ASME BPE-2016

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 Standard may be used, in whole or in part, for other systems and components where bioburden risk is a concern.