Adaptation of the 18FDG Module for the Preparation of a Sodium Fluoride [ 18F] Injection Solution in Agreement with the United States (USP 32) and European Pharmacopeia (PhEur 6)

Abstract

Objective To establish an automated procedure for the preparation of sodium fluoride 18F injection using the resources available in our laboratory for the preparation of 18FDG and to analyze the repercussion of the conditioning column of the fluoride ion entrapment on the characteristics of the final product. Material and method The sequence of an 18FDG synthesis module prepared so that it traps the fluoride ion from the cyclotron in ion-exchange resin diluted with 0.9% sodium chloride. The final solution was dosified and sterilized in a final vial in an automatized dispensing module. Three different column conditioning protocols within the process were tested. Quality controls were run according to USP 32 and EurPh 6, adding control of ethanol levels of residual solvent and quality controls of the solution at 8 h post-preparation. Results Activation of the resin cartridges with ethanol and water was the chosen procedure, with fluoride ion trapping >95% and pH around 7. Ethanol levels were <5000 ppm. Quality controls at 8 h indicated that the solution was in compliance with the USP 32 and EurPh 6 specifications. Conclusion This is an easy, low-cost, reliable automated method for sodium fluoride preparation in PET facilities with existing equipment for 18FDG synthesis and quality control.