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  • Title: Licensing a new industrial irradiator.
    Author: Bates NK, Entwistle FB.
    Journal: Health Phys; 2010 Feb; 98 Suppl 1():S12-6. PubMed ID: 20065665.
    Abstract:
    After nearly three decades of medical product sterilization, 3M launched a major new project to build and license an irradiator facility. 3M Corporate Health Physics was responsible for the licensing aspect of this project. The licensing process consisted of six amendments, over 30 submissions to the U.S. Nuclear Regulatory Commission (U.S. NRC) and four U.S. NRC site visits. It took approximately 22 months to complete. The six license amendments are reviewed and several of the submissions are discussed. These include 3M's response to the U.S. NRC's interest in the shielding calculations used for the bioshield, the development of a protocol of radiation safety system test methods, and an analysis to show that a dropped cask during loading operations would not fall on sealed sources. A number of lessons were learned during the course of licensing the new irradiator. Among these were the importance of understanding the U.S. NRC license reviewer's perspective, the need to thoroughly review the irradiator manufacturer's licensing package during project negotiations, the benefits of leaving the Health Physics Office and meeting with the non-health physicists involved in the project, and the necessity of maintaining the solid relationships that already existed with the site Radiation Safety Officer and Sterilization Engineer.
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