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ASME BPE 2022 w ERRATA

ASME BPE 2022 w ERRATA

$75.42

ASME BPE-2022 Bioprocessing Equipment

Published By Publication Date Number of Pages
ASME 2022 438
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The ASME Bioprocessing Equipment (BPE) Standard was developed to aid in the design and construction of new fluid processing equipment used in the manufacture of biopharmaceuticals, where a defined level of purity and bioburden control is required.

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PDF Pages PDF Title
5 CONTENTS
15 FOREWORD
17 STATEMENT OF POLICY ON THE USE OF THE ASME SINGLE CERTIFICATION MARK AND CODE AUTHORIZATION IN ADVERTISING
STATEMENT OF POLICY ON THE USE OF ASME MARKING TO IDENTIFY MANUFACTURED ITEMS
18 ASME BIOPROCESSING EQUIPMENT COMMITTEE
23 CORRESPONDENCE WITH THE BPE COMMITTEE
25 ASME BPE-2022 SUMMARY OF CHANGES
37 CHAPTER 1 INTRODUCTION, SCOPE, AND GENERAL REQUIREMENTS
PART GR GENERAL REQUIREMENTS
GR-1 INTRODUCTION
GR-2 SCOPE OF THE ASME BPE STANDARD
38 GR-3 MANUFACTURER’S QUALITY ASSURANCE PROGRAM
GR-4 EXAMINATION, INSPECTION, AND TESTING
GR-4.1 Inspector/Examiner
GR-4.2 Quality Inspector’s Delegate
39 Tables
Table GR-4.2-1 Quality Inspector’s Delegate Capabilities
42 GR-4.3 Responsibilities
GR-4.4 Access for Inspectors
GR-5 DOCUMENTATION
GR-5.1 General
GR-5.2 Document Requirements
43 GR-5.3 Material Test Reports/Certificates of Conformance
44 GR-5.4 Weld and Examination/Inspection Log
GR-5.5 Records Retention
GR-6 U.S. CUSTOMARY AND SI UNITS
GR-7 REFERENCES
46 GR-8 TERMS AND DEFINITIONS
55 GR-9 NOMENCLATURE
56 CHAPTER 2 CERTIFICATION
PART CR CERTIFICATION REQUIREMENTS
CR-1 PURPOSE AND SCOPE
CR-2 GENERAL
Figures
Figure CR-1-1 The ASME Single Certification Mark With the BPE Certification Designator
Table CR-1-1 Types of ASME BPE Certificates
57 CR-2.1 ASME BPE Certificate Holders
CR-2.2 ASME BPE Certificate Holder’s Responsibilities
CR-2.3 Certified Individual Requirements Under a Certificate of Authorization
59 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
60 Table MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %)
61 Table MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %)
62 Table MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations
63 MM-3.5 Reclaimed Materials
MM-3.6 Designation of Alloy and Fluid Services
MM-4 REFERENCED SPECIFICATIONS
MM-4.1 General
MM-4.2 Tubing, Piping, and Hollow Bar
Table MM-2.1-4 Wrought Copper: Nominal Compositions (wt. %) (Cleaned for Oxygen Service)
64 MM-4.3 Castings
MM-4.4 Forgings
MM-4.5 Plate, Sheet, and Strip
MM-4.6 Shapes, Rods, and Bars
65 MM-4.7 Copper Alloy Fittings
MM-5 BASE METALS AND FILLER MATERIALS
MM-5.1 General
MM-5.2 Base Metals
Table MM-5.2.1.1-1 Predicted Ferrite Number (FN) Ranges for Various Austenitic Stainless Steel Product Forms and Welds
66 MM-5.3 Filler Materials
Table MM-5.2.5-1 Materials for OEM Equipment
67 Table MM-5.3-1 Filler Metals for Austenitic Stainless Steels
69 Table MM-5.3-2 Filler Metals for Superaustenitic Stainless Steels
70 Table MM-5.3-3 Filler Metals for Duplex Stainless Steels
71 Table MM-5.3-4 Filler Metals for Nickel Alloys
72 Table MM-5.3-5 Consumable Inserts for Superaustenitic and Duplex Stainless Steels
73 MM-5.4 Heat Treatment
MM-6 MECHANICAL PROPERTIES AND LEAK TESTING
MM-6.1 Tubing/Piping
MM-6.2 Fittings and Valves
MM-6.3 Toughness
MM-6.4 Testing
MM-7 POSITIVE MATERIAL IDENTIFICATION
MM-8 CORROSION-RESISTANCE REQUIREMENTS
MM-8.1 General
74 Table MM-5.3.4-1 Brazing Filler Metals for Copper
75 MM-8.2 Corrosion Testing
MM-9 MINIMUM REQUIREMENTS FOR ALLOYS IN PART MM
MM-9.1 General
