Bioprocessing Equipment

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1 ASME BPE-2014 (Revision of ASME BPE-2012) Bioprocessing Equipment AN INTERNATIONAL STANDARD

2 ASME BPE-2014 (Revision of ASME BPE-2012) Bioprocessing Equipment AN INTERNATIONAL STANDARD Two Park Avenue New York, NY USA

3 Date of Issuance: October 10, 2014 The next edition of this Standard is scheduled for publication in This Standard will become effective 6 months after the Date of Issuance. ASME issues written replies to inquiries concerning interpretations of technical aspects of this Standard. Periodically, certain actions of the ASME BPE Committee may be published as Cases. Cases and interpretations are published on the ASME Web site under the Committee Pages at as they are issued. Errata to codes and standards may be posted on the ASME Web site under the Committee Pages to provide corrections to incorrectly published items, or to correct typographical or grammatical errors in codes and standards. Such errata shall be used on the date posted. The Committee Pages can be found at There is an option available to automatically receive an notification when errata are posted to a particular code or standard. This option can be found on the appropriate Committee Page after selecting Errata in the Publication Information section. ASME is the registered trademark of The American Society of Mechanical Engineers. This code or standard was developed under procedures accredited as meeting the criteria for American National Standards. The Standards Committee that approved the code or standard was balanced to assure that individuals from competent and concerned interests have had an opportunity to participate. The proposed code or standard was made available for public review and comment that provides an opportunity for additional public input from industry, academia, regulatory agencies, and the public-at-large. ASME does not approve, rate, or endorse any item, construction, proprietary device, or activity. ASME does not take any position with respect to the validity of any patent rights asserted in connection with any items mentioned in this document, and does not undertake to insure anyone utilizing a standard against liability for infringement of any applicable letters patent, nor assume any such liability. Users of a code or standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, is entirely their own responsibility. Participation by federal agency representative(s) or person(s) affiliated with industry is not to be interpreted as government or industry endorsement of this code or standard. ASME accepts responsibility for only those interpretations of this document issued in accordance with the established ASME procedures and policies, which precludes the issuance of interpretations by individuals. No part of this document may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission of the publisher. The American Society of Mechanical Engineers Two Park Avenue, New York, NY Copyright 2014 by THE AMERICAN SOCIETY OF MECHANICAL ENGINEERS All rights reserved Printed in U.S.A.

4 CONTENTS Foreword... Statements of Policy... Committee Roster... Summary of Changes... ix xi xii xvi Part GR General Requirements... 1 GR-1 Introduction... 1 GR-2 Scope of the ASME BPE Standard... 1 GR-3 Manufacturer s Quality Assurance Program... 1 GR-4 Inspection... 2 GR-5 Documentation... 6 GR-6 U.S. Customary and SI Units... 8 GR-7 References... 8 GR-8 Terms and Definitions... 9 Part SD Systems Design SD-1 Purpose and Scope SD-2 General Guidelines SD-3 Process Components SD-4 Process Utilities SD-5 Process Systems SD-6 Design Conformance Testing 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-5 Materials DT-6 Tests DT-7 Tolerances DT-8 Weld Ends DT-9 Hygienic Clamp Unions DT-10 Minimum Examination Requirements DT-11 Marking DT-12 Packaging Part MJ Materials Joining MJ-1 Purpose and Scope MJ-2 Materials MJ-3 Joint Design and Preparation MJ-4 Joining Processes and Procedures MJ-5 Procedure Qualifications MJ-6 Performance Qualifications MJ-7 Examination, Inspection, and Testing MJ-8 Acceptance Criteria MJ-9 Joining of Polymeric Materials MJ-10 Documentation Requirements MJ-11 Passivation Part SF Process Contact Surface Finishes SF-1 Purpose and Scope iii

