ASME BPE 2007

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ASME BPE – 2007: Bioprocessing Equipment

Published By	Publication Date	Number of Pages
ASME	2007	140

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PDF Pages	PDF Title
5	CONTENTS
6	FIGURES
7	TABLES
8	NONMANDATORY APPENDICES INDEX
9	FOREWORD
10	STATEMENT OF POLICY
11	COMMITTEE ROSTER
14	SUMMARY OF CHANGES
17	Part GR General Requirements GR-1 INTRODUCTION GR-2 SCOPE GR-3 INSPECTION GR-4 INSPECTOR/EXAMINER GR-5 RESPONSIBILITIES
18	GR-5.1 Pressure Vessels GR-5.2 Piping, Tubing, and Non-Code Vessels GR-6 ACCESS FOR INSPECTORS GR-7 MANUFACTURERŒS QUALITY ASSURANCE PROGRAM GR-8 METRIC GR-9 REFERENCES
19	GR-10 TERMS AND DEFINITIONS
25	Part SD Design for Sterility and Cleanability SD-1 INTRODUCTION SD-2 SCOPE AND PURPOSE SD-3 GENERAL GUIDELINES SD-3.1 Cleanability SD-3.1.1 SD-3.1.2 SD-3.1.3 SD-3.1.4 SD-3.1.5 SD-3.1.6 SD-3.1.7 SD-3.1.8
26	SD-3.2 Sterility SD-3.2.1 SD-3.2.2 SD-3.2.3 SD-3.3 Surface Finishes SD-3.3.1 SD-3.3.2 SD-3.3.3 SD-3.4 Materials of Construction SD-3.4.1 SD-3.4.2 SD-3.4.3 SD-3.4.4 SD-3.4.5 SD-3.4.6 SD-3.4.7 SD-3.5 Fabrication SD-3.5.1 SD-3.5.2 SD-3.5.3 SD-3.6 Static O-Rings, Seals, and Gaskets See Fig. SD-1 SD-3.6.1
27	SD-1 Hygienic Connections
28	SD-3.6.2 SD-3.6.3 SD-3.6.4 SD-3.6.5 SD-3.7 Connections and Fittings SD-3.7.1 SD-3.7.2 SD-3.7.3 SD-3.7.4 SD-3.7.5 SD-3.7.6 SD-3.7.7 SD-3.7.8 SD-3.7.9 SD-3.8 Exterior Design SD-3.9 Containment
29	SD-2 Nonhygienic Connections
30	SD-3 Flat Gasket Applications
31	SD-3.10 Miscellaneous Design Details SD-3.10.1 SD-3.10.2 SD-3.10.3 SD-3.11 System Design SD-3.11.1 SD-3.11.2 SD-3.11.3 SD-3.11.4 SD-3.11.5 SD-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With Blind Cap
32	SD-2 L/D Dimensions for Flow-Through Tee: Short Outlet Reducing Tee With Blind Cap
33	SD-3.11.6 SD-3.11.7 SD-3.11.8 SD-3.11.9 SD-3.11.10 SD-3.11.11 SD-3.11.12 SD-3.11.13 SD-3.11.14 SD-3.11.15 SD-3.11.16
34	SD-4 Recommended and Preferred Drop Designs
35	SD-3.11.17 SD-3.11.18 SD-3.12 Drainability SD-3.12.1 SD-5 Double Block-and-Bleed Valve Assembly SD-5 Double Block-and-Bleed Valve Assembly
36	SD-3.12.2 SD-3.12.3 SD-3.12.4 SD-3.12.5 SD-4 SPECIFIC GUIDELINES SD-4.1 Instrumentation SD-4.1.1 General SD-4.1.2 Relief Devices SD-4.1.3 Liquid Pressure Regulators SD-6 Instrument Location Detail: Hygienic Design
37	SD-4.1.4 Optical Components SD-4.2 Hose Assemblies SD-4.2.1 General SD-4.2.2 Flexible Element SD-4.2.3 End Connections SD-4.3 Centrifuges SD-4.3.1 General SD-4.3.2 Product Contact Surface Finishes Process Contact/Wetted Surfaces
38	SD-4.4 Filtration Equipment SD-4.5 Pumps SD-4.5.1 General SD-4.5.2 Hygienic Centrifugal Pumps SD-7 Flexible Hygienic Hose Design
39	SD-4.5.3 Hygienic Positive Displacement Pumps SD-4.6 Process Hygienic Valves SD-4.6.1 General: Valves SD-8 Tank/Vessel Vent Filters
40	SD-4.6.2 Diaphragm Valves SD-4.6.3 Stem Seal Valves. SD-4.7 Vessels, Tanks, Bioreactors, Fermenters, and Columns SD-4.7.1 General SD-4.7.2 Vessel Openings
41	SD-9 Nozzle Design
42	SD-4.7.3 Internal Components SD-4.7.4 Fabrication SD-10 Sidewall Instrument Ports SD-4 Annular Spacing Recommendations for Hygienic Dip Tubes
