Two years of experience with the [18F]FDG production module

Chemistry module for a conventional [18F]FDG production by using tetrabutylammonium bicarbonate (TBA) and an acidic hydrolysis has been manufactured and evaluated. In this experiment, 75 mM (pH 7.5-7.8) of TBA solution and a ca. 2-curies order of [18F]-fluoride have been used for the evaluation. The commercial acidic purification cartridge was purchased from GE or UKE. The operation system (OS) was programmed with Lab-View which was selected because of its easy customization of the OS. Small sized solenoid valves (Burkert; type 6124) were selected to reduce the module dimensions (W 350 x D 270 x H 250). The total time for the synthesis of [18F]FDG was 30 ± 3 min. The production yield of [18F]FDG was 60 ± 2% on an average at EOS, with the decay uncorrected. This experimental data show that the traditional chemistry module can provide a good [18F]FDG production yield by optimizing the operational conditions. The radiochemical purity, radionuclidic purity, acidity, residual solvent, osmolality and endotoxin were determined to assess the quality of [18F]FDG. The examined contents for the quality control of [18F]FDG were found to be suitable for a clinical application