ABSTRACT
The majority of sterile dosage forms are formulations of solutions; however, there are a number of sterile products in which the active pharmaceutical ingredient (API) is not in solution but may be a suspension or sterile powder. This chapter discusses the sterile bulk pharmaceutical chemicals (BPCs) can be either an API or a sterile excipient. The crystallizers, dryers, filter-dryers, mills, and other equipment commonly used can be substantially larger than the typical aseptic manufacturing and packaging equipment used in the preparation and filling of finished sterile dosage form containers. A few sterile BPC production facilities have been constructed as a single aseptic suite with both bulk manufacturing and final dose filling capability. Sterile bulk materials are unique in that nearly every finished container will exit the aseptic core, be warehoused, shipped, and later be introduced into the critical zone at another aseptic facility.
