ASME BPE-2016: Bioprocessing Equipment

CONTENTS FOREWORD STATEMENT OF POLICY COMMITTEE ROSTER SUMMARY OF CHANGES CHAPTER 1 INTRODUCTION, SCOPE, AND DEFINITIONS Part GR General Requirements GR-1 INTRODUCTION GR-2 SCOPE OF THE ASME BPE STANDARD GR-3 MANUFACTURER'S QUALITY ASSURANCE PROGRAM GR-4 INSPECTION GR-4.1 Inspector/Examiner GR-4.2 Inspector's Delegate GR-4.2.1 Levels of Qualification. GR-4.2.2 Qualification Requirements. 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 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 Turnover Package Documentation. GR-5.2.1.1.2 GR-5.3 Material Test Reports/Certificates of Compliance GR-5.3.1 Metallic Materials. 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 and Examination/Inspection Log 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 GR-8 TERMS AND DEFINITIONS CHAPTER 2 DESIGN 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. 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. 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 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 SD-3.1.2.4 Hygienic Support Systems 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 SD-3.3.2.2 Centrifugal Pumps SD-3.3.2.3 Positive Displacement Pumps SD-3.3.2.4 Rotary Lobe Pumps SD-3.4 Vessels SD-3.4.1 General. SD-3.4.2 Vessel Openings SD-3.4.3 Internal Components SD-3.4.4 Fabrication SD-3.4.5 Finishes SD-3.4.6 Sight Glasses 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 SD-3.5.3 Shafts and Keyways SD-3.5.4 Hubs and Impellers 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 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 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. SD-3.9 Spray Devices SD-3.9.1 General. SD-3.9.2 Spray Device Requirements 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 Multiaxis Dynamic Spray Device Requirements SD-3.10 Disposables That Require Presterilization or Poststerilization 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 Nonaseptic Sampling. SD-3.12 Steam Traps 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 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 SD-4.2.3 Clean/Pure Steam Valves. SD-4.3 Process Gases SD-4.3.1 Process Gas Distribution Systems. SD-4.4 Process Waste Systems SD-4.4.1 General. SD-4.4.2 Bio-Inactiviation Systems. SD-5 PROCESS SYSTEMS SD-5.1 Upstream Systems SD-5.1.1 Bioreactors and Fermentors SD-5.1.1.1 General 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 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 Back Pressure 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. 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 Description. SD-5.1.3.2 Process Parameters. SD-5.1.3.3 Performance Requirements. SD-5.1.3.4 Disk Stack Centrifuge. SD-5.1.3.4.1 Operating Capabilities and System Function. 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-5.2.2 SD-5.2.3 Chromatography. 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 Cabinet Washers SD-5.3.1.1 General SD-5.3.1.2 Cleaning Cycles SD-5.3.1.3 Rinse Requirements SD-5.3.1.4 Components SD-5.3.1.4.1 General SD-5.3.1.4.2 Washer Chamber SD-5.3.1.4.2.1 General SD-5.3.1.4.2.2 Chamber Openings SD-5.3.1.4.3 Washer Door and Door Seals SD-5.3.1.4.4 Internal Components SD-5.3.1.4.5 Air Drying, Intake, and Exhaust Systems. SD-5.3.1.4.6 Spray Systems. SD-5.3.1.4.7 Chemical Addition Systems. SD-5.3.1.4.8 Recirculation Pumps SD-5.3.1.4.9 Heat Exchangers SD-5.3.1.4.10 Instrumentation SD-5.3.1.5 Branch Connections SD-5.3.1.6 Fabrication SD-5.3.1.7 Maintenance SD-5.3.1.8 Testing. SD-5.3.1.8.1 Spray Device Coverage Test. SD-5.3.1.8.2 Drainability Test. SD-5.3.1.8.3 Cycle Performance Test. SD-5.3.1.9 Turnover Package Documentation. SD-5.3.2 Steam Sterilizers/Autoclaves SD-5.3.2.1 General. SD-5.3.2.2 Cycle Types. 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. 