Table MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic and Duplex Stainless Steels
77 PART PM POLYMERIC AND OTHER NONMETALLIC MATERIALS
PM-1 PURPOSE AND SCOPE
PM-2 MATERIALS
PM-2.1 Materials of Construction
78 Table PM-2.1.1-1 Common Thermoplastic Polymers and Applications
Table PM-2.1.2-1 Common Thermoset Polymers and Applications
79 PM-2.2 General Requirements
Table PM-2.1.3-1 Examples of Nonmetallics
80 Table PM-2.2.1-1 Content Required on the Certificate of Conformance
81 Table PM-2.2.3.2-1 Change Levels and Minimum Change Notification Requirements
82 PM-3 PROPERTIES AND PERFORMANCE
PM-3.1 Biocompatibility
PM-3.2 Extractables and Leachables
83 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
84 PM-3.9 Polymeric Surface Finish
PM-4 APPLICATIONS
PM-4.1 Single-Use Components and Assemblies
PM-4.2 Piping
85 Table PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards
86 PM-4.3 Hose Assemblies
87 PM-4.4 Polymeric Hygienic Unions
88 CHAPTER 4 DESIGN FOR MULTIUSE
PART SD SYSTEMS DESIGN FOR MULTIUSE
SD-1 PURPOSE AND SCOPE
SD-2 GENERAL GUIDELINES
SD-2.1 Containment
SD-2.2 Bioburden Control
SD-2.3 Bioburden Reduction
89 SD-2.4 Fabrication
91 Table SD-2.4.3.1-1 Slope Designations for Drainable Lines
92 SD-2.5 Hygienic System Design
SD-2.6 Animal-Derived Ingredients
SD-3 PROCESS COMPONENTS AND EQUIPMENT
SD-3.1 Connections, Fittings, and Piping
93 Figure SD-3.1.1-1 Flat Gasket Applications
94 Table SD-3.1.2.2-1 L/d Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With Blind Cap
95 Table SD-3.1.2.2-2 L/d Dimensions for Flow-Through Tee: Short-Outlet Reducing Tee With Blind Cap
97 Figure SD-3.1.2.2-1 Accepted Point-of-Use Designs
98 Figure SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly
99 SD-3.2 Hose Assemblies
100 SD-3.3 Pumps
Figure SD-3.2.1-1 Flexible Hygienic Hose Design
101 Figure SD-3.3.2.2-1 Pump Impeller Configurations
102 Figure SD-3.3.2.2-2 Acceptable Impeller Attachments
103 Figure SD-3.3.2.2-3 Casing Drain Configurations
104 Figure SD-3.3.2.2-4 Casing Drain L/d Ratios
105 SD-3.4 Vessels
Figure SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment
106 Figure SD-3.4.2-1 Nozzle Design
107 Figure SD-3.4.2-2 Side and Bottom Connections
108 Figure SD-3.4.2-3 Sidewall Nozzles
109 Figure SD-3.4.2-4 Vessel Design Tangential Nozzles
Figure SD-3.4.2-5 Typical Nozzle Detail
110 Table SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes
111 Figure SD-3.4.3-1 Accepted Nozzle Penetrations
112 Figure SD-3.4.3-2 Internal Components
113 Figure SD-3.4.6-1 Sight Glass Design (Accepted)
114 SD-3.5 Agitators and Mixers
115 Figure SD-3.5.1-1 Agitator Mounting Flanges
116 Figure SD-3.5.2-1 Shaft Coupling Construction
117 Figure SD-3.5.2-2 Shaft Coupling Seal Arrangements
119 Figure SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs
120 Figure SD-3.5.5-1 Shaft-Steady Bearing
121 SD-3.6 Heat Exchange Equipment
Figure SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount)
122 Figure SD-3.6.2-1 Double Tubesheet Heat Exchanger Bonnet Design
123 SD-3.7 Transfer Panels
124 Figure SD-3.7.1-1 Transfer Panel Looped Headers
125 Figure SD-3.7.2-1 Transfer Panel Tolerances
126 SD-3.8 Filtration Elements and Components
127 Figure SD-3.7.4-1 Transfer Panel Jumpers
129 SD-3.9 Spray Devices
130 Figure SD-3.9.1-1 Dynamic Spray Device: Single Axis
131 Figure SD-3.9.1-2 Two-Axis Dynamic Spray Device
132 Figure SD-3.9.2.1-1 Static Spray Device
Figure SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels
133 SD-3.10 Disposables That Require Presterilization or Poststerilization
SD-3.11 Sampling Systems
Figure SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels
134 SD-3.12 Steam Traps
SD-3.13 Check Valves
Figure SD-3.9.2.3-1 Impact Pattern Buildup
