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 Examples
	Fig. PI-4.1.3.2-1 Manifold or Flow Splitter for Dual-Tube Construction Flowmeters and Potential for Product Holdup
	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
	Fig. PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna
	Fig. PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location
	Fig. PI-7.3-1 Typical Installation Styles
	Fig. PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions
	Fig. PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions
	Fig. PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations
	Fig. PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations
	Fig. PI-8.1.2-1 Conductivity-Type Examples
	Fig. PI-8.1.3-1 Accepted Installations for Conductivity Sensors
	Fig. PI-8.1.3.6-1 Installation Clearance Requirements
	Fig. PI-8.2.2-1 pH Sensor Components
	Fig. PI-8.2.3-1 Accepted pH Sensor Installations
	Fig. PI-8.2.3.4-1 Accepted Mounting Orientations
	Fig. PI-8.2.3.5-1 Insertion Length or Depth
	Fig. PI-9.1.3.3-1 Vessel Light Glass Design and Mounting
	Fig. PI-9.1.3.5-1 In-Line Insertion Length
	Fig. PI-9.1.3.5-2 Insertion Probe Length
	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
	Fig. SG-2.2.2-3 Hygienic Union per DIN 11864
	Fig. SG-2.2.2-4 Hygienic Clamp Union per DIN 11864
	Fig. SG-2.2.2-5 Nonhygienic Connections
	Fig. SG-2.3.1.2-1 Weir Valves
	Fig. SG-2.3.1.2-2 Radial Valves
	Fig. SG-2.3.1.2-3 Weirless Diaphragm Valve
	Fig. SG-2.3.1.2-4 Linear Control Valves
	Fig. SG-2.3.1.2-5 Regulator Valve
	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
	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
	Fig. SG-2.3.1.9-1 Pressure Relief and Check Valves
	Fig. SG-2.3.1.10-1 Plug Valve
	Fig. SG-2.3.2.2-1 Single Mechanical Seal
	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
	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
	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
	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
	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
	Fig. SG-3.3.2.2-1 Examples of Static O-Ring Grooves
	Fig. SG-3.3.2.3-1 Seals for Rising Stem Valves
	Fig. SG-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion
	Fig. MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube-to-Tube Butt Joints
	Fig. MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Electropolished UNS S31603 Tubing
	Fig. MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically Polished UNS S31603 Tubing
	Fig. MJ-8.4-4 Acceptable and Unacceptable Metallic Weld Bead Width and Meander on Non–Process Contact Surfaces of Groove Welds on Tube-to-Tube Butt Joints
	Fig. MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds
	Fig. MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds
	Fig. CR-1-1 ASME Certification Mark With BPE Designator
	Fig. CR-2-1 Options for Certification of Organizations
	Fig. J-1.3.2.1-1 Weir-Style Diaphragm
	Fig. J-1.3.2.1-2 Weir-Style Body
	Fig. J-1.3.2.1-3 Radial-Style Body
	Fig. J-1.3.2.1-4 Manual Bonnet
	Fig. J-1.3.2.1-5 Pneumatic
	Fig. O-4-1 Flowchart of Bioprocessing Equipment/Component Evaluation Related to Extractables and Leachables Characterization
Tables
	Table GR-4.2-1 Inspector’s Delegate Capabilities
	Table SD-2.4.3.1-1 Slope Designations for Gravity-Drained Lines
	Table SD-3.1.2.2-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With Blind Cap
	Table SD-3.1.2.2-2 L/D Dimensions for Flow-Through Tee: Short-Outlet Reducing Tee With Blind Cap
	Table SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes
	Table SD-5.3.3.3-1 Flow Rates to Achieve 5 ft/sec (1.52 m/s)
	Table MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %)
	Table MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %)
	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)
	Table MM-5.2.1.2-1 Predicted Ferrite Number (FN) Ranges for Various Austenitic Stainless Steel Product Forms and Welds
	Table MM-5.2.6-1 Materials for OEM Equipment
	Table MM-5.3-1 Filler Metals
	Table MM-5.3-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels
	Table MM-5.3.3-1 Brazing Filler Metals for Copper
	Table MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic and Duplex Stainless Steels
	Table PM-2.1.1-1 Common Thermoplastic Polymers and Applications
	Table PM-2.1.2-1 Common Thermoset Polymers and Applications
	Table PM-2.1.3-1 Examples of Nonmetallics
	Table PM-2.2.1-1 Content Required on the Certificate of Compliance
	Table PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards
	Table DT-2-1 Metallic Hygienic Unions: Rated Internal Working Pressure
	Table DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components
