chapter  17
12 Pages

Installation, Commissioning, and Qualification

ByAdam Dreiblatt

Extruders, which were originally designed for use in the plastics processing industry, have been modified to suit the needs of the pharmaceutical industry. This chapter provides an overview for developers of validation protocols as well as for project engineers responsible for installing and commissioning melt extrusion equipment. The act of commissioning relies on a "quality by design" approach to ensure that critical aspects are designed into systems during the specification and design process. This is achieved through a planned and structured verification approach applied throughout the system's life cycle and will ensure that manufacturing systems are fit for use. The extruder barrels are typically heated using electrical heaters and cooled using a circulating coolant. The circulating coolant does not come in contact with the product and is typically treated water from a cooling tower or from a dedicated temperature control unit.