Microbiology of Sterilization Processes

Abstract

This chapter gives a general understanding of pharmaceutical microbiology, its role in the industry, and its impact on the quality of the finished products. Sterility can be attained by the use of validated sterilization processes under appropriate current good manufacturing practices and cannot be demonstrated by reliance on sterility testing. Aseptic processes rely on the separate sterilization for the individual components followed by assembly and sealing in a pristine environment. Typically, Geobacillus stearothermophilus spores are resistant to many sterilizing agents, so the sterilization process should determine their presence/population prior to sterilization in order to make sure that the validated sterilization cycle is adequate to ensure their elimination. The manufacturing environment can contribute to the bioburden of the materials prior to sterilization. The microbial contamination from the environment should be minimized to ensure that the validated sterilization cycles are not overburdened.