Chapter 14 - Sterilization of Pharmaceuticals: Technology, Equipment, and Validation

Abstract

Sterilization of pharmaceutical preparations intended for either parenteral, ocular, implantation, or any specific use is a mandatory clinical and regulatory requirement. Any pharmaceutical dosage form must be pyrogen-free as well as meet the pharmaceutical quality standards as described in pharmacopeias and to be safe for the intended purpose of use. Sterilization process helps in making the formulation free from any type of contaminants, pyrogen, microbes, and microbial spores. The presence of a contaminant may degrade the desired product; this is common in bacterial contamination of antibiotic fermentations where the contaminant may have to be resistant to the normal inhibitory effects of the antibiotic and degradation of the antibiotic is a common resistance mechanism. Selection of an appropriate sterilization technique is also one of the critical decisive arguments for a pharmaceutical product. This chapter provides a comprehensive overview on the concept of sterilization, including the factors affecting sterilization, risk assessment, sterility testing protocols, incubation, examination, and validation of sterility tests. The mechanism of sterilization, indicators used, and various types of sterilization methods along with exploring some newer methods such as terminal and radiation sterilization has also been covered in sufficient length.