ASME BPE
Bioprocessing Equipment
Organization: | ASME |
Publication Date: | 28 September 2012 |
Status: | inactive |
Page Count: | 292 |
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. This Standard also provides requirements for single use systems and components.
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) material joining
(g) examinations, inspections, and testing
(h) certification
This Standard is intended to apply to new fabrication and construction. It is not intended to apply to existing, in-service equipment. 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, 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.