135 SD-3.14 Orifice Plates
SD-3.15 Relief Devices
SD-3.16 Liquid Pressure Regulators
Figure SD-3.12-1 Steam Traps for Clean Steam Systems
136 SD-3.17 Strainers
Figure SD-3.17.1-1 Example Strainer Types
137 SD-3.18 Chromatography Columns
138 SD-4 PROCESS UTILITY SYSTEMS
SD-4.1 Compendial Water Systems
SD-4.2 Clean/Pure Steam Systems
139 Figure SD-4.1.2.1-1 Point-of-Use Piping
140 SD-4.3 Process Gases
Figure SD-4.1.2.2-1 Physical Break in Point-of-Use Piping
141 Figure SD-4.2.2-1 Typical Clean Steam System Isometric
142 SD-4.4 Process Waste Systems
Figure SD-4.2.2-2 Clean Steam Point-of-Use Design
143 SD-5 PROCESS SYSTEMS
SD-5.1 Bioreactors and Fermentors
144 Figure SD-5.1.4.4-1 Gas Sparging Assembly — Lance
145 Figure SD-5.1.4.4-2 Gas Sparging Assembly — Sintered
146 Figure SD-5.1.4.4-3 Gas Sparging Assembly — Ring
147 Figure SD-5.1.4.4-4 Gas Sparging Assembly — Single Orifice
149 Figure SD-5.1.4.7-1 Exhaust Gas Condenser
Figure SD-5.1.4.7-2 Exhaust Gas Heater
150 Figure SD-5.1.4.7-3 Electrically Heat Traced Filter Housing
151 Figure SD-5.1.5-1 Fermentor Sterile Envelope
152 Figure SD-5.1.5-2 Bioreactor Sterile Envelope
153 SD-5.2 Cell Disruptors
154 Figure SD-5.2.1-1 Cell Disruptor Process Flow Schematic Diagram
155 SD-5.3 Centrifuges
157 SD-5.4 Filtration
159 SD-5.5 Chromatography Systems
Figure SD-5.4.5.1-1 Tank/Vessel Vent Fillers
160 SD-5.6 Lyophilizers/Freeze Dryers
161 Figure SD-5.6.4-1 Typical Lyophilizer Component Assembly
165 Figure SD-5.6.5-1 Lyophilizer Sterile Boundary
166 SD-5.7 Solution Preparation Systems
167 SD-6 PROCESS SUPPORT SYSTEMS
SD-6.1 Cabinet Washers
170 SD-6.2 Steam Sterilizers/Autoclaves
171 SD-6.3 CIP Systems
173 Figure SD-6.3.4.1.1-1 Conical Vessel With Reduced Bottom Outlet, or Tulip Tank
174 Figure SD-6.3.4.2-1 CIP Looped Header (Supply or Return)
175 Figure SD-6.3.4.2-2 Zero-Static Chain
Figure SD-6.3.4.2-3 Swing Elbow Arrangement
176 Figure SD-6.3.4.2-4 Mix-Proof Valve Array
177 Table SD-6.3.5.2.1-1 Flow Rates to Achieve 5 ft/sec (1.5 m/s)
178 SD-6.4 Thermal Treatment Systems
179 Figure SD-6.4.1.1-1 Example of HTST Process Flow Schematic Diagram
180 Figure SD-6.4.1.1-2 Example of Direct Steam Injection UHT Process Flow Schematic Diagram
182 Figure SD-6.4.4.5-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing
183 SD-6.5 Immersion Washers
185 Figure SD-6.5.4.2-1 Immersion Tank Side Nozzle Design
186 SD-6.6 Isolator Systems
190 SD-7 DESIGN CONFORMANCE TESTING
SD-7.1 Spray Device Coverage Test
191 SD-7.2 Cleaning, Steaming, and Bioburden Control Testing
SD-7.3 Fluid Requirements for Leak Testing
SD-7.4 Vessel Drainability Test
192 CHAPTER 5 PROCESS COMPONENTS FOR MULTIUSE
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-4.2 Nonstandard Fitting Dimensions
193 DT-4.3 Special Angle Fittings Dimensions
DT-4.4 Valve Dimensions
DT-4.5 Filter Dimensions
DT-4.6 Tube Dimensions
DT-5 MATERIALS
DT-6 TESTS
DT-7 TOLERANCES
DT-7.1 Fitting and Process Component Tolerances
DT-7.2 Tubing Tolerances
DT-7.3 Transfer Panel Nozzle and Jumper Tolerances
DT-8 WELD ENDS
DT-9 HYGIENIC CLAMP UNIONS
DT-9.1 Typical Hygienic Clamp Unions
194 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
195 DT-11 MARKING
DT-11.1 Fittings, Valves, and Instrumentation Marking Information
DT-11.2 Modified Surfaces
DT-12 PACKAGING
Table DT-2-1 Metallic Fittings: Rated Internal Working Pressure
196 Table DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components, Excluding Tube
197 Table DT-3-2 Final Tolerances for Electropolished Fittings and Process Components, Excluding Tube
Table DT-4-1 Nominal O.D. Tubing Sizes
198 Table DT-4.1-1 Tangent Lengths
Table DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow
