ASME BPE 2005 Bio Process Equipment 1st Edition Amaryqueen Societon of Mechanicanol Engibeers Full Digital Chapters
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ASME BPE-2005
(Revision of ASME BPE-2002)
Bioprocessing
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Equipment
A N A M E R I C A N N AT I O N A L S TA N D A R D
The next edition of this Standard is scheduled for publication in 2007. There will be no addenda
issued to this edition.
ASME issues written replies to inquiries concerning interpretations of technical aspects of this
Standard. Interpretations are published on the ASME website under the Committee Pages at
http://www.asme.org/codes/ as they are issued.
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.
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Copyright © 2006 by
THE AMERICAN SOCIETY OF MECHANICAL ENGINEERS
All rights reserved
Printed in U.S.A.
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Statements of Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
Committee Roster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Summary of Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Part GR General Requirements
GR-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
GR-2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
GR-3 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
GR-4 Inspector/Examiner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
GR-5 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
GR-6 Access for Inspectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
GR-7 Manufacturer’s Quality Assurance Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
GR-8 Metric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
GR-9 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
GR-10 Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Part SD Design for Sterility and Cleanability
SD-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
SD-2 Scope and Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
SD-3 General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
SD-4 Specific Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
SD-5 Testing and Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
SD-6 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
SD-7 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Part DT Dimensions and Tolerances for Stainless Steel Automatic Welding and Hygienic
Clamp Tube Fittings and Process Components
DT-1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
DT-2 Pressure Rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
DT-3 Marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
DT-4 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
DT-5 Metal Thickness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
DT-6 Fitting Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
DT-7 Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
DT-8 Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
DT-9 Welding Ends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
DT-10 Hygienic Clamp Ends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
DT-11 Heat Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
DT-12 Surface Condition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
DT-13 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
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iii
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MJ-9 Performance Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
MJ-10 Documentation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
MJ-11 Passivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Part SF Stainless Steel and Higher Alloy Product Contact Surface Finishes
SF-1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
SF-2 Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
SF-3 Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
SF-4 Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
SF-7 Inspection and Techniques Employed in the Classification of Product Contact
Surface Finishes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
SF-8 Description of Various Surfaces Available on Stainless Steel and Higher
Alloys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Part SG Equipment Seals
SG-1 Scope and Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
SG-2 Seal Classes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
SG-3 General Provisions for Seals in Bioprocessing Service: User Basic Design
Requirement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
SG-4 Special Provisions for Seals in Bioprocessing Service . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Part PM Polymer-Based Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
PM-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
PM-2 Design Considerations for Polymeric Piping, Tubing, Fittings, Valve Bodies,
and Other Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
PM-3 Polymer Material Joining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
PM-4 Polymer Interior Product Contact Surfaces of Piping, Tubing, Fittings, Valve
Bodies, and Coated or Lined Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
PM-5 Materials of Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Figures
SD-1 Hygienic Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
SD-2 Non-Hygienic Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
SD-3 Flat Gasket Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
SD-4 Recommended and Preferred Drop Designs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SD-5 Double Block-and-Bleed Valve Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
SD-6 Instrument Location Detail: Hygienic Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
SD-7 Flexible Hygienic Hose Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
SD-8 Tank/Vessel Vent Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
SD-9 Nozzle Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
SD-10 Sidewall Instrument Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
SD-11 Dip Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
