The last two decades have seen a phenomenal growth of the field of
genetic or biochemical engineering and have witnessed the
development and ultimately marketing of a variety of
products-typically through the manipulation and growth of different
types of microorganisms, followed by the recovery and purification
of the associated products. The engineers and biotechnologists who
are involved in the full-scale process design of such facilities
must be familiar with the variety of unit operations and equipment
and the applicable regulatory requirements. This book describes
current commercial practice and will be useful to those engineers
working in this field in the design, construction and operation of
pharmaceutical and biotechnology plants. It will be of help to the
chemical or pharmaceutical engineer who is developing a plant
design and who faces issues such as: Should the process be batch or
continuous or a combination of batch and continuous? How should the
optimum process design be developed? Should one employ a new
revolutionary separation which could be potentially difficult to
validate or use accepted technology which involves less risk?
Should the process be run with ingredients formulated from water
for injection, deionized water, or even filtered tap water? Should
any of the separations be run in cold rooms or in glycol jacketed
lines to minimize microbial growth where sterilization is not
possible? Should the process equipment and lines be designed to be
sterilized in-place, cleaned-in-place, or should every piece be
broken down, cleaned and autoclaved after every turn?"
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