ASME BPE (Revision of ASME BPE). Bioprocessing. Equipment. AN AMERICAN NATIONAL STANDARD. Three Park Avenue. Buy ASME BPE Bioprocessing Equipment from SAI Global. No reproduction may be made of this material without written consent of ASME. ASME BPE (Revision of ASME BPE) Bioprocessing.

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No reproduction may be made of this material without written consent of ASME. March 21, The next edition of this Standard is scheduled for publication in There will be no addenda issued to this edition. ASME issues written replies to inquiries concerning interpretations of technical aspects of this Standard. 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 take any position with respect to the validity of any patent rights asserted in connection with any items mentioned in this document, awme 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 ame any form, in an electronic retrieval system or otherwise, without the prior written permission of the publisher.

Copyright c by the American Society of Mechanical Engineers. Design for Sterility and Cleanability. Joining Processes and Procedures. Weld Joint Design and Preparation. Inspection, Examination, and Testing. General Provisions for Seals in Bioprocessing Service: User Basic Design Requirement. Special Provisions for Seals in Bioprocessing Service. Recommended and Preferred Drop Designs. Double Block-and-Bleed Valve Assembly. Flexible Hygienic Hose Design. Vessel Design Tangential Nozzles. Vessel Sight Glass Design.


Side and Vpe Connections. Shaft Coupling Seal 20007. Clean Steam Point-of-Use Design. Steam Traps for Clean Steam Systems. Physical Break in Point-of-Use Piping. Transfer Panel Looped Headers.

ASME BPE – Wikipedia

Basic Components of a Seal. Single Dry Running Contacting Seal. Seal Piping and Lubrication Plans. Gas Lubricated Noncontacting Double Seal.

Tandem Seal With Barrier System. V-Ring Packing for Reciprocating Applications. Open Cross-Sectional Lip Seal. Typical Ball Valve Configuration. Slope Designations for Gravity-Drained Lines.

Recommended Flow Rates to Achieve 5 fps 1. Transfer Ssme and Jumper Tolerances. Straight Tee and Cross. Concentric and Eccentric Reducer. Hygienic Clamp Joint, deg Elbow. Short Outlet Reducing Tee.

Short Outlet Run Tee. Tube Weld Concentric and Eccentric Reducer. Weir Style Diaphragm Valve. Acceptance Criteria for Welds on Pipe. Acceptance Criteria for Welds on Tube. Acceptance Criteria for Tube-Attachment Welds. Ra Readings for Product Contact Surfaces. The initial scope was approved by the CCS on June 20,with a directive to the Board on Pressure Technology to initiate this project with the following initial scope: This bbpe is intended for design, materials, construction, inspection, and testing of vessels, piping, and asem 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 2007 part of the standard. The committee met in and there was consensus concerning the need to develop standards that would meet the requirements of operational bioprocessing, including: 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 biopharmaceutical equipment design and fabrication.

The first edition of this Standard was approved as an American National Standard on December 22, It is the aim of the Society to provide recognition of organizations so authorized. An organization holding authorization to perform various activities in accordance with the requirements of the codes and standards may state this capability in its advertising literature. Organizations that are authorized to use Symbol Stamps for marking items or constructions that have been constructed and inspected in compliance adme ASME codes and standards are issued Certificates.


It is the aim of the Society to maintain the standing of the Symbol Stamps for the benefit of the users, the enforcement jurisdictions, and bppe holders of the Stamps who comply with all requirements.

Based on these objectives, the following policy has been established on the usage in advertising of facsimiles of the symbols, certificates, and references to codes or standards construction. 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.

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.

Zinkowski, Vice Chair P. Ankers, LifeTek Solutions, Inc. Baram, Clifton Enterprises E.

ASME BPE Guidelines for Pharmaceutical Equipment

Campbell, Bechtel National, Inc. Cirillo, Jacobs Field Services R. Cotter, Cotter Brothers Corp. Dvorscek, Abbott Laboratories E. Fisher, Fisher Engineering M. Gonzalez, Retired, Amgen, Inc.

Henon, Arc Machines, Inc. Kimbrel, UltraClean Electropolish, Inc. Murakami, Hitachi Plant Technologies Ltd. Murphy, Global Stainless Ltd. Peterman, High Purity Connections, Inc.

Sisto, Purity Systems, Inc. Trumbull, Paul Mueller Co. Benway, Chair, Swagelok Co. Baram, Clifton Enterprises C. Cirillo, Jacobs Field Services B. Arnold, Pall Filtration Pte. Daly, Jacobs Engineering J. Dvorscek, Abbott Laboratories M. Fisher, Fisher Engineering G. Hobick, Holland Applied Technologies C. Kranc, Tech As,e P. McCune, Allegheny Bradford Corp.

Miller, Wyeth Biopharma J. Minor, Paul Mueller Co. Nemenoff, Habonim Industrial Valves Ltd. Obertanec, LJ Star, Inc.