SD-12 Vessel Design Tangential Nozzles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
SD-13 Vessel Sight Glass Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
SD-14 Side and Bottom Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
SD-15 Dip Tube Nozzles: Removable Designs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
SD-16 Sight Glass Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
SD-17 Internal Support Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
SD-18 Mitered Fittings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
SD-19 Typical Nozzle Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
SD-20 Double Tubesheet Heat Exchanger Bonnet Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SD-21 In-Tank Couplings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
SD-22 Removable Agitator Impeller Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
SD-23 Point-of-Use Piping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
SD-24 Transfer Panel Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
SD-25 Transfer Panel Looped Headers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
SD-26 Transfer Panel Jumpers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
MJ-1 Acceptable and Unacceptable Weld Profiles for Tube Welds . . . . . . . . . . . . . . . . . . . 71
SG-1 Basic Components of a Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
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iv
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SG-2 Single Dry Running Contacting Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
SG-3 Internally Mounted, Process Lubricated Contact Seal . . . . . . . . . . . . . . . . . . . . . . . . . . 86
SG-4 Externally Mounted, Process Lubricated Contact Seal . . . . . . . . . . . . . . . . . . . . . . . . . 87
SG-5 Double Seal Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
SG-6 Tandem Seal Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
SG-7 Seal Piping and Lubrication Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
SG-8 Gas Lubricated Noncontacting Double Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
SG-9 Tandem Seal With Barrier System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
SG-10 Typical Packing Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
SG-11 V-Ring Packing for Reciprocating Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
SG-12 Open Cross-Sectional Lip Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
SG-13 Labyrinth Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
SG-14 Typical Angle Valve With Rolling Diaphragm and Orifice . . . . . . . . . . . . . . . . . . . . . 92
SG-15 Example of Sampling Valve With Uniformly Loaded Sliding Seal . . . . . . . . . . . . . 93
SG-16 Typical In-Line Diaphragm Valve With Weir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
SG-17 Typical Ball Valve Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
PM-1 Acceptable and Unacceptable Weld Profiles for Beadless Welds . . . . . . . . . . . . . . . 100
Tables
SD-1 L/D Dimensions for Flow-Through Tee: Full-Size Standard Straight Tee With
Blind Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
SD-2 L/D Dimensions for Flow-Through Tee: Short Outlet Reducing Tee With Blind
Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
SD-3 Annular Spacing Recommendations for Hygienic Dip Tubes . . . . . . . . . . . . . . . . . . 25
SD-4 Recommended Flow Rates to Achieve 5 fps (1.52 mps) . . . . . . . . . . . . . . . . . . . . . . . 40
SD-5 Recommended Flow Rates for Cleaning Vertical Cylindrical Vessels
Having Dished Heads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
SD-6 Transfer Panel and Jumper Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
DT-1 Nominal OD Tubing Sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
DT-2 Hygienic Unions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
DT-3 Chemical Composition for Automatic Weld Ends, % . . . . . . . . . . . . . . . . . . . . . . . . . . 51
DT-4 Tangent Lengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
DT-5 Final Tolerances for Mechanically Polished Fittings and Process
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
DT-5.1 Hygienic Clamp Ferrule Standard Dimensions and Tolerances . . . . . . . . . . . . . . . . 53
DT-6 Final Tolerances for Electropolished Fittings and Process Components . . . . . . . . . 54
DT-7 Automatic Tube Weld: 90 deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
DT-8 Automatic Tube Weld: 45 deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
DT-9 Automatic Tube Weld: Straight Tee and Cross . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
DT-10 Automatic Tube Weld: Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
DT-11 Automatic Tube Weld: Concentric and Eccentric Reducer . . . . . . . . . . . . . . . . . . . . . . 56
DT-12 Automatic Tube Weld: Hygienic Clamp Joint, 90 deg Elbow . . . . . . . . . . . . . . . . . . . 56
DT-13 Automatic Tube Weld: Hygienic Clamp Joint, 45 deg Elbow . . . . . . . . . . . . . . . . . . . 57
DT-14 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint
Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
DT-15 Automatic Tube Weld: Short Outlet Hygienic Clamp Joint Tee . . . . . . . . . . . . . . . . . 58
DT-16 Hygienic Clamp Joint: 90 deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
DT-17 Hygienic Clamp Joint: 45 deg Elbow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
DT-18 Hygienic Clamp Joint: Straight Tee and Cross . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
DT-19 Hygienic Clamp Joint: Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
DT-20 Hygienic Clamp Joint: Short Outlet Reducing Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
DT-21 Hygienic Clamp Joint: Concentric and Eccentric Reducer . . . . . . . . . . . . . . . . . . . . . . 61
DT-22 Automatic Tube Weld: Ferrule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
DT-23 Automatic Tube Weld: 180 deg Return Bend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
DT-24 Hygienic Clamp Joint: 180 deg Return Bend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
