Background and importance PSMA-11 labelled with gallium-68 (PSMA11-68Ga) is a diagnostic radiopharmaceutical. Labelling is performed in a Trasis Mini all-in-one synthesiser. Sterile excipients, solvents and devices are necessary to produce a sterile and pyrogen-free injectable solution.
Aim and objectives The aim of this study was device evaluation. Two aspects were investigated: the sterility of the final preparation and the absorption of PSMA11-68Ga on the device.
Material and methods Device adsorption evaluation: radioactivity was measured with an ISOMED 2010 activity meter. PSMA11-68Ga labelling was performed and five syringes of 5 mL were filled with 1 mL from the preparation vial every 30 min after the end of the preparation. The weight activity (MBq/mg) of the preparation vial and syringes was calculated, measuring the activity and weight of each of them. At the end of the labelling process, the PSMA11-Ga68 preparation was totally filled in the preparation vial. The residual activity of different parts of the device were measured: the elution vial, the five syringes, the extraction cartridge, the synthesiser garbage, the vented filter, and three additional syringes were measured after three rinses with sodium chloride within 1 hour to 5 hours after elution. Finally, the activity of the elution vial at the end of the elution step and the activity of the final preparation vial at the end of the labelling process were compared on nine syntheses.
Final preparation sterility: media fill tests (MFT) were performed on three syntheses, replacing the excipients and solvents with tryptone-casein-soybean solution. A fertility test was performed with concentrated bacterial strains in accordance with the European Pharmacopoeia.
Results The weight activity difference between the final preparation vial and the five syringes were between 4% and 7%. Residual activities in the syringes, the vented filter, the waste garbage, the extraction cartridge and the three additional syringes were between 0.2% and 5% of the elution activity. The activity variation between the elution and final preparation vials were between –4% and +5%. The MFT did not show microbiological contamination after 14 days of incubation at 37°C. The fertility test was positive after 24 hours of incubation.
Conclusion and relevance These results show that the adsorption of PSMA11-68Ga on medical devices used for synthesis appeared to be limited. The MFT performed show that the manufacturing process was aseptic.
Conflict of interest No conflict of interest
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