ABSTRACT
This chapter addresses the issues, focusing on restrictions and adaptations required when applying sterilization or aseptic procedures to the manufacture of pharmaceutical biotechnology products. Sterilization is a fundamental unit operation in any aseptic bioprocess but it is especially relevant in processes used in biopharmaceutical industries. Biopharmaceuticals can be used either as sterile or non-sterile formulations. However, the biopharmaceuticals currently available on the market are mostly injectable and have an absolute requirement for sterility and absence of toxic or immunogenic substances in the formulation. The chapter provides theoretical and scientific concepts for sterilization focusing on pharmaceutical bioprocesses. It provides in-depth knowledge of sterilization techniques available and their impact on the properties of biopharmaceuticals. Heat is the most widely used method for sterilization, as it is safe, simple and inexpensive. Sterilization by ionizing radiation consists of exposing contaminated materials to high energy emissions to ionize atoms and thereby generate free radicals that will cause cell damage.
