ASME BPE 2024

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ASME BPE-2024 Bioprocessing Equipment

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ASME	2024	453

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Description

This ASME Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements. It covers materials, design, fabrication, inspections, testing and certification. ASME-BPE is unique in the world, having resulted from widespread industry requests for standardization. It is the leading Standard on how to design and build equipment and systems used in the production of biopharmaceuticals. It incorporates current best-practices for enhancing product purity and safety. Companies that rigorously apply ASME-BPE often can achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations.

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PDF Pages	PDF Title
4	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 BPE COMMITTEE ROSTER
23	CORRESPONDENCE WITH THE BPE COMMITTEE
25	ASME BPE-2024 SUMMARY OF CHANGES
30	CHAPTER 1 INTRODUCTION, SCOPE, AND GENERAL REQUIREMENTS PART GR GENERAL REQUIREMENTS GR-1 INTRODUCTION GR-2 SCOPE OF THE ASME BPE STANDARD
31	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
32	Tables Table GR-4.2-1 Quality Inspector’s Delegate Capabilities
35	GR-4.3 Responsibilities GR-4.4 Access for Inspectors GR-5 DOCUMENTATION GR-5.1 General GR-5.2 General List of Documents
36	GR-5.3 Document Requirements for Metallic Materials
37	GR-5.4 Records Retention GR-5.5 Document Requirements for Polymeric and Other Nonmetallic Materials GR-6 PRODUCT IDENTIFICATION AND PACKAGING GR-6.1 Marking and Labeling GR-6.2 Packaging
38	GR-7 PROCESS COMPATIBILITY GR-7.1 Materials GR-7.2 Animal-Derived Ingredients GR-8 CONTAMINATION CONTROL GR-8.1 Closed Systems GR-8.2 Open Systems GR-9 U.S. CUSTOMARY AND SI UNITS GR-10 REFERENCES
40	GR-11 TERMS AND DEFINITIONS
49	GR-12 NOMENCLATURE
50	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
51	CR-2.1 ASME BPE Certificate Holders CR-2.2 ASME BPE Certificate Holder’s Responsibilities
52	CR-2.3 Certified Individual Requirements Under a Certificate of Authorization
53	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
54	Table MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %)
55	Table MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %)
56	Table MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations
57	MM-3.5 Reclaimed Materials 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)
58	MM-4.3 Castings MM-4.4 Forgings MM-4.5 Plate, Sheet, and Strip
59	MM-4.6 Shapes, Rods, and Bars MM-5 BASE METALS AND FILLER MATERIALS MM-5.1 General MM-5.2 Base Metals
60	Table MM-5.2.1.1-1 Predicted Ferrite Number (FN) Ranges for Various Austenitic Stainless Steel Product Forms and Welds
61	MM-5.3 Filler Materials MM-5.4 Heat Treatment Table MM-5.2.5-1 Materials for OEM Equipment
62	Table MM-5.3-1 Filler Metals for Austenitic Stainless Steels
64	Table MM-5.3-2 Filler Metals for Superaustenitic Stainless Steels
65	Table MM-5.3-3 Filler Metals for Duplex Stainless Steels
66	Table MM-5.3-4 Filler Metals for Nickel Alloys
67	Table MM-5.3-5 Consumable Inserts for Superaustenitic and Duplex Stainless Steels
68	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 Table MM-5.3.4-1 Brazing Filler Metals for Copper
69	MM-7 POSITIVE MATERIAL IDENTIFICATION MM-8 CORROSION-RESISTANCE REQUIREMENTS MM-8.1 General 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
71	PART PM POLYMERIC AND OTHER NONMETALLIC MATERIALS PM-1 PURPOSE AND SCOPE PM-2 MATERIALS PM-2.1 Materials of Construction
72	PM-2.2 General Requirements
73	Table PM-2.2.1-1 Content Required on the Certificate of Conformance
