ASME BPE 2014
$98.04
ASME BPE Bioprocessing Equipment
| Published By | Publication Date | Number of Pages |
| ASME | 2014 | 328 |
This ASME Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements. It covers materials, design, fabrication, inspections, testing and certification. ASME-BPE is unique in the world, having resulted from widespread industry requests for standardization. It is the leading Standard on how to design and build equipment and systems used in the production of biopharmaceuticals. It incorporates current best-practices for enhancing product purity and safety. Companies that rigorously apply ASME-BPE often can achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations. New topics from the last revision include: • Testing procedures and acceptance criteria for valve diaphragms • Chromatography requirements • Polymeric Hygienic Unions • Steam to/through Connections • Shelf-life, storage and expiration date requirements for single-use equipment • Radar Level and Temperature Sensors • Acceptance criteria for a variance in luster • Adoption of the CA-1 Standard ASME-BPE is referenced in ASME’s B31.3 Code on Process Piping. Moreover, two weld discoloration acceptance criteria color charts, ASME BPE MP-2012 and EP-2012, are available separately. They allow you to match acceptable discoloration levels perfectly, so as to help assure optimum safety and code-compliance. Intended for regulatory agencies, multinational corporations, plant owners, pressure-equipment fabricators, designers, constructors, materials suppliers, inspection organizations, and others.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | CONTENTS |
| 11 | FOREWORD |
| 13 | STATEMENT OF POLICY |
| 14 | COMMITTEE ROSTER |
| 18 | SUMMARY OF CHANGES |
| 25 | Part GR General Requirements GR-1 INTRODUCTION GR-2 SCOPE OF THE ASME BPE STANDARD GR-3 MANUFACTURERÅ’S QUALITY ASSURANCE PROGRAM |
| 26 | GR-4 INSPECTION GR-4.1 Inspector/Examiner GR-4.2 InspectorÅ’s Delegate GR-4.2.1 Levels of Qualification. GR-4.2.2 Qualification Requirements. |
| 29 | GR-4.2.3 Certification. GR-4.2.4 Recertification. GR-4.3 Responsibilities GR-4.3.1 Pressure Vessels. GR-4.3.2 Piping, Tubing, and Non-Code Vessels. GR-4.4 Access for Inspectors |
| 30 | GR-5 DOCUMENTATION GR-5.1 General GR-5.2 Document Requirements GR-5.2.1 General List of Documents GR-5.2.1.1 Metallic Materials GR-5.2.1.1.1 Turn Over Package Documentation. GR-5.2.1.1.2 GR-5.3 Material Test Reports/Certificates of Compliance GR-5.3.1 Metallic Materials. |
| 31 | GR-5.3.2 Polymeric and Other Nonmetallic Material Components. GR-5.3.2.1 Seal Documentation. GR-5.3.2.2 Sealed Unions. GR-5.3.3 Electropolishing. GR-5.3.4 Passivation. GR-5.4 Weld Log |
| 32 | GR-5.5 Records Retention GR-5.5.1 Vessel Documentation. GR-5.5.2 Welding Documentation GR-6 U.S. CUSTOMARY AND SI UNITS GR-7 REFERENCES |
| 33 | GR-8 TERMS AND DEFINITIONS |
| 41 | Part SD Systems Design SD-1 PURPOSE AND SCOPE SD-2 GENERAL GUIDELINES SD-2.1 Containment SD-2.2 Bioburden Control SD-2.3 Bioburden Reduction SD-2.3.1 Thermal Sanitization. SD-2.3.1.1 Steam in Place. SD-2.3.1.2 Depyrogenation. SD-2.3.2 Chemical Sanitization. SD-2.4 Fabrication SD-2.4.1 Materials of Construction SD-2.4.1.1 General. |
| 42 | SD-2.4.1.2 Process Compatibility SD-2.4.1.3 Surface Coatings. SD-2.4.1.4 Transparent Materials SD-2.4.2 Cleanability SD-2.4.3 Drainability SD-2.4.3.1 General. |
| 43 | SD-2.4.3.2 Drainability Design Considerations. SD-2.4.3.3 Slope Considerations. SD-2.4.3.4 Drain Points SD-2.4.4 Miscellaneous Design Details SD-2.4.4.1 Lubricants SD-2.4.4.2 Exterior Design. SD-2.4.4.3 Surface Finishes. SD-3 PROCESS COMPONENTS SD-3.1 Connections, Fittings, and Piping SD-3.1.1 General |
| 44 | SD-3.1.2 System Design SD-3.1.2.1 General SD-3.1.2.2 Dead Legs. SD-3.1.2.3 System Piping |
| 45 | Figures Fig. SD-3.1.1-1 Flat Gasket Applications |
| 46 | Tables Table SD-3.1.2.2-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With Blind Cap |
| 47 | Table SD-3.1.2.2-2 L/D Dimensions for Flow-Through Tee:Short Outlet Reducing Tee With Blind Cap |
| 49 | Fig. SD-3.1.2.2-1 Accepted Point-of-Use Designs |
| 50 | SD-3.1.2.4 Hygienic Support Systems Fig. SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly |
| 51 | SD-3.1.2.4.1 Pipe Hangers and Supports for Metallic Piping. SD-3.1.2.4.2 Pipe Hangers and Supports for Nonmetallic Piping SD-3.2 Hose Assemblies SD-3.2.1 General SD-3.2.2 Flexible Element SD-3.2.3 End Connections SD-3.3 Pumps SD-3.3.1 Diaphragm Pumps. SD-3.3.2 Hygienic Pumps SD-3.3.2.1 General |
| 52 | SD-3.3.2.2 Centrifugal Pumps SD-3.3.2.3 Positive Displacement Pumps SD-3.3.2.4 Rotary Lobe Pumps Fig. SD-3.2.1-1 Flexible Hygienic Hose Design |
| 53 | Fig. SD-3.3.2.2-1 Pump Impeller Configurations Fig. SD-3.3.2.2-2 Acceptable Impeller Attachments |
| 54 | Fig. SD-3.3.2.2-3 Casing Drain Configurations Fig. SD-3.3.2.2-4 Casing Drain L/D Ratios |
| 55 | SD-3.4 Vessels SD-3.4.1 General SD-3.4.2 Vessel Openings Fig. SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment |
| 56 | Fig. SD-3.4.2-1 Nozzle Design |
| 57 | Fig. SD-3.4.2-2 Side and Bottom Connections Fig. SD-3.4.2-3 Sidewall Instrument Ports |
| 58 | Fig. SD-3.4.2-4 Accepted Nozzle Penetrations Table SD-3.4.2-1 Annular SpacingRecommendations for Hygienic Dip Tubes |
| 59 | Fig. SD-3.4.2-5 Vessel Design Tangential Nozzles |
| 60 | Fig. SD-3.4.2-6 Sight Glass Design (Accepted) |