DT-25 Hygienic Mechanical Joint: Short Outlet Run Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
DT-26 Hygienic Clamp Joint: Tube Weld Concentric and Eccentric Reducer . . . . . . . . . . . 64
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DT-27 Hygienic Clamp Joint: Short Outlet Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
DT-28 Automatic Tube Weld: Instrument Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
DT-29 Hygienic Clamp Joint: Instrument Tee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
DT-30 Automatic Tube Weld: Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
MJ-1 Acceptance Criteria for Welds on Pressure Vessels and Tanks . . . . . . . . . . . . . . . . . 68
MJ-2 Acceptance Criteria for Welds on Pipe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
MJ-3 Acceptance Criteria for Welds on Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
SF-1 Acceptance Criteria for Product Contact Surface Finishes of Tubing . . . . . . . . . . . 77
SF-2 Ra Readings for Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
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SF-3 Acceptance Criteria for Product Contact Surface Finishes of Fittings . . . . . . . . . . . 78
SF-4 Ra Readings for Fittings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
SF-5 Acceptance Criteria for Product Contact Surface Finishes of Valve Bodies . . . . . . 79
SF-6 Ra Readings for Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
SF-7 Acceptance Criteria for Product Contact Surface Finishes of Vessels . . . . . . . . . . . 80
SF-8 Ra Readings for Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
SF-9 Acceptance Criteria for Product Contact Surface Finishes of Other Process
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
SF-10 Ra Readings for Other Process Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
SG-1 Common Rotary Seal Materials for Biochemical and Sterile Service . . . . . . . . . . . . 88
PM-1 Size Comparison of Common Thermoplastic Sizing Standards . . . . . . . . . . . . . . . . 96
Nonmandatory Appendices
A Commentary: Slag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
B Material Examination Log and Weld Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
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FOREWORD (05)
At the 1988 ASME Winter Annual Meeting (WAM), many individuals expressed interest in
developing standards for the design of equipment and components for use in the biopharmaceuti-
cal industry. As a result of this interest, the ASME Council on Codes and Standards (CCS) was
petitioned to approve this as a project. The initial scope was approved by the CCS on June 20,
1989, with a directive to the Board on Pressure Technology to initiate this project with the following
initial scope:
This standard is intended for design, materials, construction, inspection, and testing of vessels,
piping, and related accessories such as pumps, valves, and fittings for use in the biopharmaceutical
industry. The rules provide for the adoption of other ASME and related national standards, and
when so referenced become part of the standard.
At the 1989 WAM, an ad hoc committee was formed to assess the need to develop further the
scope and action plan. The committee met in 1990 and there was consensus concerning the need
to develop standards that would meet the requirements of operational bioprocessing, including:
(a) the need for equipment designs that are both cleanable and sterilizable;
(b) the need for special emphasis on the quality of weld surfaces once the required strength
is present;
(c) the need for standardized definitions that can be used by material suppliers, designers/
fabricators, and users; and
(d) the need to integrate existing standards covering vessels, piping, appurtenances, and other
equipment necessary for the biopharmaceutical industry without infringing on the scopes of
those standards.
The BPE Main Committee was structured with six functioning subcommittees and an executive
committee comprising the main committee chair and the subcommittee chairs. The subcommit-
tees are:
(a) General Requirements;
(b) Design Relating to Sterility and Cleanability of Equipment;
(c) Dimensions and Tolerances;
(d) Material Joining;
(e) Surface Finishes; and
(f) Seals.
Throughout the development of the Standard, close liaison was made with the European CEN,
ASTM, and the AAA Dairy Standards. The purpose was to develop an ASME standard that
would be distinctive, germane, and not in conflict with other industry standards. Wherever
possible, the Committee strived to reference existing standards that are applicable to biopharma-
ceutical equipment design and fabrication.
This Standard represents the work of the BPE Standards Committee and includes the follow-
ing Parts:
(a) General Requirements;
(b) Design for Sterility and Cleanability;
(c) Dimensions and Tolerances for Stainless Steel Automatic Welding and Hygienic Clamp
Tube Fittings;
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STATEMENT OF POLICY ON THE USE OF ASME
MARKS AND CODE AUTHORIZATION IN ADVERTISING
--``````,,`,`,,`,,,`,,,,,,`,,,-`-`,,`,,`,`,,`---
conducted in accordance with the requirements of the applicable ASME code or standard.”
The ASME Symbol Stamp shall be used only for stamping and nameplates as specifically
provided in the code or standard. However, facsimiles may be used for the purpose of fostering
the use of such construction. Such usage may be by an association or a society, or by a holder
of a Symbol Stamp who may also use the facsimile in advertising to show that clearly specified
items will carry the symbol. General usage is permitted only when all of a manufacturer’s items
are constructed under the rules of the applicable code or standard.
The ASME logo, which is the cloverleaf with the letters ASME within, shall not be used by
any organization other than ASME.
The ASME codes and standards provide rules for the construction of various items. These
include requirements for materials, design, fabrication, examination, inspection, and stamping.
