco Global EngineeringJ. Ankers, Contributing Member, Ocean Alloys, LLCG. Anton, Contributing Member, QualtechJ. Blumenthal, Perceptual FocusR. Bond, Anderson Instrument Co.C. Bragg, Burns EngineeringR. Cosentino, GILTECJ. Defeo, Hoffer Flow ControlsJ. M. Featherston, Weed Instrument Co.D. Fennel, TQ - Pure SupplyJ. Gleeson, Hamilton Co.R. Govaert, Mettler-Toledo Ingold/Thornton
xvi
D. A. Gillespie, BMW ConstructorsS. T. Harrison, Harrison ElectropolishingW. M. Huitt, W. M. Huitt Co.C. E. Kettermann, RathGibsonK. J. Matheis, Sr., Complete AutomationD. P. McCune, Allegheny BradfordT. M. O’Connor, Central States Industrial EquipmentD. L. Roll, Astro PakW. L. Roth, Procter & Gamble
E. L. Gayer, Holloway AmericaD. A. Gillespie, BMWC ConstructorsM. M. Gonzalez, BioPharm Engineering ConsultantL. T. Hutton, Plasticwelding. LLCK. D. Kimbrel, UltraClean ElectropolishK. J. Matheis, Sr., Complete AutomationA. R. Obertanec, Clark-RelianceW. L. Roth, Procter & GambleM. S. Solamon, Feldmeier EquipmentT. G. Wilson, Top Line Process Equipment Co.
L. Harper, WIKA InstrumentD. Kresge, CRBA. Lamore, Burkert Fluid Control SystemsM. Muth, Wika InstrumentsJ. Nerstad, Magnetrol InternationalV. Pai, Advent EngineeringP. A. Petrillo, Millennium Facilities ResourcesG. Placide, CrossPoint EngineeringR. Shankar, Endress + HauserS. Sharon, Genentech/RocheG. Tischler, Vega AmericasP. Wagner, Anderson Instrument Co.G. Woods, CrossPoint EngineeringJ. Wynn, Paul Mueller Co.S. Zuehlke, Endress + Hauser GmbH Co. KG
ASME BPE-2016SUMMARY OF CHANGES
Following approval by the ASME BPE Committee and ASME, and after public review,ASME BPE-2016 was approved by the American National Standards Institute on June 27, 2016.
ASME BPE-2016 has been reorganized and includes editorial changes, revisions, and correctionsintroduced in ASME BPE-2014, as well as the following changes identified by a margin note, (16).
Page Location Change
1, 2 Chapter 1 Chapter designation added
GR-2 Last paragraph revised
6 GR-5.2 Revised
GR-5.2.1.1.1 Subparagraph (a)(4) revised
7 GR-5.3.1 Subparagraph (c) revised
GR-5.3.2.1 Revised in its entirety
GR-5.4 Name of Form revised
8, 9 GR-7 ASME PVHO-1, ISO 10993, and UnitedStates Pharmacopeia and NationalFormulary added
9–16 GR-8 (1) Definitions of autogenous fillet weld,finishing marks, nonsliding seal, oxideisland, scratch, seat leakage, shell leakage,sliding seal, and tack weld added
(2) Definitions of blind weld, clean-in-place(CIP), flushing (rinsing), materialmanufacturer, mechanical polishing,orange peel, PFA, rouge, and slagrevised
(3) Definition of dross deleted
18 Chapter 2 Chapter designation added
SD-2 Second paragraph added
SD-2.3.1.1 Revised in its entirety
19 SD-2.4.1.2 Subparagraph (a) revised
20 SD-2.4.3.1 Revised
SD-2.4.4.1 Subparagraph (c) revised
27 SD-3.1.2.3 Subparagraphs (b) and (g) revised
29 SD-3.3.1 Revised in its entirety
30, 33, 39 SD-3.3.2.2 Subparagraph (d) revised
SD-3.3.2.4 Subparagraph (c) revised
SD-3.4 Revised in its entirety
xvii
Page Location Change
36 Fig. SD-3.4.2-4 Redesignated
Fig. SD-3.4.2-5 Redesignated
37 Table SD-3.4.3-1 Redesignated
Figure SD-3.4.3-1 (1) Redesignated(2) Cross reference to table in Note (1)
updated
38 Figure SD-3.4.3-2 (1) Redesignated(2) Parts (a) and (b) revised
39 SD-3.5.1 (1) Figure numbers updated in subparas.(d) and (f)(1)
(2) Subparagraph (g) revised
40 Fig. SD-3.4.6-1 Redesignated
41, 44 SD-3.5.3 Subparagraphs (d) and (g) revised
46, 47 SD-3.6.1 Subparagraphs (g), (h), and (j) revised
51 SD-3.7.6 Subparagraph (b) revised