	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
	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
	Table DT-4.1.1-3 Hygienic Clamp Joint: 90-deg Elbow
	Table DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow
	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
	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
	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
	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
	Table DT-4.1.2-5 Hygienic Clamp Joint: Short-Outlet Tee
	Table DT-4.1.2-6 Automatic Tube Weld: Reducing Tee
	Table DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee
	Table DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee
	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
	Table DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer
	Table DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
	Table DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer
	Table DT-4.1.4-1 Automatic Tube Weld: Ferrule
	Table DT-4.1.5-1 Automatic Tube Weld: Cap
	Table DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap
	Table DT-4.4.1-1 Hygienic Clamp Joint: Weir-Style Diaphragm Valve
	Table DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed
	Table DT-4.5.2-1 Tapered Locking Tab Retainer: External
	Table DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances
	Table DT-7-2 Transfer Panel and Jumper Tolerances
	Table DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria
	Table MJ-6.3-1 Metallic Tube/Pipe Diameter Limits for Orbital GTAW Performance Qualification
	Table MJ-6.3-2 Metallic Weld Thickness Limits for Orbital GTAW Performance Qualification
	Table MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks
	Table MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe
	Table MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints
	Table MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds
	Table SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes
	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
	Table SF-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes
	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
	Table II-1 Standard Units
	Table D-2-1 Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System
	Table D-2-2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System
	Table D-3.1-1 Process Fluid Analyses for the Identification of Mobile Constituents of Rouge
	Table D-3.2-1 Solid Surface Analyses for the Identification of Surface Layers Composition
	Table D-4.1-1 Rouge Remediation Processes Summary
	Table E-3.2-1 Minimum Surface Requirements for Process Qualification Samples
	Table E-3.2-2 Passivation Processes
	Table E-5-1 Test Matrix for Evaluation of Cleaned and/or Passivated Surfaces
	Table F-1-1 ASTM Corrosion Tests
	Table F-3-1 PRE Numbers for Some Alloys
	Table H-3.3-1 Minimum Surface Requirements for Process Qualification Samples
	Table I-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions
	Table I-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents
	Table K-3-1 Thermoset Polymer Test Properties
	Table K-4-1 Interpretation of Thermoset Material Property Changes
Forms
	Form MEL-1 Material Examination Log
	Form MER-1 Material Examination Record
	Form WEL-1 Weld and Examination/Inspection Log
	Form R-1 Application Data Sheet
MANDATORY APPENDICES
	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
		I-4 CODE CASES
		I-5 INTERPRETATIONS
		I-6 SUBMITTALS
	MANDATORY APPENDIX II STANDARD UNITS
NONMANDATORY APPENDICES
	NONMANDATORY APPENDIX A COMMENTARY: SLAG AND OXIDE ISLANDS
	NONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION/INSPECTION DOCUMENTATION
	NONMANDATORY APPENDIX C SLOPE MEASUREMENT AND JOINT MISALIGNMENT
		C-1 GENERAL
		C-2 JOINT MISALIGNMENT
	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
			D-4.2 Class II Rouge Remediation
			D-4.3 Class III Rouge Remediation
			D-4.4 Remediation Variables
	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
			E-3.2 Procedure Qualification
			E-3.3 Procedure Documentation Requirements
		E-4 PASSIVATION QUALITY CONTROL
			E-4.1 Quality Control Surveillance
			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)
	NONMANDATORY APPENDIX F CORROSION TESTING
		F-1 GENERAL
		F-2 CORROSION TESTS
		F-3 PITTING RESISISTANCE EQUIVALENT (PRE) NUMBER
	NONMANDATORY APPENDIX G FERRITE
		G-1 GENERAL
		G-2 INFLUENCE OF FERRITE IN BIOPHARMACEUTICAL SERVICE
		G-3 CONTROL OF FERRITE CONTENT IN WELDS OF AUSTENITIC STAINLESS STEELS
	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
	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
	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 Testing.
