The ASME BPE Standard provides requirements for systems and components that are subject to cleaning and sanitization and/or sterilization including systems that are cleaned in place (CIP’d) and/or steamed in place (SIP’d) and/or other suitable processes used in the manufacturing of biopharmaceuticals. This Standard also provides requirements for single-use systems and components used in the above listed systems and components. This Standard may be used, in whole or in part, for other systems and components where bioburden risk is a concern. This Standard applies to new system (and component) design and fabrication definition of system boundaries specific metallic, polymeric, and elastomeric (e.g., seals and gaskets) materials of construction component dimensions and tolerances surface finishes materials joining examinations, inspections, and testing certification This Standard is intended to apply to new fabrication and construction. If the provisions of this Standard are optionally applied by an owner/user to existing, inservice equipment, other considerations may be necessary. For installations between new construction and an existing, in-service system, such as a retrofit, modification, or repair, the boundaries and requirements must be agreed to among the owner/user, engineer, installation contractor, and inspection contractor. For a system or component to be BPE-compliant, adherence to all applicable parts of this Standard is required.

PDF Catalog

PDF Pages	PDF Title
4	CONTENTS
13	FOREWORD
14	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
15	COMMITTEE ROSTER
19	CORRESPONDENCE WITH THE BPE COMMITTEE
21	ASME BPE-2019 SUMMARY OF CHANGES
26	CHAPTER 1 INTRODUCTION, SCOPE, AND DEFINITIONS PART GR GENERAL REQUIREMENTS GR-1 INTRODUCTION GR-2 SCOPE OF THE ASME BPE STANDARD
27	GR-3 MANUFACTURER’S QUALITY ASSURANCE PROGRAM GR-4 EXAMINATION, INSPECTION, AND TESTING GR-4.1 Inspector/Examiner GR-4.2 Inspector’s Delegate
28	GR-4.3 Responsibilities
29	Tables Table GR-4.2-1 Inspector’s Delegate Capabilities
31	GR-4.4 Access for Inspectors GR-5 DOCUMENTATION GR-5.1 General GR-5.2 Document Requirements
32	GR-5.3 Material Test Reports/Certificates of Compliance
33	GR-5.4 Weld and Examination/Inspection Log GR-5.5 Records Retention GR-6 U.S. CUSTOMARY AND SI UNITS GR-7 REFERENCES
35	GR-8 TERMS AND DEFINITIONS
43	GR-9 NOMENCLATURE
44	CHAPTER 2 DESIGN PART SD SYSTEMS DESIGN SD-1 PURPOSE AND SCOPE SD-2 GENERAL GUIDELINES SD-2.1 Containment SD-2.2 Bioburden Control SD-2.3 Bioburden Reduction
45	SD-2.4 Fabrication
46	Table SD-2.4.3.1-1 Slope Designations for Gravity-Drained Lines
47	SD-2.5 Hygienic System Design
48	SD-3 PROCESS COMPONENTS SD-3.1 Connections, Fittings, and Piping
49	Figures Figure SD-3.1.1-1 Flat Gasket Applications
50	Table SD-3.1.2.2-1 L/d Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With Blind Cap
51	Table SD-3.1.2.2-2 L/d Dimensions for Flow-Through Tee: Short-Outlet Reducing Tee With Blind Cap
53	Figure SD-3.1.2.2-1 Accepted Point-of-Use Designs
54	Figure SD-3.1.2.3-1 Double Block-and-Bleed Valve Assembly
55	SD-3.2 Hose Assemblies
56	SD-3.3 Pumps Figure SD-3.2.1-1 Flexible Hygienic Hose Design
57	Figure SD-3.3.2.2-1 Pump Impeller Configurations
58	Figure SD-3.3.2.2-3 Casing Drain Configurations
59	SD-3.4 Vessels Figure SD-3.3.2.4-1 Rotary Lobe Pump Rotor Attachment
60	Figure SD-3.4.2-1 Nozzle Design
61	Figure SD-3.4.2-2 Side and Bottom Connections Figure SD-3.4.2-3 Sidewall Instrument Ports
62	Figure SD-3.4.2-4 Vessel Design Tangential Nozzles
