Bioprocessing Piping and Equipment Design
-15%
portes grátis
Bioprocessing Piping and Equipment Design
A Companion Guide for the ASME BPE Standard
Huitt, William M. (Bill)
John Wiley & Sons Inc
12/2016
544
Dura
Inglês
9781119284239
15 a 20 dias
892
Descrição não disponível.
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
7 Design 166
7.1 BPE Scope of Design 166
7.2 Intent of Part SD 167
7.3 It's a Bug's Life 168
7.3.1 Perspective on Bacteria 168
7.4 A Preamble to Design 177
7.4.1 Undeveloped Subject Matter 177
7.4.2 Containment 177
7.4.3 Working with BPE and B31.3 180
7.4.4 Fabrication 183
7.4.5 Materials of Construction 185
7.4.6 Cleanability and Drainability 186
7.4.7 Bioprocessing System Boundaries 186
7.5 Design 186
7.5.1 The System 187
8 BPE Appendices 202
8.1 Mandatory and Nonmandatory Appendices 202
8.2 Mandatory Appendices 203
8.2.1 Mandatory Appendix I: Submittal of Technical Inquiries to the BPE Committee 203
8.2.2 Mandatory Appendix II: Standard Units 204
8.3 Nonmandatory Appendices 204
8.3.1 Nonmandatory Appendix A-Commentary: Slag 204
8.3.2 Nonmandatory Appendix B: Material and Weld Examination/Inspection Documentation 204
8.3.3 Nonmandatory Appendix C: Slope Measurement 204
8.3.4 Nonmandatory Appendix D: Rouge and Stainless Steel 204
8.3.5 Nonmandatory Appendix E: Passivation Procedure Qualification 205
8.3.6 Nonmandatory Appendix F: Corrosion Testing 205
8.3.7 Nonmandatory Appendix G: Ferrite 205
8.3.8 Nonmandatory Appendix H: Electropolishing Procedure Qualification 205
8.3.9 Nonmandatory Appendix I: Vendor Documentation Requirements for New Instruments 206
8.3.10 Nonmandatory Appendix J: Standard Process Test Conditions (SPTC) for Seal Performance Evaluation 206
8.3.11 Nonmandatory Appendix K: Standard Test Methods for Polymers 206
8.3.12 Nonmandatory Appendix L: Spray Device Coverage Testing 207
8.3.13 Nonmandatory Appendix M-Commentary: 316L Weld Heat?]Affected Zone Discoloration Acceptance Criteria 207
8.3.14 Nonmandatory Appendix N: Guidance When Choosing Polymeric and Nonmetallic Materials 207
8.3.15 Nonmandatory Appendix O: General Background/Useful Information for Extractables and Leachables 207
8.3.16 Nonmandatory Appendix P: Temperature Sensors and Associated Components 208
8.3.17 Nonmandatory Appendix Q: Instrument Receiving, Handling, and Storage 208
8.3.18 Nonmandatory Appendix R: Application Data Sheet 208
8.3.19 Nonmandatory Appendix S-Polymer Applications: Chromatography Columns 208
8.3.20 Nonmandatory Appendix T: Guidance for the Use of US Customary and SI Units 208
Appendices
Appendix A Cleaning and Leak Testing Procedure 209
Appendix B Biotechnology Inspection Guide Reference Materials and Training Aids 251
Appendix C Guide to Inspections of High Purity Water Systems 286
Appendix D Guide to Inspections of Lyophilization of Parenterals 304
Appendix E Guide to Inspections and Validation of Cleaning Processes 322
Appendix F Guide to Inspections of Dosage Form Drug Manufacturer's-CGMPR's 331
Appendix G Guide to Inspections Oral Solutions and Suspensions 349
Appendix H Guide to Inspections of Sterile Drug Substance Manufacturers 356
Appendix J Guide to Inspections of Topical Drug Products 366
Appendix K BPE History-Letters and Notes 375
Appendix L Component Dimensions 420
Further Reading 440
Index 445
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
7 Design 166
7.1 BPE Scope of Design 166
7.2 Intent of Part SD 167
7.3 It's a Bug's Life 168
7.3.1 Perspective on Bacteria 168
7.4 A Preamble to Design 177
7.4.1 Undeveloped Subject Matter 177
7.4.2 Containment 177
7.4.3 Working with BPE and B31.3 180
7.4.4 Fabrication 183
7.4.5 Materials of Construction 185
7.4.6 Cleanability and Drainability 186
7.4.7 Bioprocessing System Boundaries 186
7.5 Design 186
7.5.1 The System 187
8 BPE Appendices 202
8.1 Mandatory and Nonmandatory Appendices 202
8.2 Mandatory Appendices 203
8.2.1 Mandatory Appendix I: Submittal of Technical Inquiries to the BPE Committee 203
8.2.2 Mandatory Appendix II: Standard Units 204
8.3 Nonmandatory Appendices 204
8.3.1 Nonmandatory Appendix A-Commentary: Slag 204
8.3.2 Nonmandatory Appendix B: Material and Weld Examination/Inspection Documentation 204
