ABSTRACT
Packaging processes for sterile parenteral and ophthalmic products can be organized into the steps required to produce the primary package and the steps required to produce the secondary and tertiary package. This chapter focuses on the critical quality attributes (CQAs) controlled by the packaging processes for sterile products except for microbiological and biological CQAs, sterility and the absence of excessive levels of bacterial endotoxin, respectively. Performance history and risk analysis play an important role in the design of the sampling and inspection program for release of incoming shipments. Factory acceptance trials play a vital role in the development of the lighting configurations, camera settings and inspection tools. Most automatic ampoule filling/sealing equipment in the pharmaceutical industry utilizes the pull method for sealing the neck of the ampoule. The variety of designs for prefilled syringes and the associated filling processes is extensive, and each design presents different risks to be evaluated through validation.
