Gamma Irradiation In The Pharmaceutical Manufacturing Environment

By Betty Howard, Radiation TechTeam Manager, STERIS Isomedix Services

Many sterilization methods are available for pharmaceuticals, healthcare devices, and labware, including steam, sterile-filtration, ethylene oxide, vapor-phase hydrogen peroxide, electron-beam irradiation, and gamma irradiation. Each technique needs to be evaluated before use based on various criteria. Most importantly, one must consider how the technique will affect the final product characteristics and performance.

This article reviews the considerations for using gamma irradiation in pharmaceutical manufacturing. Specifically, the author examines what gamma irradiation is, how it works, and what manufacturers need to consider when evaluating the method for terminal sterilization of a product or component. The article, while not exhaustive, is intended to provoke consideration of this effective sterilization method.