In response to the recognized need of the nuclear medical community, ITD has developed an innovative and fully GMP compliant module capable for [11C]acetate and [18F]fluoride synthesis using the same hardware platform. The automated module consists of four main components:
The irradiated target materials and the products are coming in contact only with the sterile, single use parts of the kits, thus cross-contamination is excluded by design. The type of synthesis (e.g. acetate or fluoride) is software selectable; moreover, the module can recognize which kit has been installed on it and will prevent running the inappropriate procedure for the given kit.
[11C]CO2 produced by a cyclotron is trapped at room temperature on a molecular sieve trap inside the synthesizer, avoiding the need for liquid nitrogen or argon. The synthesizer releases [11C]CO2 into the reaction loop having its internal surface covered by thin layer of methyl magnesium chloride. The radiolabeling reaction is instant under these conditions and immediately after the end of [11C]CO2 release the intermediate crude radiolabeling mixture is hydrolyzed by excessive amount of water for injections and purified by means of solid-phase extraction cartridges. [11C]Acetate is retained by an anion exchange cartridge. The final formulation of the radiotracer is performed directly into the injection vial by detaching [11C]acetate by sterile physiologic saline solution and passing it through the 0.22 μm sterilizing filter.
18F– produced by a cyclotron by irradiating enriched H218O is transferred through a QMA cartridge where it is trapped. The cartridge is washed by sterile water for injections in order to remove any impurities. The final formulation of the radiotracer is performed directly into the injection vial by detaching [18F]fluoride from the QMA cartridge by sterile physiologic saline solution and passing it through the 0.22 μm sterilizing filter.
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