The ASME BPE Standard covers, either directly or by reference, requirements for materials, design, fabrication, examination, inspection, testing, certification (for pressure systems), and pressure relief (for pressure systems) of vessels and piping for bioprocessing systems, including sterility and cleanability, dimensions and tolerances, surface finish requirements, and seals for the bioprocessing systems in which the pressure vessels and associated piping are involved. For further information about the APME BPE standards please access the American Society of Mechanical Engineers's website.
Around 1990 the American Society of Mechanical Engineers' (ASME) Council on Codes and Standards issued a decree to the Board on Pressure Technology Codes and Standards to form a committee to investigate and catalogue the biopharmaceutical industry's concerns about inconsistencies. Consequently, the Bioprocessing Equipment ASME BPE Standards Committee was created. The committee, which consists of end users (bio-food, bio-pharmaceutical, and bio-chemical industries), equipment manufacturers or suppliers, drug manufacturers, distributors, and engineers. The objective of this ASME BPE committee was to create a standard that could bring clarity and consistency to the bioprocessing industry (bioprocessing=biotechnology=biofood + biopharma + biochemical industries) and end miscommunications, misunderstandings, misinterpretations, and ambiguities in the applicable entities.
In 1997 the first edition of the ASME BPE Standard was issued and the second edition was published in 2002 and can be acquired from Codes & Standards page.
The ASME BPE standard gives the biotechnology industries a tool to purchase, specify, and manufacture biopharmaceutical, biofood, and biochemical production equipment and systems at an even and comparable level for the benefit of the industry's engineers, manufacturers, and biotechnology end users. The standard also provides a method of ensuring that the design, production, and installation of bio-processing equipment, tubing, fittings, and components are consistent and uniform.
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