63	Figure SD-3.4.2-5 Typical Nozzle Detail Table SD-3.4.3-1 Annular Spacing Recommendations for Hygienic Dip Tubes
64	Figure SD-3.4.3-1 Accepted Nozzle Penetrations
65	Figure SD-3.4.3-2 Internal Support Members
66	SD-3.5 Agitators and Mixers
67	Figure SD-3.4.6-1 Sight Glass Design (Accepted)
68	Figure SD-3.5.1-1 Agitator Mounting Flanges
69	Figure SD-3.5.2-1 Shaft Coupling Construction
70	Figure SD-3.5.2-2 Shaft Coupling Seal Arrangements
71	Figure SD-3.5.2-3 Fastener Seal Arrangements: Alternative Bolting Designs
72	Figure SD-3.5.5-1 Shaft-Steady Bearing
73	SD-3.6 Heat Exchange Equipment Figure SD-3.5.5-2 Magnetically Coupled Mixer (Typical Bottom-Mount)
74	SD-3.7 Transfer Panels
75	Figure SD-3.6.1-1 Double Tubesheet Heat Exchanger Bonnet Design
76	Figure SD-3.7.1-1 Transfer Panel Looped Headers
77	Figure SD-3.7.2-1 Transfer Panel Tolerances (Reference Table DT-7-3)
78	Figure SD-3.7.4-1 Transfer Panel Jumpers
79	SD-3.8 Filters
80	SD-3.9 Spray Devices Figure SD-3.9.1-1 Dynamic Spray Device: Single Axis
81	Figure SD-3.9.1-2 Two-Axis Dynamic Spray Device
82	Figure SD-3.9.2.1-1 Static Spray Device
83	Figure SD-3.9.2.1-3 Flow Rate Guideline for Horizontal Cylindrical Vessels
84	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
85	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
86	SD-3.16 Liquid Pressure Regulators SD-4 PROCESS UTILITIES SD-4.1 Compendial Water Systems
87	Figure SD-4.1.2.1-1 Point-of-Use Piping
88	SD-4.2 Clean/Pure Steam Systems Figure SD-4.1.2.2-1 Physical Break in Point-of-Use Piping
89	Figure SD-4.2.2-1 Typical Clean Steam System Isometric
90	SD-4.3 Process Gases SD-4.4 Process Waste Systems Figure SD-4.2.2-2 Clean Steam Point-of-Use Design
91	SD-5 PROCESS SYSTEMS SD-5.1 Bioreactors and Fermentors
92	Figure SD-5.1.4.4-1 Gas Sparging Assembly — Lance
93	Figure SD-5.1.4.4-2 Gas Sparging Assembly — Sintered
94	Figure SD-5.1.4.4-3 Gas Sparging Assembly — Ring
95	Figure SD-5.1.4.4-4 Gas Sparging Assembly — Single Orifice
97	Figure SD-5.1.4.7-1 Exhaust Gas Condenser
98	Figure SD-5.1.4.7-3 Electrically Heat Traced Filter Housing
99	Figure SD-5.1.5-1 Fermentor Sterile Envelope
100	Figure SD-5.1.5-2 Bioreactor Sterile Envelope
101	SD-5.2 Cell Disrupters SD-5.3 Centrifuges
102	SD-5.4 Filtration Systems
103	SD-5.5 Chromatography Systems Figure SD-5.4.4-1 Tank/Vessel Vent Fillers
104	SD-5.6 Lyophilizers/Freeze Dryers
105	Figure SD-5.6.2-1 Typical Lyophilizer Component Assembly
108	Figure SD-5.6.3-1 Lyophilizer Sterile Boundary
110	SD-5.7 Solution Preparation Systems SD-6 PROCESS SUPPORT SYSTEMS SD-6.1 Cabinet Washers
114	SD-6.2 Steam Sterilizers/Autoclaves
115	SD-6.3 CIP Systems
117	Figure SD-6.3.4.6-1 CIP Looped Header (Supply or Return)
118	Figure SD-6.3.4.6-2 Zero-Static Chain Figure SD-6.3.4.6-3 Swing Elbow Arrangement Table SD-6.3.5.2-1 Flow Rates to Achieve 5 ft/sec (1.52 m/s)
119	SD-6.4 Thermal Treatment Systems
120	Figure SD-6.4.1.1-1 Example of HTST Process Flow Schematic Diagram
121	Figure SD-6.4.1.1-2 Example of Direct Steam Injection UHT Process Flow Schematic Diagram
123	Figure SD-6.4.4.5-1 Example of Additional Retention Tube Length Required to Account for Axial Mixing
124	SD-6.5 Immersion Washers
126	Figure SD-6.5.4.2-1 Immersion Tank Side Nozzle Design
127	SD-6.6 Isolator Systems
131	SD-7 DESIGN CONFORMANCE TESTING SD-7.1 Spray Device Coverage Test
132	SD-7.2 Cleaning, Steaming, and Bioburden Control Testing SD-7.3 Fluid Requirements for Leak Testing SD-7.4 Vessel Drainability Test
