ASME BPE-2019 Bioprocessing Equipment

The American Society of Mechanical Engineers. — 2019. — 381 p.The ASME Bioprocessing Equipment Standard was developed to aid in the design and construction of new fluid processing equipment used in the manufacture of biopharmaceuticals, where a defined level of purity and bioburden control is required.
The Standard typically applies to:
(a) components that are in contact with the product, raw materials, or product intermediates during manufacturing, development, or scale-up
(b) systems that are a critical part of product manufacture [eg, water- for-injection (WFI), clean steam, filtration, and intermediate product storage].