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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Examination is done by the installer or the person performing the weld while inspection must be done by the owner or his representative which may be a third party QC company or consultant. This publication will include new content on the design of process systems such as bioreactors, fermentors, autoclaves, process gasses, CIP distribution and single-use equipment.

An orbitally welded assembly for a CIP pump for a l fermentor. SBBIS designed and organized an entire facility to improve workflow and effi-ciency and to streamline pro-cedures.

Standards such as BPE operate on the assumption that quality must be built in – it cannot be added after the fact. The location of the assembly is shown on the weld map with the position of each weld numbered. The yel-low control document travels with the part as it is fabricated. You may also contact after the meeting at: 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.

Steaming for bioburden control? An orbital welding operator welding a tubing assembly at a biotechnology expansion in Singapore.

ASME BPE 修改说明介绍_图文_百度文库

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. While the AISI specified only an upper limit for sulfur of 0.

Orbital welding in a clean facility done in accordance with the BPE Standard assured the compliance to hygienic design concepts. Summary The last 20 years have seen dramatic improvements in fabrication technol-ogy.

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Improvements in Installation Practices of Bioprocess Piping Systems

Weld coupons or test welds are routinely used for Quality Assur-ance of biopharmaceutical process piping systems. 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. Metallic Materials of Construction? 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 vioprocessing cleanability.

This presentation will summarize the new BPE resources and requirements for the design and delivery of components and process systems for use in bioprocessing, pharmaceutical, and personal care product industries. Fabrication and in some cases installation and commissioning of the skids can occur at the same time as plant construction. Limits on inside diameter ID and outside diameter OD concavity and misalignment are set to promote drainability and cleanability bioprocezsing weld surfaces.

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. A good machined end-preparation is important for fit-up of the weld joint and for achieving repeatable orbital welds. 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.

ASME BPE – Wikipedia

ASME BioProcessing Equipment standard or ASME BPE 1 ASME BPE Scope This Standard deals with equipmenh requirements of the bioprocessing, pharmaceutical, and personall care product d t industries i d t i as well ll as other applications with relatively high levels of hygienic requirements, covering directly or indirectly the subjects of materials, design, fabrication, inspections, testing, and certification.

For the recent expansion at Lonza Biologics Expansion in Singapore, process equipment for the large scale mammalian biopharmaceutical production plant was fabricated, tested and disassembled in the United States, and then shipped to Singapore for reassembly onsite.

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This in-process 209 examination is done in lieu bp radiography that would otherwise be required. You may also contact after the meeting at: While the BPE Standard specifies what the end result must be, it does not provide guidelines for installers telling them how to achieve the desired results.

ASME BPE Guidelines for Pharmaceutical Equipment

Prior to the introduction of the BPE, piping and component materials in biopharmaceutical applications could be or or L or L stainless steel. When electropolishing of welded assemblies is specified, SBBIS does the electropolishing in-house to prevent the contamination that would result from transport to another facility. Welds at that time were often discolored due to poor inert gas purging.

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.

Compendial Water Bppe Seals?

The BPE Surface Finish Subcommit-tee has added a new non-mandatory appendix to the Edition of BPE that offers guidelines to owners for qualification of their passivation proce-dures. Program is starting with tubing and fitting manufacturers.

Determine where your technical strengths would help. Meets 3 times annually to: Photo courtesy of Kenyon Engineering. Weld discoloration was shown to increase with increasing amounts of oxygen added to the ID argon purge. Consistent dimensions are important as the welding current is based on wall thickness.

Equipmennt chart from AWS D 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.