ABSTRACT
Radiation processing technology is perhaps the least understood by the pharmaceutical industry compared to other technologies such as steam, dry heat, or sterilant gas. Gamma radiation processing is the exposure of a product to ionizing radiation from an isotopic source in a controlled manner. This chapter presents an outline of how to develop both a product qualification program and a viral inactivation protocol for pharmaceuticals. It discusses the use of radical scavengers, the effects of media, and the treatment of frozen products. Data on viral inactivation as it exists in the literature will be related to modern irradiation technology. The chapter also presents some of the process developments that will facilitate the use of this technology for the terminal sterilization of pharmaceutical products. The pharmaceutical industry has historically relied on steam, dry heat, ethylene oxide, filtration and chemical processes to meet sterilization or microbial load reduction requirements.