74	Table PM-2.2.3.2-1 Change Levels and Minimum Change Notification Requirements
75	PM-3 PROPERTIES AND PERFORMANCE PM-3.1 Biocompatibility PM-3.2 Extractables and Leachables
76	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
77	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-4.2 Piping
79	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
80	SD-2.4 Fabrication
82	Table SD-2.4.3.1-1 Slope Designations for Drainable Lines
83	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
84	Figure SD-3.1.1-1 Flat Gasket Applications
85	Table SD-3.1.2.2-1 L/d Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With Blind Cap
86	Table SD-3.1.2.2-2 L/d Dimensions for Flow-Through Tee: Short-Outlet Reducing Tee With Blind Cap
88	Figure SD-3.1.2.2-1 Accepted Point-of-Use Designs
89	Figure SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly
90	SD-3.2 Hose Assemblies
91	SD-3.3 Pumps Figure SD-3.2.1-1 Flexible Hygienic Hose Design
92	Figure SD-3.3.2.2-1 Pump Impeller Configurations
93	Figure SD-3.3.2.2-2 Acceptable Impeller Attachments Figure SD-3.3.2.2-3 Casing Drain Configurations
94	Figure SD-3.3.2.2-4 Casing Drain L/d Ratios
95	SD-3.4 Metallic Vessels Figure SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment
96	Figure SD-3.4.2-1 Nozzle Design
97	Figure SD-3.4.2-2 Side and Bottom Connections
98	Figure SD-3.4.2-3 Sidewall Nozzles
99	Figure SD-3.4.2-4 Vessel Design Tangential Nozzles Figure SD-3.4.2-5 Typical Nozzle Detail
100	Table SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes
101	Figure SD-3.4.3-1 Accepted Nozzle Penetrations
102	Figure SD-3.4.3-2 Internal Components
103	Figure SD-3.4.6-1 Sight Glass Design (Accepted)
104	SD-3.5 Agitators and Mixers
105	Figure SD-3.5.1-1 Agitator Mounting Flanges
106	Figure SD-3.5.2-1 Shaft Coupling Construction
107	Figure SD-3.5.2-2 Shaft Coupling Seal Arrangements
109	Figure SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs
110	Figure SD-3.5.5-1 Shaft Steady Bearing
111	SD-3.6 Heat Exchange Equipment Figure SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount)
112	Figure SD-3.6.2-1 Double Tubesheet Heat Exchanger Bonnet Design
113	SD-3.7 Transfer Panels
114	Figure SD-3.7.1-1 Transfer Panel Looped Headers
115	Figure SD-3.7.2-1 Transfer Panel Tolerances
116	SD-3.8 Filtration Elements and Components
117	Figure SD-3.7.4-1 Transfer Panel Jumpers
119	SD-3.9 Spray Devices
120	Figure SD-3.9.1-1 Dynamic Spray Device: Single Axis
121	Figure SD-3.9.1-2 Two-Axis Dynamic Spray Device
122	Figure SD-3.9.2.1-1 Static Spray Device Figure SD-3.9.2.1-2 Flow Rate Guideline for Vertical Cylindrical Vessels
123	Figure SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels
124	SD-3.10 Disposables That Require Presterilization or Poststerilization SD-3.11 Sampling Systems SD-3.12 Steam Traps Figure SD-3.9.2.3-1 Impact Pattern Buildup
125	SD-3.13 Check Valves SD-3.14 Orifice Plates SD-3.15 Relief Devices Figure SD-3.12-1 Steam Traps for Clean Steam Systems
126	SD-3.16 Liquid Pressure Regulators SD-3.17 Strainers SD-3.18 Chromatography Columns
127	Figure SD-3.17.1-1 Example Strainer Types
128	SD-3.19 Multiuse Rigid Polymeric Vessels SD-4 PROCESS UTILITY SYSTEMS SD-4.1 Compendial Water Systems
129	SD-4.2 Clean/Pure Steam Systems
130	Figure SD-4.1.2.1-1 Point-of-Use Piping
131	SD-4.3 Process Gases Figure SD-4.1.2.2-1 Physical Break in Point-of-Use Piping
132	Figure SD-4.2.2-1 Typical Clean Steam System Isometric
133	SD-4.4 Process Waste Systems Figure SD-4.2.2-2 Clean Steam Point-of-Use Design
134	SD-5 PROCESS SYSTEMS SD-5.1 Bioreactors and Fermentors
135	Figure SD-5.1.4.1.3-1 Gas Sparging Assembly — Lance
136	Figure SD-5.1.4.1.3-2 Gas Sparging Assembly — Sintered
137	Figure SD-5.1.4.1.3-3 Gas Sparging Assembly — Ring