8.3.3 Nonmandatory Appendix C: Slope Measurement 204
8.3.4 Nonmandatory Appendix D: Rouge and Stainless Steel 204
8.3.5 Nonmandatory Appendix E: Passivation Procedure Qualification 205
8.3.6 Nonmandatory Appendix F: Corrosion Testing 205
8.3.7 Nonmandatory Appendix G: Ferrite 205
8.3.8 Nonmandatory Appendix H: Electropolishing Procedure Qualification 205
8.3.9 Nonmandatory Appendix I: Vendor Documentation Requirements for New Instruments 206
8.3.10 Nonmandatory Appendix J: Standard Process Test Conditions (SPTC) for Seal Performance Evaluation 206
8.3.11 Nonmandatory Appendix K: Standard Test Methods for Polymers 206
8.3.12 Nonmandatory Appendix L: Spray Device Coverage Testing 207
8.3.13 Nonmandatory Appendix M-Commentary: 316L Weld Heat?]Affected Zone Discoloration Acceptance Criteria 207
8.3.14 Nonmandatory Appendix N: Guidance When Choosing Polymeric and Nonmetallic Materials 207
8.3.15 Nonmandatory Appendix O: General Background/Useful Information for Extractables and Leachables 207
8.3.16 Nonmandatory Appendix P: Temperature Sensors and Associated Components 208
8.3.17 Nonmandatory Appendix Q: Instrument Receiving, Handling, and Storage 208
8.3.18 Nonmandatory Appendix R: Application Data Sheet 208
8.3.19 Nonmandatory Appendix S-Polymer Applications: Chromatography Columns 208
8.3.20 Nonmandatory Appendix T: Guidance for the Use of US Customary and SI Units 208
Appendices
Appendix A Cleaning and Leak Testing Procedure 209
Appendix B Biotechnology Inspection Guide Reference Materials and Training Aids 251
Appendix C Guide to Inspections of High Purity Water Systems 286
Appendix D Guide to Inspections of Lyophilization of Parenterals 304
Appendix E Guide to Inspections and Validation of Cleaning Processes 322
Appendix F Guide to Inspections of Dosage Form Drug Manufacturer's-CGMPR's 331
Appendix G Guide to Inspections Oral Solutions and Suspensions 349
Appendix H Guide to Inspections of Sterile Drug Substance Manufacturers 356
Appendix J Guide to Inspections of Topical Drug Products 366
Appendix K BPE History-Letters and Notes 375
Appendix L Component Dimensions 420
Further Reading 440
Index 445
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
BPE standard; industry standards; bioprocessing; industrial installation; ASME; pharmaceuticals
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
7 Design 166
7.1 BPE Scope of Design 166
7.2 Intent of Part SD 167
7.3 It's a Bug's Life 168
7.3.1 Perspective on Bacteria 168
7.4 A Preamble to Design 177
7.4.1 Undeveloped Subject Matter 177
7.4.2 Containment 177
7.4.3 Working with BPE and B31.3 180
7.4.4 Fabrication 183
7.4.5 Materials of Construction 185
7.4.6 Cleanability and Drainability 186
7.4.7 Bioprocessing System Boundaries 186
7.5 Design 186
7.5.1 The System 187
8 BPE Appendices 202
8.1 Mandatory and Nonmandatory Appendices 202
8.2 Mandatory Appendices 203
8.2.1 Mandatory Appendix I: Submittal of Technical Inquiries to the BPE Committee 203
8.2.2 Mandatory Appendix II: Standard Units 204
8.3 Nonmandatory Appendices 204
8.3.1 Nonmandatory Appendix A-Commentary: Slag 204
8.3.2 Nonmandatory Appendix B: Material and Weld Examination/Inspection Documentation 204
8.3.3 Nonmandatory Appendix C: Slope Measurement 204
8.3.4 Nonmandatory Appendix D: Rouge and Stainless Steel 204
8.3.5 Nonmandatory Appendix E: Passivation Procedure Qualification 205
8.3.6 Nonmandatory Appendix F: Corrosion Testing 205
8.3.7 Nonmandatory Appendix G: Ferrite 205
8.3.8 Nonmandatory Appendix H: Electropolishing Procedure Qualification 205
8.3.9 Nonmandatory Appendix I: Vendor Documentation Requirements for New Instruments 206
8.3.10 Nonmandatory Appendix J: Standard Process Test Conditions (SPTC) for Seal Performance Evaluation 206
8.3.11 Nonmandatory Appendix K: Standard Test Methods for Polymers 206
8.3.12 Nonmandatory Appendix L: Spray Device Coverage Testing 207
8.3.13 Nonmandatory Appendix M-Commentary: 316L Weld Heat?]Affected Zone Discoloration Acceptance Criteria 207
8.3.14 Nonmandatory Appendix N: Guidance When Choosing Polymeric and Nonmetallic Materials 207
8.3.15 Nonmandatory Appendix O: General Background/Useful Information for Extractables and Leachables 207
