Radiopharmaceutical Production

The RACHEL staff, in collaboration with the dedicated personnel of the Medical Physics Department, is responsible for managing a Minitrace cyclotron (GE). The machine can accelerate negative ions (H-) to an energy of approximately 11 MeV, suitable for the production of various radionuclides, including the fluorine-18 isotope.

The cyclotron is characterized by its compact size and intrinsic shielding (self-shielding), which prevents the possible emission of radiation outside of it during usage. Radiopharmaceutical preparations take place inside shielded cells, using automated synthesis modules. The production involves two to three daily syntheses of molecules involved in metabolic or receptor processes, which are radiolabeled with fluorine-18 produced by the cyclotron (such as 18F-FDG, 18F-PSMA1007) or with other radionuclides obtained from generators, particularly gallium-68 (such as 68Ga-DOTATOC, 68Ga-PSMA11).

Each synthesis is followed by a quality control process including a series of chromatographic, spectrophotometric, analytical analyses, sterility tests, and pyrogenicity tests. Additionally, the RACHEL staff collaborate in the labeling of autologous leukocytes with the radiopharmaceutical 99mTc-HmPAO, which allows the evaluation of infections or inflammations through scintigraphic examination. Radiopharmaceuticals labeled with beta- or alpha-emitting radionuclides (such as lutetium-177, radium-223) used in Radiometabolic therapy are also manipulated and fractionated when requested.