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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.

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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

v

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-3.4 Revised in its entirety

xvii


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


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


87–94 SD-5.3.4 Revised in its entirety

Fig. SD-5.3.4.3.1-1 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


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


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


Table DT-4.1.1-4 SI column revised

137 Table DT-4.1.1-5 SI columns revised












xx





145 Table DT-4.1.3-1 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


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


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


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


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


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

Documents

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