ASME BPE-2024

ASME BPE, 2024 Edition – Bioprocessing Equipment

The ASME BPE Standard provides requirements for components, equipment, and systems when there is contact with the product, raw materials, or product intermediates during clinical or commercial manufacturing of molecules intended for human or animal medicinal applications. It also applies to supporting systems that could directly or indirectly affect the clinical or commercial process [e.g., water-for-injection (WFI), clean steam, filtration, and intermediate product storage].

The Standard is intended for clinical and commercial manufacturing of pharmaceutical and biopharmaceutical products used for human and animal medicinal applications. However, some of the principles, practices, and guidance may be used for research and development, scale-up operations, or other products where the control and reduction of microbial, particulate, and endotoxin or pyrogen contamination is considered important.

This Standard provides requirements for components, equipment, and systems designed for multiuse processes that are subject to cleaning [e.g., clean in-place (CIP), clean-out-of-place (COP)], sanitization and/or sterilization [e.g., steam-in-place (SIP)], and other operations used in the manufacturing of pharmaceuticals and biopharmaceuticals. This Standard also provides requirements for single-use systems and components that are discarded after use in one manufacturing campaign.

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