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.