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 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 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. SD-5.3.4 Thermal Treatment Systems SD-5.3.4.1 General. SD-5.3.4.1.1 Terminology. SD-5.3.4.2 Performance Requirements. SD-5.3.4.3 Thermal Treatment System Design SD-5.3.4.3.1 System Configuration SD-5.3.4.3.2 Heat Exchangers. SD-5.3.4.3.3 Steam Injectors SD-5.3.4.3.4 Flash Chambers. SD-5.3.4.3.5 Pumps. SD-5.3.4.3.6 Retention Tube SD-5.3.4.3.7 Instrumentation. SD-5.3.4.3.8 Flow Control. SD-5.3.4.3.9 Back Pressure Control. SD-5.3.4.3.10 Materials of Construction SD-5.3.4.3.11 System Interfaces SD-5.3.4.4 Operating Capabilities and System Function. SD-5.3.4.4.1 Drainability. SD-5.3.4.4.2 Cleaning. SD-5.3.4.4.3 Sterilization. SD-5.3.4.4.4 Priming. SD-5.3.4.4.5 Thermal Sanitization. SD-5.3.4.4.6 Temperature Stabilization. SD-5.3.4.4.7 Heat Treatment. SD-5.3.4.4.8 Post-Use Sequence. SD-5.3.4.5 Product Impact Considerations (Degradation, Fouling, Precipitation). SD-5.3.4.6 Testing. SD-5.3.4.7 Maintenance. SD-5.3.5 Solution Preparation Systems. SD-5.3.5.1 Contamination Control. SD-5.3.5.1.1 SD-5.3.5.1.2 SD-5.3.5.1.3 SD-5.4 Fill and Finish 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 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 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 SD-5.4.1.5 CIP of Lyophilizers SD-5.4.1.6 Bioburden Reduction in Lyophilizers. SD-5.4.1.6.1 Steam-in-Place. SD-5.4.1.6.2 Hydrogen Peroxide Sterilization. SD-5.4.1.7 Leak Rate SD-5.4.1.8 Branch Connections 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 CHAPTER 3 MATERIALS 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 MM-4 REFERENCED SPECIFICATIONS MM-4.1 General MM-4.2 Tubing/Piping MM-4.3 Castings MM-4.4 Forgings MM-4.5 Plate, Sheet, and Strip MM-4.6 Hollow Products, Rod, and Bar Stock MM-4.7 Copper Alloy Fittings MM-5 BASE METALS AND FILLER MATERIALS MM-5.1 General MM-5.2 Base Metals MM-5.2.1 Austenitic Stainless Steels MM-5.2.1.1 Weld Ends. MM-5.2.1.2 Ferrite. MM-5.2.2 Superaustenitic Stainless Steels. MM-5.2.3 Duplex Stainless Steels. MM-5.2.4 Castings. MM-5.2.5 Copper Alloys. MM-5.2.6 Special Alloys. MM-5.2.7 Unlisted Alloys. MM-5.3 Filler Materials MM-5.3.1 Austenitic Stainless Steels. MM-5.3.2 Superaustenitic and Duplex Stainless Steels. MM-5.3.3 Copper Alloys. 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 MM-6.5 Testing MM-6.6 Positive Material Identification (PMI) 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 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. PM-2.1.3 Other Nonmetallic Materials. PM-2.2 General Requirements PM-2.2.1 Certificate of Compliance. PM-2.2.2 Labeling and Marking. PM-2.2.3 Change Management PM-2.2.3.1 General. PM-2.2.3.2 Change Classifications PM-2.2.3.3 Owner/User Notification. PM-2.2.3.4 Supplier Responsibilities. PM-2.2.3.5 Owner/User Responsibilities. PM-3 PROPERTIES AND PERFORMANCE PM-3.1 Biocompatibility PM-3.2 Extractables and Leachables PM-3.2.1 General. PM-3.2.2 Extractables. PM-3.2.2.1 Polymeric Material Specific Extraction Study. PM-3.2.2.2 Extraction Study in Bioprocess Model Solutions. PM-3.2.3 Leachables. PM-3.2.4 Sample Preparation. PM-3.2.5 Documentation. PM-3.2.6 Risk Assessment. 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 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. 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-4.1.7 Particulates. PM-4.1.7.1 General. PM-4.1.7.2 Mitigation Techniques. PM-4.1.7.2.1 Suppliers. PM-4.1.7.2.2 Owner/User. PM-4.2 Piping PM-4.2.1 Sizing Comparisons. PM-4.2.2 Pressure Ratings. PM-4.2.3 Thermal Expansion. 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. 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. 