Implementation of the CLIO Automated Dispensing System for [¹⁸F] FDG: Enhancing Safety and Operational Efficiency at NINMAS

Abstract

The [18F] 2-fluoro-2-deoxyglucose, [18F] FDG is a commonly used PET radiopharmaceutical for imaging in cardiology, neurology, and oncology. Using an 18/9 MeV IBA cyclotron, [18F] FDG is produced at the National Institute of Nuclear Medicine and Allied Sciences (NINMAS) and distributed to all PET-CT facilities in Dhaka. Manual dispensing of [18F] FDG, involving repeated handling of high activity vials, was carried out for several batches before the CLIO (Volumetric dispensing system manufactured by COMECER) automated dispensing system was introduced at our institute to enhance efficiency, accuracy, and radiation safety. This study aimed toward evaluating the effectiveness of the CLIO automated dispensing system in [18F] FDG production at NINMAS, with a particular emphasis on workflow quality, operational efficiency, and radiation safety in comparison to manual dispensing. The 18O(p,n)18F nuclear reaction was used to produce [18F] Fluoride, which was synthesized to [18F] FDG using an automated synthesis module (Synthera®). The manual approach involved measuring activity in a Dose Calibrator, diluting it to the necessary concentration, and then using syringes to dispense it into individual vials. In the automated process, CLIO used robotic handling to dispense pre calculated volumes in a shielded hot cell. The exposed radiations were recorded at approximately 30 cm, 1 m, and 2 m away from the dispensing site. TLD badges and pocket dosimeters were used to track individual doses. For both processes, operational metrics such as staffing, documentation, preparation time, dose repeatability, and delivery compliance were noted. The CLIO system reduced average radiation exposure by 80–97% across all measured distances, with the largest reduction at ~30 cm (45.0 ± 2.9 μSv/h to 9.0 ± 0.6 μSv/h). Pocket dosimeter readings decreased by 66.7% (30 μSv/day to 10 μSv/day), while TLD whole-body doses remained same (<0.05 μSv/day) in both workflows. Dose preparation time per vial decreased by 50% (2.0 ± 0.5 min to 1.0 ± 0.2 min), and staff requirements per cycle fell from three to two. Dose reproducibility improved from ±6.0% to ±1.5%, and on-time delivery compliance increased from ~82% to ~97%. Documentation and labelling errors were eliminated through digital batch logs and automated barcoding. These findings support the wider use of automated dispensing systems by demonstrating a decrease in radiation exposure for employees and an increase in operational efficiency in regular radiopharmaceutical production. The significant reductions in exposure, improved dose precision, and streamlined workflow support broader adoption of automated dispensing systems in PET radiopharmaceutical production facilities.

Ban. J. Med. Phys., Vol -16, Issue -2, 2025 : 77-83