Abstract

The terminal sterilization of sterile orthopedic implants is a key process that, in addition to providing sterility, changes the material properties of the product and packaging. These changes might be observed during functionality testing and/or biological evaluation. We are establishing an additional sterilization process that appears promising from both a technical and business perspective. Our project aims to add X-ray sterilization to the established gamma sterilization for metallic hip and shoulder implants. To limit complexity, we started with a narrow product range. The main steps of our project journey are described here. Given that X-ray sterilization remains relatively new in terms of understanding the changes that might occur for product materials and functionality compared with changes observed following gamma radiation processing, this article highlights key steps in the change from gamma ray to X-ray sterilization.

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