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 Requirements. PM-4.4.6.2 Certificate of Compliance. PM-4.5 Filtration Elements and Components PM-4.5.1 General. PM-4.5.2 Filtration Formats. PM-4.5.3 Housing and Encapsulation. PM-4.5.3.1 Housings. PM-4.5.3.2 Encapsulation. PM-4.5.3.2.1 Holders. PM-4.5.4 Design for Cleaning and Sanitization PM-4.5.4.1 Cleaning. PM-4.5.4.1.1 Seals. PM-4.5.4.1.2 Exterior Surfaces. PM-4.5.4.2 Sanitization PM-4.5.4.2.1 Chemical Sanitization. PM-4.5.4.2.2 Thermal Sanitization. PM-4.5.5 Filtration Performance. PM-4.5.5.1 Service Temperature and Pressure. PM-4.5.5.2 Routine Maintenance. PM-4.5.5.2.1 Integrity Testing and Permeability PM-4.5.6 Installation. PM-4.5.7 Compliance Requirements PM-4.5.7.1 General Requirements. PM-4.5.7.2 Certificate of Compliance. PM-4.6 Polymeric Hygienic Unions PM-4.6.1 Multiuse 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. CHAPTER 4 PROCESS COMPONENTS 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 DT-4.4.1 Diaphragm Valves. DT-4.5 Filter Dimensions DT-4.5.1 Code 7 Tapered Locking Tab Retainer: Recessed. DT-4.5.2 Code 7 Tapered Locking Tab Retainer: External. 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 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 DT-11.2.1 Exceptions DT-11.3 Modified Surfaces DT-12 PACKAGING Part PI Process Instrumentation PI-1 PURPOSE AND SCOPE PI-2 PROCESS INSTRUMENTATION GENERAL REQUIREMENTS PI-2.1 General Considerations PI-2.1.1 Installation. PI-2.1.2 Internal Design and Process Connections PI-2.1.3 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. 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. PI-4.1.2 Essential Components. PI-4.1.3 Components PI-4.1.3.1 Flow Tube(s). 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. 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. 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 PI-7.2 Components PI-7.2.1 Sensors. PI-7.2.2 Thermowells. PI-7.3 Installation 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 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. PI-7.6 Sensor Calibration Verification PI-8 ANALYTICAL INSTRUMENTS PI-8.1 Conductivity PI-8.1.1 General. PI-8.1.2 Essential Components. PI-8.1.2.1 Sensor Types. PI-8.1.3 Installation. 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. 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. 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. 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(s). PI-9.1.2.2 Sensor. PI-9.1.2.3 Sight Glass. PI-9.1.3 Installation. 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. 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. SG-2.3.1.2 Diaphragm Valves SG-2.3.1.3 Ball Valve and Ball Tank Bottom Valve. SG-2.3.1.4 Rising Stem Single, Double-Seat Mix-Proof, and 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 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 SG-2.3.2.4 Flush Plans. SG-2.3.3 Other Dynamic Seals SG-2.3.3.1 Reciprocating Seals. SG-2.3.3.2 Oscillating Seals. 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 SG-3.3.2 Design SG-3.3.2.1 General SG-3.3.2.2 Static Seals SG-3.3.2.3 Valves SG-3.3.2.4 End Face Mechanical Seal General Design Requirements SG-3.4 Compliance Requirements for Sealing Elements SG-3.4.1 General Requirements. 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 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. 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 Ambient/Hot-Water Distribution Systems SG-5.3.1 Static Seal Recommendations for Compendial Water SG-5.3.1.1 Additional Considerations SG-5.3.2 Valves for Compendial Water SG-5.3.2.1 Seals for Compendial Water. SG-5.3.2.2 Valve Types for Compendial Water SG-5.3.3 Single Mechanical Seals for Compendial Water per Paras. SG-3.3.2.4(a) and (b) SG-5.3.3.1 Additional Application Conditions Relevant to Mechanical Seals. SG-5.3.3.2 Additional Equipment Characteristics Relevant to Mechanical Seals. SG-5.3.3.3 Materials of Construction. SG-5.3.3.4 Flush Plans. SG-5.4 Clean/USP Pure Steam SG-5.5 CIP CHAPTER 5 FABRICATION, ASSEMBLY, AND ERECTION 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 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 Introduction MJ-4.2 Welds Finished After Welding MJ-4.3 Welds Used in the As-Welded Condition MJ-4.4 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 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 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 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. 