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    BPE - Bioprocessing Equipment

    BPE - 2024

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    This ASME Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements. It covers materials, design, fabrication, inspections, testing and certification.
     
    ASME-BPE is unique in the world, having resulted from widespread industry requests for standardization. It is the leading Standard on how to design and build equipment and systems used in the production of biopharmaceuticals. It incorporates current best-practices for enhancing product purity and safety. Companies that rigorously apply ASME-BPE often can achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations.
     
    New topics from the last revision include:

    • Polymeric static seals and gaskets certification
    • Seal Manufacturers requirements
    • Static Seals Application for Compendial Water Systems Testing requirements
    • Seal Performance Post exposure entrapment evaluations
    • Conductivity Sensors Selection
    • Turbine Flowmeter
    • Multiuse vs. Single-Use
    • Nomenclature for “double” or “dual”; “pressurized” or “unpressurized”, mechanical seals
     
    ASME-BPE is referenced in ASME’s B31.3 Code on Process Piping.
     
    Moreover, two weld discoloration acceptance criteria color charts, ASME BPE MP-2012 and EP-2012, are available separately. They allow you to match acceptable discoloration levels perfectly, so as to help assure optimum safety and code-compliance.
     
    Intended for regulatory agencies, multinational corporations, plant owners, pressure-equipment fabricators, designers, constructors, materials suppliers, inspection organizations, and others.
     
    The ASME BPE Standard standardizes specifications for the design and construction of new fluid processing equipment used in industries that require a defined level of purity and bioburden control.

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    This standard has been placed on stabilized maintenance. Requests and recommendations for change from any materially affected and interested party will be considered. Requests should be submitted to CSAdmin@asme.org and include the Standard designation and the rationale for the request.

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