199 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
200 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
201 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
202 Table DT-4.1.1-8 Hygienic Clamp Joint: 180-deg Return Bend
Table DT-4.1.1-9 Automatic Tube Weld: 88-deg Elbow
203 Table DT-4.1.1-1 Automatic Tube Weld: 92-deg Elbow
Table DT-4.1.2-1 Automatic Tube Weld: Straight Tee and Cross
204 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
205 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
206 Table DT-4.1.2-6 Automatic Tube Weld: Reducing Tee
207 Table DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee
208 Table DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee
209 Table DT-4.1.2-9 Hygienic Clamp Joint: Short-Outlet Reducing Tee
Table DT-4.1.2-10 Automatic Tube Weld: Instrument Tee
210 Table DT-4.1.2-11 Hygienic Clamp Joint: Instrument Tee
Table DT-4.1.2-12 Automatic Tube Weld: Standard Outlet Hygienic Clamp Joint Tee
211 Table DT-4.1.2-13 Automatic Tube Weld: Standard Outlet Hygienic Clamp Joint Reducing Tee
212 Table DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer
213 Table DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
214 Table DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer
215 Table DT-4.1.4-1 Automatic Tube Weld: Ferrule
Table DT-4.1.5-1 Automatic Tube Weld: Cap
216 Table DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap
217 Table DT-4.4.1-1 Hygienic Clamp Joint: Two-Way, Weir-Style Diaphragm Valve
218 Table DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed
219 Table DT-4.5.2-1 Tapered Locking Tab Retainer: External
220 Table DT-7.1-1 Metallic Hygienic Clamp Ferrule Standard Dimensions and Tolerances
223 Table DT-7.1-2 Polymeric Hygienic Clamp Ferrule Standard Dimensions and Tolerances
226 Table DT-7.3-1 Transfer Panel and Jumper Tolerances
227 Table DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria
228 Figure DT-9.4-1 Clamp Conditions at Installation
229 Table DT-11.1.1-1 Minimum Required Marking Information
230 PART PI PROCESS INSTRUMENTATION FOR MULTIUSE
PI-1 PURPOSE AND SCOPE
PI-2 PROCESS INSTRUMENTATION GENERAL REQUIREMENTS
PI-2.1 General Considerations
PI-2.2 Instrumentation Categories
231 Figure PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples
232 Figure PI-2.2.2-1 Accepted Insertion Device Installation Examples
233 PI-3 INSTRUMENT RECEIVING, HANDLING, AND STORAGE
PI-3.1 Introduction
PI-3.2 Instrument Receiving
PI-3.3 Instrument Handling: Protection of Process Connections and Surface Finish
PI-3.4 Instrument Storage
PI-4 FLOWMETERS
PI-4.1 Coriolis Flowmeter
234 Figure PI-4.1.3.2-1 Manifold or Flow Splitter for Dual-Tube Construction Flowmeters and Potential for Product Holdup
Figure PI-4.1.3.3-1 Concentrically Reducing Process Connection
236 PI-4.2 Turbine Flowmeter
Figure PI-4.1.4.3-1 Vertical Installation
Figure PI-4.1.4.4-1 Minimum Angle of Inclination, α
237 Figure PI-4.2.2-1 Typical Turbine Flowmeters
238 PI-5 LEVEL INSTRUMENTS
PI-5.1 Radar Level Instruments
239 PI-6 PRESSURE INSTRUMENTS
PI-6.1 Pressure Sensors
Figure PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna
240 Figure PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location
241 Figure PI-6.1.2-1 Accepted Orientation and Flow
242 PI-7 TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS
PI-7.1 General
PI-7.2 Components
PI-7.3 Installation
Figure PI-7.3-1 Typical Installation Styles
243 Figure PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions
244 Figure PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions
245 Figure PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations
246 Figure PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations
