ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Sterile Engineering Design (Fermentation)

The application of techniques to prevent contamination of a fermentation process by undesirable organisms. It includes three basic phases relating to the operation of the plant. First, the fermenter with the ancillary equipment, pipework, and valves must be brought to a sterile state. Secondly, the fermenter feed must be sterilized, and finally, sterile barriers at the interface between the fermenter and the outside environment must be maintained.

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