Sterilization processes in the pharmaceutical industry

Industrial sterilization processes can be defined as those operations having as objective the destruction, permanent inactivation, or physical removal of all microorganisms. In the pharmaceutical and biotechnology industries, different sterilization methods are applied to materials, equipment, and products of different chemical composition and physical characteristics. This chapter explores the sterilization processes currently used in the industrial practice: thermal sterilization processes, radiation sterilization processes, chemical sterilization processes and sterile filtration processes. Thermal sterilization is the most commonly used sterilization method in the pharmaceutical and biotechnology industries. Industrial radiation sterilization processes utilize electron beams, gamma rays, or X-rays. Chemical sterilization is typically used for system that cannot be sterilized by other methods or for which other sterilization approaches would be impractical. Sterile filtration processes utilize both depth filters, as prefilters, in order to remove the larger amount of particle and microbial contaminants in the fluid and membrane filters, as the final sterilizing filters.