43	SD-11 Dip Tube SD-12 Vessel Design Tangential Nozzles
44	SD-13 Vessel Sight Glass Design
45	SD-4.7.5 Finishes SD-4.7.6 Sight Glasses SD-4.8 Agitators and Mixers SD-4.8.1 General SD-14-1 Dip Tube Nozzles: Removable Designs
46	SD-14-2 Side and Bottom Connections
47	SD-4.8.2 In-Tank Shaft Couplings SD-4.8.3 Shafts and Keyways SD-15 Agitator Mounting Flanges
48	SD-16 Sight Glass Design
49	SD-17 Internal Support Members
50	SD-18 Mitered Fittings SD-19 Typical Nozzle Detail
51	SD-20 Double Tubesheet Heat Exchanger Bonnet Design
52	SD-21-1 Shaft Coupling Construction
53	SD-4.8.4 Hubs and Impellers SD-4.8.5 Impeller and Shaft Support Bearings SD-21-2 Shaft Coupling Seal Arrangements
54	SD-21-3 Fastener Seal Arrangements
55	SD-21-4 Shaft Steady Bearing
56	SD-21-5 Magnetically Magnetically-Coupled Mixer (Typical
57	SD-4.8.6 Mechanical Seals SD-4.9 Heat Exchange Equipment SD-4.9.1 General
58	SD-4.9.2 Cleanability and Sterility SD-4.9.3 Gaskets and Seals SD-4.10 Cell Disrupters SD-4.10.1 SD-4.10.2 SD-4.10.3 SD-4.10.4 SD-4.10.5 SD-4.11 Compendial Water and Steam Systems SD-4.11.1 Clean Steam Distribution System Includes: Pure Steam SD-21-6 Double Mechanical Cartridge Seal With Debris Well
59	SD-22-1 Typical Clean Steam System Isometric
60	SD-4.11.2 Clean Steam Valves. SD-22-2 Clean Steam Point-of-Use Design
61	SD-4.11.3 Steam Traps SD-4.11.4 Compendial Water Systems SD-4.11.5 Point-of-Use Piping Design for Compendial Water Systems. SD-4.11.6 Critical Design Criteria for Point-of-Use Assemblies
62	SD-23 Point-of-Use Piping
63	SD-4.12 WFI Generators and Clean/Pure Steam Generators SD-4.13 Micro/Ultrafiltration and Chromatography Systems SD-4.14 Sterilizers/Autoclaves SD-23-1 Physical Break in Point-of-Use Piping
64	SD-4.15 CIP Systems and Design SD-4.15.1 General. SD-4.15.2 Design Concepts SD-4.15.3 CIP Flow Rate Guidelines for Process Lines. SD-4.15.4 Design Guidelines for Cleaning Process Vessels
65	SD-4.15.5 CIP Return Flow Design. SD-4.15.6 CIP Spray Devices SD-4.16 Transfer Panels SD-4.16.1 General SD-4.16.2 Nozzles or Ports SD-5 Recommended Flow Rates to Achieve 5 fps (1.52 mps) SD-6 Recommended Flow Rates for Cleaning Vertical Cylindrical Vessels Having Dished Heads
66	SD-4.16.3 Headers or Prepiping SD-4.16.4 Jumpers or U-Bends SD-4.16.5 Drain or Drip Pans SD-7 Transfer Panel and Jumper Tolerances
67	SD-24 Transfer Panel Tolerances
68	SD-25 Transfer Panel Looped Headers
69	SD-26 Transfer Panel Jumpers
70	SD-4.16.6 Proximity Switches SD-5 TESTING AND INSPECTION SD-5.1 Spray Ball Test SD-5.2 Sterility/Cleaning Testing SD-5.3 Hydrostatic Test SD-5.4 Drainability Test
71	SD-6 DOCUMENTATION SD-7 RESPONSIBILITIES
72	Part DT Dimensions and Tolerances for Stainless Steel Automatic Welding and Hygienic Clamp Tube Fittings and Process Components DT-1 SCOPE DT-2 PRESSURE RATING DT-3 MARKING DT-3.1 Marking Information DT-3.2 Exceptions DT-4 MATERIALS DT-5 METAL THICKNESS DT-6 FITTING DIMENSIONS
