Bioprocessing Plant Design
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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.