				J-1.2.2 Simulated Combined CIP and SIP Testing.
				J-1.2.3 Other Process Testing Considerations
					J-1.2.3.1 Vacuum.
					J-1.2.3.2 Additional 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
		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.
				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
				J-2.3.2 Dual Mechanical Seals: Liquid Lubricated by Barrier Fluid (Dual Pressurized) or by Process and Buffer Fluid (Dual Unpressurized)
			J-2.4 Mechanical Seal Testing Notes
	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
	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
			L-4.4 Inspection
		L-5 ACCEPTANCE CRITERIA
		L-6 RECOMMENDED DOCUMENTATION
	NONMANDATORY APPENDIX M COMMENTARY: UNS S31603 WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA
	NONMANDATORY APPENDIX N GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS
		N-1 GENERAL
			N-1.1 Gamma Irradiation
		N-2 PARTICULATES
			N-2.1 Characterization
			N-2.2 Levels of Acceptance
	NONMANDATORY APPENDIX O GENERAL BACKGROUND/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES
		O-1 REFERENCES
		O-2 RECOMMENDED CONDITIONS FOR A POLYMERIC MATERIAL-SPECIFIC EXTRACTION
		O-3 RECOMMENDED CONDITIONS FOR AN EXTRACTION STUDY IN BIOPROCESS MODEL SOLUTIONS
		O-4 OVERVIEW OF BIOPROCESSING EQUIPMENT/COMPONENT EVALUATION RELATED TO EXTRACTABLES AND LEACHABLES CHARACTERIZATION
	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
		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
	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
	NONMANDATORY APPENDIX R APPLICATION DATA SHEET
	NONMANDATORY APPENDIX S GUIDANCE ON POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS AND FILTRATION
		S-1 CHROMATOGRAPHY COLUMNS
			S-1.1 General
			S-1.2 Column Construction
			S-1.3 Cleaning
			S-1.4 Sanitization
		S-2 FILTRATION
			S-2.1 General
			S-2.2 Filtration Formats
				S-2.2.1 Direct Flow Filtration.
					S-2.2.1.1 Filtration Elements.
				S-2.2.2 Tangential Flow Filtration.
					S-2.2.2.1 Filtration Elements.
			S-2.3 Housings and Encapsulation
				S-2.3.1 Holders.
			S-2.4 Design for Cleaning
				S-2.4.1 Cleaning.
			S-2.5 Normalized Water Permeability (NWP) Testing
				S-2-5.1
	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
		T-3 CHECKING EQUATIONS
		T-4 SOFT CONVERSION FACTORS
	NONMANDATORY APPENDIX U POSITIVE MATERIAL IDENTIFICATION
		U-1 POSITIVE MATERIAL IDENTIFICATION
		U-2 GENERAL REQUIREMENTS
		U-3 CALIBRATION
		U-4 PROCEDURE
		U-5 PERSONNEL TRAINING AND QUALIFICATION
		U-6 ACCEPTANCE/REJECTION
		U-7 PMI REFEREE METHODS
		U-8 PMI SPECIAL CONDITIONS
	NONMANDATORY APPENDIX V PROCUREMENT SOURCES
INDEX