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ASME BPE 2022

ASME BPE 2022

$75.42

ASME BPE-2022 – Bioprocessing Equipment

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ASME 2022
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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
4 CONTENTS
14 FOREWORD
16 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
17 ASME BIOPROCESSING EQUIPMENT COMMITTEE
22 CORRESPONDENCE WITH THE BPE COMMITTEE
24 ASME BPE-2022 SUMMARY OF CHANGES
36 CHAPTER 1 INTRODUCTION, SCOPE, AND GENERAL REQUIREMENTS
PART GR GENERAL REQUIREMENTS
GR-1 INTRODUCTION
GR-2 SCOPE OF THE ASME BPE STANDARD
37 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
38 Tables
Table GR-4.2-1 Quality Inspector’s Delegate Capabilities
41 GR-4.3 Responsibilities
GR-4.4 Access for Inspectors
GR-5 DOCUMENTATION
GR-5.1 General
GR-5.2 Document Requirements
42 GR-5.3 Material Test Reports/Certificates of Conformance
43 GR-5.4 Weld and Examination/Inspection Log
GR-5.5 Records Retention
GR-6 U.S. CUSTOMARY AND SI UNITS
GR-7 REFERENCES
45 GR-8 TERMS AND DEFINITIONS
54 GR-9 NOMENCLATURE
55 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
56 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
58 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
59 Table MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %)
60 Table MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %)
61 Table MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations
62 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)
63 MM-4.3 Castings
MM-4.4 Forgings
MM-4.5 Plate, Sheet, and Strip
MM-4.6 Shapes, Rods, and Bars
64 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
65 MM-5.3 Filler Materials
Table MM-5.2.5-1 Materials for OEM Equipment
66 Table MM-5.3-1 Filler Metals for Austenitic Stainless Steels
68 Table MM-5.3-2 Filler Metals for Superaustenitic Stainless Steels
69 Table MM-5.3-3 Filler Metals for Duplex Stainless Steels
70 Table MM-5.3-4 Filler Metals for Nickel Alloys
71 Table MM-5.3-5 Consumable Inserts for Superaustenitic and Duplex Stainless Steels
72 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
73 Table MM-5.3.4-1 Brazing Filler Metals for Copper
74 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
76 PART PM POLYMERIC AND OTHER NONMETALLIC MATERIALS
PM-1 PURPOSE AND SCOPE
PM-2 MATERIALS
PM-2.1 Materials of Construction
77 Table PM-2.1.1-1 Common Thermoplastic Polymers and Applications
Table PM-2.1.2-1 Common Thermoset Polymers and Applications
78 PM-2.2 General Requirements
Table PM-2.1.3-1 Examples of Nonmetallics
79 Table PM-2.2.1-1 Content Required on the Certificate of Conformance
80 Table PM-2.2.3.2-1 Change Levels and Minimum Change Notification Requirements
81 PM-3 PROPERTIES AND PERFORMANCE
PM-3.1 Biocompatibility
PM-3.2 Extractables and Leachables
82 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
83 PM-3.9 Polymeric Surface Finish
PM-4 APPLICATIONS
PM-4.1 Single-Use Components and Assemblies
PM-4.2 Piping
84 Table PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards
85 PM-4.3 Hose Assemblies
86 PM-4.4 Polymeric Hygienic Unions
87 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
88 SD-2.4 Fabrication
90 Table SD-2.4.3.1-1 Slope Designations for Drainable Lines
91 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
92 Figure SD-3.1.1-1 Flat Gasket Applications
93 Table SD-3.1.2.2-1 L/d Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With Blind Cap
94 Table SD-3.1.2.2-2 L/d Dimensions for Flow-Through Tee: Short-Outlet Reducing Tee With Blind Cap
96 Figure SD-3.1.2.2-1 Accepted Point-of-Use Designs
97 Figure SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly
98 SD-3.2 Hose Assemblies
99 SD-3.3 Pumps
