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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Equipment size is generally staying about ll t i b t the same size or getting smaller. New Application Data Sheet for seal specification? Guidelines for Cleaning Vessels? Very low sulfur material is difficult to weld since the weld pool tends to be shallow, wide and difficult to obtain uniform joint penetration.

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. 200

ASME BPE 2009 B P E

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.

New resource material will be provided on electropolishing, passivation, elastomer performance, metallic materials of construction, polymer surface finishes, corrosion testing and stainless steel rouge. American Society of Mechanical Engineers. The last 20 years have seen dramatic improvements in fabrication technol-ogy.

The Standard is continuosly being updated to represent a consensus of current good manufacturing practices cGMP for the biopharmaceutical industry. Meets 3 times annually to: Work on the BPE was begun and the first edition was published in The BPE has also been expanded to include new sections on npe instrumentation, hygienic pumps, hygienic hose assemblies and rotary spray devices.

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ASME BPE – Wikipedia

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.

Multiple stages of approval before publication? Control of material chemistry and weld end dimensions Figure 2. Resistance to steam and corrosives? ASME BioProcessing Equipment standard or ASME BPE 1 ASME BPE Scope This Standard deals with the 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.

An orbital welding operator welding a tubing assembly at a biotechnology expansion in Singapore. The location of the assembly is shown on the weld map with the position of each weld numbered.

ASME BPE Guidelines for Pharmaceutical Equipment

Stadler, Henon and Koiro. New section on seals for i l f compendial water pumps. 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.

Photo courtesy of Kenyon Engineering. Installation practices SOPs developed by installing contractors are written procedures that all welding and installation personnel must follow. 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.

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Weld discoloration relative to amounts of oxygen added to ID purge gas.

If you want to vote on changes and updates to an international standard. 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. Weld Inspection and Examination has become more systematic in recent years.

You may also contact after the meeting at: New Nominal one inch fitting design. Welds at that time were often discolored due to poor inert gas purging. An orbitally welded assembly for a CIP pump for a l fermentor. 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.

New Design Criteria for Hygienic Clamps. Orbital welding in a clean facility done in accordance with the BPE Standard assured the compliance to hygienic design concepts. Newer designs in weld heads such as the Arc Machines, Inc.

Problems with defective welds on process equipment imported from Europe was the initial catalyst that led to work on the BPE Standard. One facility has to be accepted by: