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About This Item
Full Description
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
- new system (and component) design and fabrication
- definition of system boundaries
- specific metallic, polymeric, and elastomeric (e.g., seals and gaskets) materials of construction
- component dimensions and tolerances
- surface finishes
- materials joining
- examinations, inspections, and testing
- certification
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
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ASME BPE-2024
Bioprocessing Equipment- Most Recent
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ASME BPE-2022
Bioprocessing Equipment, Includes Errata (2023)- Historical Version
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ASME BPE-2019
viewing
Bioprocessing Equipment- Historical Version
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ASME BPE-2016
Bioprocessing Equipment- Historical Version
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ASME BPE-2014
Bioprocessing Equipment- Historical Version
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ASME BPE-2012
Bioprocessing Equipment, Includes Errata (2012)- Historical Version
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ASME BPE-2009
Bioprocessing Equipment, Includes Supplement (2011)- Historical Version
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ASME BPE-2007
Bioprocessing Equipment- Historical Version
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ASME BPE-2005
Bioprocessing Equipment- Historical Version
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ASME BPE-a-2004
Addenda A to Bioprocessing Equipment- Historical Version
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ASME BPE-2002
Bioprocessing Equipment, Includes Addenda A (2004)- Historical Version