5 SF-2 Metallic Applications SF-3 Polymeric Applications Part SG Sealing Components SG-1 Purpose and Scope SG-2 Sealing Component Types SG-3 Sealing Components General Design Requirements (General Provisions) SG-4 Seal Performance Requirements SG-5 Seal Applications Part PM Polymeric and Other Nonmetallic Materials PM-1 Purpose and Scope PM-2 Materials PM-3 Properties and Performance PM-4 Applications Part CR Certification CR-1 Purpose and Scope CR-2 General Part MM Metallic Materials MM-1 Purpose and Scope MM-2 Alloy Designations MM-3 Uses of Specifications MM-4 Referenced Specifications MM-5 Fabrication MM-6 Mechanical Properties MM-7 Corrosion Resistance Requirements MM-8 Addition of New Alloys to Part MM Part PI Process Instrumentation PI-1 Purpose and Scope PI-2 Process Instrumentation General Requirements PI-3 Instrument Receiving, Handling, and Storage PI-4 Flowmeters PI-5 Level Instruments PI-6 Pressure Instruments PI-7 Temperature Sensors and Associated Components PI-8 Analytical Instruments PI-9 Optical Figures SD Flat Gasket Applications SD Accepted Point-of-Use Designs SD Double Block-and-Bleed Valve Assembly SD Flexible Hygienic Hose Design SD Pump Impeller Configurations SD Acceptable Impeller Attachments SD Casing Drain Configurations SD Casing Drain L/D Ratios SD Rotary Lobe Pump Rotor Attachment SD Nozzle Design SD Side and Bottom Connections SD Sidewall Instrument Ports SD Accepted Nozzle Penetrations SD Vessel Design Tangential Nozzles SD Sight Glass Design (Accepted) SD Typical Nozzle Detail SD Internal Support Members iv

6 SD Agitator Mounting Flanges SD Shaft Coupling Construction SD Shaft Coupling Seal Arrangments SD Fastener Seal Arrangements SD Shaft Steady Bearing SD Magnetically Coupled Mixer (Typical Bottom-Mount) SD Double Tubesheet Heat Exchanger Bonnet Design SD Transfer Panel Looped Headers SD Transfer Panel Tolerances SD Transfer Panel Jumpers SD Tapered Locking Tab Retainer Recessed SD Tapered Locking Tab Retainer External SD Dynamic Spray Device: Single Axis SD Two Axes Dynamic Spray Device SD Static Spray Device SD Flow Rate Guideline for Vertical Cylindrical Vessels SD Flow Rate Guideline for Horizontal Cylindrical Vessels SD Impact Pattern Build-Up SD Steam Traps for Clean Steam Systems SD Point-of-Use Piping SD Physical Break in Point-of-Use Piping SD Typical Clean Steam System Isometric SD Clean Steam Point-of-Use Design SD Fermentor Sterile Envelope SD Bioreactor Sterile Envelope SD Gas Sparging Assembly Lance SD Gas Sparging Assembly Sintered SD Gas Sparging Assembly Ring SD Gas Sparging Assembly Single Orifice SD Exhaust Gas Condenser SD Exhaust Gas Heater SD Electrically Heat Traced Filter Housing SD Tank/Vessel Vent Filters SD CIP Looped Header (Supply or Return) SD Zero-Static Chain SD Swing Elbow Arrangement SD Typical Lyophilizer Component Assembly SD Lyophilizer Sterile Boundary DT-2-1 Clamp Conditions at Installation MJ Acceptable and Unacceptable Weld Profiles for Tube Welds MJ Discoloration Acceptance Criteria for Weld Heat-Affected Zones on MJ Electropolished 316L Tubing Discoloration Acceptance Criteria for Weld Heat-Affected Zones on Mechanically Polished 316L Tubing MJ Acceptable and Unacceptable Weld Bend Width and Meander MJ Acceptable Weld Profiles for Tube-Attachment Fillet Welds MJ Acceptable and Unacceptable Weld Profiles for Beadless Welds SG Hygienic Union per Table DT SG Hygienic Clamp Union per Table DT SG Hygienic Union per DIN SG Hygienic Clamp Union per DIN SG Nonhygienic Connections SG Weir Valves SG Radial Valves SG Weirless Diaphragm Valve SG Linear Control Valves v

