A proposal for installation, operaticon, and performance qualification protocol for hot cells for radiopharmaceuticals production

Background: According to the International Organization for Standardization (ISO), "quality assurance" is an all planned and systematic set of actions that are necessary to guarantee that a product or service will satisfy the requirements as to quality. As such, it is comprehensive and covers all relevant procedures, activities, and actions. This article aims to present a proposal for a checklist to be performed in the installation, operation and performance qualification for hotcells in agreement with the relevant standards recommendations. Methods: The checklist was applied during the installation of a hot cell in a cyclotron facility in Brazil. It was done a compilation of different guidelines for the qualification of hot cells proposing a comprehensive list of aspects to be verified during their installation, operation, and performance in a cyclotron facility, which is useful worldwide. Results: During the test, it was possible to identify unappropriated conditions in operation and performance qualification, allowing the team to take actions and make adjustments before acceptation and full use of the hot cell. Conclusion: The use of the proposed questionnaire during the installation of the hot cell can be applied worldwide, allowed us to spot the problems and solve them, shortening the equipment approval time for use in the routine production of sterile positron emitting radiopharmaceuticals for human use.