| 61 | SD-3.4.3 Internal Components SD-3.4.4 Fabrication SD-3.4.5 Finishes SD-3.4.6 Sight Glasses Fig. SD-3.4.2-7 Typical Nozzle Detail |
| 62 | Fig. SD-3.4.3-1 Internal Support Members |
| 63 | SD-3.4.7 Portable Tanks. SD-3.4.8 Media Bulk Containers. SD-3.4.9 Cryogenic Containers. SD-3.5 Agitators and Mixers SD-3.5.1 General SD-3.5.2 In-Tank Shaft Couplings |
| 64 | SD-3.5.3 Shafts and Keyways SD-3.5.4 Hubs and Impellers Fig. SD-3.5.1-1 Agitator Mounting Flanges |
| 65 | Fig. SD-3.5.2-1 Shaft Coupling Construction |
| 66 | Fig. SD-3.5.2-2 Shaft Coupling Seal Arrangements |
| 67 | SD-3.5.5 Impeller and Shaft Support Bearings SD-3.5.6 Mechanical Seals SD-3.6 Heat Exchange Equipment SD-3.6.1 General Fig. SD-3.5.2-3 Fastener Seal Arrangements |
| 68 | Fig. SD-3.5.5-1 Shaft Steady Bearing |
| 69 | Fig. SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) |
| 70 | Fig. SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design |
| 71 | SD-3.6.2 Cleaning and Steaming SD-3.6.3 Gaskets and Seals SD-3.7 Transfer Panels SD-3.7.1 General SD-3.7.2 Nozzles or Ports SD-3.7.3 Headers or Pre-piped Manifolds SD-3.7.4 Jumpers or U-Bends |
| 72 | Fig. SD-3.7.1-1 Transfer Panel Looped Headers |
| 73 | Fig. SD-3.7.2-1 Transfer Panel Tolerances (Reference Table DT-7-2) |
| 74 | Fig. SD-3.7.4-1 Transfer Panel Jumpers |
| 75 | SD-3.7.5 Drain or Drip Pans SD-3.7.6 Proximity Switches SD-3.8 Filters SD-3.8.1 Code 7 Cartridge Lock Design. SD-3.8.1.1 Design Features. SD-3.8.1.2 Testing. |
| 76 | SD-3.9 Spray Devices SD-3.9.1 General. Fig. SD-3.8.1.1-1 Tapered Locking Tab Retainer — Recessed |
| 77 | SD-3.9.2 Spray Device Requirements Fig. SD-3.8.1.1-2 Tapered Locking Tab Retainer — External |
| 78 | Fig. SD-3.9.1-1 Dynamic Spray Device: Single Axis Fig. SD-3.9.1-2 Two Axes Dynamic Spray Device |
| 79 | SD-3.9.2.1 Static Spray Device Requirements SD-3.9.2.2 Single Axis Dynamic Spray Device Requirements SD-3.9.2.3 Multi-Axis Dynamic Spray Device Requirements |
| 80 | Fig. SD-3.9.2.1-1 Static Spray Device Fig. SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels |
| 81 | Fig. SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels Fig. SD-3.9.2.3-1 Impact Pattern Build-Up |
| 82 | SD-3.10 Disposables That Require Pre-Sterilization or Post-Sterilization SD-3.11 Sampling Systems SD-3.11.1 General SD-3.11.2 Aseptic Sampling Systems SD-3.11.2.1 Basic Requirements SD-3.11.2.2 Installation. SD-3.11.2.3 Sample Collecting SD-3.11.3 Non-Aseptic Sampling. SD-3.12 Steam Traps Fig. SD-3.12-1 Steam Traps for Clean Steam Systems |
| 83 | SD-3.13 Check Valves SD-3.14 Orifice Plates SD-3.15 Relief Devices SD-3.16 Liquid Pressure Regulators SD-4 PROCESS UTILITIES SD-4.1 Compendial Water Systems SD-4.1.1 Compendial Water Generation |
| 84 | SD-4.1.2 Compendial Water Distribution Systems SD-4.1.2.1 Point-of-Use Piping Design for Compendial Water Systems. SD-4.1.2.2 Critical Design Criteria for Point-of-Use Assemblies SD-4.2 Clean/Pure Steam Systems SD-4.2.1 Clean/Pure Steam Generation SD-4.2.2 Clean/Pure Steam Distribution System |
| 85 | Fig. SD-4.1.2.1-1 Point-of-Use Piping |
| 86 | SD-4.2.3 Clean/Pure Steam Valves. SD-4.3 Process Gases SD-4.3.1 Process Gas Distribution Systems. Fig. SD-4.1.2.2-1 Physical Break in Point-of-Use Piping |
| 87 | Fig. SD-4.2.2-1 Typical Clean Steam System Isometric |
| 88 | SD-4.4 Process Waste Systems SD-4.4.1 Bio-Kill Systems. SD-5 PROCESS SYSTEMS SD-5.1 Upstream Systems SD-5.1.1 Bioreactors and Fermentors SD-5.1.1.1 General Fig. SD-4.2.2-2 Clean Steam Point-of-Use Design |
| 89 | Fig. SD-5.1.1.1-1 Fermentor Sterile Envelope |
| 90 | Fig. SD-5.1.1.1-2 Bioreactor Sterile Envelope |
| 91 | SD-5.1.1.2 Inlet Gas Assembly. SD-5.1.1.2.1 Flow Control Devices SD-5.1.1.2.2 Inlet Filter Assembly SD-5.1.1.2.3 Gas Sparging Assemblies |
| 92 | Fig. SD-5.1.1.2.3-1 Gas Sparging Assembly — Lance |
| 93 | Fig. SD-5.1.1.2.3-2 Gas Sparging Assembly — Sintered |
| 94 | Fig. SD-5.1.1.2.3-3 Gas Sparging Assembly — Ring |
| 95 | Fig. SD-5.1.1.2.3-4 Gas Sparging Assembly — Single Orifice |
| 96 | SD-5.1.1.2.4 Inlet Gas Piping SD-5.1.1.3 Exhaust Gas Assembly. SD-5.1.1.3.1 Exhaust Filter SD-5.1.1.3.2 Exhaust Gas Piping SD-5.1.1.3.3 Backpressure Control Devices SD-5.1.1.4 Piping Systems SD-5.1.1.4.1 Feed Lines. SD-5.1.1.4.2 Dip Tubes. |
| 97 | Fig. SD-5.1.1.3.1-1 Exhaust Gas Condenser Fig. SD-5.1.1.3.1-2 Exhaust Gas Heater |
| 98 | Fig. SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing |
| 99 | SD-5.1.1.4.3 Harvest Valves/Bottom Outlet Valve. SD-5.1.1.5 Miscellaneous Internal Components SD-5.1.1.5.1 Agitation Assemblies. SD-5.1.1.5.2 Mechanical Foam Breaker Assemblies. SD-5.1.1.5.3 Internal Coils SD-5.1.1.5.4 Baffles. SD-5.1.1.5.5 Sprayballs/Devices/Wands. SD-5.1.1.6 Instrumentation SD-5.1.2 Cell Disrupters SD-5.1.3 Centrifuges SD-5.1.3.1 General |
| 100 | SD-5.1.3.2 Process Contact Surface Finishes Wetted Surfaces SD-5.2 Downstream Systems SD-5.2.1 Filtration SD-5.2.1.1 General SD-5.2.1.1.1 Cleaning SD-5.2.1.1.2 Sanitization. SD-5.2.1.2 Micro/Ultrafiltration Systems SD-5.2.1.3 Depth Filtration. SD-5.2.1.4 Tangential/Cross Flow Filtration. SD-5.2.3 Chromatography. |
| 101 | SD-5.2.3.1 Cleaning. SD-5.2.3.2 Sanitization SD-5.2.3.2.1 Chemical Sanitization. SD-5.2.3.2.2 Thermal Sanitization. SD-5.3 Process Support Systems SD-5.3.1 Washers. SD-5.3.2 Steam Sterilizers/Autoclaves SD-5.3.2.1 General. SD-5.3.2.2 Cycle Types. Fig. SD-5.2.1.1-1 Tank/Vessel Vent Filters |
