BPE 2009 BIOPROCESSING EQUIPMENT PDF

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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The most extensive revision to date!

Not too restrictive or expensive? Documents Flashcards Grammar checker. This has virtually eliminated all of the problems related to sulfur content and greatly improved installation of biopharmaceutical systems. Go to a meeting and listen to the Subcommittee Sessions.

Program is starting with tubing and fitting manufacturers.

In an engineer at a biotechnology plant in San Francisco, California was preparing to install some process equipment and recognized that the welds on the equipment were of insufficient quality to meet the stringent hygienic requirements necessary for growing cells in culture. Participate in a Task Group. The BPE Standard is a consensus standard with work done by volunteers.

Should I become a member? Weld discoloration was shown to increase with increasing amounts of bio;rocessing added to the ID argon purge.

ASME BPE 修改说明介绍_图文_百度文库

Developed and maintained by a balanced group of experts? One of the contributions of the BPE Standard to achieving high quality hygienic welds was to specify the amount of color permitted on the ID of the weld and heat-affected zone HAZ.

Welding documentation includes docu-ments certifying the equiipment procedures and welding personnel to ASME Sect. New Process Systems Design Requirements! The BPE recommended the use of L for weld bjoprocessing but there is considerable heat-to-heat variation in the weldability of stainless steel so even when only L is used, variations in trace element composition, especially sulfur content can cause problems in welding.

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Prior to the introduction of the BPE, piping and component materials in biopharmaceutical applications could be or or L or L stainless steel. Passivation Procedure Qualification 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.

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.

Weld discoloration relative to amounts of oxygen added to ID purge gas. An example equipmentt how a manufac-turer of bioprocessing equip-ment optimized their production, Sartorius BBI Sys-tems, Inc. 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.

New Design Criteria for Hygienic Clamps.

Improvements in Installation Practices of Bioprocess Piping Systems

But a greater problem results when welding fittings to tubing with large differences in the sulfur content. Photo courtesy of Protech Process, Inc.

The BPE Committee has reached its initial goal of achieving welds of consistent high quality compatible with the princi-ples of hygienic design. Photo courtesy of Kenyon Engineering. A good machined end-preparation is important for fit-up of the weld joint and for gioprocessing repeatable orbital welds.

ASME BPE – Wikipedia

In this case, the weld pool may shift favoring the low sulfur heat and lack of penetration may occur. Although the repeatability of orbital welding power supplies had the potential to deliver higher productivity than manual welding because of improved weld repeatability and less need for re-work, conditions existing in the Industry at that time made the fulfillment of this promise problematic.

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While the AISI specified only an upper limit for sulfur of 0. 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. Unpenetrated welds are entrapment sites for product and are difficult to clean. This assures that procedures are consistenly carried out and increases the likelyhood that all welds will be of similar high quality.

Orbital welding has been central to this advancement while standardiza-tion of weld end dimensions and chemistry by the BPE have resulted in more repeatable welding procedures. New resource material will be provided on electropolishing, passivation, elastomer performance, metallic materials of construction, polymer surface finishes, corrosion testing and stainless steel rouge.

Installation practices SOPs developed by installing contractors are written procedures that all welding and installation personnel must follow. The Standard is continuosly being updated to represent a consensus of current good manufacturing practices cGMP for the biopharmaceutical industry.

This means that all of the materials and components must be inspected prior to installation and provision for weld inspection and documentation must happen during the manufacture of the skid. Color chart from AWS D