7 SG Regulator Valve SG Ball Valves SG Rising Stem Single, Double Seat Mix Proof, and Needle Valves SG Butterfly Valve SG Back Pressure Control Valve SG Pinch Valve SG Pressure Relief and Check Valves SG Plug Valve SG Single Mechanical Seal SG Single Seal for Top Entry Agitator SG Dual Pressurized Mechanical Seal for Pumps SG Dual Pressurized Mechanical Seal for Top Entry Agitator SG Dual Unpressurized Mechanical Seal for Pumps SG Flush Plan SG Flush Plan SG Flush Plan SG Flush Plan SG Flush Plan SG Flush Plan 52 for Pump SG Flush Plan 52 for Top Entry Agitator SG Flush Plan BPE52 for Pump SG Flush Plan 53 for Pump SG Flush Plan 53 for Top Entry Agitator SG Flush Plan 54 for Pump SG Flush Plan 54 for Top Entry Agitator SG Flush Plan 55 for Pump SG Flush Plan 55 for Top Entry Agitator SG Flush Plan 74 for Pump SG Flush Plan 74 for Top Entry Agitator SG Static O-Ring SG Seals for Rising Stem Valves SG Typical Hygienic Clamp Union: Allowable Gasket Intrusion CR-1-1 ASME Certification Mark With BPE Designator CR-2-1 Options for Certification of Organizations PI In-Line and At-Line Instrument Installation Examples PI Accepted Insertion Device Installation Examples PI Manifold or Flow Splitter for Dual Tube Construction Flowmeters and Potential for Product Holdup PI Concentrically Reducing Process Connection PI Vertical Installation PI Minimum Angle of Inclination, PI Bulb, Horn, Isolated Horn, and Rod Style Antenna PI Dead Band, Measuring Range, and Mounting Location PI Typical Installation Styles PI Accepted Elbow Orientations and Flow Directions PI Accepted Nonintrusive Orientations and Flow Directions PI Sensor Insertion Lengths for Tee Installations PI Sensor Insertion Lengths for Elbow Installations PI Conductivity Type Examples PI Accepted Installations for Conductivity Sensors PI Installation Clearance Requirements PI ph Sensor Components PI Accepted ph Sensor Installations PI Accepted Mounting Orientations PI Insertion Length or Depth PI Vessel Light Glass Design and Mounting vi

8 PI In-Line Insertion Length PI Insertion Probe Length Tables GR Inspector s Delegate Capabilities... 3 SD Slope Designations for Gravity-Drained Lines SD L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight SD Tee With Blind Cap L/D Dimensions for Flow-Through Tee: Short Outlet Reducing Tee With Blind Cap SD Annular Spacing Recommendations for Hygienic Dip Tubes SD Flow Rates to Achieve 5 ft/sec (1.52 m/s) DT-2-1 Hygienic Unions: Rated Internal Working Pressure DT-3-1 Final Tolerances for Mechanically Polished Fittings and Process Components DT-3-2 Final Tolerances for Electropolished Fittings and Process Components DT-4-1 Nominal O.D. Tubing Sizes DT Tangent Lengths DT Automatic Tube Weld: 90-deg Elbow DT Automatic Tube Weld: Hygienic Clamp Joint, 90-deg Elbow DT Hygienic Clamp Joint: 90-deg Elbow DT Automatic Tube Weld: 45-deg Elbow DT Automatic Tube Weld: Hygienic Clamp Joint, 45-deg Elbow DT Hygienic Clamp Joint: 45-deg Elbow DT Automatic Tube Weld: 180-deg Return Bend DT Hygienic Clamp Joint: 180-deg Return Bend DT Automatic Tube Weld: Straight Tee and Cross DT Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee DT Hygienic Mechanical Joint: Short Outlet Run Tee DT Hygienic Clamp Joint: Straight Tee and Cross DT Hygienic Clamp Joint: Short Outlet Tee DT Automatic Tube Weld: Reducing Tee DT Automatic Tube Weld: Short Outlet Hygienic Clamp, Joint Reducing Tee DT Hygienic Clamp Joint: Reducing Tee DT Hygienic Clamp Joint: Short Outlet Reducing Tee DT Automatic Tube Weld: Instrument Tee DT Hygienic Clamp Joint: Instrument Tee DT Automatic Tube Weld: Concentric and Eccentric Reducer DT Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer DT Hygienic Clamp Joint: Concentric and Eccentric Reducer DT Automatic Tube Weld: Ferrule DT Automatic Tube Weld: Cap DT Hygienic Clamp Joint: Solid End Cap DT Hygienic Clamp Joint: Weir Style Diaphragm Valve DT-7-1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances DT-7-2 Transfer Panel and Jumper Tolerances DT Hygienic Clamp Ferrule: Design Criteria MJ Tube/Pipe Diameter Limits for Orbital GTAW Performance Qualification MJ Weld Thickness Limits for Orbital GTAW Performance Qualification MJ Visual Examination Acceptance Criteria for Welds on Pressure Vessels and Tanks MJ Visual Examination Acceptance Criteria for Welds on Pipe MJ Visual Examination Acceptance Criteria for Groove Welds on Tube-to-Tube Butt Joints MJ Visual Examination Acceptance Criteria for Tube-Attachment Welds vii