Figure SD-3.2.1-1 Flexible Hygienic Hose Design
100 Figure SD-3.3.2.2-1 Pump Impeller Configurations
101 Figure SD-3.3.2.2-2 Acceptable Impeller Attachments
102 Figure SD-3.3.2.2-3 Casing Drain Configurations
103 Figure SD-3.3.2.2-4 Casing Drain L/d Ratios
104 SD-3.4 Vessels
Figure SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment
105 Figure SD-3.4.2-1 Nozzle Design
106 Figure SD-3.4.2-2 Side and Bottom Connections
107 Figure SD-3.4.2-3 Sidewall Nozzles
108 Figure SD-3.4.2-4 Vessel Design Tangential Nozzles
Figure SD-3.4.2-5 Typical Nozzle Detail
109 Table SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes
110 Figure SD-3.4.3-1 Accepted Nozzle Penetrations
111 Figure SD-3.4.3-2 Internal Components
112 Figure SD-3.4.6-1 Sight Glass Design (Accepted)
113 SD-3.5 Agitators and Mixers
114 Figure SD-3.5.1-1 Agitator Mounting Flanges
115 Figure SD-3.5.2-1 Shaft Coupling Construction
116 Figure SD-3.5.2-2 Shaft Coupling Seal Arrangements
118 Figure SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs
119 Figure SD-3.5.5-1 Shaft-Steady Bearing
120 SD-3.6 Heat Exchange Equipment
Figure SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount)
121 Figure SD-3.6.2-1 Double Tubesheet Heat Exchanger Bonnet Design
122 SD-3.7 Transfer Panels
123 Figure SD-3.7.1-1 Transfer Panel Looped Headers
124 Figure SD-3.7.2-1 Transfer Panel Tolerances
125 SD-3.8 Filtration Elements and Components
126 Figure SD-3.7.4-1 Transfer Panel Jumpers
128 SD-3.9 Spray Devices
129 Figure SD-3.9.1-1 Dynamic Spray Device: Single Axis
130 Figure SD-3.9.1-2 Two-Axis Dynamic Spray Device
131 Figure SD-3.9.2.1-1 Static Spray Device
Figure SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels
132 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
133 SD-3.12 Steam Traps
SD-3.13 Check Valves
Figure SD-3.9.2.3-1 Impact Pattern Buildup
134 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
135 SD-3.17 Strainers
Figure SD-3.17.1-1 Example Strainer Types
136 SD-3.18 Chromatography Columns
137 SD-4 PROCESS UTILITY SYSTEMS
SD-4.1 Compendial Water Systems
SD-4.2 Clean/Pure Steam Systems
138 Figure SD-4.1.2.1-1 Point-of-Use Piping
139 SD-4.3 Process Gases
Figure SD-4.1.2.2-1 Physical Break in Point-of-Use Piping
140 Figure SD-4.2.2-1 Typical Clean Steam System Isometric
141 SD-4.4 Process Waste Systems
Figure SD-4.2.2-2 Clean Steam Point-of-Use Design
142 SD-5 PROCESS SYSTEMS
SD-5.1 Bioreactors and Fermentors
143 Figure SD-5.1.4.4-1 Gas Sparging Assembly — Lance
144 Figure SD-5.1.4.4-2 Gas Sparging Assembly — Sintered
145 Figure SD-5.1.4.4-3 Gas Sparging Assembly — Ring
146 Figure SD-5.1.4.4-4 Gas Sparging Assembly — Single Orifice
148 Figure SD-5.1.4.7-1 Exhaust Gas Condenser
Figure SD-5.1.4.7-2 Exhaust Gas Heater
149 Figure SD-5.1.4.7-3 Electrically Heat Traced Filter Housing
150 Figure SD-5.1.5-1 Fermentor Sterile Envelope
151 Figure SD-5.1.5-2 Bioreactor Sterile Envelope
152 SD-5.2 Cell Disruptors
153 Figure SD-5.2.1-1 Cell Disruptor Process Flow Schematic Diagram
154 SD-5.3 Centrifuges
156 SD-5.4 Filtration
158 SD-5.5 Chromatography Systems
Figure SD-5.4.5.1-1 Tank/Vessel Vent Fillers
159 SD-5.6 Lyophilizers/Freeze Dryers
160 Figure SD-5.6.4-1 Typical Lyophilizer Component Assembly
164 Figure SD-5.6.5-1 Lyophilizer Sterile Boundary
165 SD-5.7 Solution Preparation Systems
166 SD-6 PROCESS SUPPORT SYSTEMS
SD-6.1 Cabinet Washers
169 SD-6.2 Steam Sterilizers/Autoclaves
170 SD-6.3 CIP Systems
172 Figure SD-6.3.4.1.1-1 Conical Vessel With Reduced Bottom Outlet, or Tulip Tank
173 Figure SD-6.3.4.2-1 CIP Looped Header (Supply or Return)
174 Figure SD-6.3.4.2-2 Zero-Static Chain
Figure SD-6.3.4.2-3 Swing Elbow Arrangement
175 Figure SD-6.3.4.2-4 Mix-Proof Valve Array
176 Table SD-6.3.5.2.1-1 Flow Rates to Achieve 5 ft/sec (1.5 m/s)
