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About This Item

 

Full Description

The ASME BPE Standard provides requirements for systems and components that are subject to cleaning and sanitization and/or sterilization including systems that are cleaned in place (CIP'd) and/or steamed in place (SIP'd) and/or other suitable processes used in the manufacturing of biopharmaceuticals.

This Standard also provides requirements for single-use systems and components used in the above listed systems and components. This Standard may be used, in whole or in part, for other systems and components where bioburden risk is a concern.

This Standard applies to
  1. new system (and component) design and fabrication
  2. definition of system boundaries
  3. specific metallic, polymeric, and elastomeric (e.g., seals and gaskets) materials of construction
  4. component dimensions and tolerances
  5. surface finishes
  6. materials joining
  7. examinations, inspections, and testing
  8. certification
This Standard is intended to apply to new fabrication and construction. If the provisions of this Standard are optionally applied by an owner/user to existing, inservice equipment, other considerations may be necessary.

For installations between new construction and an existing, in-service system, such as a retrofit, modification, or repair, the boundaries and requirements must be agreed to among the owner/user, engineer, installation contractor, and inspection contractor.

For a system or component to be BPE-compliant, adherence to all applicable parts of this Standard is required.
 

Document History

  1. ASME BPE-2019

    👀currently
    viewing


    Bioprocessing Equipment

    • Most Recent
  2. ASME BPE-2016


    Bioprocessing Equipment

    • Historical Version
  3. ASME BPE-2014


    Bioprocessing Equipment

    • Historical Version
  4. ASME BPE-2012


    Bioprocessing Equipment, Includes Errata (2012)

    • Historical Version
  5. ASME BPE-2009


    Bioprocessing Equipment, Includes Supplement (2011)

    • Historical Version
  6. ASME BPE-2007


    Bioprocessing Equipment

    • Historical Version
  7. ASME BPE-2005


    Bioprocessing Equipment

    • Historical Version
  8. ASME BPE-a-2004


    Addenda A to Bioprocessing Equipment

    • Historical Version
  9. ASME BPE-2002


    Bioprocessing Equipment, Includes Addenda A (2004)

    • Historical Version
  10. ASME BPE-1997


    Bioprocessing Equipment - OUT OF PRINT

    • Historical Version