3M Company, Corporate Health Physics, St. Paul, MN 55144, USA.
Health Phys. 2010 Feb;98 Suppl 1:S12-6. doi: 10.1097/HP.0b013e3181be35fb.
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.
经过近三十年的医疗产品灭菌，3M 启动了一个重大的新项目，建造并许可一个辐照设施。3M 公司的企业健康物理学负责该项目的许可方面。许可过程包括六次修订，向美国核管理委员会（U.S. NRC）提交了 30 多份申请，进行了四次美国核管理委员会现场访问。大约需要 22 个月才能完成。对这六次许可证修正案进行了审查，并讨论了其中的几份申请。其中包括 3M 对美国核管理委员会对生物屏蔽所使用的屏蔽计算的兴趣的回应，制定了辐射安全系统测试方法的协议，以及分析表明在装载操作中掉落的桶不会落在密封源上。在为新的辐照器获得许可的过程中，我们吸取了许多经验教训。其中包括理解美国核管理委员会许可审查员观点的重要性，在项目谈判期间彻底审查辐照器制造商的许可包的必要性，离开健康物理学办公室并与参与项目的非健康物理学家会面的好处，以及保持与现场辐射安全官员和灭菌工程师已经存在的牢固关系的必要性。
