ASME BPE 2005
$98.04
ASME BPE – 2005: Bioprocessing Equipment
| Published By | Publication Date | Number of Pages |
| ASME | 2005 | 130 |
There is a newer edition of this document available. This Standard deals with the requirements applicable to the design used in the bioprocessing, pharmaceutical, and personal care product industries, covering directly or indirectly the subjects of materials, design, fabrication, pressure systems (vessels and piping), examination, inspection, testing, and certification. Engineering judgments must be consistent with the fundamental principles of this Standard. Such judgments shall not be used to override mandatory regulations or specific prohibitions of this Standard.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | CONTENTS |
| 5 | Figures |
| 6 | Tables |
| 7 | Nonmandatory Appendices |
| 8 | FOREWORD |
| 9 | STATEMENTS OF POLICY |
| 10 | COMMITTEE ROSTER |
| 13 | SUMMARY OF CHANGES |
| 18 | Part GR General Requirements GR-1 INTRODUCTION GR-2 SCOPE GR-3 INSPECTION GR-4 INSPECTOR/EXAMINER GR-5 RESPONSIBILITIES |
| 19 | GR-5.1 Pressure Vessels GR-5.2 Piping, Tubing, and Noncode Vessels GR-6 ACCESS FOR INSPECTORS GR-7 MANUFACTURERŒS QUALITY ASSURANCE PROGRAM GR-8 METRIC GR-9 REFERENCES |
| 20 | 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 Non-Hygienic 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-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-3.11.4 SD-3.11.5 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 |
| 34 | SD-4 Recommended and Preferred Drop Designs |
| 35 | SD-3.11.15 SD-3.11.16 SD-3.11.17 SD-3.11.18 SD-3.11.19 SD-3.12 Drainability SD-3.12.1 SD-3.12.2 SD-5 Double Block-and-Bleed Valve Assembly |
| 36 | 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-4.1.4 Optical Components SD-6 Instrument Location Detail: Hygienic Design |
| 37 | SD-4.2 Hose Assemblies SD-4.2.1 General SD-4.2.2 Flexible Element SD-7 Flexible Hygienic Hose Design |
| 38 | SD-4.2.3 End Connections SD-4.3 Centrifuges SD-4.3.1 General SD-4.3.2 Internal Surface Finishes Process Contact/Wetted Surfaces SD-4.4 Filtration Equipment SD-4.5 Pumps SD-4.5.1 General SD-4.5.2 Hygienic Centrifugal Pumps |
| 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-4.7.5 Finishes SD-10 Sidewall Instrument Ports SD-3 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-14 Side and Bottom Connections |
| 46 | SD-4.7.6 Sight Glasses SD-4.8 Agitators and Mixers SD-4.8.1 General SD-4.8.2 In-Tank Couplings See Fig. SD-21 SD-15 Dip Tube Nozzles: Removable Designs |
| 47 | SD-16 Sight Glass Design |
| 48 | SD-17 Internal Support Members |
| 49 | SD-18 Mitered Fittings SD-19 Typical Nozzle Detail |
| 50 | SD-20 Double Tubesheet Heat Exchanger Bonnet Design |
| 51 | SD-21 In-Tank Couplings |
| 52 | SD-4.8.3 Keyways SD-4.8.4 Shafts and Shaft Sleeves SD-4.8.5 Hubs and Impellers SD-4.8.6 Steady Bearings SD-4.8.7 Mechanical Seals SD-4.9 Heat Exchange Equipment SD-4.9.1 General |
| 53 | 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 Pure/Clean Steam Distribution System SD-22 Removable Agitator Impeller Design |
| 54 | SD-4.11.2 Pure/Clean Steam Valves. 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 |
| 55 | SD-23 Point-of-Use Piping |
| 56 | SD-4.12 WFI Generators and Clean/Pure Steam Generators SD-4.13 Micro/Ultrafiltration and Chromatography Systems SD-4.14 Sterilizers/Autoclaves SD-4.15 CIP Systems and Design SD-4.15.1 General. |