53 SD-3.8.1.1 References to figures in subparas. (b)(1)and (b)(2) updated to tables
SD-3.8.1.2 References to figures updated to tables
Fig. SD-3.8.1.1-1 Deleted (incorporated intoTable DT-4.5.1-1)
Fig. SD-3.8.1.1-2 Deleted (incorporated intoTable DT-4.5.2-1)
55 SD-3.9.2 Subparagraph (k) revised
57 Fig. SD-3.9.2.1-3 Revised
58 SD-3.11.1 Subparagraph (b) revised
SD-3.11.2.2 Revised
60 SD-4.1.1 Subparagraphs (a) and (b) revised
SD-4.2.1 Subparagraphs (a) and (b) revised
62, 64, 65 SD-4.3.1 Subparagraph (b) revised
SD-4.4 Revised in its entirety
SD-5.1.1.1 Subparagraph (c) revised
75 SD-5.1.1.4.2 Subparagraph (b) figure number updated
76, 77 SD-5.1.3 Revised in its entirety
SD-5.2.1.1 Subparagraph (e) revised
78–81 SD-5.2.2 Added
SD-5.3.1 Revised in its entirety
84, 85 SD-5.3.3.3 Revised in its entirety
xviii
Page Location Change
87–94 SD-5.3.4 Revised in its entirety
Fig. SD-5.3.4.3.1-1 Added
Fig. SD-5.3.4.3.1-2 Added
Fig. SD-5.3.4.3.6-1 Added
SD-5.3.5 Revised in its entirety
SD-5.4 Title revised
SD-5.4.1.1 First paragraph revised
100 SD-6.4 Subparagraph (a) revised
101, 104 Chapter 3 Chapter designation added
MM-2.1 Revised
MM-3.1 Revised
MM-3.2 Revised
MM-3.3 Revised
MM-3.5 Revised
102 Table MM-2.1-1 Fifth column revised
104 Table MM-2.1-4 Revised
MM-4.1 Revised
106–108 MM-5 Revised in its entirety
Table MM-5.2.1.2-1 (1) Redesignated(2) Title revised(3) Third row revised
Table MM-5.2.6-1 Redesignated
MM-6.1 Table numbers updated
MM-6.3 Revised
MM-6.4 Revised
MM-6.6 Added
109, 110 Table MM-5.3-1 Redesignated
111 Table MM-5.3-2 Redesignated
112 Table MM-5.3.3-1 Redesignated
Table MM-5.4-1 Added
113 MM-7.2 Subparagraph (b) revised
MM-8.1 First paragraph revised
114 PM-1 Revised
PM-2 Revised
PM-2.1 Revised
PM-2.1.1 Fourth paragraph revised
PM-2.1.2 Revised
115 PM-2.1.3 Second paragraph revised
xix
Page Location Change
116 PM-2.2.3 Added
117 Table PM-2.2.1-1 Revised
118 PM-3.2 Revised in its entirety
120 PM-4.1.2 Cross-reference added
PM-4.1.5 Revised
PM-4.1.5.1 First paragraph revised
PM-4.1.6 Revised
121 PM-4.1.7 Added
125, 126 PM-4.5 Added
128 Chapter 4 Chapter designation added
DT-2 Revised
129 DT-4.4 Second paragraph revised
DT-4.5 Added
DT-7 First paragraph revised
DT-8 First paragraph revised
DT-9.3 Revised
130 DT-9.4 Subparagraphs (c) and (d) figure numberupdated
132 Table DT-2-1 Title revised
134 Table DT-4.1-1 U.S. Customary column revised
135 Table DT-4.1.1-1 SI column revised
Table DT-4.1.1-2 SI columns revised
136 Table DT-4.1.1-3 SI column revised
Table DT-4.1.1-4 SI column revised
137 Table DT-4.1.1-5 SI columns revised
Table DT-4.1.1-6 SI column revised
138 Table DT-4.1.1-7 SI columns revised
Table DT-4.1.1-8 SI columns revised
139 Table DT-4.1.2-1 SI column revised
Table DT-4.1.2-2 SI columns revised
140 Table DT-4.1.2-3 SI columns revised
Table DT-4.1.2-4 SI column revised
141 Table DT-4.1.2-5 SI columns revised
Table DT-4.1.2-6 SI columns revised
142 Table DT-4.1.2-7 SI columns revised
143 Table DT-4.1.2-8 SI columns revised
xx
Page Location Change
144 Table DT-4.1.2-9 SI columns revised
Table DT-4.1.2-10 SI columns revised
Table DT-4.1.2-11 SI columns revised
145 Table DT-4.1.3-1 Revised
146 Table DT-4.1.3-2 Revised
147 Table DT-4.1.3-3 Revised
148 Table DT-4.1.4-1 Revised
Table DT-4.1.5-1 SI column revised
149 Table DT-4.1.5-2 SI column revised
150 Table DT-4.4.1-1 SI column revised
151 Table DT-4.5.1-1 Added
152 Table DT-4.5.2-1 Added
153, 154 Table DT-7-1 Revised
155 Table DT-7-2 Revised
156 Table DT-9.3-1 Revised
157, 158 PI-1 Revised
PI-2 Revised in its entirety
166 PI-7.3.6 Subparagraph (b) editorially revised
