Bioprocessing Piping and Equipment Design

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.

Auteur

William M. (Bill) Huitt has been involved in industrial piping design, engineering and construction since 1965. Positions have included design engineer, piping design instructor, project engineer, project supervisor, piping department supervisor, engineering manager and president of W. M. Huitt Co., a piping consulting firm founded in 1987. His experience covers both the engineering and construction fields and crosses industry lines to include petroleum refining, chemical, petrochemical, pharmaceutical, pulp & paper, nuclear power, biofuel, and coal gasification. He has written numerous specifications, guidelines, papers, and magazine articles on the topic of piping design and engineering. Bill is a past member of ISPE (International Society of Pharmaceutical Engineers), CSI (Construction Specifications Institute) and current member of ASME (American Society of Mechanical Engineers).

Contenu

List of Figures xx

List of Tables xxix

List of Forms xxxi

Series Preface xxxii

Preface xxxiii

Acknowledgments lxxvii

About the Author lxxx

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

1.1 Introduction 1

1.2 Scope of the ASME BPE Standard 2

1.3 Intent of the BPE Standard 6

1.4 ASME B31.3 Chapter X 7

1.5 Terms and Definitions 8

1.6 Quality Assurance 11

1.6.1 Documentation 13

1.7 An Essential Understanding of Codes and Standards 17

1.8 Source of BPE Content 20

1.8.1 Government Regulations 20

1.8.2 Generally Accepted Principals and Practices of the Industry 21

1.8.3 Research and Testing Done by the BPE Membership 21

1.9 ASME B31.3 Process Piping Code Chapter X 22

1.9.1 B31.3 Chapter X as Supplement to the Base Code 23

1.9.2 Harmonization of the BPE Standard and B31.3 Chapter X 24

2 Materials 25

2.1 Scope of this Chapter 25

2.2 Materials of Construction 25

2.3 Metallic Materials 26

2.3.1 Understanding ASTM Material Designations 27

2.3.2 Stainless Steel 36

2.3.3 The World of Crystallography 37

2.3.4 Pitting Resistance Equivalent Number (PREn) 42

2.3.5 Alloying Constituents in Austenitic Stainless Steel 45

2.3.6 Dual Certified Stainless Steels 46

2.3.7 So Why 316L Stainless Steel? 47

2.4 Nonmetallic Materials 49

2.4.1 What Are Nonmetallic Materials? 49

2.4.2 Extractables and Leachables 52

2.4.3 Single?]Use Systems and Components 54

2.5 Surface Finish 57

2.6 Rouge 63

2.6.1 Class I Rouge 64

2.6.2 Class II Rouge 65

2.6.3 Class III Rouge 66

2.6.4 Background on Rouge 68

2.6.5 Source of Rouge 69

2.7 Electropolishing 70

2.7.1 Irregularities or Flaws in Electropolishing 74

2.8 Passivation 76

3 Process Components 81

3.1 Process Components 81

3.2 Pressure Ratings 81

3.2.1 Pressure Ratings of Welded Components 81

3.2.2 Pressure Ratings and Other Fundamentals of Hygienic Clamp Joint Unions 86

3.3 Hygienic Clamp and Automatic Tube Weld Fittings 89

3.4 Sanitary Valves 101

3.5 Seals 102

3.6 Instruments 105

3.6.1 Coriolis Flow Meter 106

3.6.2 Radar Level Instruments 106

3.6.3 Pressure Instruments 106

3.6.4 Temperature Instruments 106

3.6.5 Analytical Instruments 106

3.6.6 Optical Devices 107

4 Fabrication, Assembly, and Installation 108

4.1 Scope and Introduction to this Chapter 108

4.1.1 Scope 108

4.1.2 Introduction 108

4.2 Fabrication 111

4.2.1 Fabrication Drawings and Spool Pieces 111

4.3 Fabrication of Metallic Tubing 116

4.3.1 Welding Documentation and Retention 116

4.3.2 Welding for Piping Systems 119

4.4 Fabrication of Nonmetallic Piping and Tubing 126

4.4.1 Fabrication of Polymeric Components 126

4.5 Assembly and Installation 131

4.5.1 General 131

4.5.2 Characteristics of the Hygienic Clamp Joint 131

4.6 The Piping Installation Process 140

4.6.1 Field Assembly and Installation (Stick Built) 140

4.6.2 As?]Built and Other Drawings 142

4.6.3 Skid or Module Fabrication 144

5 Examination, Inspection, and Testing 147

5.1 Examination, Inspection, and Testing 147

5.2 Examination 148

5.2.1 Weld Examination 150

5.3 Inspection 153

5.4 Leak Testing of Piping 155

6 Equipment and Component Quality 157

6.1 Assured Quality 157

6.2 BPE Certification 157

6.3 A Quality Management System 161 6.4 Purpose 164...