| 57 | 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 SD-4.15.5 CIP Return Flow Design. SD-4 Recommended Flow Rates to Achieve 5 fps (1.52 mps) SD-5 Recommended Flow Rates for Cleaning Vertical Cylindrical Vessels Having Dished Heads |
| 58 | 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-4.16.3 Headers or Prepiping SD-4.16.4 Jumpers or U-Bends |
| 59 | SD-24 Transfer Panel Tolerances |
| 60 | SD-25 Transfer Panel Looped Headers |
| 61 | SD-4.16.5 Drain or Drip Pans SD-4.16.6 Proximity Switches SD-5 TESTING AND INSPECTION SD-5.1 Spray Ball Test SD-6 Transfer Panel and Jumper Tolerances |
| 62 | SD-26 Transfer Panel Jumpers |
| 63 | SD-5.2 Sterility/Cleaning Testing SD-5.3 Hydrostatic Test SD-5.4 Drainability Test SD-6 DOCUMENTATION SD-7 RESPONSIBILITIES |
| 64 | 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 |
| 65 | 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 |
| 66 | 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-14.2 Documentation Verification DT-14.3 Physical Examination |
| 67 | DT-V-5 METAL THICKNESS 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 OD Tubing Sizes |
| 68 | DT-2 Hygienic Unions DT-3 Chemical Composition for Automatic Weld Ends, % DT-4 Tangent Lengths |
| 69 | DT-5 Final Tolerances for Mechanically Polished Fittings and Process Components |
| 70 | DT-5.1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances |
| 71 | 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 |
| 72 | DT-9 Automatic Tube Weld: Straight Tee and Cross DT-10 Automatic Tube Weld: Reducing Tee |
| 73 | DT-11 Automatic Tube Weld: Concentric and Eccentric Reducer DT-12 Automatic Tube Weld: Hygienic Clamp Joint, 90 deg Elbow |
| 74 | DT-13 Automatic Tube Weld: Hygienic Clamp Joint, 45 deg Elbow DT-14 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Reducing Tee |
| 75 | DT-15 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee DT-16 Hygienic Clamp Joint: 90 deg Elbow |
| 76 | DT-17 Hygienic Clamp Joint: 45 deg Elbow DT-18 Hygienic Clamp Joint: Straight Tee and Cross |
| 77 | DT-19 Hygienic Clamp Joint: Reducing Tee DT-20 Hygienic Clamp Joint: Short Outlet Reducing Tee |
| 78 | DT-21 Hygienic Clamp Joint: Concentric and Eccentric Reducer |
| 79 | DT-22 Automatic Tube Weld: Ferrule |
| 80 | DT-23 Automatic Tube Weld: 180 deg Return Bend DT-24 Hygienic Clamp Joint: 180 deg Return Bend |
| 81 | DT-25 Hygienic Mechanical Joint: Short Outlet Run Tee DT-26 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer |
| 82 | 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 |
| 83 | 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 |
| 84 | 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-5 FILLER MATERIAL MJ-6 WELD ACCEPTANCE CRITERIA MJ-6.1 General MJ-6.2 Pressure Vessels and Tanks |
| 85 | MJ-6.3 Piping MJ-6.4 Tubing MJ-1 Acceptance Criteria for Welds on Pressure Vessels and Tanks |
| 86 | MJ-6.4.1 Rewelding. MJ-6.4.2 Sample Welds. MJ-7 INSPECTION, EXAMINATION, AND TESTING MJ-7.1 Scope MJ-7.2 Types of Examinations MJ-7.2.1 Pressure Vessels and Tanks. MJ-2 Acceptance Criteria for Welds on Pipe |
| 87 | MJ-3 Acceptance Criteria for Welds on Tube |
| 88 | MJ-1 Acceptable and Unacceptable Weld Profiles for Tube Welds |
| 89 | MJ-7.2.2 Piping. MJ-7.2.3 Tubing. 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. 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. |
| 90 | 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 MJ-10.2 Materials Documentation MJ-10.2.1 Materials Examination. MJ-10.2.2 Material Test Reports. |
| 91 | MJ-10.3 Weld Log MJ-11 PASSIVATION |