247 PI-7.4 Performance
PI-7.5 Selection
PI-7.6 Sensor Calibration Verification
PI-8 ANALYTICAL INSTRUMENTS
PI-8.1 Conductivity
248 Figure PI-8.1.2-1 Conductivity Sensor Components
249 Figure PI-8.1.3.2-1 Acceptable Orientations for Conductivity Sensors
Figure PI-8.1.3.4-1 Installation Clearance Requirements
250 PI-8.2 pH Sensors
Figure PI-8.2.2-1 pH Sensor Components
251 PI-9 OPTICAL
PI-9.1 Optical Devices
Figure PI-8.2.3.3-1 Accepted Mounting Orientations
253 Figure PI-9.1.3.2-1 Vessel Light Glass Design and Mounting
254 Figure PI-9.1.3.4-1 In-Line Insertion Length
Figure PI-9.1.3.4-2 Insertion Probe Length
255 PART MC COMPONENTS FOR MULTIUSE
MC-1 PURPOSE AND SCOPE
MC-2 SEALING COMPONENT TYPES
MC-2.1 General
MC-2.2 Static Seals
256 Figure MC-2.2.2-1 Hygienic Union per Table DT-7.1-1
Figure MC-2.2.2-2 Hygienic Clamp Union per Table DT-7.1-1
257 Figure MC-2.2.2-3 Hygienic Union per DIN 11864
Figure MC-2.2.2-4 Hygienic Clamp Union per DIN 11864
258 Figure MC-2.2.2-5 Nonhygienic Connections
259 MC-2.3 Dynamic Seals
260 Figure MC-2.3.1.2-1 Weir Valves
Figure MC-2.3.1.2-2 Radial Valves
261 Figure MC-2.3.1.2-3 Weirless Diaphragm Valve
Figure MC-2.3.1.2-4 Linear Control Valves
262 Figure MC-2.3.1.2-5 Regulator Valve
Figure MC-2.3.1.3-1 Ball Valves
263 Figure MC-2.3.1.4-1 Rising Stem Single, Double-Seat Mix-Proof, and Needle Valves
Figure MC-2.3.1.5-1 Butterfly Valve
Figure MC-2.3.1.7-1 Back Pressure Control Valve
264 Figure MC-2.3.1.8-1 Pinch Valve
265 Figure MC-2.3.1.9-1 Pressure Relief and Check Valves
266 Figure MC-2.3.1.10-1 Plug Valve
267 Figure MC-2.3.2.2-1 Single Mechanical Seal
Figure MC-2.3.2.2-2 Single Seal for Top-Entry Agitator
Figure MC-2.3.2.3-1 Dual Mechanical Seal–Pressurized for Pumps
Figure MC-2.3.2.3-2 Dual Mechanical Seal–Pressurized for Top-Entry Agitator
268 Figure MC-2.3.2.3-3 Dual Mechanical Seal–Unpressurized for Pumps
269 Figure MC-2.3.2.4-1 Flush Plan 01
Figure MC-2.3.2.4-2 Flush Plan 02
Figure MC-2.3.2.4-3 Flush Plan 03
270 Figure MC-2.3.2.4-4 Flush Plan 11
Figure MC-2.3.2.4-5 Flush Plan 32
Figure MC-2.3.2.4-6 Flush Plan 52 for Pump
271 Figure MC-2.3.2.4-7 Flush Plan 52 for Top-Entry Agitator
Figure MC-2.3.2.4-8 Flush Plan BPE52 for Pump
Figure MC-2.3.2.4-9 Flush Plan 53 for Pump
Figure MC-2.3.2.4-10 Flush Plan 53 for Top-Entry Agitator
272 Figure MC-2.3.2.4-11 Flush Plan 54 for Pump
Figure MC-2.3.2.4-12 Flush Plan 54 for Top-Entry Agitator
Figure MC-2.3.2.4-13 Flush Plan 55 for Pump
Figure MC-2.3.2.4-14 Flush Plan 55 for Top-Entry Agitator
273 MC-3 SEALING COMPONENTS GENERAL DESIGN REQUIREMENTS (GENERAL PROVISIONS)
MC-3.1 Process Conditions
MC-3.2 System Requirements
MC-3.3 Seal Construction
Figure MC-2.3.2.4-15 Flush Plan 74 for Pump
Figure MC-2.3.2.4-16 Flush Plan 74 for Top-Entry Agitator
275 Figure MC-3.3.2.2-1 Examples of Static O-Ring Grooves
277 Figure MC-3.3.2.3-1 Seals for Rising Stem Valves
278 MC-3.4 Conformance Requirements for Sealing Elements
279 MC-3.5 Seal Identification
MC-3.6 Other Seal Requirements
MC-4 SEAL PERFORMANCE REQUIREMENTS
MC-4.1 General Requirements
MC-4.2 Static Seal Performance
280 MC-4.3 Dynamic Seal Performance
Figure MC-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion
281 MC-5 SEAL APPLICATIONS
MC-5.1 General Considerations
282 MC-5.2 Process Systems
MC-5.3 Compendial Ambient/Hot-Water Distribution Systems
MC-5.4 Pure Steam Distribution Systems
283 MC-5.5 CIP
284 CHAPTER 6 FABRICATION, ASSEMBLY, AND ERECTION FOR MULTIUSE
PART MJ MATERIALS JOINING FOR MULTIUSE
MJ-1 PURPOSE AND SCOPE
MJ-2 MATERIALS
MJ-2.1 Base Metals
MJ-2.2 Filler Metals
285 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
286 Figure MJ-3.2-1 Unacceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations
