Abstract
The study presents a comparative analysis of pharmacy-based and industrial production of the radiopharmaceutical 2-[¹⁸F]fluoro-2-deoxy-D-glucose (¹⁸F-FDG). The study compares the infrastructure, synthesis process, purification and dispensing systems, as well as quality control procedures, including radionuclidic and radiochemical purity, residual solvents, bacterial endotoxins, pH and sterility. The study demonstrates that small-scale pharmacy production based on a compact cyclotron complex with cassette synthesis modules provides product quality comparable to centralized industrial production on a high-energy cyclotron with an extended analytical infrastructure. The pharmacy model allows implementation of a “dose-on-demand” principle, reducing activity losses and ensuring flexible supply for patients of a specific center. The industrial model provides high throughput and centralized supply for a network of PET centers. The results emphasize that both organizational models are capable of maintaining high quality and safety standards for ¹⁸F-FDG, while the choice of an appropriate production scheme depends on the size of the center, patient flow, and regional logistic conditions.