Temperature impact on [68Ga]Ga-edotreotide for the shipping of radioactive material in shielded container

Abstract

Abstract Introduction To reduce costs of gallium-68 activity in nuclear medicine, a subcontracting activity has been settled for [68Ga]Ga-edotreotide preparations. Cold kits are radiolabeled in our radiopharmacy and shipped out to nearby hospitals. According to the Summary of Product Characteristics (SmPC), preparations must be stored below 25 °C until expiration (4 h). Objective The aim of this study was to define the impact of high temperature on preparation quality during shipping. Materials & methods After radiolabeling, vials were placed in “type A” package until their expiry date. Four kits were stored in “Type A” container exposed to an outside temperature of 50 °C to represent extreme temperature conditions and one kit was kept at room temperature and used as a control. For each preparation, pH, organoleptic properties and radiochemical purity (RCP) were evaluated. RCP was measured using two radio thin layer chromatography, to evaluate the rates of gallium-68 colloids and free gallium-68. Samples were withdrawn at the end of preparation (t0), at t0 + 1 h or at t0 + 2 h and at t0 + 4 h. Results RCPs and pH of the radiopharmaceutical were all conform from t0 to t0 + 4 h. Four hours storage in “type A” package at 50 °C does not show any impact on physical and chemical quality of the preparation. Thanks to it expanded polyethylene foam which absorbs impacts; “Type A” package might acts as thermal barrier and enables the temperature regulation of shipped vials. Conclusion A monitored expedition in temperature-controlled vehicle does not seem necessary in those conditions.