| 102 | SD-5.3.2.2.1 Hard Goods Cycles. SD-5.3.2.2.2 Liquid Cycles. SD-5.3.2.2.3 Air Filter Sterilization. SD-5.3.2.3 Components SD-5.3.2.3.1 General SD-5.3.2.3.2 Doors. SD-5.3.2.3.3 Sterile Air/Vent Filters. SD-5.3.2.3.4 Steam Traps. SD-5.3.2.3.5 Loading Carts/Trays. SD-5.3.2.3.6 Valves. SD-5.3.2.3.7 Check Valves. SD-5.3.2.3.8 Jacket. |
| 103 | SD-5.3.2.4 Other Features SD-5.3.2.4.1 Drain Temperature. SD-5.3.2.4.2 Instrumentation. SD-5.3.3 CIP Systems and Design SD-5.3.3.1 General SD-5.3.3.1.1 Scope and Definitions SD-5.3.3.1.2 CIP System Operating Capabilities SD-5.3.3.1.3 CIP System Functionality |
| 104 | SD-5.3.3.2 CIP Skid Design SD-5.3.3.3 CIP Flow Rate Guidelines for Process Lines SD-5.3.3.4 Design Guidelines for Cleaning Process Vessels Table SD-5.3.3.3-1 Flow Rates to Achieve5 ft/sec (1.52 m/s) |
| 105 | SD-5.3.3.5 CIP Distribution Design SD-5.3.3.5.1 CIP Distribution Guidelines Supply and Return SD-5.3.3.5.2 CIP Distribution Piping SD-5.3.3.5.3 CIP Return Pumps SD-5.3.3.5.4 CIP Return Eductors. |
| 106 | Fig. SD-5.3.3.5.1-1 CIP Looped Header (Supply or Return) Fig. SD-5.3.3.5.1-2 Zero-Static Chain Fig. SD-5.3.3.5.1-3 Swing Elbow Arrangement |
| 107 | SD-5.3.4 Ultra High Temperature Sterilizers. SD-5.3.5 Media Prep. SD-5.4 Formulation Systems SD-5.4.1 Lyophilizers/Freeze Dryers SD-5.4.1.1 General. SD-5.4.1.2 Components. SD-5.4.1.2.1 General SD-5.4.1.2.2 Lyophilizer Chamber SD-5.4.1.2.3 Condenser Vessel SD-5.4.1.2.4 Lyophilizer Shelves |
| 108 | Fig. SD-5.4.1.2-1 Typical Lyophilizer Component Assembly |
| 109 | SD-5.4.1.2.5 Vacuum Systems SD-5.4.1.2.6 Isolation Bellows SD-5.4.1.2.7 Internal Moving Parts. SD-5.4.1.2.8 Spray Devices SD-5.4.1.2.9 Gas Filter Assemblies |
| 110 | SD-5.4.1.2.10 Doors and Door Seals SD-5.4.1.2.11 Valves SD-5.4.1.2.12 Instruments SD-5.4.1.3 Sterile Boundary. SD-5.4.1.4 Internal Connections and Fasteners |
| 111 | SD-5.4.1.5 CIP of Lyophilizers Fig. SD-5.4.1.3-1 Lyophilizer Sterile Boundary |
| 112 | SD-5.4.1.6 Bioburden Reduction in Lyophilizers. SD-5.4.1.6.1 Steam-in-Place SIP. SD-5.4.1.6.2 Hydrogen Peroxide Sterilization. SD-5.4.1.7 Leak Rate SD-5.4.1.8 Branch Connections |
| 113 | SD-6 DESIGN CONFORMANCE TESTING SD-6.1 Spray Device Coverage Test SD-6.2 Cleaning, Steaming, and Bioburden Control Testing SD-6.3 Fluid Requirements for Leak Testing SD-6.4 Vessel Drainability Test |
| 114 | Part DT Dimensions and Tolerances for Process Components DT-1 PURPOSE AND SCOPE DT-2 PRESSURE RATING DT-3 WALL THICKNESS DT-4 DIMENSIONS DT-4.1 Fitting Dimensions DT-4.1.1 Elbows/Bends. DT-4.1.2 Tees/Crosses. DT-4.1.3 Reducers. DT-4.1.4 Ferrules. DT-4.1.5 Caps. DT-4.2 Nonstandard Fitting Dimensions DT-4.3 Special Angle Fittings Dimensions DT-4.4 Valve Dimensions |
| 115 | DT-4.4.1 Diaphragm Valves. DT-5 MATERIALS DT-6 TESTS DT-7 TOLERANCES DT-8 WELD ENDS DT-9 HYGIENIC CLAMP UNIONS DT-9.1 Typical Hygienic Clamp Unions DT-9.2 Hygienic Gaskets DT-9.3 Connections DT-9.4 Hygienic Clamps DT-10 MINIMUM EXAMINATION REQUIREMENTS DT-10.1 Visual Inspection |
| 116 | DT-10.2 Documentation Verification DT-10.3 Physical Examination DT-11 MARKING DT-11.1 Fitting Marking Information DT-11.1.1 Exceptions DT-11.2 Valve Marking Information |
| 117 | DT-11.2.1 Exceptions DT-11.3 Modified Surfaces DT-12 PACKAGING |
| 118 | Fig. DT-2-1 Clamp Conditions at Installation |
| 119 | Table DT-2-1 Hygienic Unions: Rated Internal Working Pressure |
| 120 | Table DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components |
| 121 | Table DT-3-2 Final Tolerances for Electropolished Fittings and Process Components Table DT-4-1 Nominal O.D. Tubing Sizes Table DT-4.1-1 Tangent Lengths |
| 122 | Table DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow Table DT-4.1.1-2 Automatic Tube Weld: Hygienic Clamp Joint, 90-deg Elbow |
| 123 | Table DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Elbow Table DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow |
| 124 | Table DT-4.1.1-5 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow Table DT-4.1.1-6 Hygienic Clamp Joint: 45-deg Elbow |
| 125 | Table DT-4.1.1-7 Automatic Tube Weld: 180-deg Return Bend Table DT-4.1.1-8 Hygienic Clamp Joint: 180-deg Return Bend |
| 126 | Table DT-4.1.2-1 Automatic Tube Weld: Straight Tee and Cross Table DT-4.1.2-2 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee |
| 127 | Table DT-4.1.2-3 Hygienic Mechanical Joint: Short Outlet Run Tee Table DT-4.1.2-4 Hygienic Clamp Joint: Straight Tee and Cross |
| 128 | Table DT-4.1.2-5 Hygienic Clamp Joint: Short Outlet Tee Table DT-4.1.2-6 Automatic Tube Weld: Reducing Tee |
| 129 | Table DT-4.1.2-7 Automatic Tube Weld: Short Outlet Hygienic Clamp, Joint Reducing Tee |
| 130 | Table DT-4.1.2-8 Hygienic Clamp Joint: Reducing |
| 131 | Table DT-4.1.2-9 Hygienic Clamp Joint: Short Outlet Reducing Tee Table DT-4.1.2-10 Automatic Tube Weld: Instrument Tee Table DT-4.1.2-11 Hygienic Clamp Joint: Instrument Tee |
| 132 | Table DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer |
| 133 | Table DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer |
| 134 | Table DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer |
| 135 | Table DT-4.1.4-1 Automatic Tube Weld: Ferrule |
| 136 | Table DT-4.1.5-1 Automatic Tube Weld: Cap Table DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap |
| 137 | Table DT-4.4.1-1 Hygienic Clamp Joint: Weir Style Diaphragm Valve |
| 138 | Table DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances |
| 140 | Table DT-7-2 Transfer Panel and Jumper Tolerances |
