Radiopharmaceuticals production: validation process application

The mission of Nuclear Medicine should be to provide effective and time sparing modalities according to validated procedures, complying to regulations issued on the operator, patient protection and quality. Most of the diagnostic nuclear medicine procedures involve the use of radiopharmaceuticals in form of lyophilized obtained from commercial kits, which are reconstituted with radionuclide of interest, usually Tc-99m. High quality and safety standards allow to avoid unnecessary patient radiation exposure and to obtain the best diagnostic efficacy. A pivotal aspect to ensure the product pharmaceutical quality is to keep the radiopharmaceutical at the temperature indicated by the manufacturer. The use of isolators for the production and the presence of heat sources may compromise this condition. The purpose of this work was to apply the validation method of the process to evaluate the impact of storage temperature on the quality of radiopharmaceuticals. The ‘‘validation’’ is the statement of the process ability to provide reproducible results in order to obtain targeted requirements. This certification should be issued after an analysis of the whole process aimed to identify the critical points and the measures to be taken into account to ensure the imposed results, and the tests.