138	Figure SD-5.1.4.1.3-4 Gas Sparging Assembly — Single Orifice
139	Figure SD-5.1.4.2.1-1 Exhaust Gas Condenser Figure SD-5.1.4.2.1-2 Exhaust Gas Heater
140	Figure SD-5.1.4.2.1-3 Electrically Heat Traced Filter Housing
142	Figure SD-5.1.5-1 Fermentor Sterile Envelope
143	Figure SD-5.1.5-2 Bioreactor Sterile Envelope
144	SD-5.2 Cell Disruptors
145	Figure SD-5.2.1-1 Cell Disruptor Process Flow Schematic Diagram
146	SD-5.3 Centrifuges
148	SD-5.4 Filtration
149	Figure SD-5.4.5.1-1 Tank/Vessel Vent Fillers
150	SD-5.5 Chromatography Systems
152	SD-5.6 Lyophilizers/Freeze Dryers
153	Figure SD-5.6.4-1 Typical Lyophilizer Component Assembly
156	Figure SD-5.6.5-1 Lyophilizer Sterile Boundary
158	SD-5.7 Solution Preparation Systems
159	SD-6 PROCESS SUPPORT SYSTEMS SD-6.1 Cabinet Washers
162	SD-6.2 Steam Sterilizers/Autoclaves
163	SD-6.3 CIP Systems
165	Figure SD-6.3.4.1.1-1 Conical Vessel With Reduced Bottom Outlet, or Tulip Tank
167	Figure SD-6.3.4.2-1 CIP Looped Header (Supply or Return) Figure SD-6.3.4.2-2 Zero-Static Chain Figure SD-6.3.4.2-3 Swing Elbow Arrangement
168	Figure SD-6.3.4.2-4 Mix-Proof Valve Array
169	Table SD-6.3.5.2.1-1 Flow Rates to Achieve 5 ft/sec (1.5 m/s)
170	SD-6.4 Thermal Treatment Systems
171	Figure SD-6.4.1.1-1 Example of HTST Process Flow Schematic Diagram
172	Figure SD-6.4.1.1-2 Example of Direct Steam Injection UHT Process Flow Schematic Diagram
174	Figure SD-6.4.4.5-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing
175	SD-6.5 Immersion Washers
177	Figure SD-6.5.4.2-1 Immersion Tank Side Nozzle Design
178	SD-6.6 Isolator Systems
182	SD-7 DESIGN CONFORMANCE TESTING SD-7.1 Spray Device Coverage Test
183	SD-7.2 Cleaning, Steaming, and Bioburden Control Testing SD-7.3 Fluid Requirements for Leak Testing SD-7.4 Vessel Drainability Test
184	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
185	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 DT-9.2 Hygienic Gaskets
186	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 Fittings, Valves, and Instrumentation Marking Information
187	DT-11.2 Modified Surfaces DT-12 PACKAGING Table DT-2-1 Metallic Fittings: Rated Internal Working Pressure
188	Table DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components, Excluding Tube
190	Table DT-3-2 Final Tolerances for Electropolished Fittings and Process Components, Excluding Tube Table DT-4-1 Nominal O.D. Tubing Sizes
191	Table DT-4.1-1 Tangent Lengths Table DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow
192	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
193	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
194	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
195	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
196	Table DT-4.1.1-10 Automatic Tube Weld: 92-deg Elbow Table DT-4.1.2-1 Automatic Tube Weld: Straight Tee and Cross
197	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
198	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
199	Table DT-4.1.2-6 Automatic Tube Weld: Reducing Tee
200	Table DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee
201	Table DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee
202	Table DT-4.1.2-9 Hygienic Clamp Joint: Short-Outlet Reducing Tee
203	Table DT-4.1.2-10 Automatic Tube Weld: Instrument Tee Table DT-4.1.2-11 Hygienic Clamp Joint: Instrument Tee Table DT-4.1.2-12 Automatic Tube Weld: Standard Outlet Hygienic Clamp Joint Tee
204	Table DT-4.1.2-13 Automatic Tube Weld: Standard Outlet Hygienic Clamp Joint Reducing Tee
205	Table DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer
206	Table DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
207	Table DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer
