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. Milton, Alfa Laval J. OE Group 6 group. It is the aim of the Society to provide recognition of organizations so authorized. Elbich, Exigo Manufacturing R. Vpe, Jacobs Field Services.

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Problems with defective welds on process equipment imported from Europe was the initial catalyst that led to work on the BPE Standard. OE Group 6 group. Orbital welding in a clean facility done in accordance with the BPE Standard assured the compliance to hygienic design concepts. Photo courtesy of American Welding Society. Standards such as BPE operate on the assumption that quality must be built in — it cannot be added after the fact. Photo cour-tesy of Arc Machines, Inc.

Use of the BPE Bioproocessing 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. Orbital weld cut open for inspec-tion of the ID bioprocesing. One facility has to be accepted by: Installation of equipment in biopharmaceutical applications have been made more efficient by the use of skid-mounted equipment modules so that installation and fabrication can be telescoped into a shorter timescale.

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. Guidelines for Cleaning Vessels? Process piping lines are sloped for drainability as gravity is the most efficient means of draining fluid from a system. Not too restrictive or expensive? The most extensive revision to date! Should I become a member? It has helped to consolidate acceptable practices including procedures for examination, inspection and documentation of welds in bioprocess piping sys-tems.

While no color is per-mitted on the weld itself, a slight color may be allowed on the HAZ. New Application Data Sheet for seal specification? 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.

Compendial Water Pump Seals? In the past there were many places in systems and bioprocesssing that an orbital weld head would not fit so a larger percentage of welds had to be done man-ually. American Society of Mechanical Engineers. Resistance to steam and corrosives? 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 Qualifications for Inspectors and Examiners must also be included. Determine where your technical strengths would help. 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.

Participate in a Task Group. Welds at that time were often discolored due to poor inert gas purging. You may also contact after the meeting at: For equiipment 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 bioprocezsing onsite.

Photo courtesy of Kenyon Engineering. In this case, the weld pool may shift favoring the low sulfur heat and lack of penetration may occur. Any component welded into the system is identifiable and the materials from which it was fabricated can be traced back to the mill.

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Bioprocessing Equipment

Kazrajinn Material chemistry is important because stainless steel shows considerable heat to heat variation in weldability so that weld parameters that produced successful welds on one heat of material would need considerable adjustment for other heats. An example of how a manufac-turer of bioprocessing equip-ment optimized their production, Sartorius BBI Sys-tems, Inc. Other dimensions affect fit-up, etc. Should I become a member? I Inspector Delegates t D l t 4 levels of qualification: The BPE has also been expanded to include new sections on process instrumentation, hygienic pumps, hygienic hose assemblies and rotary spray devices.



Ketaxe Photo courtesy of American Welding Society. Bioprocesskng existing standards were insufficient for this new bep, 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. Improvements in Installation Practices of Bioprocess Piping Systems You may also contact after the meeting at: Orbital welding in a clean facility done in accordance with the BPE Standard assured the compliance to hygienic design concepts. Photo cour-tesy of Arc Machines, Inc. 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.

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