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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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Perona, Advance Fittings Corp. Acceptance Criteria for Tube-Attachment Welds.

The conformance of material should be explicitly stated e. When markings are required on process contact surfaces, other methods of identification should be used. Brown, Chair, Swagelok Co. 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: SD Shaft Coupling Construction 15 deg to 45 deg min. Linear porosity generally occurs in the root pass from inadequate joint penetration.

SD-7, illustrations c and d. The use of short welding ferrules should be incorporated into the design. Brockmann, Alfa Laval, Inc. Proper application and engineering with respect to return pump selection, spray device selection, and piping installation make it possible to conduct such cleaning operations with a high degree of uniformity and dependability.

SD, illustrations a and b ]. Items or requirements that are not specifically hpe in this Standard cannot be considered prohibited. The first edition of this Standard was approved as an American National Standard on December 22, Examples of sealed fasteners are shown in Fig.


Consideration should be given to increasing the drain port connection size in lieu of increasing pan depth. Orbital welding can be done with the addition of filler material or as a fusion process without the addition of filler.

It is the responsibility of the end-user to establish complaince with applicable standards e. Recommended c Typical Hygienic Clamp Union — asmee. The lines should be continuously pitched above the minimum slope.

McGonigle, Active Chemical Corp. Dvorscek, Bep Laboratories R. A crack may not be detected with a stylus. Hobick, Holland Applied Technologies C. It shall be the responsibility of all parties involved to adhere to the concepts of this Part as they apply to advance the knowledge and database for sterilizable and cleanable equipment and systems.

See illustration in Table DT for the proper orientation.

ASME BPE Guidelines for Pharmaceutical Equipment

Dvorscek, Abbott Laboratories E. Hygienic Clamp Joint, deg Elbow. Tam, Teknor Apex Co. Fisher, Fisher Engineering G.

Recommended and Preferred Drop Designs. The notification of an impending inspection should be mutually agreed to by the manufacturer and the inspector. Arnold, Pall Filtration Pte. Dvorscek, Abbott Laboratories M.

ASME BPE – Wikipedia

Valve seals should comply with Part SG of this Standard. O-ring grooves should be designed with cleaning in mind without diminishing their functionality. Drago, Garlock Sealing Technologies P. All testing and quality assurance documentation will be stamped with date and time.


All vessels should be checked for drainability during fabrication. Bongiorno, Flow Smart, Inc.

ASME BPE Bioprocessing Equipment_图文_百度文库

An examiner, defined as a person who performs quality control examinations for a manufacturer as an employee of the manufacturer as defined in ASME B Current design and operating practices developed bep the pharmaceutical industry to meet FDA requirements as published in the Code of Federal Regulations, Chapter 1, Title 21, Parts and Henry, Advanced Couplings Ltd.

Supporting skid frame structures and modules should be constructed from fully sealed tubes or pipes, which are easily cleaned. Once formed, these materials can be reshaped. The purpose was to develop an ASME standard that would be distinctive, germane, and not in conflict with other industry standards.

See also gas tungstenarc welding. Materials of construction shall be corrosion resistant and compatible with chemical and physical performance and designed for steam service. Organizations that are authorized to use Symbol Stamps for marking items or constructions that have been constructed and inspected in compliance with ASME codes and standards are issued Certificates.

SD Redesignated as Fig.