The role of pharmaceutical analysis in ensuring the safety of drug radiation sterilization

Abstract

Radiation sterilization is a widely used method for ensuring the sterility of medical and pharmaceutical products. The process involves exposing the products to ionizing radiation, which destroys microorganisms such as bacteria, viruses, and fungi, rendering the products sterile. The most commonly used ionizing radiation sterilization methods are highly penetrating with low dose rate gamma-irradiation from isotopic sources and less penetrating but with high dose rate e-beam from accelerators. This review provides an overview of the principles and applications of radiation sterilization, including the types of radiation sources used, the differences between them that may affect the efficacy of the process, and the regulatory requirements for radiation sterilization of active pharmaceutical ingredients and drug dosage forms. This review focuses on the analytical methods used to evaluate the effect of irradiation on drug substances. Finally, it discusses studies on radiation sterilization of various groups of drugs, including anthracyclines, β-lactam antibiotics, chloramphenicol and its derivatives, sulphonamides, antifungal drugs, β-blockers, nonsteroidal anti-inflammatory drugs, steroids, and others, and drug dosage forms.