208	Table DT-4.1.4-1 Automatic Tube Weld: Ferrule
209	Table DT-4.1.5-1 Automatic Tube Weld: Cap
210	Table DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap
211	Table DT-4.4.1-1 Hygienic Clamp Joint: Two-Way, Weir-Style Diaphragm Valve
212	Table DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed
213	Table DT-4.5.2-1 Tapered Locking Tab Retainer: External
214	Table DT-7.1-1 Metallic Hygienic Clamp Ferrule Standard Dimensions and Tolerances
217	Table DT-7.1-2 Polymeric Hygienic Clamp Ferrule Standard Dimensions and Tolerances
220	Table DT-7.2-1 Tubing End Square Cut Tolerances
221	Table DT-7.3-1 Transfer Panel and Jumper Tolerances
222	Table DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria
223	Figure DT-9.4-1 Clamp Conditions at Installation
224	Table DT-11.1.1-1 Minimum Required Marking Information
225	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
226	Figure PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples
227	Figure PI-2.2.2-1 Accepted Insertion Device Installation Examples
228	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
229	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
231	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
232	Figure PI-4.2.2-1 Typical Turbine Flowmeters
233	PI-5 LEVEL INSTRUMENTS PI-5.1 Free-Space Radar Level Instruments
234	Figure PI-5.1.2-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna Figure PI-5.1.3.1-1 Dead Band, Measuring Range, and Mounting Location
235	PI-6 PRESSURE INSTRUMENTS PI-6.1 Pressure Sensors PI-7 TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS PI-7.1 General PI-7.2 Components PI-7.3 Installation
236	Figure PI-6.1.2-1 Accepted Orientation and Flow
237	Figure PI-7.3-1 Typical Installation Styles
238	Figure PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions Figure PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions
239	PI-7.4 Performance PI-7.5 Selection
240	Figure PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations
241	Figure PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations
242	PI-7.6 Sensor Calibration Verification PI-8 ANALYTICAL INSTRUMENTS PI-8.1 Conductivity Figure PI-8.1.2-1 Conductivity Sensor Components
243	PI-8.2 pH Sensors
244	Figure PI-8.1.3.2-1 Acceptable Orientations for Conductivity Sensors Figure PI-8.1.3.4-1 Installation Clearance Requirements
245	Figure PI-8.2.2-1 pH Sensor Components Figure PI-8.2.3.3-1 Accepted Mounting Orientations
246	PI-8.4 Total Organic Carbon Instruments PI-9 OPTICAL PI-9.1 Optical Devices
247	Figure PI-8.4.3-1 Accepted Installation for a TOC Instrument
248	Figure PI-9.1.3.2-1 Vessel Light Glass Design and Mounting
249	Figure PI-9.1.3.4-1 In-Line Insertion Length Figure PI-9.1.3.4-2 Insertion Probe Length
250	PART MC COMPONENTS FOR MULTIUSE MC-1 PURPOSE AND SCOPE MC-2 SEALING COMPONENT TYPES MC-2.1 General MC-2.2 Static Seals
251	Figure MC-2.2.2-1 Hygienic Union, Ferrules per Table DT-7.1-1 or Table DT-7.1-2 Figure MC-2.2.2-2 Hygienic Clamp Union, Ferrules per Table DT-7.1-1 or Table DT-7.1-2
252	Figure MC-2.2.2-3 Hygienic Union per DIN 11864 Figure MC-2.2.2-4 Hygienic Clamp Union per DIN 11864
253	Figure MC-2.2.2-5 Nonhygienic Connections
254	MC-2.3 Dynamic Seals
255	Figure MC-2.3.1.2-1 Weir Valves Figure MC-2.3.1.2-2 Radial Valves
256	Figure MC-2.3.1.2-3 Weirless Diaphragm Valve Figure MC-2.3.1.2-4 Linear Control Valves
257	Figure MC-2.3.1.2-5 Regulator Valve Figure MC-2.3.1.3-1 Ball Valves
258	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
259	Figure MC-2.3.1.8-1 Pinch Valve
260	Figure MC-2.3.1.9-1 Check Valves
261	Figure MC-2.3.1.10-1 Plug Valve
262	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
