Assessment of Radiochemical Yield and Quality Controls of [18F]FDG Production at Vietnam's Korean Cyclotron Facility: A Two-Year Experience (2023-2024)

다국어 초록 (Multilingual Abstract)

Purpose: The objective of this study was to evaluate the estimated radiochemical yield (RCY) and quality of routine [18F]FDG production over two-year period (2023 to 2024) at Vietnam’s Korean cyclotron facility, utilizing the Samyoung Unitech cyclotron (KOTRON-13, 13 MeV) and TRASIS radiosynthesizer (AllInOne 18).
Methods: [18F]Fluoride was generated using a Samyoung Unitech cyclotron, producing up to maximum 2 Ci of [18F] radioactivity per run, with 10-14 runs conducted weekly. The [18F]FDG production was carried out using the radiosynthesizer utilizing FDG Dual cassettes through nucleophilic radiofluorination of mannose triflate followed by basic hydrolysis. Quality Controls, including radiochemical purity, radionuclidic purity and identity, chemical purity, residual solvents, bacterial endotoxins, and sterility, were performed in accordance with TCCS 01:2019/HIC Standards using miniGITA TLC Scanner, Mucha MCA, Agilent 1260 GC, Radio-HPLC Agilent 1260 – GINA Star and Endosafe Nexgen-PTS. Facility design and operation were managed in accordance with International Atomic Energy Agency guidelines to ensure GMP-WHO compliance.
Results: All quality control tests met the TCCS 01:2019/HIC Standards requirements, ensuring the safety of patient injections. The RCY were within acceptable ranges. The RCY of the second runs was consistently higher than that of the first runs throughout the study period. The RCY for both runs were gradually light decrease, with no significant correlation between cyclotron maintenance and subsequent RCY.
Conclusions: Further investigation is needed to identify factors contributing to the decreasing radiochemical yield.