Items constructed in accordance with all of the applicable rules of ASME are identified with the
official Symbol Stamp described in the governing code or standard.
Markings such as “ASME” and “ASME Standard” or any other marking including “ASME”
or the various Symbol Stamps shall not be used on any item that is not constructed in accordance
with all of the applicable requirements of the code or standard.
Items shall not be described on ASME Data Report Forms nor on similar forms referring to
ASME which tend to imply that all requirements have been met when in fact they have not been
met. Data Report Forms covering items not fully complying with ASME requirements shall not
refer to ASME or they shall clearly identify all exceptions to the ASME requirements.
ASME’s role as an accrediting rather than certifying organization shall be made clear on
stampings, labels, or nameplate markings by inclusion of the words: Certified
by .
(Fabricator)
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Visit https://ebookname.com today to explore
a vast collection of ebooks across various
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ASME BIOPROCESSING EQUIPMENT COMMITTEE
(The following is the roster of the Committee at the time of approval of this Standard.)
OFFICERS
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A. P. Cirillo, Chair
B. K. Henon, Vice Chair
P. D. Stumpf, Secretary
COMMITTEE PERSONNEL
J. Ankers, Life Tek Solutions, Inc. T. Hoobyar, Asepco, Inc.
D. D. Baram, Clifton Enterprises L. T. Hutton, Arkema, Inc.
E. A. Benway, Swagelok Co. A. Konopka, Eli Lilly & Co.
C. R. Brown, Swagelok Co. J. T. Mahar, Cuno, Inc.
W. H. Cagney, GBSC Engineering F. J. Manning, VNE Corp.
H. Murphy, Global Stainless Ltd.
R. D. Campbell, Purity Systems, Inc.
M. Pelletier, IDC
A. P. Cirillo, FST Biopharm Services
L. J. Peterman, Robert-James Sales
J. Dvorscek, Abbott Laboratories W. L. Roth, Procter & Gamble
E. B. Fisher, Fisher Engineering D. P. Sisto, Purity Systems, Inc.
M. M. Gonzalez, Amgen, Inc. P. D. Stumpf, The American Society of Mechanical Engineers
B. K. Henon, Arc Machines, Inc. C. A. Trumbull, Paul Mueller Co.
M. A. Hohmann, Eli Lilly & Co. R. J. Zinkowski, ITT Engineered Valves
EXECUTIVE COMMITTEE
B. K. Henon, Chair, Arc Machines, Inc. M. M. Gonzalez, Amgen, Inc.
J. Ankers, Life Tek Solutions, Inc. L. T. Hutton, Arkema, Inc.
E. A. Benway, Swagelok Co. K. Kimbrel, Central States Industrial
C. R. Brown, Swagelok Co. F. J. Manning, VNE Corp.
W. H. Cagney, GBSC Engineering H. Murphy, Global Stainless Ltd.
R. D. Campbell, Purity Systems, Inc. D. Smith, Consultant
A. P. Cirillo, FST Biopharm Services C. Trumbull, Paul Mueller Co.
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P. E. Trunzo, MKS Instruments R. T. Warf, WB Moore, Inc.
V. Tsui, Elan Pharmaceuticals R. J. Zinkowski, ITT Engineered Valves
B. J. Uhlenkamp, DCI, Inc.
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B. A. Billmyer, Central States Industrial Equipment P. McClune, ITT Engineered Valves