263	MC-2.3.2.4 Seal Support System Plans. Figure MC-2.3.2.3-3 Dual Mechanical Seal–Unpressurized for Pumps
264	Figure MC-2.3.2.4-1 Plan 01 Figure MC-2.3.2.4-2 Plan 02
265	Figure MC-2.3.2.4-3 Plan 03 Figure MC-2.3.2.4-4 Plan 11 Figure MC-2.3.2.4-5 Plan 32 Figure MC-2.3.2.4-6 Plan 52 for Pump
266	Figure MC-2.3.2.4-7 Plan 52 for Top-Entry Agitator Figure MC-2.3.2.4-8 Plan 53 for Pump Figure MC-2.3.2.4-9 Plan 53 for Top-Entry Agitator Figure MC-2.3.2.4-10 Plan 54 for Pump
267	Figure MC-2.3.2.4-11 Plan 54 for Top-Entry Agitator Figure MC-2.3.2.4-12 Plan 55 for Pump Figure MC-2.3.2.4-13 Plan 55 With Buffer Fluid From Pump Discharge Figure MC-2.3.2.4-14 Plan 55 for Top-Entry Agitator
268	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 Plan 74 for Pump Figure MC-2.3.2.4-16 Plan 74 for Top-Entry Agitator
270	Figure MC-3.3.2.2-1 Examples of Static O-Ring Grooves
272	Figure MC-3.3.2.3-1 Seals for Rising Stem Valves
273	MC-3.4 Conformance Requirements for Sealing Elements
274	MC-3.5 Seal Identification MC-4 SEAL PERFORMANCE REQUIREMENTS MC-4.1 General Requirements MC-4.2 Static Seal Performance
275	MC-4.3 Dynamic Seal Performance Figure MC-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion
276	MC-5 HOSE ASSEMBLIES MC-5.1 General MC-5.2 Hose Construction
277	MC-5.3 Hose Assembly Performance MC-5.4 Hose Assembly Installation MC-5.5 Conformance Requirements for Hose Assemblies
278	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
279	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 and Fittings MJ-3.5 Tube-Attachment Welds
280	Figure MJ-3.1-1 Vent Hole Examples
281	Figure MJ-3.2-1 Unacceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations
282	Figure MJ-3.2-2 Acceptable Pressure Vessel and Tank Head-to-Shell Joint Configurations
283	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
284	MJ-6.3 Tubing 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
285	MJ-7.3 Examination, Inspection, and Testing Requirements
286	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-8.5 Tube-Attachment Welds MJ-8.6 Brazed Joints MJ-9 JOINING OF POLYMERIC MATERIALS MJ-9.1 General
287	Table MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks
289	Table MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe
291	Table MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints
293	Figure MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube-to-Tube Butt Joints
294	Figure MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Electropolished UNS S31603 Tubing
295	Figure MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically Polished UNS S31603 Tubing
296	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
297	Table MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds
299	MJ-9.2 Weld Joint Design and Preparation MJ-9.3 Joining Processes and Procedures MJ-9.4 Procedure Qualifications Figure MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds
300	MJ-9.5 Performance Qualifications MJ-9.6 Examination, Inspection, and Testing MJ-9.7 Weld Acceptance Criteria
301	MJ-9.8 Documentation Requirements MJ-10 DOCUMENTATION REQUIREMENTS MJ-11 PASSIVATION Table MJ-9.7.1-1 Visual Examination Acceptance Criteria for Polymeric Pipe Beadless Welds
302	Figure MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds
303	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
304	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
305	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
306	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
307	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
308	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 Integrity Versus Leak Testing and Correlation to Maximum Allowable Leakage Limit SU-3.3 Common Leak and Integrity Test Methods
