Bioprocessing Plant Design

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Chapter: Pharmaceutical Engineering: Bioprocessing

The foregoing discussion focused on major elements of bioprocessing activities, namely water treatment and reactor design.


BIOPROCESSING PLANT DESIGN

The foregoing discussion focused on major elements of bioprocessing activities, namely water treatment and reactor design. Heating, ventilation, and air con-ditioning (HVAC) and steam production, described elsewhere in this text, are also requirements for bioprocessing. The design of a bioprocessing plant is subject to cGMPs, which emphasize control and reproducibility. It is clear that the application of such principles to other pharmaceutical processes of a more mechanical nature may readily be achieved. The biological nature of the pro-cesses being controlled challenges the engineers and scientists involved.

As with any regulated process, specifications must be prepared in advance and acceptance criteria established for subsequent quality control checks. Vali-dation of the facility and process should be considered essential to design, construction, and start-up. Documentation of design and construction ensures appropriate specifications for subsequent validation.

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