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【国外标准】 Bioprocessing Equipment, Includes Errata (2023)

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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: - Aseptic and Containment Isolators - Immersion (COP) Washers - Seals Applications Guide for Compendial Water Systems - Mechanical Seal Face Material Selection for Compendial Water Pumps - Pure Steam Distribution Systems - Conductivity Sensors Selection - Pressure and Turbine Flow - Thermal Welding of Thermoplastic Elastomer Tubing - Mechanical Hose Barb Connections - Nomenclature   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.

基本信息

  • 标准号:

    ASME BPE-2022

  • 标准名称:

    Bioprocessing Equipment, Includes Errata (2023)

  • 英文名称:

    Bioprocessing Equipment, Includes Errata (2023)
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