scope:

SCOPE OF THE ASME BPE STANDARD

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 applications. This Standard may be used, in whole or in part, for other applications 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

(h) 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, in-service 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.

The owner/user determines which requirements of the Standard are applicable to individual components, equipment, or systems based on intended service. However, for a component, equipment, or system to be BPE-conforming, adherence to all applicable requirements of this Standard is mandatory.