73	DT-6.1 Special Angle Fittings DT-7 TESTS DT-8 TOLERANCES DT-9 WELDING ENDS DT-10 HYGIENIC CLAMP ENDS DT-11 HEAT TREATMENT DT-12 SURFACE CONDITION DT-13 PACKAGING DT-14 MINIMUM EXAMINATION REQUIREMENTS DT-14.1 Visual Inspection DT-14.2 Documentation Verification
74	DT-14.3 Physical Examination Subsection DT-V Dimensions and Tolerances for Stainless Steel Valves With Automatic Welding and Hygienic Clamp Tube Ends DT-V-1 SCOPE DT-V-2 PRESSURE RATING DT-V-3 MARKING DT-V-3.1 Marking Information DT-V-3.2 Exceptions DT-V-4 MATERIALS DT-V-5 METAL THICKNESS
75	DT-V-6 VALVE DIMENSION DT-V-7 TESTS DT-V-8 TOLERANCES DT-V-9 WELDING ENDS DT-V-10 HYGIENIC CLAMP ENDS DT-V-11 SURFACE CONDITION DT-1 Nominal O.D. Tubing Sizes
76	DT-2 Hygienic Unions DT-3 Chemical Composition for Automatic Weld Ends, % DT-4 Tangent Lengths
77	DT-5 Final Tolerances for Mechanically Polished Fittings and Process Components
78	DT-5.1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances
79	DT-6 Final Tolerances for Electropolished Fittings and Process Components DT-7 Automatic Tube Weld: 90 deg-Elbow DT-8 Automatic Tube Weld: 45-deg Elbow
80	DT-9 Automatic Tube Weld: Straight Tee and Cross DT-10 Automatic Tube Weld: Reducing Tee
81	DT-11 Automatic Tube Weld: Concentric and Eccentric Reducer DT-12 Automatic Tube Weld: Hygienic Clamp Joint, 90 deg-Elbow
82	DT-13 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow DT-14 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Reducing Tee
83	DT-15 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee DT-16 Hygienic Clamp Joint: 90 deg-Elbow
84	DT-17 Hygienic Clamp Joint: 45 deg-Elbow DT-18 Hygienic Clamp Joint: Straight Tee and Cross
85	DT-19 Hygienic Clamp Joint: Reducing Tee DT-20 Hygienic Clamp Joint: Short Outlet Reducing Tee
86	DT-21 Hygienic Clamp Joint: Concentric and Eccentric Reducer
87	DT-22 Automatic Tube Weld: Ferrule
88	DT-23 Automatic Tube Weld: 180-deg Return Bend DT-24 Hygienic Clamp Joint: 180-deg Return Bend
89	DT-25 Hygienic Mechanical Joint: Short Outlet Run Tee DT-26 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
90	DT-27 Hygienic Clamp Joint: Short Outlet Tee DT-28 Automatic Tube Weld: Instrument Tee DT-29 Hygienic Clamp Joint: Instrument Tee DT-30 Automatic Tube Weld: Cap
91	DT-V-1 Hygienic Clamp Joint: Weir Style Diaphragm Valve
92	Part MJ Material Joining MJ-1 SCOPE MJ-2 MATERIALS MJ-2.1 Stainless Steels MJ-2.2 Nickel Alloys MJ-2.3 Mechanically Polished Material MJ-2.4 Electropolished Material MJ-2.5 Other Materials MJ-2.6 Weld and Finish Samples MJ-3 JOINING PROCESSES AND PROCEDURES MJ-3.1 Welds Finished After Welding MJ-3.2 Welds Used in the As-Welded Condition
93	MJ-3.3 Nonmetallics MJ-3.4 Mechanical Connections MJ-4 WELD JOINT DESIGN AND PREPARATION MJ-4.1 General MJ-4.2 Pressure Vessels and Tanks MJ-4.3 Piping MJ-4.4 Tubing MJ-4.5 Tube-Attachment Welds MJ-5 FILLER MATERIAL
94	MJ-6 WELD ACCEPTANCE CRITERIA MJ-6.1 General MJ-6.2 Pressure Vessels and Tanks MJ-6.3 Piping MJ-6.4 Tubing MJ-6.4.1 Sample Welds. MJ-6.4.2 Rewelding. MJ-6.5 Tube-Attachment Welds MJ-6.5.1 Sample Welds. MJ-6.5.2 Rewelding. MJ-7 INSPECTION, EXAMINATION, AND TESTING MJ-7.1 Scope MJ-7.2 Types of Examinations MJ-7.2.1 Pressure Vessels and Tanks.
