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This standard is for use by organizations that procure and/or integrate EEE parts and/or assemblies containing such items. The requirements of this standard are generic and intended to be applied/flowed down, as applicable, through the supply chain to all organizations that procure EEE parts and/or assemblies, regardless of type, size, and product provided. The mitigation of counterfeit EEE parts in this standard is risk-based and these mitigation steps will vary depending on the application, desired performance, and reliability of the equipment/hardware.
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.