Conclusion

No single idea will solve all the potential challenges related to sterilization. A combination of tests are required for optimum results. This article, therefore, cannot address all the possible options to consider when selecting a sterilization method, but it does aim to demonstrate that making minor changes early in the development process can enable terminal irradiation. Terminal sterilization can have many benefits as long as one considers the critical factors to the product's success and usability. These factors may include the cost and time to manufacture a finished product, available facilities and equipment to make and sterilize the product with the chosen method, stability, safety, efficacy, potency, costs, regulatory requirements, and even customer expectations. Each factor must be considered to successfully select a sterilization process.

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Betty Howard is the Radiation TechTeam Manager for STERIS Isomedix Services, Radiation Technology Center at Steris, 7828 Nagle Ave., Morton Grove, IL 60053, tel. 847.966.1160, betty_howard@steris.com
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