9 SF Acceptance Criteria for Metallic Process Contact Surface Finishes SF Additional Acceptance Criteria for Electropolished Metallic Process Contact Surface Finishes SF R a Readings for Metallic Process Contact Surfaces SF Acceptance Criteria for Metallic Passivated Process Contact Surface Finishes SF Acceptance Criteria for Polymeric Process Contact Surface Finishes SF R a Readings for Polymeric Process Contact Surfaces PM Common Thermoplastic Polymers and Applications PM Common Thermoset Polymers and Applications PM Examples of Nonmetallics PM Content Required on the Certificate of Compliance PM Size Comparison of Common Thermoplastic Sizing Standards MM Wrought Stainless Steels: Nominal Compositions (wt. %) MM Wrought Nickel Alloys: Nominal Compositions (wt. %) MM Stainless Steel and Nickel Alloy Cast Designations MM Wrought Copper: Nominal Compositions (wt. %) (Cleaned for Oxygen Service) MM Filler Metals MM Consumable Inserts for Superaustenitic and Duplex Stainless Steels MM Predicted Ferrite Number (FN) Ranges for Various 316 Product Forms and Welds MM Materials for OEM Equipment MM Brazing Filler Metals for Copper Mandatory Appendices I Submittal of Technical Inquiries to the Bioprocessing Equipment (BPE) Committee II Standard Units Nonmandatory Appendices A Commentary: Slag B Material and Weld Examination/Inspection Documentation C Slope Measurement D Rouge and Stainless Steel E Passivation Procedure Qualification F Corrosion Testing G Ferrite H Electropolishing Procedure Qualification I Vendor Documentation Requirements for New Instruments J Standard Process Test Conditions (SPTC) for Seal Performance Evaluation K Standard Test Methods for Polymers L Spray Device Coverage Testing M Commentary: 316L Weld Heat-Affected Zone Discoloration Acceptance Criteria N Guidance When Choosing Polymeric and Nonmetallic Materials O General Background/Useful Information for Extractables and Leachables P Temperature Sensors and Associated Components Q Instrument Receiving, Handling, and Storage R Application Data Sheet S Polymer Applications: Chromatography Columns T Guidance for the Use of U.S. Customary and SI Units Index viii

Bioprocessing Equipment

ASME BPE-2009 (Revision of ASME BPE-2007) Bioprocessing Equipment A N I N T E R N A T I O N A L S T A N D A R D ASME BPE-2009 (Revision of ASME BPE-2007) Bioprocessing Equipment AN INTERNATIONAL STANDARD