| 141 | Table DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria |
| 142 | Part MJ Materials Joining MJ-1 PURPOSE AND SCOPE MJ-2 MATERIALS MJ-2.1 Base Metals MJ-2.1.1 Stainless Steels MJ-2.1.2 Nickel Alloys. MJ-2.1.3 Copper Alloys. MJ-2.1.4 Other Metals. MJ-2.2 Filler Metals MJ-2.2.1 Stainless Steels. MJ-2.2.2 Nickel Alloys. MJ-2.2.3 Copper Alloys. MJ-2.3 Nonmetallics |
| 143 | MJ-3 JOINT DESIGN AND PREPARATION MJ-3.1 General MJ-3.2 Pressure Vessels and Tanks MJ-3.3 Piping MJ-3.4 Tubing MJ-3.5 Tube-Attachment Welds MJ-3.6 Brazed Joints MJ-4 JOINING PROCESSES AND PROCEDURES MJ-4.1 Welds Finished After Welding MJ-4.2 Welds Used in the As-Welded Condition |
| 144 | MJ-4.3 Brazing MJ-5 PROCEDURE QUALIFICATIONS MJ-5.1 Pressure Vessels and Tanks MJ-5.2 Piping MJ-5.3 Tubing MJ-5.4 Duplex Stainless Steels MJ-5.5 Brazing MJ-6 PERFORMANCE QUALIFICATIONS MJ-6.1 Pressure Vessels and Tanks MJ-6.2 Piping MJ-6.3 Tubing Table MJ-6.3-1 Tube/Pipe Diameter Limits for Orbital GTAW Performance Qualification Table MJ-6.3-2 Weld Thickness Limits for Orbital GTAW Performance Qualification |
| 145 | MJ-6.4 Brazing MJ-7 EXAMINATION, INSPECTION, AND TESTING MJ-7.1 Examination Procedures MJ-7.1.1 Pressure Vessels and Tanks. MJ-7.1.2 Piping. MJ-7.1.3 Tubing. MJ-7.1.4 Tube Attachments. MJ-7.1.5 Brazing. MJ-7.2 Personnel Requirements MJ-7.2.1 Pressure Vessels and Tanks. MJ-7.2.2 Piping. MJ-7.2.3 Tubing. MJ-7.2.4 Tube Attachments. MJ-7.2.5 Copper Tubing/Piping. MJ-7.2.6 Examination Personnel Eye Examination Requirements. MJ-7.3 Examination, Inspection, and Testing Requirements MJ-7.3.1 Pressure Vessels and Tanks MJ-7.3.2 Piping |
| 146 | MJ-7.3.3 Tubing MJ-7.3.4 Tube Attachments MJ-7.3.5 Brazing MJ-7.4 Records MJ-8 ACCEPTANCE CRITERIA MJ-8.1 General MJ-8.2 Pressure Vessel and Tank Welds MJ-8.3 Piping Welds MJ-8.4 Tubing Welds |
| 147 | MJ-8.4.1 Sample Welds. MJ-8.4.2 Rewelding. MJ-8.5 Tube-Attachment Welds MJ-8.5.1 Sample Welds. MJ-8.5.2 Rewelding. MJ-8.6 Brazed Joints MJ-9 JOINING OF POLYMERIC MATERIALS MJ-9.1 General MJ-9.2 Weld Joint Design and Preparation MJ-9.2.1 Tubing and Piping. MJ-9.3 Joining Processes and Procedures MJ-9.3.1 Beadless Welding. MJ-9.3.1.1 Records. MJ-9.3.2 Noncontact IR and Contact Butt Fusion Welding. MJ-9.3.3 Socket Fusion Welding. |
| 148 | MJ-9.4 Procedure Qualifications MJ-9.5 Performance Qualifications MJ-9.6 Examination, Inspection, and Testing MJ-9.6.1 Examination Procedures. MJ-9.6.2 Personnel Requirements MJ-9.6.2.1 Personnel Qualifications. MJ-9.6.2.2 Examination Personnel Eye Examination Requirements. MJ-9.6.3 Examination, Inspection, and Testing Requirements MJ-9.6.3.1 Examination. MJ-9.6.3.2 Inspection. |
| 149 | MJ-9.6.3.3 Testing. MJ-9.6.4 Records. MJ-9.7 Weld Acceptance Criteria MJ-9.7.1 Acceptance Criteria for Beadless Welds. MJ-9.7.2 Acceptance Criteria for Nonbeadless Welds. MJ-9.7.3 Acceptance Criteria for Sample Welds. MJ-9.7.4 Rewelding. MJ-9.8 Documentation Requirements MJ-10 DOCUMENTATION REQUIREMENTS MJ-11 PASSIVATION |
| 150 | Table MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Pressure Vessels and Tanks |
| 152 | Table MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Pipe |
| 154 | Table MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Tube-to-Tube Butt Joints |
| 156 | Fig. MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Tube Welds |
| 157 | Fig. MJ-8.4-2 Discoloration Acceptance Criteria for Weld Heat Affected Zones on Electropolished 316L Tubing |
| 158 | Fig. MJ-8.4-3 Discoloration Acceptance Criteria for Weld Heat Affected Zones on MechanicallyPolished 316L Tubing |
| 159 | Fig. MJ-8.4-4 Acceptable and Unacceptable Weld Bead Width and Meander |
| 160 | Table MJ-8.5-1 Visual Examination Acceptance Criteria for Tube-Attachment Welds |
| 162 | Fig. MJ-8.5-1 Acceptable Weld Profiles for Tube-Attachment Fillet Welds |
| 163 | Fig. MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds |
| 164 | Part SF Process Contact Surface Finishes SF-1 PURPOSE AND SCOPE SF-2 METALLIC APPLICATIONS SF-2.1 Applicable Systems SF-2.2 Acceptance Criteria SF-2.3 Examination Techniques Employed in the Classification of Process Contact Surface Finishes SF-2.4 Surface Condition SF-2.5 Electropolishing Procedure Qualification SF-2.6 Passivation Procedure |
| 165 | Table SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes |
| 166 | SF-2.7 Normative References Table SF-2.2-2 Additional Acceptance Criteria for Electropolished Metallic Process Contact Surface Finishes Table SF-2.4-1 Ra Readings for Metallic Process Contact Surfaces |
| 167 | SF-2.8 Rouge and Stainless Steel SF-3 POLYMERIC APPLICATIONS SF-3.1 Applicable Systems SF-3.2 Materials SF-3.3 Examination Techniques Employed in the Classification of Process Contact Surface Finishes Table SF-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes |
| 168 | SF-3.4 Surface Condition Table SF-3.3-1 Acceptance Criteria for Polymeric Process Contact Surface Finishes Table SF-3.4-1 Ra Readings for Polymeric Process Contact Surfaces |
| 169 | Part SG Sealing Components SG-1 PURPOSE AND SCOPE SG-2 SEALING COMPONENT TYPES SG-2.1 General SG-2.2 Static Seals SG-2.2.1 General. SG-2.2.2 Hygienic Unions. SG-2.2.3 O-Ring Seals. SG-2.2.4 Other Static Seals. SG-2.3 Dynamic Seals SG-2.3.1 Valves SG-2.3.1.1 General. |
| 170 | Fig. SG-2.2.2-1 Hygienic Union per Table DT-7-1 Fig. SG-2.2.2-2 Hygienic Clamp Union per Table DT-7-1 |
| 171 | Fig. SG-2.2.2-3 Hygienic Union per DIN 11864 Fig. SG-2.2.2-4 Hygienic Clamp Union per DIN 11864 |