| 92 | 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 DELETED SF-6 DELETED SF-7 INSPECTION AND TECHNIQUES EMPLOYED IN THE CLASSIFICATION OF PRODUCT CONTACT SURFACE FINISHES SF-8 DESCRIPTION OF VARIOUS SURFACES AVAILABLE ON STAINLESS STEEL AND HIGHER ALLOYS |
| 94 | SF-1 Acceptance Criteria for Product Contact Surface Finishes of Tubing SF-2 Ra Readings for Tubing |
| 95 | SF-3 Acceptance Criteria for Product Contact Surface Finishes of Fittings SF-4 Ra Readings for Fittings |
| 96 | SF-5 Acceptance Criteria for Product Contact Surface Finishes of Valve Bodies SF-6 Ra Readings for Valves |
| 97 | SF-7 Acceptance Criteria for Product Contact Surface Finishes of Vessels SF-8 Ra Readings for Vessels |
| 98 | SF-9 Acceptance Criteria for Product Contact Surface Finishes of Other Process Components SF-10 Ra Readings for Other Process Components |
| 99 | 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-3 GENERAL PROVISIONS FOR SEALS IN BIOPROCESSING SERVICE: USER BASIC DESIGN REQUIREMENT SG-3.1 Seal Performance SG-3.1.1 Service Temperature. |
| 100 | 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 |
| 101 | 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. SG-3.5 Sealing Systems SG-3.5.1 Mechanical Seal. SG-3.5.2 Types of Seal Systems Based on Lubrication. |
| 102 | SG-3.5.3 Seal Arrangement. SG-3.5.3.1 Single Seal SG-3.5.3.2 Dual Seals. SG-1 Basic Components of a Seal |
| 103 | SG-3.5.4 Cartridge Seals. SG-3.5.5 Materials of Construction. SG-2 Single Dry Running Contacting Seal SG-3 Internally Mounted, Process Lubricated Contact Seal |
| 104 | SG-4 Externally Mounted, Process Lubricated Contact Seal SG-5 Double Seal Installation |
| 105 | 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-6 Tandem Seal Installation SG-1 Common Rotary Seal Materials for Biochemical and Sterile Service |
| 106 | SG-3.5.6.3 Basic Review of Rotary Sealing Systems 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-7 Seal Piping and Lubrication Plans |
| 107 | SG-8 Gas Lubricated Noncontacting Double Seal SG-9 Tandem Seal With Barrier System |
| 108 | SG-10 Typical Packing Installation SG-11 V-Ring Packing for Reciprocating Applications SG-12 Open Cross-Section Lip Seal SG-13 Labyrinth Seal |
| 109 | SG-4.1.1.2 Types of Primary Valve Stem Seals and Their Requirements. SG-4.1.1.3 SG-4.1.1.4 SG-14 Typical Angle Valve With Rolling Diaphragm and Orifice |
| 110 | SG-4.1.1.5 SG-4.1.1.6 Additional Requirements for Elastomeric or Polymeric Seals Used as Valve Closure Members. SG-15 Example of Sampling Valve With Uniformly Loaded Sliding Seal SG-16 Typical In-Line Diaphragm Valve With Weir |
| 111 | SG-4.1.1.7 Diaphragm Marking. SG-4.1.1.8 SG-4.1.2 Type 2 Rotary Valve Stem Seals. SG-17 Typical Ball Valve Configuration |
| 112 | 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 |
| 113 | PM-1 Size Comparison of Common Thermoplastic Sizing Standards |
| 114 | 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-3 POLYMER MATERIAL JOINING PM-3.1 Scope |
| 115 | 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. |
| 116 | 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 or 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 |
| 117 | PM-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds |
| 118 | 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 |
| 119 | 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 |
| 120 | A COMMENTARY: SLAG |
| 121 | B MATERIAL EXAMINATION LOG AND WELD LOG |
| 126 | INDEX |
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