ABSTRACT
Sterile powder filling is primarily used for antibiotics that are sensitive to hydrolysis. This chapter focuses on the final steps in the preparation of the bulk sterile powder. In the bulk chemical production facility the drug substance is produced under tight controls for the introduction of particulate matter and contamination. Once the drug substance has been synthesized, a solution of it is filtered. The sterile preparation of the bulk drug substance and the subsequent manufacture of the pharmaceutical drug product are processed under aseptic processing conditions. The formulation of a sterile injectable powder is the bulk drug substance and its sterilization is the responsibility of the drug substance manufacturer. The drug substance is milled and sized through a predetermined screen, resulting in a particular particle size distribution. Such a step is generally not done for sterile products due to the risk of microbial contamination and the introduction of particulate matter.