309	SU-4 BIOCOMPATIBILITY SU-5 EXTRACTABLES AND LEACHABLES SU-5.1 General 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
310	SU-9 STERILIZATION AND BIOBURDEN REDUCTION SU-9.1 Ionizing Radiation SU-9.2 Steam Sterilization SU-9.3 Chemical Sterilization SU-10 SHELF LIFE, STORAGE, AND EXPIRATION DATE
311	SU-11 PARTICULATES SU-11.1 General SU-11.2 Particulate-Monitoring Program SU-11.3 Mitigation Techniques SU-12 DESIGN CONFORMANCE Table SU-12-1 Single-Use Design Aspects
312	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)
313	SC-3.1 Materials SC-3.2 Qualifications SC-4 POLYMERIC HYGIENIC UNIONS SC-5 VALVES SC-5.1 General SC-5.2 Pinch Clamps SC-5.3 Pinch Valves
314	Figure SC-5.2-1 Typical Pinch Clamps
315	SC-5.4 Diaphragm Valves SC-5.5 Material Requirements Figure SC-5.3-1 Typical Pinch Valves
316	Figure SC-5.4-1 Typical Diaphragm Valve
317	SC-5.6 Valve Performance SC-5.7 Identification Requirements
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	PART SI SINGLE-USE PROCESS INSTRUMENTATION SI-1 PURPOSE AND SCOPE SI-2 SINGLE-USE PROCESS INSTRUMENTATION GENERAL REQUIREMENTS
321	Table II-1 Standard Units MANDATORY APPENDICES 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 SLAG AND OXIDE ISLAND FORMATION IN WELDS
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 E-4 PASSIVATION QUALITY CONTROL
341	E-5 EVALUATION OF CLEANED AND PASSIVATED SURFACES
342	Table E-3.2-2 Passivation Processes
344	Table E-5-1 Test Matrix for Evaluation of Cleaned and Passivated Surfaces
348	NONMANDATORY APPENDIX F CORROSION TESTING F-1 GENERAL F-2 CORROSION TESTS F-3 PITTING RESISTANCE EQUIVALENT (PRE) NUMBER
349	Table F-1-1 Corrosion Tests
351	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
352	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
353	NONMANDATORY APPENDIX H ELECTROPOLISHING PROCEDURE QUALIFICATION H-1 SCOPE H-2 PURPOSE H-3 ELECTROPOLISHING PROCESS H-4 ELECTROPOLISHING PROCEDURE QUALIFICATION
354	Form EPPS-1 Suggested Format for Electropolishing Procedure Specification (EPPS)
355	Form EPQR-1 Suggested Format for Electropolishing Procedure Qualification Record (EPQR)
356	Table H-4.3-1 Procedure Qualification Acceptance Criteria for Test Coupons
357	NONMANDATORY APPENDIX J VENDOR DOCUMENTATION REQUIREMENTS FOR NEW INSTRUMENTS J-1 OVERVIEW J-2 INSTRUCTIONS FOR USE
358	Table J-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions
359	Table J-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents
360	NONMANDATORY APPENDIX K STANDARD PROCESS TEST CONDITIONS (SPTC) FOR SEAL PERFORMANCE EVALUATION K-1 SEALING COMPONENT PERFORMANCE EVALUATION
362	Figure K-1.3.2.1-1 Weir-Style Diaphragm
365	Figure K-1.3.2.1-2 Weir-Style Body Figure K-1.3.2.1-3 Radial-Style Body
366	Figure K-1.3.2.1-4 Manual Bonnet Figure K-1.3.2.1-5 Pneumatic K-2 MECHANICAL SEAL PERFORMANCE EVALUATION
370	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
371	Table L-3-1 Thermoset Polymer Test Properties L-5 TESTING PROTOCOLS FOR THERMOSET POLYMERS
372	Table L-4-1 Interpretation of Thermoset Material Property Changes
373	NONMANDATORY APPENDIX M SPRAY DEVICE COVERAGE TESTING M-1 SCOPE M-2 PURPOSE M-3 MATERIALS M-4 PROCEDURE
374	M-5 ACCEPTANCE CRITERIA M-6 RECOMMENDED DOCUMENTATION
375	NONMANDATORY APPENDIX N EXPLANATION OF WELD BEAD AND HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA ON UNS S31603
376	NONMANDATORY APPENDIX O GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS O-1 GENERAL
377	Table O-1.1-1 Common Thermoplastic Polymers and Applications Table O-1.2-1 Common Thermoset Polymers and Applications O-2 PARTICULATES
378	Table O-1.3-1 Examples of Nonmetallics
379	NONMANDATORY APPENDIX P GENERAL BACKGROUND/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES P-1 REFERENCES P-2 RECOMMENDED CONDITIONS FOR A POLYMERIC MATERIAL-SPECIFIC EXTRACTION