| 172 | Fig. SG-2.2.2-5 Nonhygienic Connections |
| 173 | SG-2.3.1.2 Diaphragm Valves SG-2.3.1.3 Ball Valve, Ball Tank Bottom Valve. SG-2.3.1.4 Rising Stem Single, Double Seat Mix Proof, Needle Valves. SG-2.3.1.5 Butterfly Valves. SG-2.3.1.6 Thermostatic Steam Trap. SG-2.3.1.7 Back Pressure Control Valve. SG-2.3.1.8 Pinch Valve. SG-2.3.1.9 Check, Pressure Relief, and Safety Pressure Relief Valves Fig. SG-2.3.1.2-1 Weir Valves |
| 174 | Fig. SG-2.3.1.2-2 Radial Valves Fig. SG-2.3.1.2-3 Weirless Diaphragm Valve |
| 175 | Fig. SG-2.3.1.2-4 Linear Control Valves Fig. SG-2.3.1.2-5 Regulator Valve |
| 176 | Fig. SG-2.3.1.3-1 Ball Valves Fig. SG-2.3.1.4-1 Rising Stem Single, Double Seat Mix Proof, and Needle Valves |
| 177 | Fig. SG-2.3.1.5-1 Butterfly Valve Fig. SG-2.3.1.7-1 Back Pressure Control Valve Fig. SG-2.3.1.8-1 Pinch Valve |
| 178 | Fig. SG-2.3.1.9-1 Pressure Relief and Check Valves |
| 179 | SG-2.3.1.10 Plug Valves. SG-2.3.2 Mechanical Seals SG-2.3.2.1 General SG-2.3.2.2 Single Mechanical Seals SG-2.3.2.3 Dual Mechanical Seals Fig. SG-2.3.1.10-1 Plug Valve Fig. SG-2.3.2.2-1 Single Mechanical Seal |
| 180 | Fig. SG-2.3.2.2-2 Single Seal for Top Entry Agitator Fig. SG-2.3.2.3-1 Dual Pressurized Mechanical Seal for Pumps Fig. SG-2.3.2.3-2 Dual Pressurized Mechanical Seal for Top Entry Agitator |
| 181 | SG-2.3.2.4 Flush Plans. Fig. SG-2.3.2.3-3 Dual Unpressurized Mechanical Seal for Pumps Fig. SG-2.3.2.4-1 Flush Plan 01 Fig. SG-2.3.2.4-2 Flush Plan 02 Fig. SG-2.3.2.4-3 Flush Plan 03 |
| 182 | Fig. SG-2.3.2.4-4 Flush Plan 11 Fig. SG-2.3.2.4-5 Flush Plan 32 Fig. SG-2.3.2.4-6 Flush Plan 52 for Pump Fig. SG-2.3.2.4-7 Flush Plan 52 for Top Entry Agitator |
| 183 | SG-2.3.3 Other Dynamic Seals SG-2.3.3.1 Reciprocating Seals. SG-2.3.3.2 Oscillating Seals. Fig. SG-2.3.2.4-8 Flush Plan BPE52 for Pump Fig. SG-2.3.2.4-9 Flush Plan 53 for Pump Fig. SG-2.3.2.4-10 Flush Plan 53 for Top Entry Agitator Fig. SG-2.3.2.4-11 Flush Plan 54 for Pump |
| 184 | Fig. SG-2.3.2.4-12 Flush Plan 54 for Top Entry Agitator Fig. SG-2.3.2.4-13 Flush Plan 55 for Pump Fig. SG-2.3.2.4-14 Flush Plan 55 for Top Entry Agitator Fig. SG-2.3.2.4-15 Flush Plan 74 for Pump Fig. SG-2.3.2.4-16 Flush Plan 74 for Top Entry Agitator |
| 185 | SG-3 SEALING COMPONENTS GENERAL DESIGN REQUIREMENTS GENERAL PROVISIONS SG-3.1 Seal Design Conditions 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 |
| 186 | SG-3.3.2 Design SG-3.3.2.1 General SG-3.3.2.2 Static Seals |
| 187 | SG-3.3.2.3 Valves Fig. SG-3.3.2.2-1 Static O-Ring |
| 189 | SG-3.3.2.4 End Face Mechanical Seal General Design Requirements Fig. SG-3.3.2.3-1 Seals for Rising Stem Valves |
| 190 | SG-3.4 Compliance Requirements for Sealing Elements SG-3.4.1 General Requirements. |
| 191 | SG-3.4.2 Certificate of Compliance. SG-3.4.3 Test Requirements. SG-3.4.4 Additional Requirements. SG-3.5 Seal Identification SG-3.6 Other Seal Requirements SG-4 SEAL PERFORMANCE REQUIREMENTS SG-4.1 General Requirements SG-4.2 Static Seal Performance |
| 192 | SG-4.3 Dynamic Seal Performance SG-4.3.1 Valve Seal Performance. SG-4.3.1.1 New Valve Seal Performance. SG-4.3.2 Mechanical Seal Performance. SG-4.3.2.1 New Mechanical Seal Performance. Fig. SG-4.2-1 Typical Hygienic Clamp Union:Allowable Gasket Intrusion |
| 193 | SG-4.3.2.2 Installed Seals. SG-5 SEAL APPLICATIONS SG-5.1 General Considerations SG-5.2 Process Systems SG-5.3 Compendial Water Systems SG-5.3.1 Seals for Centrifugal Compendial Water Pumps SG-5.4 Clean/USP Pure Steam SG-5.5 CIP |
| 194 | Part PM Polymeric and Other Nonmetallic Materials PM-1 PURPOSE AND SCOPE PM-2 MATERIALS PM-2.1 Materials of Construction PM-2.1.1 Thermoplastic Polymers. PM-2.1.2 Thermoset Polymers. |
| 195 | PM-2.1.3 Other Nonmetallic Materials. PM-2.2 General Requirements PM-2.2.1 Certificate of Compliance. Table PM-2.1.1-1 Common Thermoplastic Polymers and Applications Table PM-2.1.2-1 Common Thermoset Polymers and Applications |
| 196 | PM-2.2.2 Labeling and Marking. PM-3 PROPERTIES AND PERFORMANCE PM-3.1 Biocompatibility Table PM-2.1.3-1 Examples of Nonmetallics |
| 197 | PM-3.2 Extractables and Leachables PM-3.2.1 General. PM-3.2.2 Terminology. PM-3.2.3 Extractables PM-3.2.3.1 Sample Preparation. PM-3.2.3.2 Extract Analysis. Table PM-2.2.1-1 Content Required on the Certificate of Compliance |
| 198 | PM-3.2.3.3 Risk Assessment. PM-3.2.4 Leachables PM-3.2.4.1 Sample Preparation. PM-3.2.4.2 Leachable Fluid Analysis. PM-3.2.4.3 Risk Assessment. PM-3.2.4.4 Bracketed Leachable Testing. PM-3.3 Physical and Mechanical Properties of Thermoplastic Polymers PM-3.4 Chemical Compatibility of Thermoplastic Polymers PM-3.5 Physical and Mechanical Properties of Thermoset Polymers PM-3.6 Chemical Compatibility of Thermoset Elastomers PM-3.7 Physical and Mechanical Properties of Other Nonmetallic Materials |
| 199 | PM-3.8 Chemical Compatibility of Nonmetallic Materials PM-3.9 Polymeric Surface Finish PM-4 APPLICATIONS PM-4.1 Single-Use Components and Assemblies PM-4.1.1 Identification. PM-4.1.1.1 Labeling. PM-4.1.1.2 Certificate of Compliance. PM-4.1.2 Inspection and Packaging. PM-4.1.2.1 Inspection. PM-4.1.2.2 Packaging. PM-4.1.3 Joining Methods. PM-4.1.4 Biocompatibility. |
| 200 | PM-4.1.5 Sterilization Bioburden Control. PM-4.1.5.1 Gamma Irradiation. PM-4.1.6 Shelf Life, Storage, and Expiration Date. PM-4.2 Piping PM-4.2.1 Sizing Comparisons. PM-4.2.2 Pressure Ratings. PM-4.2.3 Thermal Expansion. |