H. Murphy, Global Stainless
C. H. Carnes, Purity Systems, Inc.
L. J. Peterman, Robert-James Sales
C. Chapman, GEMU Valves
S. M. Reed, Austin-Reed Corp.
P. M. Dunbar, VNE Corp. C. Taylor, Crane Saunders
J. Dvorscek, Abbott Laboratories T. A. Willis, United Stainless, Inc.
R. F. Foley, Parsons T. G. Wilson, Top Line Process Equipment Co.
M. M. Gonzalez, Amgen, Inc. T. J. Winter, Winter Technologies
SUBCOMMITTEE ON SEALS
C. R. Brown, Chair, Swagelok Co. D. W. Newman, Newman Sanitary Gasket Co.
D. D. Baram, Clifton Enterprises A. R. Obertanec, LJ Star, Inc.
L. Bongiorno, Flow Smart, Inc. M. Pelletier, IDC
J. M. Burke, Fisher Controls/Baumann Division R. Schnell, Dupont Performance Elastomers
R. J. Elbich, Exigo Manufacturing
J. R. Van Der Post, Hyjoin Ltd.
M. C. Gagne, Alpha Bio
J. Vitti, Crane/Saunders Bio-Pharm
C. Hartrampf, GEMU Valves, Inc.
D. Helmke, Flow Products, LLC J. D. Vogel, Amgen, Inc.
L. T. Hutton, Arkema, Inc. R. T. Warf, WB Moore, Inc.
D. T. Klees, Endress & Hauser R. J. Zinkowski, ITT Engineered Valves
A. Kranc, Industrial Construction/Design M. A. Zumbrum, Maztech, Inc.
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SUBCOMMITTEE ON POLYMERS AND ELASTOMERS
L. T. Hutton, Chair, Arkema, Inc. M. L. Krauss, Solvay Solexis
R. Hanselka, Vice Chair, IES B. B. MacDonald, United Association
J. E. Alexander, Newman Sanitary Gasket, Inc. D. M. Marks, DME Alliance, Inc.
S. M. Parker, Chemineer, Inc.
H. P. Fisher, Fisher/Moore
R. W. Schnell, Dupont Performance Elastomers
J. C. Fulcher, J2D, Inc.
D. A. Seiler, Arkema, Inc.
R. Govaert, Asahi America, Inc. T. Sixsmith, George Fischer, Inc.
L. L. Jenkins, Dupont P. Tollens, Endress & Hauser
D. P. Kemkes, Entegris, Inc. J. D. Vogel, Amgen, Inc.
P. R. Khaladkar, Dupont M. A. Zumbrum, Maztech, Inc.
--``````,,`,`,,`,,,`,,,,,,`,,,-`-`,,`,,`,`,,`---
EUROPEAN BPE SUBCOMMITTEE
H. Murphy, Chair, Global Stainless Ltd. G. Kroehnert, Dockweiler AG
G. Elkabir, Vice Chair, EGMO Ltd. F. Riedewald, IDC
J. Henry, Advanced Couplings Ltd.
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ASME BPE-2005
SUMMARY OF CHANGES
Following approval by the ASME BPE Committee and ASME, and after public review, ASME
BPE-2005 was approved by the American National Standards Institute on December 22, 2005.
ASME BPE-2005 includes editorial changes, revisions, and corrections introduced in ASME
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Page Location Change
30 Fig. SD-16 Revised in its entirety
33 Fig. SD-20 Title and figure revised in its entirety
35 SD-4.8.4(e) Last line deleted
SD-4.9.1(g) Revised
36 SD-4.9.1(h) Revised
SD-4.11 Title revised
37 SD-4.11.3(b) Revised
SD-4.11.4 Revised in its entirety
SD-4.11.5 Added
SD-4.11.6 Added
38 Fig. SD-23 Added
40–44 SD-4.15.1(c)(5) Revised
Table SD-4 Former Table SD-6 redesignated as Table
SD-4
Table SD-5 Former Table SD-7 redesignated as Table
SD-5
SD-4.16 Added
Fig. SD-24 Added
Fig. SD-25 Added
Table SD-6 Added
45 Fig. SD-26 Added
47 DT-3.1 First paragraph revised
DT-3.2 Old DT-3.2 deleted and DT-3.3
redesignated as new DT-3.2
48 DT-8 Fourth paragraph revised
DT-10 Second paragraph added
DT-14 Added
49 DT-V-3.1 First paragraph revised
DT-V-3.2 Old DT-3.2 deleted and DT-V-3.3
redesignated as new DT-V-3.2
51 Table DT-4 General Note added
53 Table DT-5.1 Added
59 Table DT-17 Under A, sixth entry revised
62 Table DT-22 Revised
67, 68 MJ-6.2 Revised
MJ-6.3 Revised
MJ-6.4 (1) First paragraph revised
(2) MJ-6.4.1 revised
(3) MJ-6.4.2 revised in its entirety
(4) MJ-6.4.3 through MJ-6.5 deleted
Table MJ-1 Added
xiii
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SF-1 Revised
SF-2 Revised
SF-3(d) Revised
SF-4(a) Revised
SF-5 Deleted
SF-6 Deleted
SF-7 Revised
84 SG-3.3.1(f) Added
SG-3.4.3 Revised
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also
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