Bioprocessing Piping and Equipment Design

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

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).