Strategies For Gamma Sterilization Of Pharmaceuticals

Sterility is desirable not only for medical devices, but also to ensure the safety of parenterals or injectable drugs. Various methods of reducing microbial load in drugs and parenterals are available.

By Ruth Garcia, Betty Howard, Rose LaRue, Glenn Parton, and John Walker, Steris Isomedix Services

A crucial step in pharmaceutical production is sterilization. There are many sterilization methods to choose from, such as steam, sterile filtration, ethylene oxide gas (EtO), electron beam (E-beam), and gamma radiation. Each technique has aspects that make it suitable or unsuitable for the sterilization of a particular product.

For example, EtO, while being a highly effective method, leaves behind potentially hazardous residuals and cannot reach products in airtight packages. E-beam, while being one of the fastest methods of sterilization, cannot penetrate well into dense product or bulk packaging of some products. In addition, the product complexities of heterogeneous components often require extensive product qualification. Gamma radiation can cause certain product and package materials to degrade.