133	CHAPTER 3 MATERIALS PART MM METALLIC MATERIALS MM-1 PURPOSE AND SCOPE MM-2 ALLOY DESIGNATIONS MM-2.1 General MM-3 USES OF SPECIFICATIONS MM-3.1 General MM-3.2 Listed Specifications MM-3.3 Unlisted Specifications MM-3.4 Unknown Materials MM-3.5 Reclaimed Materials
134	Table MM-2.1-1 Wrought Stainless Steels: Nominal Compositions (wt. %)
135	Table MM-2.1-2 Wrought Nickel Alloys: Nominal Compositions (wt. %)
136	MM-3.6 Designation of Alloy and Fluid Service MM-4 REFERENCED SPECIFICATIONS MM-4.1 General MM-4.2 Tubing/Piping Table MM-2.1-3 Stainless Steel and Nickel Alloy Cast Designations Table MM-2.1-4 Wrought Copper: Nominal Compositions (wt. %) (Cleaned for Oxygen Service)
137	MM-4.3 Castings MM-4.4 Forgings MM-4.5 Plate, Sheet, and Strip
138	MM-4.6 Hollow Products, Rod, and Bar Stock MM-4.7 Copper Alloy Fittings MM-5 BASE METALS AND FILLER MATERIALS MM-5.1 General MM-5.2 Base Metals
139	MM-5.3 Filler Materials Table MM-5.2.1.2-1 Predicted Ferrite Number (FN) Ranges for Various Austenitic Stainless Steel Product Forms and Welds
140	MM-5.4 Heat Treatment MM-6 MECHANICAL PROPERTIES MM-6.1 General MM-6.2 Tubing/Piping MM-6.3 Fittings and Valves MM-6.4 Toughness MM-6.5 Testing MM-7 POSITIVE MATERIAL IDENTIFICATION Table MM-5.2.6-1 Materials for OEM Equipment
141	Table MM-5.3-1 Filler Metals
145	Table MM-5.3-2 Consumable Inserts for Superaustenitic and Duplex Stainless Steels
146	Table MM-5.3.3-1 Brazing Filler Metals for Copper
147	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 MM-9.1.1 Wrought, Cast, and Welded Fabricated Applications MM-9.1.2 Specialty OEM Material Applications Table MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic and Duplex Stainless Steels Table MM-5.4-1 Solution Anneal Heat Treatment Requirements for Superaustenitic and Duplex Stainless Steels
149	PART PM POLYMERIC AND OTHER NONMETALLIC MATERIALS PM-1 PURPOSE AND SCOPE PM-2 MATERIALS PM-2.1 Materials of Construction
150	PM-2.2 General Requirements Table PM-2.1.1-1 Common Thermoplastic Polymers and Applications Table PM-2.1.2-1 Common Thermoset Polymers and Applications
151	Table PM-2.1.3-1 Examples of Nonmetallics
152	Table PM-2.2.1-1 Content Required on the Certificate of Compliance
153	PM-3 PROPERTIES AND PERFORMANCE PM-3.1 Biocompatibility Table PM-2.2.3.2-1 Change Levels and Minimum Change Notification Requirements
154	PM-3.2 Extractables and Leachables PM-3.3 Physical and Mechanical Properties of Thermoplastic Polymers
155	PM-3.4 Chemical Compatibility of Thermoplastic Polymers PM-3.5 Physical and Mechanical Properties of Thermoset Polymers PM-3.6 Chemical Compatibility of Thermoset Elastomers PM-3.7 Physical and Mechanical Properties of Other Nonmetallic Materials PM-3.8 Chemical Compatibility of Nonmetallic Materials PM-3.9 Polymeric Surface Finish PM-4 APPLICATIONS PM-4.1 Single-Use Components and Assemblies PM-4.2 Piping
156	Table PM-4.2.1-1 Size Comparison of Common Thermoplastic Sizing Standards
157	PM-4.3 Hose Assemblies
159	PM-4.4 Chromatography Columns
160	PM-4.5 Filtration Elements and Components
161	PM-4.6 Polymeric Hygienic Unions
162	CHAPTER 4 PROCESS COMPONENTS PART DT DIMENSIONS AND TOLERANCES FOR PROCESS COMPONENTS DT-1 PURPOSE AND SCOPE DT-2 PRESSURE RATING DT-3 WALL THICKNESS DT-4 DIMENSIONS DT-4.1 Fitting Dimensions DT-4.2 Nonstandard Fitting Dimensions
163	DT-4.3 Special Angle Fittings Dimensions DT-4.4 Valve Dimensions DT-4.5 Filter Dimensions DT-5 MATERIALS DT-6 TESTS DT-7 TOLERANCES DT-8 WELD ENDS DT-9 HYGIENIC CLAMP UNIONS DT-9.1 Typical Hygienic Clamp Unions DT-9.2 Hygienic Gaskets DT-9.3 Connections
164	DT-9.4 Hygienic Clamps DT-10 MINIMUM EXAMINATION REQUIREMENTS DT-10.1 Visual Inspection DT-10.2 Documentation Verification DT-10.3 Physical Examination DT-11 MARKING DT-11.1 Fitting Marking Information
