ABSTRACT
The production of radiopharmaceuticals for human administration should comply with Good Manufacturing Practice Guidelines (GMP) along with relevant national and international rules for working with ionizing radiation. Careful consideration needs to be given to the design of facilities to ensure that all relevant requirements are adhered to. The need for protection of staff from excessive exposure to ionizing radiation requires adequate shielding to be in place. The degree of shielding and monitoring depends largely on the radionuclides used. Ventilation systems should be designed to prevent contamination of surrounding areas and to ensure a suitably clean environment in line with GMP requirements for aseptic production. Especially when using high-energy PET radionuclides, fully automated synthesis modules in highly shielded hot cells are necessary. Shielding of radionuclide delivery lines from cyclotrons also needs careful consideration. Finally, shielding during quality control procedures needs to be considered with a view to limiting staff radiation exposure.
