scope:

This Standard covers, either directly or by reference, requirements for materials, design, fabrication, examina- tion, inspection, testing, certification (for pressure sys- tems), and pressure relief (for pressure systems) of vessels and piping for bioprocessing systems, including sterility and cleanability, dimensions and tolerances, surface finish requirements, and seals for the bioprocess- ing systems in which the pressure vessels and associated piping are involved. This Bioprocessing Equipment (BPE) Standard does not address all aspects of these activities, and those aspects that are not specifically addressed should not be considered prohibited. Engi- neering judgment must be consistent with the philosophy of this Standard, and such judgments must never be used to ovemde mandatory requirements or specific prohibitions of this Standard.