165	DT-11.2 Valve Marking Information DT-11.3 Modified Surfaces DT-12 PACKAGING Table DT-2-1 Metallic Hygienic Unions: Rated Internal Working Pressure
166	Figure DT-2-1 Clamp Conditions at Installation
167	Table DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components
168	Table DT-3-2 Final Tolerances for Electropolished Fittings and Process Components Table DT-4-1 Nominal O.D. Tubing Sizes Table DT-4.1-1 Tangent Lengths
169	Table DT-4.1.1-1 Automatic Tube Weld: 90-deg Elbow
170	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
171	Table DT-4.1.1-4 Automatic Tube Weld: 45-deg Elbow
172	Table DT-4.1.1-5 Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow Table DT-4.1.1-6 Hygienic Clamp Joint: 45-deg Elbow
173	Table DT-4.1.1-7 Automatic Tube Weld: 180-deg Return Bend Table DT-4.1.1-8 Hygienic Clamp Joint: 180-deg Return Bend
174	Table DT-4.1.2-1 Automatic Tube Weld: Straight Tee and Cross Table DT-4.1.2-2 Automatic Tube Weld: Short-Outlet Hygienic Clamp Joint Tee
175	Table DT-4.1.2-3 Hygienic Mechanical Joint: Short-Outlet Run Tee
176	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
177	Table DT-4.1.2-6 Automatic Tube Weld: Reducing Tee
178	Table DT-4.1.2-7 Automatic Tube Weld: Short-Outlet Hygienic Clamp, Joint Reducing Tee
179	Table DT-4.1.2-8 Hygienic Clamp Joint: Reducing Tee
180	Table DT-4.1.2-9 Hygienic Clamp Joint: Short-Outlet Reducing Tee Table DT-4.1.2-10 Automatic Tube Weld: Instrument Tee
181	Table DT-4.1.2-11 Hygienic Clamp Joint: Instrument Tee
182	Table DT-4.1.3-1 Automatic Tube Weld: Concentric and Eccentric Reducer
183	Table DT-4.1.3-2 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer
184	Table DT-4.1.3-3 Hygienic Clamp Joint: Concentric and Eccentric Reducer
185	Table DT-4.1.4-1 Automatic Tube Weld: Ferrule Table DT-4.1.5-1 Automatic Tube Weld: Cap
186	Table DT-4.1.5-2 Hygienic Clamp Joint: Solid End Cap
187	Table DT-4.4.1-1 Hygienic Clamp Joint: Weir-Style Diaphragm Valve
188	Table DT-4.5.1-1 Tapered Locking Tab Retainer: Recessed
189	Table DT-4.5.2-1 Tapered Locking Tab Retainer: External
190	Table DT-7-1 Metallic Hygienic Clamp Ferrule Standard Dimensions and Tolerances
193	Table DT-7-2 Polymeric Hygienic Clamp Ferrule Standard Dimensions and Tolerances
196	Table DT-7-3 Transfer Panel and Jumper Tolerances
197	Table DT-9.3-1 Hygienic Clamp Ferrule: Design Criteria
198	PART PI PROCESS INSTRUMENTATION PI-1 PURPOSE AND SCOPE PI-2 PROCESS INSTRUMENTATION GENERAL REQUIREMENTS PI-2.1 General Considerations PI-2.2 Instrumentation Categories
199	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 Figure PI-2.2.1-1 In-Line and At-Line Instrument Installation Examples
200	Figure PI-2.2.2-1 Accepted Insertion Device Installation Examples
201	Figure PI-4.1.3.2-1 Manifold or Flow Splitter for Dual-Tube Construction Flowmeters and Potential for Product Holdup
202	Figure PI-4.1.3.3-1 Concentrically Reducing Process Connection Figure PI-4.1.4.3-1 Vertical Installation
203	PI-4.2 Turbine Flowmeter Figure PI-4.1.4.4-1 Minimum Angle of Inclination, α
204	Figure PI-4.2.2-1 Typical Turbine Flowmeters
205	PI-5 LEVEL INSTRUMENTS PI-5.1 Radar Level Instruments
206	PI-6 PRESSURE INSTRUMENTS PI-6.1 Pressure Sensors Figure PI-5.1.2.1-1 Bulb, Horn, Isolated Horn, and Rod-Style Antenna
207	Figure PI-5.1.3.3-1 Dead Band, Measuring Range, and Mounting Location
208	Figure PI-6.1.2-1 Accepted Orientation and Flow
209	PI-7 TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS PI-7.1 General PI-7.2 Components PI-7.3 Installation