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. 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 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 SF-2.7 Normative References 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 SF-3.4 Surface Condition CHAPTER 6 CERTIFICATION Part CR Certification Requirements CR-1 PURPOSE AND SCOPE CR-2 GENERAL CR-2.1 ASME BPE Certificate Holders CR-2.2 ASME BPE Certificate Holder's Responsibilities CR-2.3 Certification Designator CR-2.4 Subcontracting 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 CR-2.5.3 Evaluation of the Quality Management System. CR-2.5.4 Applicant'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. CR-2.5.9 Corrective Action. Figures Fig. SD-3.1.1-1 Flat Gasket Applications Fig. SD-3.1.2.2-1 Accepted Point-of-Use Designs Fig. SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly Fig. SD-3.2.1-1 Flexible Hygienic Hose Design Fig. SD-3.3.2.2-1 Pump Impeller Configurations Fig. SD-3.3.2.2-2 Acceptable Impeller Attachments Fig. SD-3.3.2.2-3 Casing Drain Configurations Fig. SD-3.3.2.2-4 Casing Drain L/D Ratios Fig. SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment Fig. SD-3.4.2-1 Nozzle Design Fig. SD-3.4.2-2 Side and Bottom Connections Fig. SD-3.4.2-3 Sidewall Instrument Ports Fig. SD-3.4.2-4 Vessel Design Tangential Nozzles Fig. SD-3.4.2-5 Typical Nozzle Detail Fig. SD-3.4.3-1 Accepted Nozzle Penetrations Fig. SD-3.4.3-2 Internal Support Members Fig. SD-3.4.6-1 Sight Glass Design (Accepted) Fig. SD-3.5.1-1 Agitator Mounting Flanges Fig. SD-3.5.2-1 Shaft Coupling Construction Fig. SD-3.5.2-2 Shaft Coupling Seal Arrangements Fig. SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs Fig. SD-3.5.5-1 Shaft-Steady Bearing Fig. SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount) Fig. SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design Fig. SD-3.7.1-1 Transfer Panel Looped Headers Fig. SD-3.7.2-1 Transfer Panel Tolerances Fig. SD-3.7.4-1 Transfer Panel Jumpers Fig. SD-3.9.1-1 Dynamic Spray Device: Single Axis Fig. SD-3.9.1-2 Two Axes Dynamic Spray Device Fig. SD-3.9.2.1-1 Static Spray Device Fig. SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels Fig. SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels Fig. SD-3.9.2.3-1 Impact Pattern Buildup Fig. SD-3.12-1 Steam Traps for Clean Steam Systems Fig. SD-4.1.2.1-1 Point-of-Use Piping Fig. SD-4.1.2.2-1 Physical Break in Point-of-Use Piping Fig. SD-4.2.2-1 Typical Clean Steam System Isometric Fig. SD-4.2.2-2 Clean Steam Point-of-Use Design Fig. SD-5.1.1.1-1 Fermentor Sterile Envelope Fig. SD-5.1.1.1-2 Bioreactor Sterile Envelope Fig. SD-5.1.1.2.3-1 Gas Sparging Assembly — Lance Fig. SD-5.1.1.2.3-2 Gas Sparging Assembly — Sintered Fig. SD-5.1.1.2.3-3 Gas Sparging Assembly — Ring Fig. SD-5.1.1.2.3-4 Gas Sparging Assembly — Single Orifice Fig. SD-5.1.1.3.1-1 Exhaust Gas Condenser Fig. SD-5.1.1.3.1-2 Exhaust Gas Heater Fig. SD-5.1.1.3.1-3 Electrically Heat Traced Filter Housing Fig. SD-5.2.1.1-1 Tank/Vessel Vent Filters 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 Fig. SD-5.3.4.3.1-1 Example HTST Process Flow Schematic Diagram Fig. SD-5.3.4.3.1-2 Example Direct Steam Injection UHT Process Flow Schematic Diagram Fig. SD-5.3.4.3.6-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing Fig. SD-5.4.1.2-1 Typical Lyophilizer Component Assembly Fig. SD-5.4.1.3-1 Lyophilizer Sterile Boundary Fig. DT-2-1 Clamp Conditions at Installation Fig. PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples Fig. PI-2.2.2-1 Accepted Insertion Device Installation Exam