8.3.16 Nonmandatory Appendix P: Temperature Sensors and Associated Components 208
8.3.17 Nonmandatory Appendix Q: Instrument Receiving, Handling, and Storage 208
8.3.18 Nonmandatory Appendix R: Application Data Sheet 208
8.3.19 Nonmandatory Appendix S-Polymer Applications: Chromatography Columns 208
8.3.20 Nonmandatory Appendix T: Guidance for the Use of US Customary and SI Units 208
Appendices
Appendix A Cleaning and Leak Testing Procedure 209
Appendix B Biotechnology Inspection Guide Reference Materials and Training Aids 251
Appendix C Guide to Inspections of High Purity Water Systems 286
Appendix D Guide to Inspections of Lyophilization of Parenterals 304
Appendix E Guide to Inspections and Validation of Cleaning Processes 322
Appendix F Guide to Inspections of Dosage Form Drug Manufacturer's-CGMPR's 331
Appendix G Guide to Inspections Oral Solutions and Suspensions 349
Appendix H Guide to Inspections of Sterile Drug Substance Manufacturers 356
Appendix J Guide to Inspections of Topical Drug Products 366
Appendix K BPE History-Letters and Notes 375
Appendix L Component Dimensions 420
Further Reading 440
Index 445
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
7 Design 166
7.1 BPE Scope of Design 166
7.2 Intent of Part SD 167
7.3 It's a Bug's Life 168
7.3.1 Perspective on Bacteria 168
7.4 A Preamble to Design 177
7.4.1 Undeveloped Subject Matter 177
7.4.2 Containment 177
7.4.3 Working with BPE and B31.3 180
7.4.4 Fabrication 183
7.4.5 Materials of Construction 185
7.4.6 Cleanability and Drainability 186
7.4.7 Bioprocessing System Boundaries 186
7.5 Design 186
7.5.1 The System 187
8 BPE Appendices 202
8.1 Mandatory and Nonmandatory Appendices 202
8.2 Mandatory Appendices 203
8.2.1 Mandatory Appendix I: Submittal of Technical Inquiries to the BPE Committee 203
8.2.2 Mandatory Appendix II: Standard Units 204
8.3 Nonmandatory Appendices 204
8.3.1 Nonmandatory Appendix A-Commentary: Slag 204
8.3.2 Nonmandatory Appendix B: Material and Weld Examination/Inspection Documentation 204
8.3.3 Nonmandatory Appendix C: Slope Measurement 204
8.3.4 Nonmandatory Appendix D: Rouge and Stainless Steel 204
8.3.5 Nonmandatory Appendix E: Passivation Procedure Qualification 205
8.3.6 Nonmandatory Appendix F: Corrosion Testing 205
8.3.7 Nonmandatory Appendix G: Ferrite 205
8.3.8 Nonmandatory Appendix H: Electropolishing Procedure Qualification 205
8.3.9 Nonmandatory Appendix I: Vendor Documentation Requirements for New Instruments 206
8.3.10 Nonmandatory Appendix J: Standard Process Test Conditions (SPTC) for Seal Performance Evaluation 206
8.3.11 Nonmandatory Appendix K: Standard Test Methods for Polymers 206
8.3.12 Nonmandatory Appendix L: Spray Device Coverage Testing 207
8.3.13 Nonmandatory Appendix M-Commentary: 316L Weld Heat?]Affected Zone Discoloration Acceptance Criteria 207
8.3.14 Nonmandatory Appendix N: Guidance When Choosing Polymeric and Nonmetallic Materials 207
8.3.15 Nonmandatory Appendix O: General Background/Useful Information for Extractables and Leachables 207
8.3.16 Nonmandatory Appendix P: Temperature Sensors and Associated Components 208
8.3.17 Nonmandatory Appendix Q: Instrument Receiving, Handling, and Storage 208
8.3.18 Nonmandatory Appendix R: Application Data Sheet 208
8.3.19 Nonmandatory Appendix S-Polymer Applications: Chromatography Columns 208
8.3.20 Nonmandatory Appendix T: Guidance for the Use of US Customary and SI Units 208
Appendices
Appendix A Cleaning and Leak Testing Procedure 209
Appendix B Biotechnology Inspection Guide Reference Materials and Training Aids 251
Appendix C Guide to Inspections of High Purity Water Systems 286
Appendix D Guide to Inspections of Lyophilization of Parenterals 304
Appendix E Guide to Inspections and Validation of Cleaning Processes 322
Appendix F Guide to Inspections of Dosage Form Drug Manufacturer's-CGMPR's 331
Appendix G Guide to Inspections Oral Solutions and Suspensions 349
Appendix H Guide to Inspections of Sterile Drug Substance Manufacturers 356
Appendix J Guide to Inspections of Topical Drug Products 366
Appendix K BPE History-Letters and Notes 375
Appendix L Component Dimensions 420
Further Reading 440
Index 445
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