Combination Products: Gamma Sterilization Applications and Markets

Gamma sterilization is well established as a reliable, effective process for the traditional medical device market. The next generation of medical devices is emerging, and gamma technology is poised to make a significant contribution in this exciting new market.

Combination products include drug device combinations and regenerative medicine products, where biological and pharmaceutical components are added to medical devices and natural or synthetic scaffolds in order to enhance device effectiveness or in some cases provide radical new treatments for disease by helping the body to regenerate specific cells.

The effects of gamma on traditional devices have been studied for many years and are well understood. Combination products incorporate biological materials that have typically not been treated with gamma due to compatibility issues. That said, the industry recognizes gamma technology as a simple, cost effective sterilization solution, so it's investing in advancing the technology to allow for broader application. In addition, these products are typically high value and low volume so that a different approach to sterilization may be required.

Nordion, as the leader in gamma sterilization technology, continues to be at the forefront of this evolution. Our expertise in radiation physics and irradiator design has led to the development of patented technology for delivering the highly precise doses required by some of the next generation of medical devices. In addition, functionality such as temperature and environmental control and advanced dosimetry systems, are being incorporated into new irradiator platforms that will serve both the development and small volume production markets, while being scalable to larger volumes.