| 201 | Table PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards |
| 202 | PM-4.2.4 System Support Criteria PM-4.2.4.1 Support Distances. PM-4.2.4.2 Hanger and Clamp Types. PM-4.2.5 Connections and Fittings. PM-4.3 Hose Assemblies PM-4.3.1 General. PM-4.3.2 Hose Construction PM-4.3.2.1 Flexible Elements. PM-4.3.2.2 Mechanically Affixed and Reusable End Connections. PM-4.3.2.3 Flare-Through End Connections. PM-4.3.2.4 Molded-in-Place End Connections. PM-4.3.2.5 Hose Materials. |
| 203 | PM-4.3.3 Hose Assembly Performance. PM-4.3.3.1 Service Temperatures and Pressures. PM-4.3.3.2 Nonroutine Events. PM-4.3.3.3 Cleaning Systems PM-4.3.3.4 Sterilizing Systems. PM-4.3.4 Hose Assembly Installation. PM-4.3.5 Compliance Requirements PM-4.3.5.1 General Requirements. PM-4.3.5.2 Certificate of Compliance. PM-4.3.5.3 Test Requirements. PM-4.4 Chromatography Columns PM-4.4.1 General. PM-4.4.2 Pressure-Retaining Parts. PM-4.4.3 Design for Cleaning and Sanitization PM-4.4.3.1 Cleaning. |
| 204 | PM-4.4.3.1.1 Seals. PM-4.4.3.1.2 Exterior Surfaces. PM-4.4.3.1.3 Hygienic Connections. PM-4.4.3.2 Sanitization PM-4.4.3.2.1 Chemical Sanitization. PM-4.4.3.2.2 Thermal Sanitization. PM-4.4.4 Column Materials. PM-4.4.5 Column Performance. PM-4.4.5.1 Service Temperature and Pressure. PM-4.4.5.2 Routine Maintenance. PM-4.4.6 Compliance Requirements PM-4.4.6.1 General Requirementsnts. PM-4.4.6.2 Certificate of Compliance. PM-4.5 Filtration Elements and Components PM-4.6 Polymeric Hygienic Unions PM-4.6.1 Multi-Use PM-4.6.1.1 Installation. PM-4.6.1.2 Performance. PM-4.6.1.3 Cleaning. PM-4.6.1.4 Bioburden Control PM-4.6.1.5 Seals PM-4.6.2 Single-Use. PM-4.6.2.1 Installation. PM-4.6.2.2 Performance. PM-4.6.2.3 Seals. PM-4.7 Steam-Through and Steam-to Connections PM-4.7.1 General Requirements. |
| 206 | Part CR Certification CR-1 PURPOSE AND SCOPE CR-2 GENERAL CR-2.1 ASME BPE Certificate Holders Fig. CR-1-1 ASME Certification Mark With BPE Designator |
| 207 | CR-2.2 ASME BPE Certificate HolderÅ’s Responsibilities CR-2.3 Certification Designator CR-2.4 Subcontracting Fig. CR-2-1 Options for Certification of Organizations |
| 208 | CR-2.5 Quality Management System CR-2.5.1 Quality Management System Control. CR-2.5.1.1 CR-2.5.1.2 CR-2.5.2 Requirements for Designated Oversight. CR-2.5.2.1 Duties of the Certified Individual. CR-2.5.2.2 Requirements for the Certified Individual |
| 209 | CR-2.5.3 Evaluation of the Quality Management System. CR-2.5.4 ApplicantÅ’s Facilities and Equipment. CR-2.5.5 Personnel. CR-2.5.6 Monitoring of Quality Control Measuring and Testing Devices CR-2.5.7 Discrepancies With Measuring and Testing Devices CR-2.5.8 Internal Audits. |
| 210 | CR-2.5.9 Corrective Action. |
| 211 | Part MM Metallic Materials MM-1 PURPOSE AND SCOPE MM-2 ALLOY DESIGNATIONS MM-2.1 General MM-3 USES OF SPECIFICATIONS MM-3.1 General MM-3.2 Listed Specifications MM-3.3 Unlisted Specifications MM-3.4 Unknown Materials MM-3.5 Reclaimed Materials MM-3.6 Designation of Alloy and Fluid Service |
| 212 | Table MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %) |
| 213 | Table MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %) |
| 214 | MM-4 REFERENCED SPECIFICATIONS MM-4.1 General MM-4.2 Tubing/Piping Table MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations Table MM-2.1-4 Wrought Copper: Nominal Compositions (wt. %) (Cleaned for Oxygen Service) |
| 215 | MM-4.3 Castings MM-4.4 Forgings MM-4.5 Plate, Sheet, and Strip |
| 216 | MM-4.6 Hollow Products, Rod, and Bar Stock MM-4.7 Copper Alloy Fittings MM-5 FABRICATION MM-5.1 General MM-5.1.1 Austenitic Stainless Steel Weld Ends. |
| 217 | MM-5.1.2 Superaustenitic and Duplex Stainless Steels. MM-5.1.3 Castings. MM-5.1.4 Ferrite. MM-5.1.5 Special Materials. MM-5.1.6 Copper Alloy Tubing Systems. MM-5.2 Filler Metals and Consumable Inserts MM-5.2.1 Austenitic Stainless Steels. MM-5.2.2 Superaustenitic Stainless Steels. MM-5.2.3 Consumable Inserts for Orbital Welding of Listed Alloys. MM-5.2.4 Duplex Stainless Steels. |
| 218 | Table MM-5.1.2-1 Filler Metals |
| 220 | Table MM-5.1.2-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels Table MM-5.1.4-1 Predicted Ferrite Number (FN) Ranges for Various 316 Product Forms and Welds Table MM-5.1.5-1 Materials for OEM Equipment |
| 221 | MM-5.2.5 Copper Alloys. MM-5.3 Field Bending of Tubing MM-5.4 Heat Treatment MM-6 MECHANICAL PROPERTIES MM-6.1 General MM-6.2 Tubing/Piping MM-6.3 Fittings and Valves MM-6.4 Toughness Table MM-5.2.5-1 Brazing Filler Metals for Copper |
| 222 | MM-6.5 Testing MM-7 CORROSION RESISTANCE REQUIREMENTS MM-7.1 General MM-7.2 Corrosion Testing MM-8 ADDITION OF NEW ALLOYS TO PART MM MM-8.1 General |
| 223 | Part PI Process Instrumentation PI-1 PURPOSE AND SCOPE PI-2 PROCESS INSTRUMENTATION GENERAL REQUIREMENTS PI-2.1 General Considerations PI-2.1.1 Additional Considerations PI-2.1.2 Exterior Design. PI-2.2 Instrumentation Categories PI-2.2.1 In-Line Devices. PI-2.2.2 Insertion Devices. PI-2.2.3 At-Line Devices. |
| 224 | PI-2.2.4 Off-Line Devices. PI-3 INSTRUMENT RECEIVING, HANDLING, AND STORAGE PI-3.1 Introduction PI-3.2 Instrument Receiving PI-3.2.1 Original Packaging. PI-3.3 Instrument Handling: Protection of Process Connections and Surface Finish PI-3.4 Instrument Storage PI-3.4.1 Special Considerations. PI-3.4.2 Instrument Shelf Life and Environmental Requirements. PI-4 FLOWMETERS PI-4.1 Coriolis Flowmeter PI-4.1.1 General Considerations. Fig. PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples |
