John Logar
As the world of biologics and medical devices come together, the need for novel sterilization approaches increases. Devices that include an active ingredient (i.e. combination products) sometimes fall in between the historical sterilization processes established for each product; aseptic manufacturing for biologics and terminal sterilization for medical devices. However, utilizing a combination of these processes can ensure you meet your sterility assurance requirement while maintaining the efficacy of your active ingredient. As with most active products, ionizing radiation will adversely affect the potency and ultimately the intended effect of the product. As a result, the amount of ionizing radiation the product is exposed to needs to be minimized. This presentation will discuss the challenges associated with terminally sterilizing a combination product with ionizing radiation and outline the novel approaches taken to ensure achieving the required sterility assurance did not severely impact the functionality or economic viability of the product.