The ASME BPE Standard provides requirements forsystems and components that are subject to cleaningand sanitization and/or sterilization including systemsthat are cleaned in place (CIP'd) and/or steamed inplace (SIP'd) and/or other suitable processes used inthe manufacturing of biopharmaceuticals. This Standardalso provides requirements for single use systems andcomponents 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 riskis a concern.