Bioprocessing Piping and Equipment Design

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).

• List of Figures xxList of Tables xxixList of Forms xxxiSeries Preface xxxiiPreface xxxiiiAcknowledgments lxxviiAbout the Author lxxx1 Introduction, Scope, and General Requirements of the BPE 11.1 Introduction 11.2 Scope of the ASME BPE Standard 21.3 Intent of the BPE Standard 61.4 ASME B31.3 Chapter X 71.5 Terms and Definitions 81.6 Quality Assurance 111.6.1 Documentation 131.7 An Essential Understanding of Codes and Standards 171.8 Source of BPE Content 201.8.1 Government Regulations 201.8.2 Generally Accepted Principals and Practices of the Industry 211.8.3 Research and Testing Done by the BPE Membership 211.9 ASME B31.3 Process Piping Code Chapter X 221.9.1 B31.3 Chapter X as Supplement to the Base Code 231.9.2 Harmonization of the BPE Standard and B31.3 Chapter X 242 Materials 252.1 Scope of this Chapter 252.2 Materials of Construction 252.3 Metallic Materials 262.3.1 Understanding ASTM Material Designations 272.3.2 Stainless Steel 362.3.3 The World of Crystallography 372.3.4 Pitting Resistance Equivalent Number (PREn) 422.3.5 Alloying Constituents in Austenitic Stainless Steel 452.3.6 Dual Certified Stainless Steels 462.3.7 So Why 316L Stainless Steel? 472.4 Nonmetallic Materials 492.4.1 What Are Nonmetallic Materials? 492.4.2 Extractables and Leachables 522.4.3 Single]Use Systems and Components 542.5 Surface Finish 572.6 Rouge 632.6.1 Class I Rouge 642.6.2 Class II Rouge 652.6.3 Class III Rouge 662.6.4 Background on Rouge 682.6.5 Source of Rouge 692.7 Electropolishing 702.7.1 Irregularities or Flaws in Electropolishing 742.8 Passivation 763 Process Components 813.1 Process Components 813.2 Pressure Ratings 813.2.1 Pressure Ratings of Welded Components 813.2.2 Pressure Ratings and Other Fundamentals of Hygienic Clamp Joint Unions 863.3 Hygienic Clamp and Automatic Tube Weld Fittings 893.4 Sanitary Valves 1013.5 Seals 1023.6 Instruments 1053.6.1 Coriolis Flow Meter 1063.6.2 Radar Level Instruments 1063.6.3 Pressure Instruments 1063.6.4 Temperature Instruments 1063.6.5 Analytical Instruments 1063.6.6 Optical Devices 1074 Fabrication, Assembly, and Installation 1084.1 Scope and Introduction to this Chapter 1084.1.1 Scope 1084.1.2 Introduction 1084.2 Fabrication 1114.2.1 Fabrication Drawings and Spool Pieces 1114.3 Fabrication of Metallic Tubing 1164.3.1 Welding Documentation and Retention 1164.3.2 Welding for Piping Systems 1194.4 Fabrication of Nonmetallic Piping and Tubing 1264.4.1 Fabrication of Polymeric Components 1264.5 Assembly and Installation 1314.5.1 General 1314.5.2 Characteristics of the Hygienic Clamp Joint 1314.6 The Piping Installation Process 1404.6.1 Field Assembly and Installation (Stick Built) 1404.6.2 As]Built and Other Drawings 1424.6.3 Skid or Module Fabrication 1445 Examination, Inspection, and Testing 1475.1 Examination, Inspection, and Testing 1475.2 Examination 1485.2.1 Weld Examination 1505.3 Inspection 1535.4 Leak Testing of Piping 1556 Equipment and Component Quality 1576.1 Assured Quality 1576.2 BPE Certification 1576.3 A Quality Management System 1616.4 Purpose 1647 Design 1667.1 BPE Scope of Design 1667.2 Intent of Part SD 1677.3 It’s a Bug’s Life 1687.3.1 Perspective on Bacteria 1687.4 A Preamble to Design 1777.4.1 Undeveloped Subject Matter 1777.4.2 Containment 1777.4.3 Working with BPE and B31.3 1807.4.4 Fabrication 1837.4.5 Materials of Construction 1857.4.6 Cleanability and Drainability 1867.4.7 Bioprocessing System Boundaries 1867.5 Design 1867.5.1 The System 1878 BPE Appendices 2028.1 Mandatory and Nonmandatory Appendices 2028.2 Mandatory Appendices 2038.2.1 Mandatory Appendix I: Submittal of Technical Inquiries to the BPE Committee 2038.2.2 Mandatory Appendix II: Standard Units 2048.3 Nonmandatory Appendices 2048.3.1 Nonmandatory Appendix A—Commentary: Slag 2048.3.2 Nonmandatory Appendix B: Material and Weld Examination/Inspection Documentation 2048.3.3 Nonmandatory Appendix C: Slope Measurement 2048.3.4 Nonmandatory Appendix D: Rouge and Stainless Steel 2048.3.5 Nonmandatory Appendix E: Passivation Procedure Qualification 2058.3.6 Nonmandatory Appendix F: Corrosion Testing 2058.3.7 Nonmandatory Appendix G: Ferrite 2058.3.8 Nonmandatory Appendix H: Electropolishing Procedure Qualification 2058.3.9 Nonmandatory Appendix I: Vendor Documentation Requirements for New Instruments 2068.3.10 Nonmandatory Appendix J: Standard Process Test Conditions (SPTC) for Seal Performance Evaluation 2068.3.11 Nonmandatory Appendix K: Standard Test Methods for Polymers 2068.3.12 Nonmandatory Appendix L: Spray Device Coverage Testing 2078.3.13 Nonmandatory Appendix M—Commentary: 316L Weld Heat]Affected Zone Discoloration Acceptance Criteria 2078.3.14 Nonmandatory Appendix N: Guidance When Choosing Polymeric and Nonmetallic Materials 2078.3.15 Nonmandatory Appendix O: General Background/Useful Information for Extractables and Leachables 2078.3.16 Nonmandatory Appendix P: Temperature Sensors and Associated Components 2088.3.17 Nonmandatory Appendix Q: Instrument Receiving, Handling, and Storage 2088.3.18 Nonmandatory Appendix R: Application Data Sheet 2088.3.19 Nonmandatory Appendix S—Polymer Applications: Chromatography Columns 2088.3.20 Nonmandatory Appendix T: Guidance for the Use of US Customary and SI Units 208AppendicesAppendix A Cleaning and Leak Testing Procedure 209Appendix B Biotechnology Inspection Guide Reference Materials and Training Aids 251Appendix C Guide to Inspections of High Purity Water Systems 286Appendix D Guide to Inspections of Lyophilization of Parenterals 304Appendix E Guide to Inspections and Validation of Cleaning Processes 322Appendix F Guide to Inspections of Dosage Form Drug Manufacturer’s—CGMPR’s 331Appendix G Guide to Inspections Oral Solutions and Suspensions 349Appendix H Guide to Inspections of Sterile Drug Substance Manufacturers 356Appendix J Guide to Inspections of Topical Drug Products 366Appendix K BPE History—Letters and Notes 375Appendix L Component Dimensions 420Further Reading 440Index 445