177 SD-6.4 Thermal Treatment Systems
178 Figure SD-6.4.1.1-1 Example of HTST Process Flow Schematic Diagram
179 Figure SD-6.4.1.1-2 Example of Direct Steam Injection UHT Process Flow Schematic Diagram
181 Figure SD-6.4.4.5-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing
182 SD-6.5 Immersion Washers
184 Figure SD-6.5.4.2-1 Immersion Tank Side Nozzle Design
185 SD-6.6 Isolator Systems
189 SD-7 DESIGN CONFORMANCE TESTING
SD-7.1 Spray Device Coverage Test
190 SD-7.2 Cleaning, Steaming, and Bioburden Control Testing
SD-7.3 Fluid Requirements for Leak Testing
SD-7.4 Vessel Drainability Test
191 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
192 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
193 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
194 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
195 Table DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components, Excluding Tube
196 Table DT-3-2 Final Tolerances for Electropolished Fittings and Process Components, Excluding Tube
Table DT-4-1 Nominal O.D. Tubing Sizes
197 Table DT-4.1-1 Tangent Lengths
Table DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow
198 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
199 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
200 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
201 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
202 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
203 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
204 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
205 Table DT-4.1.2-6 Automatic Tube Weld: Reducing Tee
206 Table DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee
207 Table DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee
208 Table DT-4.1.2-9 Hygienic Clamp Joint: Short-Outlet Reducing Tee
Table DT-4.1.2-10 Automatic Tube Weld: Instrument Tee
209 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
210 Table DT-4.1.2-13 Automatic Tube Weld: Standard Outlet Hygienic Clamp Joint Reducing Tee
211 Table DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer
212 Table DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
213 Table DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer
214 Table DT-4.1.4-1 Automatic Tube Weld: Ferrule
Table DT-4.1.5-1 Automatic Tube Weld: Cap
215 Table DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap
216 Table DT-4.4.1-1 Hygienic Clamp Joint: Two-Way, Weir-Style Diaphragm Valve
217 Table DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed
218 Table DT-4.5.2-1 Tapered Locking Tab Retainer: External
219 Table DT-7.1-1 Metallic Hygienic Clamp Ferrule Standard Dimensions and Tolerances
222 Table DT-7.1-2 Polymeric Hygienic Clamp Ferrule Standard Dimensions and Tolerances
225 Table DT-7.3-1 Transfer Panel and Jumper Tolerances
226 Table DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria
227 Figure DT-9.4-1 Clamp Conditions at Installation
228 Table DT-11.1.1-1 Minimum Required Marking Information
229 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
230 Figure PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples
231 Figure PI-2.2.2-1 Accepted Insertion Device Installation Examples
232 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
233 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
235 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
236 Figure PI-4.2.2-1 Typical Turbine Flowmeters
237 PI-5 LEVEL INSTRUMENTS
PI-5.1 Radar Level Instruments
238 PI-6 PRESSURE INSTRUMENTS
PI-6.1 Pressure Sensors
Figure PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna
239 Figure PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location
240 Figure PI-6.1.2-1 Accepted Orientation and Flow
