ABSTRACT
It is not within the scope of this chapter to describe validation concepts in
general, but rather, to identify those aspects of melt extrusion that differentiate it from the validation of conventional pharmaceutical equipment and pro-
cesses. Because melt extrusion technology has not yet gained widespread
acceptance as a traditional pharmaceutical unit operation, the installation,
commissioning, and validation of extrusion equipment have not been widely
discussed in the pharmaceutical literature (1). Extruders are rather unfamiliar
to those writing validation protocols, creating problems in both documenta-
tion and expectations for the users of such equipment. It is the objective of
this chapter to provide an overview for developers of validation protocols as
well as for project engineers responsible for installing and commissioning
melt extrusion equipment.
