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 Standardmay be used, in whole or in part, for other systems and components where bioburden risk is a concern.
This Standard applies to
(a) new system (and component) design and fabrication
(b) definition of system boundaries
(c) specific metallic, polymeric, and elastomeric (e.g., seals and gaskets) materials of construction
(d) component dimensions and tolerances
(e) surface finishes
(f) materials joining
(g) examinations, inspections, and testing
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.
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