287 Figure MJ-3.2-2 Acceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations
288 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
289 MJ-6.4 Brazing
MJ-7 EXAMINATION, INSPECTION, AND TESTING
MJ-7.1 Examination Procedures
MJ-7.2 Personnel Requirements
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
290 MJ-7.3 Examination, Inspection, and Testing Requirements
MJ-7.4 Records
MJ-8 ACCEPTANCE CRITERIA
MJ-8.1 General
291 MJ-8.2 Pressure Vessel and Tank Welds
MJ-8.3 Piping Welds
MJ-8.4 Tubing Welds
MJ-8.5 Tube-Attachment Welds
MJ-8.6 Brazed Joints
MJ-9 JOINING OF POLYMERIC MATERIALS
MJ-9.1 General
MJ-9.2 Weld Joint Design and Preparation
292 Table MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks
294 Table MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe
296 Table MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints
298 Figure MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube-to-Tube Butt Joints
299 Figure MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Electropolished UNS S31603 Tubing
300 Figure MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically Polished UNS S31603 Tubing
301 Figure 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
302 Table MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds
304 MJ-9.3 Joining Processes and Procedures
MJ-9.4 Procedure Qualifications
MJ-9.5 Performance Qualifications
Figure MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds
305 MJ-9.6 Examination, Inspection, and Testing
MJ-9.7 Weld Acceptance Criteria
MJ-9.8 Documentation Requirements
306 MJ-10 DOCUMENTATION REQUIREMENTS
MJ-11 PASSIVATION
Table MJ-9.7.1-1 Visual Examination Acceptance Criteria for Polymeric Pipe Beadless Welds
307 Figure MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds
308 PART SF PROCESS CONTACT SURFACE FINISHES FOR MULTIUSE
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
309 SF-2.4 Surface Condition
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
310 SF-2.5 Electropolishing Procedure Qualification
SF-2.6 Passivation Procedure
SF-2.7 Normative References
SF-2.8 Rouge and Stainless Steel
Table SF-2.4.1-1 Ra Readings for Metallic Process Contact Surfaces
311 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
Table SF-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes
312 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
313 CHAPTER 7 DESIGN FOR SINGLE-USE
PART SU SYSTEMS DESIGN FOR SINGLE-USE
SU-1 GENERAL
SU-2 GENERAL GUIDELINES
SU-3 INTEGRITY
SU-3.1 Maintenance of Integrity
SU-3.2 Common Leak Test Methods
SU-4 BIOCOMPATIBILITY
SU-5 EXTRACTABLES AND LEACHABLES
SU-5.1 General
314 SU-6 IDENTIFICATION
SU-6.1 Labeling
SU-7 CERTIFICATE OF CONFORMANCE
SU-8 INSPECTION AND PACKAGING
SU-8.1 Inspection
SU-8.2 Packaging
SU-9 STERILIZATION (BIOBURDEN CONTROL)
SU-9.1 Gamma Irradiation
SU-10 SHELF LIFE, STORAGE, AND EXPIRATION DATE
315 SU-11 PARTICULATES
SU-11.1 General
SU-11.2 Particulate-Monitoring Program
SU-11.3 Mitigation Techniques
316 CHAPTER 8 PROCESS COMPONENTS FOR SINGLE-USE
PART SC COMPONENTS FOR SINGLE-USE
SC-1 STEAM-THROUGH AND STEAM-TO CONNECTORS
SC-2 ASEPTIC CONNECTORS
SC-2.1 Manufacturer Responsibilities
SC-2.2 Owner/User Responsibilities
SC-3 FLEXIBLE BIOPROCESS CONTAINERS (BAGS)
317 SC-3.1 Materials
SC-3.2 Qualifications
SC-4 POLYMERIC HYGIENIC UNIONS
318 CHAPTER 9 FABRICATION, ASSEMBLY, AND ERECTION FOR SINGLE-USE
PART SJ JOINING METHODS FOR SINGLE-USE
SJ-1 GENERAL
SJ-2 MECHANICAL HOSE BARB CONNECTIONS
SJ-2.1 Operating Conditions
SJ-2.2 Assembly
SJ-2.3 Qualification
SJ-3 THERMAL WELDING OF THERMOPLASTIC ELASTOMER TUBING
SJ-3.1 Specifications
SJ-3.2 Design Parameters
