Impact of radiation sterilization on single-use products

Gamma irradiation is a widely accepted method to sterilize medical devices, biopharmaceuticals, and food products, offering numerous benefits including minimal toxicity. Numerous global facilities provide gamma irradiation services for sterilization purposes. Over the past ten years, innovative technologies have also emerged. These irradiation technologies are reliable and consistent, ensuring long-term sterility by eliminating the risk of contamination. Besides the sterility claim, it is well known that ionizing radiation would modify the physical-mechanical-tribological and chemical properties of polymers. A three-level approach (i.e. molecular level, macromolecular level and material level) for investigation of plastic materials was used, with a focus on a multilayer film as an example. The effects of radiation sterilization on the physical, mechanical, and chemical properties of multilayer films have been studied thoroughly using different techniques. Considering that irradiation creates free radicals, which serve as the basis for polymer modifications, ESR spectroscopy was performed to monitor these radicals and understand the polymer modifications post-irradiation. The results will be shared with the communities.
Dr. Samuel Dorey, Principal Scientist Materials & Irradiations - Sartorius Stedim