Bioprocessing piping and equipment design : a companion guide for the ASME BPE standard / William M. (Bill) Huitt.

Format:

Book

Author/Creator:

Huitt, William M., 1943- author.

Series:

Wiley-ASME Press Series

Wiley ASME Press Series

Language:

English

Subjects (All):

Biochemical engineering--Equipment and supplies--Standards--Handbooks, manuals, etc.

Biochemical engineering.

Chemical plants--Piping--Standards--Handbooks, manuals, etc.

Chemical plants.

Physical Description:

1 online resource (546 p.)

Edition:

1st ed.

Place of Publication:

Hoboken, New Jersey : Wiley, 2017.

Summary:

The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard's content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.

Contents:

Intro

Title Page

Copyright Page

Contents

List of Figures

List of Tables

List of Forms

Series Preface

Preface

Acknowledgments

About the Author

Chapter 1 Introduction, Scope, and General Requirements of the BPE

1.1 Introduction

1.2 Scope of the ASME BPE Standard

1.3 Intent of the BPE Standard

1.4 ASME B31.3 Chapter X

1.5 Terms and Definitions

1.6 Quality Assurance

1.6.1 Documentation

1.7 An Essential Understanding of Codes and Standards

1.8 Source of BPE Content

1.8.1 Government Regulations

1.8.2 Generally Accepted Principals and Practices of the Industry

1.8.3 Research and Testing Done by the BPE Membership

1.9 ASME B31.3 Process Piping Code Chapter X

1.9.1 B31.3 Chapter X as Supplement to the Base Code

1.9.2 Harmonization of the BPE Standard and B31.3 Chapter X

Chapter 2 Materials

2.1 Scope of this Chapter

2.2 Materials of Construction

2.3 Metallic Materials

2.3.1 Understanding ASTM Material Designations

2.3.2 Stainless Steel

2.3.3 The World of Crystallography

2.3.4 Pitting Resistance Equivalent Number (PREn)

2.3.5 Alloying Constituents in Austenitic Stainless Steel

2.3.6 Dual Certified Stainless Steels

2.3.7 So Why 316L Stainless Steel?

2.4 Nonmetallic Materials

2.4.1 What Are Nonmetallic Materials?

2.4.2 Extractables and Leachables

2.4.3 Single-Use Systems and Components

2.5 Surface Finish

2.6 Rouge

2.6.1 Class I Rouge

2.6.2 Class II Rouge

2.6.3 Class III Rouge

2.6.4 Background on Rouge

2.6.5 Source of Rouge

2.7 Electropolishing

2.7.1 Irregularities or Flaws in Electropolishing

2.8 Passivation

Chapter 3 Process Components

3.1 Process Components

3.2 Pressure Ratings

3.2.1 Pressure Ratings of Welded Components.

3.2.2 Pressure Ratings and Other Fundamentals of Hygienic Clamp Joint Unions

3.3 Hygienic Clamp and Automatic Tube Weld Fittings

3.4 Sanitary Valves

3.5 Seals

3.6 Instruments

3.6.1 Coriolis Flow Meter

3.6.2 Radar Level Instruments

3.6.3 Pressure Instruments

3.6.4 Temperature Instruments

3.6.5 Analytical Instruments

3.6.6 Optical Devices

Chapter 4 Fabrication, Assembly, and Installation

4.1 Scope and Introduction to this Chapter

4.1.1 Scope

4.1.2 Introduction

4.2 Fabrication

4.2.1 Fabrication Drawings and Spool Pieces

4.3 Fabrication of Metallic Tubing

4.3.1 Welding Documentation and Retention

4.3.2 Welding for Piping Systems

4.4 Fabrication of Nonmetallic Piping and Tubing

4.4.1 Fabrication of Polymeric Components

4.5 Assembly and Installation

4.5.1 General

4.5.2 Characteristics of the Hygienic Clamp Joint

4.6 The Piping Installation Process

4.6.1 Field Assembly and Installation (Stick Built)

4.6.2 As-Built and Other Drawings

4.6.3 Skid or Module Fabrication