241 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
242 Figure PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions
243 Figure PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions
244 Figure PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations
245 Figure PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations
246 PI-7.4 Performance
PI-7.5 Selection
PI-7.6 Sensor Calibration Verification
PI-8 ANALYTICAL INSTRUMENTS
PI-8.1 Conductivity
247 Figure PI-8.1.2-1 Conductivity Sensor Components
248 Figure PI-8.1.3.2-1 Acceptable Orientations for Conductivity Sensors
Figure PI-8.1.3.4-1 Installation Clearance Requirements
249 PI-8.2 pH Sensors
Figure PI-8.2.2-1 pH Sensor Components
250 PI-9 OPTICAL
PI-9.1 Optical Devices
Figure PI-8.2.3.3-1 Accepted Mounting Orientations
252 Figure PI-9.1.3.2-1 Vessel Light Glass Design and Mounting
253 Figure PI-9.1.3.4-1 In-Line Insertion Length
Figure PI-9.1.3.4-2 Insertion Probe Length
254 PART MC COMPONENTS FOR MULTIUSE
MC-1 PURPOSE AND SCOPE
MC-2 SEALING COMPONENT TYPES
MC-2.1 General
MC-2.2 Static Seals
255 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
256 Figure MC-2.2.2-3 Hygienic Union per DIN 11864
Figure MC-2.2.2-4 Hygienic Clamp Union per DIN 11864
257 Figure MC-2.2.2-5 Nonhygienic Connections
258 MC-2.3 Dynamic Seals
259 Figure MC-2.3.1.2-1 Weir Valves
Figure MC-2.3.1.2-2 Radial Valves
260 Figure MC-2.3.1.2-3 Weirless Diaphragm Valve
Figure MC-2.3.1.2-4 Linear Control Valves
261 Figure MC-2.3.1.2-5 Regulator Valve
Figure MC-2.3.1.3-1 Ball Valves
262 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
263 Figure MC-2.3.1.8-1 Pinch Valve
264 Figure MC-2.3.1.9-1 Pressure Relief and Check Valves
265 Figure MC-2.3.1.10-1 Plug Valve
266 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
267 Figure MC-2.3.2.3-3 Dual Mechanical Seal–Unpressurized for Pumps
268 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
269 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
270 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
271 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
272 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
274 Figure MC-3.3.2.2-1 Examples of Static O-Ring Grooves
276 Figure MC-3.3.2.3-1 Seals for Rising Stem Valves
277 MC-3.4 Conformance Requirements for Sealing Elements
278 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
279 MC-4.3 Dynamic Seal Performance
Figure MC-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion
280 MC-5 SEAL APPLICATIONS
MC-5.1 General Considerations
281 MC-5.2 Process Systems
MC-5.3 Compendial Ambient/Hot-Water Distribution Systems
MC-5.4 Pure Steam Distribution Systems
282 MC-5.5 CIP
283 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
284 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
285 Figure MJ-3.2-1 Unacceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations
286 Figure MJ-3.2-2 Acceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations
287 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
288 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
289 MJ-7.3 Examination, Inspection, and Testing Requirements
MJ-7.4 Records
MJ-8 ACCEPTANCE CRITERIA
MJ-8.1 General
290 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
291 Table MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks
293 Table MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe
295 Table MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints
297 Figure MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube-to-Tube Butt Joints
298 Figure MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Electropolished UNS S31603 Tubing
299 Figure MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically Polished UNS S31603 Tubing
