ABSTRACT
Sterile product manufacturing facility projects are risky undertakings. In order to produce a finished product that meets the requirements defined in the GMP guidelines issued by the FDA, the facility and the processes that are used to produce drug components must rely heavily on the ability of the mechanical systems and equipment to produce and maintain sanitary conditions. To say that these facilities are mechanically intensive is an understatement. The massive amounts of piping and ductwork required to support sterile manufacturing cause many kinds of complications for designers who design facilities, craftsmen who build them, and operators who have the responsibility to maintain product that meets GMP.