170 PI-7.6 Editorially revised
178 PI-9.1.1 Revised
PI-9.1.2.1 Revised
PI-9.1.2.2 Revised
PI-9.1.2.3 Revised in its entirety
PI-9.1.3 Revised
PI-9.1.3.1 Revised
PI-9.1.3.2 Revised
PI-9.1.3.5 First paragraph revised
PI-9.1.3.6 First paragraph revised
PI-9.1.4.1 Revised
PI-9.1.4.2 Revised
181 PI-9.1.4.4 Revised
PI-9.1.5 Revised
PI-9.1.6 Deleted
186 SG-2.3.1.6 Figure number updated
192, 193, 194, 198 SG-2.3.2.3 Subparagraph (b)(5) revised
SG-2.3.2.4 Subparagraphs (a) through (d), (f), and(h) through (k) revised
xxi
Page Location Change
199 SG-3.3.1 Subparagraphs (a), (d)(4), and (e) revised
200 Fig. SG-3.3.2.2-1 Title revised
201 SG-3.3.2.3 Subparagraph (a)(13) revised
206, 207 SG-4.3.1.1 Revised in its entirety
SG-5.1 Revised in its entirety
207, 208 SG-5.3 Revised in its entirety
209 Chapter 5 Chapter designation added
MJ-2.1.1 Cross-references in subparas. (a) and (c)updated
MJ-2.2.1 Revised
210, 211 MJ-2.2.2 Revised
MJ-2.2.3 Revised
MJ-2.3 Revised
MJ-3.1 Revised
MJ-3.2 Revised
MJ-3.3 Revised
MJ-3.4 Revised
MJ-3.5 Revised in its entirety
MJ-4 (1) New MJ-4.1 added, and remainingparagraphs redesignated
(2) MJ-4.2 and MJ-4.3 revised
Table MJ-6.3-1 Revised in its entirety
212 Table MJ-6.3-2 Revised in its entirety
213, 214 MJ-7.3.3 Subparagraph (b) revised
MJ-8.1 Revised
MJ-9.3 Revised
215 Table MJ-8.2-1 (1) Title and tenth row revised(2) Eleventh row added
216, 217 Table MJ-8.3-1 (1) Title and tenth and 18th rows revised(2) Eleventh row and Note (4) added
218, 219 Table MJ-8.4-1 Revised in its entirety
220 Fig. MJ-8.4-1 (1) Title and illustration (e) revised(2) Illustration (g) added
221 Fig. MJ-8.4-2 (1) Red circles added(2) Paragraph underneath figure revised
222 Fig. MJ-8.4-3 (1) Red circles added(2) Paragraph underneath figure revised
223 Fig. MJ-8.4-4 Title and General Note revised
224, 225 Table MJ-8.5-1 Revised in its entirety
xxii
Page Location Change
226 Fig. MJ-8.5-1 (1) Illustration (a) revised(2) Illustration (c) added
227 MJ-9.3.1 Revised
MJ-9.3.2 Revised
MJ-9.3.3 Revised
MJ-9.4 Revised
228 MJ-9.6.3.2 Revised
MJ-9.7.1 Subparagraph (d) revised
MJ-9.8 Subparagraph (a) revised
229 Fig. MJ-9.7.1-1 Revised in its entirety
230 SF-2.4 Revised
231 Table SF-2.2-1 Last row deleted
232 Table SF-2.2-2 (1) Second row deleted(2) New second and current fifth rows
revised
235 Chapter 6 Chapter designation added
Part CR Part title revised
251 D-4.2 Editorially revised
272 G-1 Revised
G-3 Revised
276, 277 Table I-1.1-1 Definitions of VDRs 10, 11, and 13revised
279–281 J-1.1 Revised
J-1.2 Paragraph added
J-1.2.1 Subparagraphs (b)(6), (d)(2), (e), and(f)(5) revised
J-1.2.2 Added, and remaining paragraphsredesignated
J-1.2.3.2 Revised
286 J-2.3 Last sentence editorially revised
290 K-5.2 Subparagraphs (a), (b), and (c) revised
291 Table K-3-1 General Note revised to Note (1)
296 N-1.1 Added
N-2 Revised in its entirety
xxiii
Page Location Change
297 O-1 (1) ICH Q3A updated(2) ISO 10993-18:2005(E), Part 5 added(3) Parenteral Drug Association, EDQM
Council of Europe, BioProcessInternational, John Wiley & Sons,International Society forPharmaceutical Engineering, and USPreferences added
(4) NRI reference deleted
O-2 Title revised
298 O-3 Title and subpara. (d) revised
O-4 Added
299 Fig. O-4-1 Added
306–308 Nonmandatory Appendix S Title revised
S-1 (1) Title revised(2) S-1.1 designation added, and
remaining paragraph redesignated
S-2 Added
309 T-2 Subparagraph (c) revised
311, 312 Nonmandatory AddedAppendix U
313 Nonmandatory AddedAppendix V
315–328 Index Updated
xxiv
Recommended