319 SJ-3.3 Acceptance Criteria
320 MANDATORY APPENDICES
MANDATORY APPENDIX I SUBMITTAL OF TECHNICAL INQUIRIES TO THE BIOPROCESSING EQUIPMENT (BPE) COMMITTEE
321 Table II-1 Standard Units
MANDATORY APPENDIX II STANDARD UNITS
322 MANDATORY APPENDIX III SINGLE-USE COMPONENTS AND ASSEMBLIES
323 MANDATORY APPENDIX IV NOMENCLATURE
325 NONMANDATORY APPENDICES
NONMANDATORY APPENDIX A COMMENTARY: SLAG AND OXIDE ISLANDS
326 NONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION/INSPECTION DOCUMENTATION
327 Forms
Form MEL-1 Material Examination Log
328 Form MER-1 Material Examination Record
329 Form WEL-1 Weld and Examination/Inspection Log
330 NONMANDATORY APPENDIX C SLOPE MEASUREMENT AND JOINT MISALIGNMENT
C-1 GENERAL
C-2 JOINT MISALIGNMENT
331 NONMANDATORY APPENDIX D ROUGE AND STAINLESS STEEL
D-1 GENERAL
D-2 CONSIDERATIONS FOR REDUCING ROUGE FORMATION
D-3 EVALUATION METHODS TO MEASURE ROUGE
D-4 METHODS TO REMEDIATE THE PRESENCE OF ROUGE IN A SYSTEM
333 Table D-2-1 Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System
334 Table D-2-2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System
335 Table D-3.1-1 Process Fluid Analyses for the Identification of Mobile Constituents of Rouge
336 Table D-3.2-1 Solid Surface Analyses for the Identification of Surface Layers Composition
337 Table D-4.1-1 Rouge Remediation Processes Summary
339 NONMANDATORY APPENDIX E PASSIVATION PROCEDURE QUALIFICATION
E-1 GENERAL
E-2 PURPOSE OF PASSIVATION TREATMENTS
340 Table E-3.2-1 Minimum Surface Requirements for Process Qualification Samples
E-3 PASSIVATION PROCEDURE (SEE SF-2.6)
E-4 PASSIVATION QUALITY CONTROL
341 Table E-3.2-2 Passivation Processes
342 E-5 EVALUATION OF CLEANED AND PASSIVATED SURFACES
343 Table E-5-1 Test Matrix for Evaluation of Cleaned and Passivated Surfaces
347 NONMANDATORY APPENDIX F CORROSION TESTING
F-1 GENERAL
F-2 CORROSION TESTS
F-3 PITTING RESISTANCE EQUIVALENT (PRE) NUMBER
348 Table F-1-1 ASTM Corrosion Tests
349 Table F-3-1 PRE Numbers for Stainless Steels per Table MM-2.1-1 and for Nickel Alloys per Table MM-2.1-2
350 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
351 NONMANDATORY APPENDIX H ELECTROPOLISHING PROCEDURE QUALIFICATION
H-1 SCOPE
H-2 PURPOSE
H-3 ELECTROPOLISH PROCEDURE QUALIFICATION
352 Table H-3.3-1 Minimum Surface Requirements for Process Qualification Samples
353 NONMANDATORY APPENDIX J VENDOR DOCUMENTATION REQUIREMENTS FOR NEW INSTRUMENTS
J-1 OVERVIEW
J-2 INSTRUCTIONS FOR USE
354 Table J-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions
355 Table J-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents
356 NONMANDATORY APPENDIX K STANDARD PROCESS TEST CONDITIONS (SPTC) FOR SEAL PERFORMANCE EVALUATION
K-1 SEALING COMPONENT PERFORMANCE EVALUATION
358 Figure K-1.3.2.1-1 Weir-Style Diaphragm
361 Figure K-1.3.2.1-2 Weir-Style Body
Figure K-1.3.2.1-3 Radial-Style Body
362 Figure K-1.3.2.1-4 Manual Bonnet
Figure K-1.3.2.1-5 Pneumatic
K-2 MECHANICAL SEAL PERFORMANCE EVALUATION
366 NONMANDATORY APPENDIX L STANDARD TEST METHODS FOR POLYMERS
L-1 STANDARD TEST METHODS FOR THERMOPLASTIC POLYMERS
L-2 STANDARD TEST METHODS FOR THERMOSET POLYMERS
L-3 THERMOSET POLYMER TEST PROPERTIES
L-4 INTERPRETATION OF THERMOSET MATERIAL PROPERTY CHANGES
L-5 TESTING PROTOCOLS FOR THERMOSET POLYMERS
367 Table L-3-1 Thermoset Polymer Test Properties
368 Table L-4-1 Interpretation of Thermoset Material Property Changes
369 NONMANDATORY APPENDIX M SPRAY DEVICE COVERAGE TESTING
M-1 SCOPE
M-2 PURPOSE
M-3 MATERIALS
M-4 PROCEDURE
370 M-5 ACCEPTANCE CRITERIA
M-6 RECOMMENDED DOCUMENTATION
371 NONMANDATORY APPENDIX N COMMENTARY: UNS S31603 WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA
