Purpose and Scope
The ASME Bioprocessing Equipment (BPE) Standard was developed to aid in the design and construction of new fluid processing equipment used in the manufacture of biopharmaceuticals, where a defined level of purity and bioburden control is required. The Standard typically applies to (a) components that are in contact with the product, raw materials, or product intermediates during manufacturing, development, or scale-up (b) systems that are a critical part of product manufacture .g., water-for-injection (WFI), clean steam, filtration, and intermediate product storage Within scope also is the design and construction of piping systems for hygienic service. Multi-Use metallic, Multi-Use plastic and Single-Use materials of construction and design, are all covered in the scope of the 2022 edition. New editions of the ASME BPE Standard may be used beginning with the date of issuance and become effective 6 months after the date of issuance. 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. It 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. It may be used in other cases with consensus between the system owner/user, engineer, installation contractor, and inspection contractor. Please note: This paraphrased information comes from Part GR-1 and GR-2 of the ASME BPE Standard, 2022 edition, and was condensed for brevity to a broader audience. ''The intent of this article is general knowledge and general information for a wider audience outside of bioprocessing and engineering''. Please purchase a copy of the most recent edition for complete understanding, reference, detail, context and content.Structure
The ASME BPE is a voluntary consensus standard written by a team of over three hundred balanced subject matter experts. These individuals provide their knowledge and experience to drive technology and innovation forward safely and responsibly for the manufacturing of modern biopharmaceuticals. ASME controls the development and approval of all content by rigorous policies and procedures, ensuring that a thorough vetting process occurs and that the information published is reliable and trustworthy. The Standard (2022 Edition) is split into the following Chapters and Parts. The teams that develop each Part function as working teams, to develop, approve and refine content.Chapter 1, Introduction, Scope, and General Requirements
Part GR, General RequirementsChapter 2, Certification
Part CR, Certification RequirementsChapter 3, Materials
Part MM, Metallic MaterialsChapter 4, Design for Multiuse
Part SD, Systems Design for MultiuseChapter 5, Process Components for Multiuse
Part DT, Dimensions and Tolerances for Process ComponentsChapter 6, Fabrication, Assembly, and Erection for Multiuse
Part MJ, Materials Joining for MultiuseChapter 7, Design for Single-Use
Part SU, Systems Design for Single-UseChapter 8, Process Components for Single-Use
Part SC, Components for Single-UseChapter 9, Fabrication, Assembly, and Erection for Single-Use
Part SJ, Joining Methods for Single-UseHow to get involved
The ASME BPE meets three times a year in person, but offline meetings occur to develop and refine existing content. Unless otherwise stated, the sessions are free and open to all, and volunteers are welcome. ASME posts the details for all meetings on their website; the link is also below.False claims of codification
At least as early as April 19, 2011, ASME published a web page which falsely indicated the ASME BPE standard had been adopted by the State of California. The statement was based upon California's codification of Section 443, Group L—known as the "L Occupancy"—within Part 1 of the California Building Code. The web page claimed that the "L Occupancy" referenced the ASME BPE standard, but no such reference appears as described. A codification of the ASME BPE standard via such a reference is generally precluded by the building code's own requirement that any content that is not a building standard as defined in California's Health and Safety Code Section 18909 shall not be construed as part of the provisions of the California Building Code (Part 1, Chapter 1, Section 1.1.6). The web page has been removed.See also
*References
External links
Bioprocessing Equipment Certification