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ASME BPE

Bioprocessing Equipment

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Organization: ASME
Publication Date: 14 October 2016
Status: active
Page Count: 354
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 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

(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, 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

BPE
June 10, 2019
Bioprocessing Equipment
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...
ASME BPE
October 14, 2016
Bioprocessing Equipment
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...
October 10, 2014
Bioprocessing Equipment
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...
September 28, 2012
Bioprocessing Equipment
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...
June 1, 2011
Supplement to ASME BPE Bioprocessing Equipment
This Standard deals with the requirements of the bioprocessing, pharmaceutical, and personal care product industries as well as other applications with relatively high levels of hygienic...
October 20, 2009
Bioprocessing Equipment
This Standard deals with the requirements of the bioprocessing, pharmaceutical, and personal care product industries as well as other applications with relatively high levels of hygienic...
January 1, 2007
Bioprocessing Equipment
FOREWORD At the 1988 ASME Winter Annual Meeting (WAM), many individuals expressed interest in developing standards for the design of equipment and components for use in the biopharmaceutical...
January 1, 2005
Bioprocessing Equipment
This Standard deals with the requirements of the bioprocessing, pharmaceutical, and personal care product industries as well as other applications with relatively high levels of hygienic...
July 26, 2002
Bioprocessing Equipment
This Standard deals with the requirements of the bioprocessing industry, covering directly or indirectly the subjects of materials, design, fabrications, pressure systems (vessels and piping),...
January 1, 2002
Bioprocessing Equipment
This Standard deals with the requirements of the bioprocessing industry, covering directly or indirectly the subjects of materials, design, fabrications, pressure systems (vessels and piping),...
October 17, 1997
Bioprocessing Equipment
This Standard covers, either directly or by reference, requirements for materials, design, fabrication, examina- tion, inspection, testing, certification (for pressure sys- tems), and pressure relief...
October 17, 1997
Bioprocessing Equipment
At the 1988 ASME Winter Annual Meeting (WAM), many individuals expressed interest in developing standards for the design of equipment and components for use in the biopharmaceutical industry. As a...

References

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