210	PI-7.4 Performance Figure PI-7.3-1 Typical Installation Styles
211	Figure PI-7.3.4-1 Accepted Elbow Orientations and Flow Directions Figure PI-7.3.4-2 Accepted Nonintrusive Orientations and Flow Directions
212	Figure PI-7.3.5-1 Sensor Insertion Lengths for Tee Installations
213	Figure PI-7.3.5-2 Sensor Insertion Lengths for Elbow Installations
214	PI-7.5 Selection PI-7.6 Sensor Calibration Verification PI-8 ANALYTICAL INSTRUMENTS PI-8.1 Conductivity
215	Figure PI-8.1.2-1 Conductivity-Type Examples
216	PI-8.2 pH — Glass Measuring Electrode Figure PI-8.1.3-1 Accepted Installations for Conductivity Sensors Figure PI-8.1.3.6-1 Installation Clearance Requirements
217	Figure PI-8.2.2-1 pH Sensor Components
218	Figure PI-8.2.3-1 Accepted pH Sensor Installations
219	Figure PI-8.2.3.4-1 Accepted Mounting Orientations
220	PI-9 OPTICAL PI-9.1 Optical Devices Figure PI-8.2.3.5-1 Insertion Length or Depth
222	Figure PI-9.1.3.3-1 Vessel Light Glass Design and Mounting
223	Figure PI-9.1.3.5-1 In-Line Insertion Length Figure PI-9.1.3.5-2 Insertion Probe Length
224	PART SG SEALING COMPONENTS SG-1 PURPOSE AND SCOPE SG-2 SEALING COMPONENT TYPES SG-2.1 General SG-2.2 Static Seals
225	Figure SG-2.2.2-1 Hygienic Union per Table DT-7-1 Figure SG-2.2.2-2 Hygienic Clamp Union per Table DT-7-1 Figure SG-2.2.2-3 Hygienic Union per DIN 11864
226	Figure SG-2.2.2-4 Hygienic Clamp Union per DIN 11864
227	Figure SG-2.2.2-5 Nonhygienic Connections
228	SG-2.3 Dynamic Seals
229	Figure SG-2.3.1.2-1 Weir Valves Figure SG-2.3.1.2-2 Radial Valves
230	Figure SG-2.3.1.2-3 Weirless Diaphragm Valve Figure SG-2.3.1.2-4 Linear Control Valves
231	Figure SG-2.3.1.2-5 Regulator Valve Figure SG-2.3.1.3-1 Ball Valves
232	Figure SG-2.3.1.4-1 Rising Stem Single, Double-Seat Mix-Proof, and Needle Valves Figure SG-2.3.1.5-1 Butterfly Valve Figure SG-2.3.1.7-1 Back Pressure Control Valve
233	Figure SG-2.3.1.8-1 Pinch Valve
234	Figure SG-2.3.1.9-1 Pressure Relief and Check Valves
236	Figure SG-2.3.1.10-1 Plug Valve Figure SG-2.3.2.2-1 Single Mechanical Seal Figure SG-2.3.2.2-2 Single Seal for Top-Entry Agitator Figure SG-2.3.2.3-1 Dual Pressurized Mechanical Seal for Pumps Figure SG-2.3.2.3-2 Dual Pressurized Mechanical Seal for Top-Entry Agitator Figure SG-2.3.2.3-3 Dual Unpressurized Mechanical Seal for Pumps
238	Figure SG-2.3.2.4-1 Flush Plan 01 Figure SG-2.3.2.4-2 Flush Plan 02 Figure SG-2.3.2.4-3 Flush Plan 03 Figure SG-2.3.2.4-4 Flush Plan 11 Figure SG-2.3.2.4-5 Flush Plan 32
239	Figure SG-2.3.2.4-6 Flush Plan 52 for Pump Figure SG-2.3.2.4-7 Flush Plan 52 for Top-Entry Agitator Figure SG-2.3.2.4-8 Flush Plan BPE52 for Pump Figure SG-2.3.2.4-9 Flush Plan 53 for Pump Figure SG-2.3.2.4-10 Flush Plan 53 for Top-Entry Agitator
240	Figure SG-2.3.2.4-11 Flush Plan 54 for Pump Figure SG-2.3.2.4-12 Flush Plan 54 for Top-Entry Agitator Figure SG-2.3.2.4-13 Flush Plan 55 for Pump Figure SG-2.3.2.4-14 Flush Plan 55 for Top-Entry Agitator Figure SG-2.3.2.4-15 Flush Plan 74 for Pump Figure SG-2.3.2.4-16 Flush Plan 74 for Top-Entry Agitator
241	SG-3 SEALING COMPONENTS GENERAL DESIGN REQUIREMENTS (GENERAL PROVISIONS) SG-3.1 Seal Design Conditions SG-3.2 System Requirements SG-3.3 Seal Construction
243	Figure SG-3.3.2.2-1 Examples of Static O-Ring Grooves
245	Figure SG-3.3.2.3-1 Seals for Rising Stem Valves
246	SG-3.4 Compliance Requirements for Sealing Elements
247	SG-3.5 Seal Identification SG-3.6 Other Seal Requirements SG-4 SEAL PERFORMANCE REQUIREMENTS SG-4.1 General Requirements SG-4.2 Static Seal Performance
