ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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ASME Bioprocessing Equipment (BPE)

The ASME Bioprocessing Equipment Standard was developed to aid in the design and construction of new fluid processing equipment used in industries that require a defined level of purity and bioburden control.

The Standard typically applies to:

1. Components that are in contact the product, raw materials, or product intermediates during manufacturing, development, or scale-up.

2. Systems that are a critical part of product manufacture, (e.g., water-for-injection (WFI), pure steam, filtration, and intermediate product storage).

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