Adaptación del módulo de 18FDG para la preparación de una disolución inyectable de [18F] fluoruro sódico de conformidad con la Farmacopea Americana (USP 32) y Europea (PhEur 6) / 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)

Objetivos. Establecer un procedimiento automatizado para la preparación de la disolución inyectable de [18F] NaF utilizando los recursos disponibles en nuestro laboratorio para la preparación de 18FDG, analizando la repercusión del acondicionamiento de la columna de atrapamiento del ion fluoruro sobre las características del producto final. Material y método. Se modificó la secuencia de un módulo de síntesis de 18FDG automatizado de manera que el ion fluoruro procedente del ciclotrón se atrapa en resina de intercambio aniónico y se eluye con cloruro sódico 0,9%. La disolución final se dosifica y autoclava en envase final en equipo automatizado. Dentro del proceso, se estudiaron tres protocolos diferentes de acondicionamiento de columna. Se realizaron los controles de calidad descritos en USP 32 y PhEur 6, añadiendo el control de etanol como disolvente residual y los controles de calidad de la disolución a las 8 h de la preparación. Resultados. La activación de los cartuchos de resina con etanol y agua presenta una atrapamiento del ion fluoruro > 95% y pH en torno a 7, por lo que es el procedimiento de acondicionamiento de elección. La concentración de etanol se mantuvo < 5.000 ppm. Los controles efectuados a las 8 h indicaban que la disolución mantenía las especificaciones de USP 32 y PhEur 6. Conclusiones. Se describe un método automatizado sencillo, económico y reproducible, de preparación de una disolución inyectable de 18F-fluoruro sódico al alcance de cualquier centro con equipamiento convencional para síntesis y control de calidad de 18FDG(AU)

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 < 5.000 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(AU)

[Adaptation of the (18)FDG module for the preparation of a sodium fluoride [(18)F] injection solution in agreement with the United States (USP 32) and European Pharmacopeia (PhEur 6)]. / Adaptación del módulo de (18)FDG para la preparación de una disolucióninyectable de [(18)F] fluoruro sódico de conformidad con la Farmacopea Americana(USP 32) y Europea (PhEur 6).

OBJECTIVE: To establish an automated procedure for the preparation of sodium fluoride (18)F injection using the resources available in our laboratory for the preparation of (18)FDG 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 (18)FDG 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 < 5.000 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 (18)FDG synthesis and quality control.