248	SG-4.3 Dynamic Seal Performance Figure SG-4.2-1 Typical Hygienic Clamp Union: Allowable Gasket Intrusion
249	SG-5 SEAL APPLICATIONS SG-5.1 General Considerations SG-5.1.1 Static Seals.
250	SG-5.2 Process Systems SG-5.3 Compendial Ambient/Hot-Water Distribution Systems SG-5.3.1 Valves for Compendial Water SG-5.3.1.1 Seals for Compendial Water. SG-5.3.1.2 Valve Types for Compendial Water SG-5.3.2 Single Mechanical Seals for Compendial Water per SG-3.3.2.4(a) and SG-3.3.2.4(b) SG-5.3.2.1 Additional Application Conditions Relevant to Mechanical Seals. SG-5.3.2.2 Additional Equipment Characteristics Relevant to Mechanical Seals. SG-5.3.2.3 Materials of Construction. SG-5.3.2.4 Flush Plans. SG-5.4 Pure Steam Distribution Systems
251	SG-5.4.1 Static Seal Recommendations for Pure Steam Distribution Systems. SG-5.4.2 Valves for Pure Steam Distribution Systems SG-5.4.2.1 Valve Seals. SG-5.4.2.2 Valve Types SG-5.5 CIP
252	CHAPTER 5 FABRICATION, ASSEMBLY, AND ERECTION PART MJ MATERIALS JOINING MJ-1 PURPOSE AND SCOPE MJ-2 MATERIALS MJ-2.1 Base Metals MJ-2.2 Filler Metals
253	MJ-2.3 Nonmetallics MJ-3 JOINT DESIGN AND PREPARATION MJ-3.1 General MJ-3.2 Pressure Vessels and Tanks MJ-3.3 Piping MJ-3.4 Tubing MJ-3.5 Tube-Attachment Welds MJ-3.6 Brazed Joints
254	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
255	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
256	MJ-7.3 Examination, Inspection, and Testing Requirements MJ-7.4 Records MJ-8 ACCEPTANCE CRITERIA MJ-8.1 General
257	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
258	Table MJ-8.2-1 Visual Examination Acceptance Criteria for Welds on Metallic Pressure Vessels and Tanks
259	Table MJ-8.3-1 Visual Examination Acceptance Criteria for Welds on Metallic Pipe
260	Table MJ-8.4-1 Visual Examination Acceptance Criteria for Groove Welds on Metallic Tube-to-Tube Butt Joints
262	MJ-9.3 Joining Processes and Procedures MJ-9.4 Procedure Qualifications MJ-9.5 Performance Qualifications MJ-9.6 Examination, Inspection, and Testing
263	Figure MJ-8.4-1 Acceptable and Unacceptable Weld Profiles for Groove Welds on Metallic Tube-to-Tube Butt Joints
264	Figure MJ-8.4-2 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on ElectropolishedUNS S31603 Tubing
265	Figure MJ-8.4-3 Discoloration Acceptance Criteria for Welds and Heat-Affected Zones on Mechanically PolishedUNS S31603 Tubing
266	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
267	Table MJ-8.5-1 Visual Examination Acceptance Criteria for Metallic Tube-Attachment Welds
269	MJ-9.7 Weld Acceptance Criteria Figure MJ-8.5-1 Acceptable Weld Profiles for Metallic Tube-Attachment Fillet Welds
270	Figure MJ-9.7.1-1 Acceptable and Unacceptable Weld Profiles for Polymeric Beadless Welds
271	MJ-9.8 Documentation Requirements MJ-10 DOCUMENTATION REQUIREMENTS MJ-11 PASSIVATION
272	PART SF PROCESS CONTACT SURFACE FINISHES SF-1 PURPOSE AND SCOPE SF-2 METALLIC APPLICATIONS SF-2.1 Applicable Systems SF-2.2 Acceptance Criteria SF-2.3 Examination Techniques Employed in the Classification of Process Contact Surface Finishes SF-2.4 Surface Condition
273	Table SF-2.2-1 Acceptance Criteria for Metallic Process Contact Surface Finishes
274	SF-2.5 Electropolishing Procedure Qualification SF-2.6 Passivation Procedure SF-2.7 Normative References Table SF-2.2-2 Additional Acceptance Criteria for Electropolished Metallic Process Contact SurfaceFinishes Table SF-2.4.1-1 Ra Readings for Metallic Process Contact Surfaces
