Optimizing the Production of ¹⁸F-Fdg: Quality Control and Advanced Dosimetry in at a Pet Radiopharmaceutical Center

Abstract

The production of radiopharmaceuticals, such as ¹⁸F-fluorodeoxyglucose (¹⁸F-FDG), is essential for the conduct of clinical studies through Positron Emission Tomography (PET), especially in the fields of oncology, neurology and cardiology. In this sense, the purpose of this study was to optimize quality control procedures (QAC) and dosimetric strategies linked to the production of ¹⁸F-FDG, focusing on the application of the HPLC chromatographic method and advanced dosimetry systems at the Radiopharmaceutical Production Center of EsSalud Callao. A total of four production batches, representing the years 2017 and 2018, were examined, and an occupational dosimetric evaluation was conducted in 2023. The critical parameters that were analyzed included radiochemical purity, radionuclide purity, pH, the presence of bacterial endotoxins, sterility, and residual solvent levels. The mean radiochemical purity ascertained by HPLC was 98%. The mean retention time was 8.33 minutes, with a standard deviation of 24%. It is noteworthy that all batches of the product under scrutiny conformed to the standards set forth by USP-NF 2021 and the Argentine Pharmacopoeia. Improvements were implemented in the handling of the purification columns (QMA, C18, Alumina B, and SCX). In addition, the efficacy of the nanoDOT (36.23–50.89 mGy) and TLD (1.77–15.06 mSv) dosimetric systems was verified under simulated exposure conditions. The results confirmed that the optimized protocols conform to regulatory standards, ensuring the quality of ¹⁸F-FDG and decreasing the radiological impact on personnel. Likewise, a mean yield of the PETtrace 800 GE cyclotron (16.5 MeV) of 74 was evidenced. 98% per batch, with a production capacity of up to 5000 mCi per cycle. The study offers a replicable model to improve efficiency, safety and traceability in the production of radiopharmaceuticals, promoting their standardization in similar centers and strengthening the role of nuclear medicine in clinical diagnosis.