Irradiation of pharmaceuticals: A literature review

Regulatory authorities require pharmaceuticals to be sterilized wherever practicable by a terminal sterilization method that is sterilized in the final container rather than by aseptic techniques. Hence, many pharmaceuticals that are heat labile are being sterilized by gamma irradiation. In view of the increasing interest in this sterilization technology in the pharmaceutical industry, an updated review of the effects of ionizing radiation (gamma, electron beam and X-ray) on pharmaceuticals is in place. This review on the effects of irradiating pharmaceuticals and pharmaceutical materials, attempts to cover the pertinent literature from 1995 to 2020. The reviewed data give useful insights into overall radiation stability of these products, and indicate whether more extensive testing of the product is worth undertaking.

Automated summary

Regulatory authorities require pharmaceuticals to be sterilized by terminal sterilization method instead of aseptic techniques, leading to an increasing use of gamma irradiation for heat labile pharmaceuticals. An updated review on the effects of ionizing radiation on pharmaceuticals from 1995 to 2020 provides insights into radiation stability and the need for extensive testing on these products.