Clinical doses production of pharmaceutical grade Sodium[18F]Fluoride using modified integrated fluidic processor in a SYNTHERA® module

Abstract A fully automated large-scale production of sodium [18F]fluoride ([18F]NaF) using SYNTHERA module with a modification in integrated fluidic processor (IFP) is reported. This modified IFP module is used to prepare [18F]NaF with more than 98% non-decay corrected radiochemical yield (RCY) within 5 min with specifications in accordance with United State Pharmacopeia (USP) monograph. The graphical user interface (GUI) is designed to perform the synthesis steps either manually or automatically and give information to the operator during the course of production. The desired clinical results add support to indigenously produced [18F]NaF as a pharmaceutical grade diagnostic radiopharmaceutical.