The objective of the Radioisotope and Radiopharmaceutical Production Facility Verification activity is to ensure that the cyclotron-powered Radioisotope and Radiopharmaceutical Production Facility is declared safe for the safety of workers, the community, and the environment. The verification team ensures that the completed design meets safety standards by performing calculations on radiation-resistant buildings and main equipment, supporting equipment, human resource competencies, and operating procedures for production activities that have met radiation safety and source security requirements.

The inspection team, led by the Directorate of Licensing of Radiation Facilities and Radioactive Materials (DPFRZR) BAPETEN, Ishak, with team members Iin Indartati, Made Pramayuni, Ahmad Maulana, Lilis Misnawati, and B’tara Panjiweda Nisditya Pramana, conducted verification for radioisotope and radiopharmaceutical production facilities with the modality of GE brand cyclotron machine type PETtrace 860.

The scope of the onsite inspection includes document and technical inspection of the conformity of the design of the built facility and the adequacy of the thickness of the radiation barrier in the cyclotron bunker, inspection of facilities including target material reception and storage facilities, Cyclotron facilities, and radiopharmaceutical production facilities; Cyclotron machine commissioning test and bombard test of radioisotope production and radiopharmaceutical synthesis process in the hotcell, quality control of radioisotope and radiopharmaceutical production results, safety systems and cyclotron operating systems; measurement of radiation exposure at the facility; and quality control equipment; inspection of waste processing systems (solid, liquid and gas), inspection of radiation protection equipment and tools, and personnel inspection.

Based on the results of the verification of the Radioisotope and Radiopharmaceutical Production Operation permit, PT Bio Farma is committed to completing the findings submitted by the BAPETEN team within a certain time limit. The smoothness of the verification activities at the Radioisotope and Radiopharmaceutical Production Facilities of PT Bio Farma, which followed and welcomed the progress of the activities until the end, and any deficiencies are considered as input and technical suggestions for the fulfilment of radiation safety in accordance with applicable laws and safety standards.

It is expected that with the Cyclotron Facility, Indonesia can be more independent in meeting the needs of radioisotopes and radiopharmaceutical products for nuclear medicine facilities in Indonesia and strengthen Indonesia's resilience in the health sector. This facility will produce radioisotope F-18 with sufficient production capacity to meet the needs of government and private hospitals throughout Indonesia. [DPFRZR/Dwiangesti/BHKK/CD/Translator: GP]