275	SF-2.8 Rouge and Stainless Steel SF-3 POLYMERIC APPLICATIONS SF-3.1 Applicable Systems SF-3.2 Materials SF-3.3 Examination Techniques Employed in the Classification of Process Contact Surface Finishes Table SF-2.6-1 Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes
276	SF-3.4 Surface Condition 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
277	CHAPTER 6 CERTIFICATION PART CR CERTIFICATION REQUIREMENTS CR-1 PURPOSE AND SCOPE CR-2 GENERAL CR-2.1 ASME BPE Certificate Holders CR-2.2 ASME BPE Certificate Holder’s Responsibilities Figure CR-1-1 ASME Certification Mark With BPE Designator
278	CR-2.3 Certification Designator CR-2.4 Quality Management System
279	MANDATORY APPENDICES MANDATORY APPENDIX I SUBMITTAL OF TECHNICAL INQUIRIES TO THE BIOPROCESSING EQUIPMENT (BPE) COMMITTEE
280	Table II-1 Standard Units MANDATORY APPENDIX II STANDARD UNITS
281	MANDATORY APPENDIX III SINGLE-USE COMPONENTS AND ASSEMBLIES III-1 GENERAL III-2 GENERAL GUIDELINES III-3 MATERIALS III-4 BIOCOMPATIBILITY III-5 EXTRACTABLES AND LEACHABLES III-6 COMPONENTS
282	III-7 JOINING METHODS III-8 IDENTIFICATION III-9 CERTIFICATE OF COMPLIANCE III-10 INSPECTION AND PACKAGING
283	III-11 STERILIZATION (BIOBURDEN CONTROL) III-12 SHELF LIFE, STORAGE, AND EXPIRATION DATE III-13 PARTICULATES
285	MANDATORY APPENDIX IV NOMENCLATURE
287	NONMANDATORY APPENDICES NONMANDATORY APPENDIX A COMMENTARY: SLAG AND OXIDE ISLANDS
288	NONMANDATORY APPENDIX B MATERIAL AND WELD EXAMINATION/INSPECTION DOCUMENTATION
289	Forms Form MEL-1 Material Examination Log
290	Form MER-1 Material Examination Record
291	Form WEL-1 Weld and Examination/Inspection Log
292	NONMANDATORY APPENDIX C SLOPE MEASUREMENT AND JOINT MISALIGNMENT C-1 GENERAL C-2 JOINT MISALIGNMENT
293	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
295	Table D-2-1 Considerations That Affect the Amount of Rouge Formation During the Fabrication of a System
296	Table D-2-2 Considerations That Affect the Amount of Rouge Formation During the Operation of a System
297	Table D-3.1-1 Process Fluid Analyses for the Identification of Mobile Constituents of Rouge
298	Table D-3.2-1 Solid Surface Analyses for the Identification of Surface Layers Composition
299	Table D-4.1-1 Rouge Remediation Processes Summary
301	NONMANDATORY APPENDIX E PASSIVATION PROCEDURE QUALIFICATION E-1 GENERAL E-2 PURPOSE OF PASSIVATION TREATMENTS
302	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
303	Table E-3.2-2 Passivation Processes
304	E-5 EVALUATION OF CLEANED AND PASSIVATED SURFACES
305	Table E-5-1 Test Matrix for Evaluation of Cleaned and/or Passivated Surfaces
309	NONMANDATORY APPENDIX F CORROSION TESTING F-1 GENERAL F-2 CORROSION TESTS F-3 PITTING RESISTANCE EQUIVALENT (PRE) NUMBER
310	Table F-1-1 ASTM Corrosion Tests
311	Table F-3-1 PRE Numbers for Some Alloys
312	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
313	NONMANDATORY APPENDIX H ELECTROPOLISHING PROCEDURE QUALIFICATION H-1 SCOPE H-2 PURPOSE H-3 ELECTROPOLISH PROCEDURE QUALIFICATION
314	Table H-3.3-1 Minimum Surface Requirements for Process Qualification Samples
315	NONMANDATORY APPENDIX J VENDOR DOCUMENTATION REQUIREMENTS FOR NEW INSTRUMENTS J-1 OVERVIEW J-2 INSTRUCTIONS FOR USE
316	Table J-1.1-1 Vendor Documentation Requirements for New Instruments: Section 1, VDR Definitions
317	Table J-1.2-1 Vendor Documentation Requirements for New Instruments: Section 2, Instrument Types and Required Documents