300 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
301 Table MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds
303 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
304 MJ-9.6 Examination, Inspection, and Testing
MJ-9.7 Weld Acceptance Criteria
MJ-9.8 Documentation Requirements
305 MJ-10 DOCUMENTATION REQUIREMENTS
MJ-11 PASSIVATION
Table MJ-9.7.1-1 Visual Examination Acceptance Criteria for Polymeric Pipe Beadless Welds
306 Figure MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds
307 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
308 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
309 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
310 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
311 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
312 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
313 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
314 SU-11 PARTICULATES
SU-11.1 General
SU-11.2 Particulate-Monitoring Program
SU-11.3 Mitigation Techniques
315 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)
316 SC-3.1 Materials
SC-3.2 Qualifications
SC-4 POLYMERIC HYGIENIC UNIONS
317 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
318 SJ-3.3 Acceptance Criteria
319 MANDATORY APPENDICES
MANDATORY APPENDIX I SUBMITTAL OF TECHNICAL INQUIRIES TO THE BIOPROCESSING EQUIPMENT (BPE) COMMITTEE
320 Table II-1 Standard Units
MANDATORY APPENDIX II STANDARD UNITS
321 MANDATORY APPENDIX III SINGLE-USE COMPONENTS AND ASSEMBLIES
322 MANDATORY APPENDIX IV NOMENCLATURE
324 NONMANDATORY APPENDICES
NONMANDATORY APPENDIX A COMMENTARY: SLAG AND OXIDE ISLANDS
325 NONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION/INSPECTION DOCUMENTATION
326 Forms
Form MEL-1 Material Examination Log
327 Form MER-1 Material Examination Record
328 Form WEL-1 Weld and Examination/Inspection Log
329 NONMANDATORY APPENDIX C SLOPE MEASUREMENT AND JOINT MISALIGNMENT
C-1 GENERAL
C-2 JOINT MISALIGNMENT
330 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
332 Table D-2-1 Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System
333 Table D-2-2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System
334 Table D-3.1-1 Process Fluid Analyses for the Identification of Mobile Constituents of Rouge
335 Table D-3.2-1 Solid Surface Analyses for the Identification of Surface Layers Composition
336 Table D-4.1-1 Rouge Remediation Processes Summary
338 NONMANDATORY APPENDIX E PASSIVATION PROCEDURE QUALIFICATION
E-1 GENERAL
E-2 PURPOSE OF PASSIVATION TREATMENTS
339 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
340 Table E-3.2-2 Passivation Processes
341 E-5 EVALUATION OF CLEANED AND PASSIVATED SURFACES
342 Table E-5-1 Test Matrix for Evaluation of Cleaned and Passivated Surfaces
346 NONMANDATORY APPENDIX F CORROSION TESTING
F-1 GENERAL
F-2 CORROSION TESTS
F-3 PITTING RESISTANCE EQUIVALENT (PRE) NUMBER
347 Table F-1-1 ASTM Corrosion Tests
348 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
349 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
350 NONMANDATORY APPENDIX H ELECTROPOLISHING PROCEDURE QUALIFICATION
H-1 SCOPE
H-2 PURPOSE
H-3 ELECTROPOLISH PROCEDURE QUALIFICATION
351 Table H-3.3-1 Minimum Surface Requirements for Process Qualification Samples
352 NONMANDATORY APPENDIX J VENDOR DOCUMENTATION REQUIREMENTS FOR NEW INSTRUMENTS
J-1 OVERVIEW
J-2 INSTRUCTIONS FOR USE
353 Table J-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions
354 Table J-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents
355 NONMANDATORY APPENDIX K STANDARD PROCESS TEST CONDITIONS (SPTC) FOR SEAL PERFORMANCE EVALUATION
K-1 SEALING COMPONENT PERFORMANCE EVALUATION
357 Figure K-1.3.2.1-1 Weir-Style Diaphragm
360 Figure K-1.3.2.1-2 Weir-Style Body
