This verification aimed to ensure that all aspects of the facility, from building design, safety system, main and supporting equipment, to human resource competency, met radiation safety and radioactive source security standards. This is crucial to protect workers, patients, the public, and the environment from potential radiation hazards.

The BAPETEN inspection team was led by DPFRZR Director Asep Saefulloh Hermawan, with members from the BAPETEN Radiation Supervisory Team: Iin Indartati, Herry Irawan, Dewi Lelyana Maharani, Toni Wahyu Pamungkas, and Naufal Alif Syarifuddin. The team verified a facility using a GE PETtrace 860 cyclotron to produce the radiopharmaceutical F-18 Fluorodeoxyglucose (FDG).

The scope of the inspection included:

• Verification of documents and technical conformity of the facility design,
• Evaluation of the thickness of the radiation barrier wall in the cyclotron bunker,
• Inspection of the target material receiving and storage area, the radiopharmaceutical production area, and the cyclotron safety and operation systems,
• Cyclotron commissioning tests, F-18 production bombardment tests, and FDG synthesis in the hot cell,
• Radiation exposure measurements, production quality testing, and inspection of the waste treatment system (solid, liquid, and gas).
• Inspection of radiation protection equipment and support personnel.

Based on the verification results, PT Global Onkolab Farma expressed its commitment to immediately follow up and complete the technical notes from the BAPETEN team within the specified timeframe. The company welcomed this verification process and considered it an important input for continuously improving safety aspects in accordance with national and international laws and standards.

As a subsidiary of PT Kalbe Farma, PT Global Onkolab Farma focuses on the development and production of cancer drugs, prioritizing cutting-edge technology and local production to deliver high-quality yet affordable oncology products.

This radiopharmaceutical production facility is expected to strengthen medical services in hospitals, particularly in meeting the need for Positron Emission Tomography-Computed Tomography (PET/CT scan) examinations, while simultaneously expanding public access to comprehensive cancer detection and therapy services. [DPFRZR/Dwiangesti/BHKK/SP/Translator: GP]