Chapter 5 Examination, Inspection, and Testing

5.1 Examination, Inspection, and Testing

5.2 Examination

5.2.1 Weld Examination

5.3 Inspection

5.4 Leak Testing of Piping

Chapter 6 Equipment and Component Quality

6.1 Assured Quality

6.2 BPE Certification

6.3 A Quality Management System

6.4 Purpose

Chapter 7 Design

7.1 BPE Scope of Design

7.2 Intent of Part SD

7.3 It's a Bug's Life

7.3.1 Perspective on Bacteria

7.4 A Preamble to Design

7.4.1 Undeveloped Subject Matter

7.4.2 Containment

7.4.3 Working with BPE and B31.3

7.4.4 Fabrication

7.4.5 Materials of Construction

7.4.6 Cleanability and Drainability

7.4.7 Bioprocessing System Boundaries

7.5 Design

7.5.1 The System

Chapter 8 BPE Appendices

8.1 Mandatory and Nonmandatory Appendices.

8.2 Mandatory Appendices

8.2.1 Mandatory Appendix I: Submittal of Technical Inquiries to the BPE Committee

8.2.2 Mandatory Appendix II: Standard Units

8.3 Nonmandatory Appendices

8.3.1 Nonmandatory Appendix A-Commentary: Slag

8.3.2 Nonmandatory Appendix B: Material and Weld Examination/Inspection Documentation

8.3.3 Nonmandatory Appendix C: Slope Measurement

8.3.4 Nonmandatory Appendix D: Rouge and Stainless Steel

8.3.5 Nonmandatory Appendix E: Passivation Procedure Qualification

8.3.6 Nonmandatory Appendix F: Corrosion Testing

8.3.7 Nonmandatory Appendix G: Ferrite

8.3.8 Nonmandatory Appendix H: Electropolishing Procedure Qualification

8.3.9 Nonmandatory Appendix I: Vendor Documentation Requirements for New Instruments

8.3.10 Nonmandatory Appendix J: Standard Process Test Conditions (SPTC) for Seal Performance Evaluation

8.3.11 Nonmandatory Appendix K: Standard Test Methods for Polymers

8.3.12 Nonmandatory Appendix L: Spray Device Coverage Testing

8.3.13 Nonmandatory Appendix M-Commentary: 316L Weld Heat-Affected Zone Discoloration Acceptance Criteria

8.3.14 Nonmandatory Appendix N: Guidance When Choosing Polymeric and Nonmetallic Materials

8.3.15 Nonmandatory Appendix O: General Background/Useful Information for Extractables and Leachables

8.3.16 Nonmandatory Appendix P: Temperature Sensors and Associated Components

8.3.17 Nonmandatory Appendix Q: Instrument Receiving, Handling, and Storage

8.3.18 Nonmandatory Appendix R: Application Data Sheet

8.3.19 Nonmandatory Appendix S-Polymer Applications: Chromatography Columns

8.3.20 Nonmandatory Appendix T: Guidance for the Use of US Customary and SI Units

Appendix A Cleaning and Leak Testing Procedure

Appendix B Biotechnology Inspection Guide Reference Materials and Training Aids.

Appendix C Guide to Inspections of High Purity Water Systems

Appendix D Guide to Inspections of Lyophilization of Parenterals

Appendix E Guide to Inspections and Validation of Cleaning Processes

Appendix F Guide to Inspections of Dosage Form Drug Manufacturer's-CGMPR's

Appendix G Guide to Inspections Oral Solutions and Suspensions

Appendix H Guide to Inspections of Sterile Drug Substance Manufacturers

Appendix J Guide to Inspections of Topical Drug Products

Appendix K BPE History-Letters and Notes

Appendix L Component Dimensions

Further Reading

Index

Supplemental Images

EULA.

Notes:

"This Work is a co-publication between ASME Press and John Wiley & Sons, Inc."

Includes bibliographical references and index.

Description based on print version record.

ISBN:

9781523154920

1523154926

9781119284253

1119284252

9781119284246

1119284244

9781119284260

1119284260

OCLC:

959881693