318	NONMANDATORY APPENDIX K STANDARD PROCESS TEST CONDITIONS (SPTC) FOR SEAL PERFORMANCE EVALUATION K-1 SEALING COMPONENT PERFORMANCE EVALUATION
320	K-2 MECHANICAL SEAL PERFORMANCE EVALUATION
321	Figure K-1.3.2.1-1 Weir-Style Diaphragm
324	Figure K-1.3.2.1-2 Weir-Style Body Figure K-1.3.2.1-3 Radial-Style Body Figure K-1.3.2.1-4 Manual Bonnet Figure K-1.3.2.1-5 Pneumatic
328	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
329	Table L-3-1 Thermoset Polymer Test Properties
330	Table L-4-1 Interpretation of Thermoset Material Property Changes
331	NONMANDATORY APPENDIX M SPRAY DEVICE COVERAGE TESTING M-1 SCOPE M-2 PURPOSE M-3 MATERIALS M-4 PROCEDURE M-4.2 Application of Fluorescent Solution
332	M-4.3 Execute Rinse M-4.4 Inspection M-5 ACCEPTANCE CRITERIA M-6 RECOMMENDED DOCUMENTATION
333	NONMANDATORY APPENDIX N COMMENTARY: UNS S31603 WELD HEAT-AFFECTED ZONE DISCOLORATION ACCEPTANCE CRITERIA
334	NONMANDATORY APPENDIX O GUIDANCE WHEN CHOOSING POLYMERIC AND NONMETALLIC MATERIALS O-1 GENERAL O-2 PARTICULATES
335	NONMANDATORY APPENDIX P GENERAL BACKGROUND/USEFUL INFORMATION FOR EXTRACTABLES AND LEACHABLES P-1 REFERENCES
336	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
337	Figure P-4-1 Flowchart of Bioprocessing Equipment/Component Evaluation Related to Extractables and Leachables Characterization
338	NONMANDATORY APPENDIX Q TEMPERATURE SENSORS AND ASSOCIATED COMPONENTS Q-1 GENERAL Q-2 EXTERNAL SUPPORT COMPONENTS Q-3 MEASUREMENT ACCURACY
339	Q-4 SELECTION Q-5 MAINTENANCE
340	NONMANDATORY APPENDIX R INSTRUMENT RECEIVING, HANDLING, AND STORAGE R-1 INTRODUCTION R-2 INSTRUMENT RECEIVING R-3 INSTRUMENT HANDLING R-4 STORAGE
341	NONMANDATORY APPENDIX S APPLICATION DATA SHEET
342	Form S-1 Application Data Sheet
343	NONMANDATORY APPENDIX T GUIDANCE ON POLYMER APPLICATIONS: CHROMATOGRAPHY COLUMNS AND FILTRATION T-1 CHROMATOGRAPHY COLUMNS T-2 FILTRATION
346	NONMANDATORY APPENDIX U GUIDANCE FOR THE USE OF U.S. CUSTOMARY AND SI UNITS U-2 GUIDELINES USED TO DEVELOP SI EQUIVALENTS
347	U-3 CHECKING EQUATIONS U-4 SOFT CONVERSION FACTORS
348	NONMANDATORY APPENDIX W POSITIVE MATERIAL IDENTIFICATION W-1 GENERAL W-2 GENERAL REQUIREMENTS
349	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
351	NONMANDATORY APPENDIX Y PROCUREMENT SOURCES
352	NONMANDATORY APPENDIX Z QUALITY MANAGEMENT SYSTEM Z-1 SCOPE AND PURPOSE Z-2 GENERAL Z-3 QUALITY MANAGEMENT SYSTEM MANUAL
356	NONMANDATORY APPENDIX AA STATIC SEALS APPLICATION GUIDE FOR COMPENDIAL WATER SYSTEMS AA-1 GENERAL AA-2 MATERIAL CLASS DESCRIPTIONS1Reference ASTM D1418, Standard Practice for Rubber and Rubber Latices — Nomenclature.
357	Table AA-1-1 Static Seals for Use in Compendial Water Systems (SG-2.2.1)
359	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
361	NONMANDATORY APPENDIX CC EXAMINATION, INSPECTION, AND CROSS REFERENCES
364	NONMANDATORY APPENDIX DD CONDUCTIVITY SENSOR SELECTION GUIDE DD-1 PURPOSE DD-2 GENERAL CONSIDERATIONS OF COMMON SENSE TECHNOLOGIES
365	Figure DD-2.1.1-1 Conductivity Scale Table DD-2.6-1 Technological Considerations
366	INDEX

Published By	Publication Date	Number of Pages
ASME	2019	381


PDF Format	Searchable	Printable	Preview Now

Standard Title	ASME BPE-2019: Bioprocessing Equipment
Published Code	ASME
Publication Date	2019
Pages Count	381

ASME BPE 2019

PDF Catalog

Related products

ASME PTB 2 2022

ASME BPE 2019 Portuguese