380	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
381	Figure P-4-1 Flowchart of Bioprocessing Equipment/Component Evaluation Related to Extractables and Leachables Characterization
382	NONMANDATORY APPENDIX Q TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS Q-1 GENERAL Q-2 EXTERNAL SUPPORT COMPONENTS Q-3 MEASUREMENT ACCURACY
383	Q-4 SELECTION Q-5 MAINTENANCE
384	NONMANDATORY APPENDIX R INSTRUMENT RECEIVING, HANDLING, AND STORAGE R-1 INTRODUCTION R-2 INSTRUMENT RECEIVING R-3 INSTRUMENT HANDLING R-4 STORAGE
385	NONMANDATORY APPENDIX S APPLICATION DATA SHEET
386	Form S-1 Application Data Sheet
387	NONMANDATORY APPENDIX T GUIDANCE ON POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS AND FILTRATION T-1 CHROMATOGRAPHY COLUMNS T-2 FILTRATION
390	NONMANDATORY APPENDIX U GUIDANCE FOR THE USE OF U.S. CUSTOMARY AND SI UNITS U-2 GUIDELINES USED TO DEVELOP SIEQUIVALENTS
391	U-3 CHECKING EQUATIONS U-4 SOFT CONVERSION FACTORS
392	NONMANDATORY APPENDIX W POSITIVE MATERIAL IDENTIFICATION W-1 GENERAL W-2 GENERAL REQUIREMENTS
393	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
395	NONMANDATORY APPENDIX Y PROCUREMENT SOURCES
396	NONMANDATORY APPENDIX Z QUALITY MANAGEMENT SYSTEM Z-1 SCOPE AND PURPOSE Z-2 GENERAL Z-3 QUALITY MANAGEMENT SYSTEM MANUAL
400	NONMANDATORY APPENDIX AA SEAL APPLICATION MATERIAL SELECTION GUIDE AA-1 GENERAL AA-2 MATERIAL CLASS DESCRIPTIONS
401	AA-3 COMPENDIAL AMBIENT AND HOT-WATER DISTRIBUTION SYSTEMS
402	AA-4 PURE STEAM
403	Figure AA-3.2.1-1 Polymeric Static and Dynamic Seal Selection for Use in Compendial Water Systems
405	Figure AA-3.2.3-1 Mechanical Seal Face Material Selection for Compendial Water Pumps
406	NONMANDATORY APPENDIX BB MECHANICAL SEAL FACE MATERIAL SELECTION FOR COMPENDIAL WATER PUMPS
407	NONMANDATORY APPENDIX CC EXAMINATION, INSPECTION, AND TESTING CROSS-REFERENCES
410	NONMANDATORY APPENDIX DD CONDUCTIVITY SENSOR SELECTION GUIDE DD-1 PURPOSE DD-2 GENERAL CONSIDERATIONS OF COMMON SENSOR TECHNOLOGIES
411	Figure DD-2.1.1-1 Conductivity Scale Table DD-2.6-1 Technological Considerations
412	NONMANDATORY APPENDIX EE VESSEL FLANGE, AGITATOR, AND MECHANICAL SEAL DESIGN FOR BOTTOM-MOUNT AGITATORS EE-1 PURPOSE EE-2 SCOPE EE-3 COMPONENT DESIGN
413	Figure EE-3-1 Direct-Mount Agitator
414	Figure EE-3-2 Pedestal-Mount Agitator
415	Figure EE-3.1-1 Registered Fit to Ensure Concentricity: Seal Housing-to-Drive Pilot
416	Figure EE-3.2-1 Dual Mechanical Seal Assembly
417	Figure EE-3.2-2 Seal Assembly to Flange O-Ring Detail
418	Table EE-3.3-1 Vessel Flange Bore per Shaft Diameter
419	Figure EE-3.3-1 Vessel Flange With Piloted Bore
420	Figure EE-3.3-2 Vessel Flange Tolerance Parameters
421	Table EE-3.3-2 Vessel Flange Fabrication Tolerance Guidelines
422	NONMANDATORY APPENDIX FF LEAK AND INTEGRITY TEST METHODS FOR SINGLE-USE SYSTEMS FF-1 CONCEPT OF MAXIMUM ALLOWABLE LEAKAGE LIMIT (MALL) FOR SINGLE-USE SYSTEMS
423	Table FF-1-1 Leak and Integrity Test, Nondestructive Methods
425	Table FF-1-2 Leak and Integrity Test, Destructive Methods
428	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
429	Table GG-2-1 Typical Retention Devices by Tubing Type and Operating Pressure GG-2 DESIGN GUIDANCE
430	NONMANDATORY APPENDIX HH PHYSICAL AND FUNCTIONAL TESTING REFERENCES USED TO CHARACTERIZE SINGLE-USE BAGS
431	Table HH-1 Physical Testing References Used to Characterize Single-Use Bags
432	Table HH-2 Functional Testing References Used to Characterize Single-Use Bags
433	NONMANDATORY APPENDIX JJ SIZE COMPARISON OF COMMON THERMOPLASTIC SIZING STANDARDS
434	Table JJ-1 Size Comparison of Common Thermoplastic Sizing Standards
435	INDEX