95	MJ-7.2.2 Piping. MJ-7.2.3 Tubing. MJ-1 Acceptance Criteria for Welds on Pressure Vessels and Tanks
96	MJ-7.2.4 Tube-Attachment Welds. MJ-2 Acceptance Criteria for Welds on Pipe
97	MJ-3 Acceptance Criteria for Welds on Tube
98	MJ-1 Acceptable and Unacceptable Weld Profiles for Tube Welds
99	MJ-7.3 Examination Procedures MJ-7.3.1 Pressure Vessels and Tanks. MJ-7.3.2 Piping. MJ-7.3.3 Tubing. MJ-7.4 Supplementary Examinations MJ-7.5 Testing MJ-7.5.1 Pressure Vessels and Tanks. MJ-7.5.2 Piping.
100	MJ-7.5.3 Tubing. MJ-7.6 Records MJ-7.6.1 Pressure Vessels and Tanks. MJ-7.6.2 Piping. MJ-7.6.3 Tubing. MJ-8 PROCEDURE QUALIFICATION MJ-8.1 Pressure Vessels and Tanks MJ-8.2 Piping MJ-8.3 Tubing MJ-9 PERFORMANCE QUALIFICATION MJ-9.1 Pressure Vessels and Tanks MJ-9.2 Piping MJ-9.3 Tubing MJ-10 DOCUMENTATION REQUIREMENTS MJ-10.1 Turn Over Package Documentation Required
101	MJ-10.2 Materials Documentation MJ-10.2.1 Materials Examination. MJ-10.2.2 Material Test Reports. MJ-10.3 Weld Log MJ-11 PASSIVATION
102	Part SF Stainless Steel and Higher Alloy Product Contact Surface Finishes SF-1 SCOPE SF-2 OBJECTIVE SF-3 APPLICATIONS SF-4 MATERIAL SF-5 INSPECTION AND TECHNIQUES EMPLOYED IN THE CLASSIFICATION OF PRODUCT CONTACT SURFACE FINISHES SF-6 SURFACE CONDITION
103	SF-7 ELECTROPOLISHING PROCEDURE QUALIFICATION SF-8 PASSIVATION SF-1 Acceptance Criteria for Stainless Steel and Higher Alloy Mechanically Polished Product Contact Surface
104	SF-2 Acceptance Criteria for Mechanically Polished and Electropolished Product Contact Surface Finishes SF-3 Ra Readings for Product Contact Surfaces
105	Part SG Equipment Seals SG-1 SCOPE AND PURPOSE SG-1.1 Scope SG-1.2 Purpose SG-2 SEAL CLASSES SG-2.1 Class I Seals SG-2.2 Class II Seals SG-2.3 Class III Seals SG-2.4 Hygienic Fitting Seals SG-2.4.1 Hygienic Fitting Seal Intrusion.
106	SG-3 GENERAL PROVISIONS FOR SEALS IN BIOPROCESSING SERVICE: USER BASIC DESIGN REQUIREMENT SG-3.1 Seal Performance SG-3.1.1 Service Temperature. SG-3.1.2 Service Pressure. SG-3.1.3 Bioburden. SG-3.1.4 Cavitation Resistance. SG-3.1.5 Sterilization. SG-3.1.6 Cleaning. SG-3.1.7 Passivation. SG-3.2 System Requirements SG-3.2.1 Cleaning Systems SG-3.2.2 Sterilizing Systems. SG-3.2.3 Passivation Systems. SG-3.3 Seal Construction SG-3.3.1 Materials
107	SG-3.3.2 Crevices. SG-3.3.3 Dead Spaces. SG-3.4 Compliance Requirements SG-3.4.1 General Requirements. SG-3.4.2 Certificate of Compliance. SG-3.4.3 Test Requirements.
