Aseptic process validation of [18F]Sodium Fluoride radiopharmaceutical in-house production

Sodium fluoride ([18F]NaF) is a PET radiopharmaceutical for vizualization of the skeletal system and microcalcification. In originally designed in-house method, [18F]NaF recovered in aqueous solution after cyclotron irradiation, sterilized by passage through 0.22 µm sterile filter dispensed under aseptic conditions. To ensure microbiological safety drugs produced conditions, validation procedures always recommended. This essential radiopharmaceuticals because most them are released administration before any sterility test can be completed due to their radioactive nature. study reports process applied internal production carried out two phases: testing number viable microorganisms product prior sterilization simulation studies (media fill tests). We found that all samples were endotoxin concentration was well below maximum acceptable level reported Ph Eur. monograph on [18F]NaF. The results confirmed entire strictly conditions following validated preserving final product.