372 NONMANDATORY APPENDIX O GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS
O-1 GENERAL
O-2 PARTICULATES
373 NONMANDATORY APPENDIX P GENERAL BACKGROUND/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES
P-1 REFERENCES
374 P-2 RECOMMENDED CONDITIONS FOR A POLYMERIC MATERIAL-SPECIFIC EXTRACTION
P-3 RECOMMENDED CONDITIONS FOR AN EXTRACTION STUDY IN BIOPROCESS MODEL SOLUTIONS
P-4 OVERVIEW OF BIOPROCESSING EQUIPMENT/COMPONENT EVALUATION RELATED TO EXTRACTABLES AND LEACHABLES CHARACTERIZATION
375 Figure P-4-1 Flowchart of Bioprocessing Equipment/Component Evaluation Related to Extractables and Leachables Characterization
376 NONMANDATORY APPENDIX Q TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS
Q-1 GENERAL
Q-2 EXTERNAL SUPPORT COMPONENTS
Q-3 MEASUREMENT ACCURACY
377 Q-4 SELECTION
Q-5 MAINTENANCE
378 NONMANDATORY APPENDIX R INSTRUMENT RECEIVING, HANDLING, AND STORAGE
R-1 INTRODUCTION
R-2 INSTRUMENT RECEIVING
R-3 INSTRUMENT HANDLING
R-4 STORAGE
379 NONMANDATORY APPENDIX S APPLICATION DATA SHEET
380 Form S-1 Application Data Sheet
381 NONMANDATORY APPENDIX T GUIDANCE ON POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS AND FILTRATION
T-1 CHROMATOGRAPHY COLUMNS
T-2 FILTRATION
384 NONMANDATORY APPENDIX U GUIDANCE FOR THE USE OF U.S. CUSTOMARY AND SI UNITS
U-2 GUIDELINES USED TO DEVELOP SI EQUIVALENTS
385 U-3 CHECKING EQUATIONS
U-4 SOFT CONVERSION FACTORS
386 NONMANDATORY APPENDIX W POSITIVE MATERIAL IDENTIFICATION
W-1 GENERAL
W-2 GENERAL REQUIREMENTS
387 W-3 CALIBRATION
W-4 PROCEDURE
W-5 PERSONNEL TRAINING AND QUALIFICATION
W-6 ACCEPTANCE/REJECTION
W-7 PMI REFEREE METHODS
W-8 PMI SPECIAL CONDITIONS
389 NONMANDATORY APPENDIX Y PROCUREMENT SOURCES
390 NONMANDATORY APPENDIX Z QUALITY MANAGEMENT SYSTEM
Z-1 SCOPE AND PURPOSE
Z-2 GENERAL
Z-3 QUALITY MANAGEMENT SYSTEM MANUAL
394 NONMANDATORY APPENDIX AA STATIC SEALS APPLICATION GUIDE FOR COMPENDIAL WATER SYSTEMS
AA-1 GENERAL
AA-2 MATERIAL CLASS DESCRIPTIONS
395 Table AA-1-1 Static Seals for Use in Compendial Water Systems (MC-2.2.1)
397 Figure BB-1-1 Mechanical Seal Face Material Selection for Compendial Water Pumps
NONMANDATORY APPENDIX BB MECHANICAL SEAL FACE MATERIAL SELECTION FOR COMPENDIAL WATER PUMPS
BB-1 GENERAL
399 NONMANDATORY APPENDIX CC EXAMINATION, INSPECTION, AND TESTING CROSS-REFERENCES
402 NONMANDATORY APPENDIX DD CONDUCTIVITY SENSOR SELECTION GUIDE
DD-1 PURPOSE
DD-2 GENERAL CONSIDERATIONS OF COMMON SENSOR TECHNOLOGIES
403 Figure DD-2.1.1-1 Conductivity Scale
Table DD-2.6-1 Technological Considerations
404 NONMANDATORY APPENDIX EE VESSEL FLANGE, AGITATOR, AND MECHANICAL SEAL DESIGN FOR BOTTOM-MOUNT AGITATORS
EE-1 PURPOSE
EE-2 SCOPE
EE-3 COMPONENT DESIGN
405 Figure EE-3-1 Direct-Mount Agitator
406 Figure EE-3-2 Pedestal-Mount Agitator
407 Figure EE-3.1-1 Registered Fit to Ensure Concentricity: Seal Housing-to-Drive Pilot
408 Figure EE-3.2-1 Dual Mechanical Seal Assembly
409 Figure EE-3.2-2 Seal Assembly to Flange O-Ring Detail
410 Table EE-3.3-1 Vessel Flange Bore per Shaft Diameter
411 Figure EE-3.3-1 Vessel Flange With Piloted Bore
412 Figure EE-3.3-2 Vessel Flange Tolerance Parameters
413 Table EE-3.3-2 Vessel Flange Fabrication Tolerance Guidelines
414 NONMANDATORY APPENDIX FF LEAK TEST METHODS FOR SINGLE-USE COMPONENTS AND ASSEMBLIES
415 Table FF-1 Leak Test, Nondestructive Methods
417 Table FF-2 Leak Test, Destructive Methods
419 Figure GG-1.2-1 Typical Polymeric Single-Use Hose Barb Featuring Mono-Barb Design
NONMANDATORY APPENDIX GG SINGLE-USE MECHANICAL HOSE BARB DESIGN RECOMMENDATIONS
GG-1 TERMINOLOGY
420 Table GG-2-1 Typical Retention Devices by Tubing Type and Operating Pressure
GG-2 DESIGN GUIDANCE
421 INDEX  

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