| 225 | Fig. PI-2.2.2-1 Accepted Insertion Device Installation Examples |
| 226 | PI-4.1.2 Essential Components. PI-4.1.3 Components PI-4.1.3.1 Flow Tubes. PI-4.1.3.2 Manifold or Flow Splitter. PI-4.1.3.3 Process Connections. PI-4.1.4 Installation. PI-4.1.4.1 Drainability. PI-4.1.4.2 Cleanability. PI-4.1.4.3 Mounting Location. PI-4.1.4.4 Orientation. Fig. PI-4.1.3.2-1 Manifold or Flow Splitter for Dual Tube Construction Flowmeters and Potential for Product Holdup |
| 227 | Fig. PI-4.1.3.3-1 Concentrically Reducing Process Connection Fig. PI-4.1.4.3-1 Vertical Installation Fig. PI-4.1.4.4-1 Minimum Angle of Inclination, a |
| 228 | PI-4.1.4.5 Special Considerations for Passivation of Coriolis Flowmeters. PI-4.1.5 Performance. PI-4.1.5.1 Accuracy. PI-4.1.5.2 Process Influences. PI-4.1.5.3 Ambient Influences. PI-4.1.6 Selection. PI-4.1.7 Maintenance. PI-4.1.7.1 Seals/Gaskets. PI-4.1.7.2 Recalibration/Verification Schedule. PI-5 LEVEL INSTRUMENTS PI-5.1 Radar Level Instruments PI-5.1.1 General. PI-5.1.2 Essential Components. |
| 229 | PI-5.1.2.1 Antenna. PI-5.1.2.2 Process Connection. PI-5.1.3 Installation. PI-5.1.3.1 Drainability. PI-5.1.3.2 Cleanability. PI-5.1.3.3 Mounting Location. PI-5.1.3.4 Orientation. PI-5.1.3.5 Insertion Length/Depth. PI-5.1.3.6 Special Considerations. PI-5.1.4 Performance. PI-5.1.4.1 Accuracy. PI-5.1.4.2 Process Influences. PI-5.1.4.3 Ambient Influences. PI-5.1.5 Selection. PI-6 PRESSURE INSTRUMENTS PI-7 TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS PI-7.1 General Fig. PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod Style Antenna |
| 230 | PI-7.2 Components PI-7.2.1 Sensors. PI-7.2.2 Thermowells. PI-7.3 Installation Fig. PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location |
| 231 | PI-7.3.1 Drainability. PI-7.3.2 Cleanability. PI-7.3.3 Mounting Location. PI-7.3.4 Orientation PI-7.3.5 Insertion Length/Depth Fig. PI-7.3-1 Typical Installation Styles |
| 232 | Fig. PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions Fig. PI-7.3.4-2 Accepted Nonintrusive Orientation and Flow Directions |
| 233 | Fig. PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations |
| 234 | PI-7.3.6 Special Considerations PI-7.4 Performance PI-7.4.1 Accuracy. PI-7.4.2 Response Time. PI-7.4.3 Process Influences. PI-7.4.4 Ambient Influences. PI-7.5 Selection PI-7.5.1 Sensor Selection. PI-7.5.2 Thermowell Selection. |
| 235 | PI-7.6 Sensor Calibration Verification PI-7.6.1 Methods. PI-8 ANALYTICAL INSTRUMENTS PI-8.1 Conductivity PI-8.1.1 General. Fig. PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations |
| 236 | PI-8.1.2 Essential Components. PI-8.1.2.1 Sensor Types. PI-8.1.3 Installation. Fig. PI-8.1.2-1 Conductivity Type Examples |
| 237 | PI-8.1.3.1 Drainability. PI-8.1.3.2 Cleanability. PI-8.1.3.3 Mounting Location. PI-8.1.3.4 Orientation. PI-8.1.3.5 Immersion Length/Depth. PI-8.1.3.6 Special Consideration. PI-8.1.4 Performance. PI-8.1.4.1 Accuracy. PI-8.1.4.2 Response Time. Fig. PI-8.1.3-1 Accepted Installations for Conductivity Sensors |
| 238 | PI-8.1.4.3 Process Influences. PI-8.1.4.4 Ambient Influences. PI-8.1.5 Selection. PI-8.1.6 Maintenance PI-8.1.6.1 Calibration/Verification Schedule. PI-8.2 pH — Glass Measuring Electrode PI-8.2.1 General. PI-8.2.2 Components. PI-8.2.3 Installation. Fig. PI-8.1.3.6-1 Installation Clearance Requirements Fig. PI-8.2.2-1 pH Sensor Components |
| 239 | PI-8.2.3.1 Drainability. PI-8.2.3.2 Cleanability. PI-8.2.3.3 Mounting Location. PI-8.2.3.4 Orientation. PI-8.2.3.5 Insertion Length/Depth. PI-8.2.3.6 Special Considerations. PI-8.2.4 Performance. PI-8.2.4.1 Accuracy. PI-8.2.4.2 Response Time. PI-8.2.4.3 Process Influences. PI-8.2.4.4 Ambient Influences. |
| 240 | Fig. PI-8.2.3-1 Accepted pH Sensor Installations |
| 241 | Fig. PI-8.2.3.4-1 Accepted Mounting Orientations |
| 242 | PI-8.2.5 Selection. PI-8.2.6 Maintenance. PI-8.2.6.1 Calibration/Verification Schedule. PI-9 OPTICAL PI-9.1 Optical Devices PI-9.1.1 General. PI-9.1.2 Components PI-9.1.2.1 Light Source. PI-9.1.2.2 Sensor. PI-9.1.2.3 Sight Glass. PI-9.1.3 Installation. Fig. PI-8.2.3.5-1 Insertion Length or Depth |
| 243 | PI-9.1.3.1 Drainability. PI-9.1.3.2 Cleanability. PI-9.1.3.3 Mounting Location. PI-9.1.3.4 Orientation. PI-9.1.3.5 Insertion Length. PI-9.1.3.6 Special Considerations. PI-9.1.4 Performance. PI-9.1.4.1 Accuracy. PI-9.1.4.2 Response Time. PI-9.1.4.3 Process Influences. PI-9.1.4.4 Ambient Influences. PI-9.1.5 Selection. PI-9.1.6 Maintenance. PI-9.1.6.1 Calibration/Verification. |
| 244 | Fig. PI-9.1.3.3-1 Vessel Light Glass Design and Mounting |
| 245 | Fig. PI-9.1.3.5-1 In-Line Insertion Length Fig. PI-9.1.3.5-2 Insertion Probe Length |
| 247 | MANDATORY APPENDIX I SUBMITTAL OF TECHNICAL INQUIRIES TO THE BIOPROCESSING EQUIPMENT BPE COMMITTEE I-1 INTRODUCTION I-2 INQUIRY FORMAT I-3 REVISIONS OR ADDITIONS |
| 248 | I-4 CODE CASES I-5 INTERPRETATIONS I-6 SUBMITTALS |
| 249 | MANDATORY APPENDIX II STANDARD UNITS II-1 GENERAL |
| 250 | NONMANDATORY APPENDICES NONMANDATORY APPENDIX A COMMENTARY: SLAG A-1 GENERAL |
| 251 | NONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION/INSPECTION DOCUMENTATION |
| 255 | NONMANDATORY APPENDIX C SLOPE MEASUREMENT C-1 GENERAL |
| 256 | NONMANDATORY APPENDIX D ROUGE AND STAINLESS STEEL D-1 GENERAL D-2 CONSIDERATIONS FOR REDUCING ROUGE FORMATION D-2.1 System Fabrication D-2.2 System Operation D-3 EVALUATION METHODS TO MEASURE ROUGE D-3.1 Process Fluid Analyses D-3.2 Solid Surface Analyses D-4 METHODS TO REMEDIATE THE PRESENCE OF ROUGE IN A SYSTEM D-4.1 Class I Rouge Remediation |
