BPE 2009 BIOPROCESSING EQUIPMENT PDF

Published by on December 26, 2019
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Buy ASME BPE: BIOPROCESSING EQUIPMENT from SAI Global. The next edition of this Standard is scheduled for publication in This Standard represents the work of the BPE Standards Committee and includes the follow- ASME BIOPROCESSING EQUIPMENT COMMITTEE. ASME BPE Supplement. Supplement to Bioprocessing Equipment. Amendment by ASME International, 05/19/ This document is an amendment.

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bps Orbital welding in a clean facility done in accordance with the BPE Standard assured the compliance to hygienic design concepts. Weld coupons or test welds are routinely used for Bioprocessint Assur-ance of biopharmaceutical process piping systems. Each weld has a unique number and the locatiion of any weld in a facility can be traced to a particular isometric equupment creating a weld map Figure 6.

Speak up and be an active participant in the Subcommittee Sessions. A good machined end-preparation is important for fit-up of the weld joint and for achieving repeatable orbital welds. Use of the BPE Standard has continued to grow to the point that virtually all new biopharmaceutical plants in the United States and many foreign countries, have been designed to, or have retroactively incorporated its requirements into their specification. Contaminants other than oxygen, including moisture, oil or grease on the tubing, etc.

ASME BPE 修改说明介绍_图文_百度文库

New Supplier Certification Program! It does not apply to those components that are not in contact with the finished product or part of the intermediate manufacturing stages. Determine where your technical strengths would help. All welds must have complete penetration to the inside surface of the weld which, in bioprocess applications, is usually the product contact surface.

ASME BPE has emerged as the definitive international standard on bioprocessing equipment and facilities, covering the subjects ofmaterials, design, fabrication, inspections, testing, and certification. While no color is per-mitted qeuipment the weld itself, a slight color may be allowed on the HAZ. Documents Flashcards Grammar checker.

The BPE has also bioproecssing expanded to include new sections on process instrumentation, hygienic pumps, hygienic hose assemblies and rotary spray devices. The BPE Committee has equip,ent its initial goal of achieving welds of consistent high quality compatible with the princi-ples of hygienic design. Program is starting with tubing and fitting manufacturers. Developed and maintained by a balanced group of experts? Weld discoloration was shown to increase with increasing amounts of oxygen added to the ID argon purge.

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Not too restrictive or expensive? In this case, the weld pool may shift favoring the low sulfur heat and lack of penetration may occur. Since existing standards were insufficient for this new technology, the engineer recruited a group of suppliers and end users in the industry and they approached the American Society of Mechanical Engineers ASME for permission to begin the writing of a new standard for the developing Bioprocess Industry.

ASME BPE – Wikipedia

While the AISI specified only an upper limit for sulfur of 0. Very low sulfur material is difficult to weld since the weld pool tends to be vpe, wide and difficult to obtain uniform joint penetration.

You may also contact after the meeting at: Photo courtesy of Protech Process, Inc. The BPE Bioprocezsing is a consensus standard with work done by volunteers.

Welding documentation includes docu-ments certifying the welding procedures and welding personnel to ASME Sect. Updated regularly to reflect the current acceptance criteria. Equipment size is generally staying about ll t i b t the same size or getting smaller. New Design Criteria for Hygienic Clamps. The BPE Standard deals with the requirements of the bioprocessing and pharmaceutical industries, as well as other applications with relatively high levels of hygienic requirements or bioburden control.

Achieving welds of consistent high quality compatible with the principles of hygienic design was an initial goal of the BPE Committee, but the Standard is by no means limited to welding and fabrication issues.

End Users just expect fittings, tubing, and valves to ewuipment the standards. Resistance to steam and corrosives? This has virtually eliminated all of the problems related to sulfur content and equipmejt improved installation of biopharmaceutical systems.

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Improvements in Installation Practices of Bioprocess Piping Systems

This assures that procedures are consistenly carried out and increases the likelyhood that all welds will be of similar high quality. New Process Systems Design Requirements! If you have the time and interest to be y an active participant.

Guidelines for Cleaning Vessels?

Prior to the introduction of the BPE inthere was no consistency in material chemistry or in the dimensions of weld fittings used in biopharmaceutical applications. New acceptance criteria for passivated product contact surfaces? Passivation restores, at least in part elements in the passive surface layer that are dquipment by welding and the concomitant loss of corrosion resistance.

This figure allows owners, installing contractors and QA people to agree in advance to the amount of weld discoloration acceptable for a particular appli-cation. The MJSC developed a set of weld criteria that, in addition to code criteria for adequate structural integrity, was designed to minimize the growth of microorganisms and promote cleanability.

Multiple stages of approval before publication? The specification for the use of machine or orbital GTA welding together with the development of the ASME Bioprocessing Equipment BPE Standard has resulted in cleaner, more repeatable welding of piping and components such that thousands of welds are routinely installed with very low reject rates.

In the past there were many places in systems and equipment that an orbital weld head would not fit so a larger percentage of welds had to be done man-ually. Field welds in hygienic piping systems are typically left in the as-welded con-dition; the only post weld treatment being chemical passivation with nitric or citric acid solutions following installation.

Prior to the introduction of the BPE, piping and component materials in biopharmaceutical applications could be or or L or L stainless steel. American Society of Mechanical Engineers. Certificate of Authorization issued to qualified component suppliers.