108	SG-3.5 Sealing Systems SG-3.5.1 Mechanical Seal. SG-3.5.2 Types of Seal Systems Based on Lubrication. SG-3.5.3 Seal Arrangement. SG-3.5.3.1 Single Seal SG-1 Basic Components of a Sea
109	SG-2 Single Dry Running Contacting Seal SG-3 Internally Mounted, Process Lubricated Contact Seal
110	SG-3.5.3.2 Dual Seals. SG-3.5.4 Cartridge Seals. SG-3.5.5 Materials of Construction. SG-4 Externally Mounted, Process Lubricated Contact Seal
111	SG-5 Double Seal Installation SG-6 Tandem Seal Installation SG-5 Double Seal Installation SG-6 Tandem Seal Installation
112	SG-3.5.6 Seal Piping and Lubrication Support Equipment SG-3.5.6.1 Single Seal SG-3.5.6.2 Dual Seals SG-7 Seal Piping and Lubrication Plans
113	SG-3.5.6.3 Basic Review of Rotary Sealing Systems SG-8 Gas Lubricated Noncontacting Double Seal
114	SG-9 Tandem Seal With Barrier System SG-10 Typical Packing Installation
115	SG-4 SPECIAL PROVISIONS FOR SEALS IN BIOPROCESSING SERVICE SG-4.1 Group 2 Dynamic Seals SG-4.1.1 Type 1 Reciprocating Valve Stem Seals SG-4.1.1.1 SG-4.1.1.2 Types of Primary Valve Stem Seals and Their Requirements. SG-11 V-Ring Packing for Reciprocating Applications SG-12 Open Cross-Section Lip Seal SG-13 Labyrinth Seal
116	SG-4.1.1.3 SG-4.1.1.4 SG-4.1.1.5 SG-4.1.1.6 Additional Requirements for Elastomeric or Polymeric Seals Used as Valve Closure Members. SG-4.1.1.7 Diaphragm Marking. SG-4.1.1.8 SG-14 Typical Angle Valve With Rolling Diaphragm and Orifice
117	SG-15 Example of Sampling Valve With Uniformly Loaded Sliding Seal SG-16 Typical In-Line Diaphragm Valve With Weir
118	SG-4.1.2 Type 2 Rotary Valve Stem Seals. SG-17 Typical Ball Valve Configuration
119	Part PM Polymer-Based Materials PM-1 INTRODUCTION PM-1.1 Scope and Purpose PM-2 DESIGN CONSIDERATIONS FOR POLYMERIC PIPING, TUBING, FITTINGS, VALVE BODIES, AND OTHER COMPONENTS PM-2.1 Sizing Comparisons PM-2.2 Pressure Ratings PM-2.3 Thermal Expansion
120	PM-2.4 System Support Criteria PM-2.4.1 Support Distances. PM-2.4.2 Hanger and Clamp Types. PM-2.5 Connections and Fittings PM-2.6 Materials PM-2.6.1 Extractables and Leachables.
121	PM-1 Size Comparison of Common Thermoplastic Sizing Standards
122	PM-3 POLYMER MATERIAL JOINING PM-3.1 Scope PM-3.2 Joining Processes and Procedures for Tube and Pipe Systems PM-3.2.1 Beadless Welding. PM-3.2.2 Noncontact IR Butt Fusion. PM-3.2.3 Contact Butt Fusion. PM-3.2.4 Socket Fusion. PM-3.3 Joint Design and Preparation PM-3.3.1 Tubing and Pipe.
123	PM-3.4 Weld Acceptance Criteria PM-3.4.1 Weld Acceptance for Beadless Welds. PM-3.4.1.1 Cracks and Crevices. PM-3.4.1.2 Pits and Pores. PM-3.4.1.3 Voids. PM-3.4.1.4 Fit-up and Mismatch. PM-3.4.1.5 Inclusions. PM-3.4.1.6 Discoloration. PM-3.4.1.7 Concavity. PM-3.4.2 Examination Procedures for Nonbeadless Welds. PM-3.4.3 Testing. PM-3.4.4 Records. PM-3.5 Documentation Requirements
124	PM-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds
125	PM-4 POLYMER INTERIOR PRODUCT CONTACT SURFACES OF PIPING, TUBING, FITTINGS, VALVE BODIES, AND COATED OR LINED VESSELS PM-5 MATERIALS OF CONSTRUCTION PM-5.1 Scope PM-5.2 Thermoplastic Materials PM-5.2.1 Fluorinated Ethylene-Propylene FEP. PM-5.2.2 Perfluoroalkoxy PFA. PM-5.2.3 Polypropylene PP. PM-5.2.4 Polytetrafluoroethylene PTFE and Modified Polytetrafluoroethylene M PTFE. PM-5.2.5 Polyvinylidene Fluoride PVDF and Polyvinylidene Fluoride/Hexafluoropropylene PVDF/HFP. PM-5.2.6 Filler Materials. PM-5.3 Thermoset Elastomers
126	PM-5.3.1 Ethylene Propylene EPM and EPDM. PM-5.3.2 Silicone VMQ. PM-5.3.3 Fluoroelastomer FKM. PM-5.3.4 Perfluoroelastomer FFKM. PM-5.4 New Materials
127	A COMMENTARY: SLAG A-1 GENERAL
128	B MATERIAL EXAMINATION LOG AND WELD LOG
133	C SLOPE MEASUREMENT C-1 GENERAL
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