Figure K-1.3.2.1-3 Radial-Style Body
361 Figure K-1.3.2.1-4 Manual Bonnet
Figure K-1.3.2.1-5 Pneumatic
K-2 MECHANICAL SEAL PERFORMANCE EVALUATION
365 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
366 Table L-3-1 Thermoset Polymer Test Properties
367 Table L-4-1 Interpretation of Thermoset Material Property Changes
368 NONMANDATORY APPENDIX M SPRAY DEVICE COVERAGE TESTING
M-1 SCOPE
M-2 PURPOSE
M-3 MATERIALS
M-4 PROCEDURE
369 M-5 ACCEPTANCE CRITERIA
M-6 RECOMMENDED DOCUMENTATION
370 NONMANDATORY APPENDIX N COMMENTARY: UNS S31603 WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA
371 NONMANDATORY APPENDIX O GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS
O-1 GENERAL
O-2 PARTICULATES
372 NONMANDATORY APPENDIX P GENERAL BACKGROUND/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES
P-1 REFERENCES
373 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
374 Figure P-4-1 Flowchart of Bioprocessing Equipment/Component Evaluation Related to Extractables and Leachables Characterization
375 NONMANDATORY APPENDIX Q TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS
Q-1 GENERAL
Q-2 EXTERNAL SUPPORT COMPONENTS
Q-3 MEASUREMENT ACCURACY
376 Q-4 SELECTION
Q-5 MAINTENANCE
377 NONMANDATORY APPENDIX R INSTRUMENT RECEIVING, HANDLING, AND STORAGE
R-1 INTRODUCTION
R-2 INSTRUMENT RECEIVING
R-3 INSTRUMENT HANDLING
R-4 STORAGE
378 NONMANDATORY APPENDIX S APPLICATION DATA SHEET
379 Form S-1 Application Data Sheet
380 NONMANDATORY APPENDIX T GUIDANCE ON POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS AND FILTRATION
T-1 CHROMATOGRAPHY COLUMNS
T-2 FILTRATION
383 NONMANDATORY APPENDIX U GUIDANCE FOR THE USE OF U.S. CUSTOMARY AND SI UNITS
U-2 GUIDELINES USED TO DEVELOP SI EQUIVALENTS
384 U-3 CHECKING EQUATIONS
U-4 SOFT CONVERSION FACTORS
385 NONMANDATORY APPENDIX W POSITIVE MATERIAL IDENTIFICATION
W-1 GENERAL
W-2 GENERAL REQUIREMENTS
386 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
388 NONMANDATORY APPENDIX Y PROCUREMENT SOURCES
389 NONMANDATORY APPENDIX Z QUALITY MANAGEMENT SYSTEM
Z-1 SCOPE AND PURPOSE
Z-2 GENERAL
Z-3 QUALITY MANAGEMENT SYSTEM MANUAL
393 NONMANDATORY APPENDIX AA STATIC SEALS APPLICATION GUIDE FOR COMPENDIAL WATER SYSTEMS
AA-1 GENERAL
AA-2 MATERIAL CLASS DESCRIPTIONS
394 Table AA-1-1 Static Seals for Use in Compendial Water Systems (MC-2.2.1)
396 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
398 NONMANDATORY APPENDIX CC EXAMINATION, INSPECTION, AND TESTING CROSS-REFERENCES
401 NONMANDATORY APPENDIX DD CONDUCTIVITY SENSOR SELECTION GUIDE
DD-1 PURPOSE
DD-2 GENERAL CONSIDERATIONS OF COMMON SENSOR TECHNOLOGIES
402 Figure DD-2.1.1-1 Conductivity Scale
Table DD-2.6-1 Technological Considerations
403 NONMANDATORY APPENDIX EE VESSEL FLANGE, AGITATOR, AND MECHANICAL SEAL DESIGN FOR BOTTOM-MOUNT AGITATORS
EE-1 PURPOSE
EE-2 SCOPE
EE-3 COMPONENT DESIGN
404 Figure EE-3-1 Direct-Mount Agitator
405 Figure EE-3-2 Pedestal-Mount Agitator
406 Figure EE-3.1-1 Registered Fit to Ensure Concentricity: Seal Housing-to-Drive Pilot
407 Figure EE-3.2-1 Dual Mechanical Seal Assembly
408 Figure EE-3.2-2 Seal Assembly to Flange O-Ring Detail
409 Table EE-3.3-1 Vessel Flange Bore per Shaft Diameter
410 Figure EE-3.3-1 Vessel Flange With Piloted Bore
411 Figure EE-3.3-2 Vessel Flange Tolerance Parameters
412 Table EE-3.3-2 Vessel Flange Fabrication Tolerance Guidelines
413 NONMANDATORY APPENDIX FF LEAK TEST METHODS FOR SINGLE-USE COMPONENTS AND ASSEMBLIES
414 Table FF-1 Leak Test, Nondestructive Methods
416 Table FF-2 Leak Test, Destructive Methods
418 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
419 Table GG-2-1 Typical Retention Devices by Tubing Type and Operating Pressure
GG-2 DESIGN GUIDANCE
420 INDEX  

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