| 257 | D-4.2 Class II Rouge Remediation D-4.3 Class III Rouge Remediation D-4.4 Remediation Variables |
| 265 | NONMANDATORY APPENDIX E PASSIVATION PROCEDURE QUALIFICATION E-1 GENERAL E-2 PURPOSE OF PASSIVATION TREATMENTS E-2.1 Why Passivation Is Necessary E-2.2 When Passivation Is Necessary E-3 PASSIVATION PROCEDURE SEE SF-2.6 E-3.1 Procedure Description |
| 266 | E-3.2 Procedure Qualification E-3.3 Procedure Documentation Requirements E-4 PASSIVATION QUALITY CONTROL E-4.1 Quality Control Surveillance |
| 269 | E-4.2 Certificate of Passivation Compliance E-5 EVALUATION OF CLEANED AND PASSIVATED SURFACES E-5.1 Acceptance Criteria for Cleaned and/or Passivated Process Contact Surfaces See Table SF-2.6-1 |
| 275 | NONMANDATORY APPENDIX F CORROSION TESTING F-1 GENERAL F-2 CORROSION TESTS F-3 PITTING RESISISTANCE EQUIVALENT PRE NUMBER |
| 278 | NONMANDATORY APPENDIX G FERRITE G-1 GENERAL G-2 INFLUENCE OF FERRITE IN BIOPHARMACEUTICAL SERVICE G-3 CONTROL OF FERRITE CONTENT IN WELDS OF 316 STAINLESS STEELS |
| 279 | NONMANDATORY APPENDIX H ELECTROPOLISHING PROCEDURE QUALIFICATION H-1 SCOPE H-2 PURPOSE H-3 ELECTROPOLISH PROCEDURE QUALIFICATION H-3.1 Method Procedure H-3.2 Essential Variables H-3.3 Vendor Documentation H-3.4 Certificate of Compliance |
| 281 | NONMANDATORY APPENDIX I VENDOR DOCUMENTATION REQUIREMENTS FOR NEW INSTRUMENTS I-1 OVERVIEW I-1.1 Section 1: VDR Definitions I-1.2 Section 2: Instrument Types and Required Documents I-2 INSTRUCTIONS FOR USE |
| 285 | NONMANDATORY APPENDIX J STANDARD PROCESS TEST CONDITIONS SPTC FOR SEAL PERFORMANCE EVALUATION J-1 SEALING COMPONENT PERFORMANCE EVALUATION J-1.1 Material and Component Testing J-1.1.1 Test Article Requirements J-1.2 Exposure Testing J-1.2.1 Simulated Steam-in-Place SIP Testing. |
| 286 | J-1.2.2 Other Process Testing Considerations J-1.2.2.1 Vacuum. J-1.2.2.2 Cleaning Chemicals. J-1.3 Test Acceptance Criteria J-1.3.1 Hygienic Fittings. J-1.3.2 Valve Diaphragms. J-1.3.2.1 General Requirements for Performance Evaluation Test for Valve Diaphragms, per This Nonmandatory Appendix. J-1.3.2.2 Test Acceptance Criteria — Required Criteria for Hygienic Performance of Diaphragms |
| 291 | J-2 MECHANICAL SEAL PERFORMANCE EVALUATION J-2.1 Mechanical Seal Performance Evaluation J-2.1.1 Factors Affecting Seal Performance. J-2.1.2 Design Parameters. J-2.2 Exceptions to Normal Seal Performance J-2.2.1 Event-Based Operational Failures. J-2.2.2 Design and Application-Based Failures. |
| 292 | J-2.2.3 Equipment-Based Failures. J-2.3 Mechanical Seal Integrity Tests J-2.3.1 Single Mechanical Seals: Liquid Lubricated by Process |
| 293 | J-2.3.2 Dual Mechanical Seals: Liquid Lubricated by Barrier Fluid Dual Pressurized or by Process and Buffer Fluid Dual Unpressurized |
| 294 | J-2.4 Mechanical Seal Testing Notes |
| 295 | NONMANDATORY APPENDIX K STANDARD TEST METHODS FOR POLYMERS K-1 STANDARD TEST METHODS FOR THERMOPLASTIC POLYMERS K-2 STANDARD TEST METHODS FOR THERMOSET POLYMERS K-3 THERMOSET POLYMER TEST PROPERTIES K-4 INTERPRETATION OF THERMOSET MATERIAL PROPERTY CHANGES K-5 TESTING PROTOCOLS FOR THERMOSET POLYMERS K-5.1 Samples K-5.2 Immersion Fluids K-5.3 Qualification Testing K-5.4 Elastomer Testing: Property Retention |
| 298 | NONMANDATORY APPENDIX L SPRAY DEVICE COVERAGE TESTING L-1 SCOPE L-2 PURPOSE L-3 MATERIALS L-4 PROCEDURE L-4.1 Equipment Preparation L-4.2 Application of Fluorescent Solution L-4.3 Execute Rinse |
| 299 | L-4.4 Inspection L-5 ACCEPTANCE CRITERIA L-6 RECOMMENDED DOCUMENTATION |
| 300 | NONMANDATORY APPENDIX M COMMENTARY: 316L WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA M-1 GENERAL |
| 301 | NONMANDATORY APPENDIX N GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS N-1 GENERAL N-2 PARTICULATES |
| 302 | NONMANDATORY APPENDIX O GENERAL BACKGROUND/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES O-1 REFERENCES O-2 RECOMMENDED CONDITIONS FOR AN EXTRACTABLES STUDY O-3 RECOMMENDED MODEL PROCESS CONDITIONS FOR A BRACKETED STUDY |
| 303 | NONMANDATORY APPENDIX P TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS P-1 GENERAL P-1.1 General Considerations P-2 EXTERNAL SUPPORT COMPONENTS P-3 MEASUREMENT ACCURACY P-3.1 Sensor Accuracy P-3.2 Wiring and Cabling P-3.3 Electronics P-3.4 Process Influences P-3.5 Ambient Influences |
| 304 | P-4 SELECTION P-4.1 Sensor Selection P-4.2 Transmitter Selection P-5 MAINTENANCE P-5.1 Sensor Calibration Verification P-5.2 Sensor Inspection |
| 305 | NONMANDATORY APPENDIX Q INSTRUMENT RECEIVING, HANDLING, AND STORAGE Q-1 INTRODUCTION Q-2 INSTRUMENT RECEIVING Q-2.1 Warnings and Documentation Q-2.2 Incoming Inspection Q-3 INSTRUMENT HANDLING Q-3.1 Instrument Assembly Segregation Q-3.2 Component Labels Q-4 STORAGE |
| 306 | NONMANDATORY APPENDIX R APPLICATION DATA SHEET |
| 309 | NONMANDATORY APPENDIX S POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS S-1 GENERAL S-2 COLUMN CONSTRUCTION S-2.1 Cleaning S-2.2 Sanitization |
| 310 | NONMANDATORY APPENDIX T GUIDANCE FOR THE USE OF U.S. CUSTOMARY AND SI UNITS T-1 USE OF UNITS IN THE STANDARD T-2 GUIDELINES USED TO DEVELOP SI EQUIVALENTS |
| 311 | T-3 CHECKING EQUATIONS T-4 SOFT CONVERSION FACTORS |
| 313 | INDEX |
Related products
-
ASME PTB 2 2022
ASME PTB-2-2022 Guide to Life Cycle Management of Pressure Equipment Integrity Published By Publication Date…
