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Objectives: Recent gallium-68 labeled peptides are of increasing interest in PET imaging in nuclear medicine. Somakit TOC® is a radiopharmaceutical kit registered in the European Union for the preparation of [68Ga]Ga-DOTA-TOC used for the diagnosis of neuroendocrine tumors. Development of a labeling process using a synthesizer is particularly interesting for the quality and reproducibility of the final product although only manual processes are described in the Summary of Product (SmPC) of the registered product. The aim of the present study was therefore to evaluate the feasibility and value of using an automated synthesizer for the preparation of [68Ga]Ga-DOTA-TOC according to the SmPC of the Somakit TOC®., Methods: Three methods of preparation were compared; each followed the SmPC of the Somakit TOC®. Over time, overheads, and overexposure were evaluated for each method., Results: Mean±SD preparation time was 26.2±0.3 minutes for the manual method, 28±0.5 minutes for the semi-automated, and 40.3±0.2 minutes for the automated method. Overcost of the semi-automated method is 0.25€ per preparation for consumables and from 0.58€ to 0.92€ for personnel costs according to the operator (respectively, technician or pharmacist). For the automated method, overcost is 70€ for consumables and from 4.06€ to 6.44€ for personnel. For the manual method, extremity exposure was 0.425mSv for the right finger, and 0.350mSv for the left finger; for both the semi-automated and automated method extremity exposure were below the limit of quantification., Conclusion: The present study reports for the first time both the feasibility of using a [68Ga]- radiopharmaceutical kit with a synthesizer and the limits for the development of a fully automated process., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Objective: The present study had determine the impact of prolonged storage in a cartridge or syringe on the quality of the [18F]-radiopharmaceuticals used in our center [18F]fludeoxyglucose and [18F]fluorocholine). [18F]-radiopharmaceuticals registered as ready-to-use drugs are prepared in multidose flasks. When the change of packaging must be made extemporaneously for the preparation of patient unit doses in a syringe or cartridge, this is under the responsibility of radiopharmacists. As drug quality in medical devices (syringe or cartridge) is not evaluated during the marketing authorization of such radiopharmaceuticals, an evaluation of drug stability in such devices seems interesting. In addition, if there are difficulties in patient care (placement of the catheter, lack of personal, etc.) or equipment problems (technical issue with the automated dispenser delaying the delivery of the prepared dose), the contact time of [18F]-radiopharmaceuticals with the medical devices (cartridge or syringe) increases., Methods: Appearance, pH, radiochemical purity, sterility and endotoxin tests were made according the current European Pharmacopoeia. Adsorption tests were made according the literature., Results: There was no drug absorption of [18F]fludeoxyglucose or [18F]fluorocholine after 1.5h, which may be related to their hydrophilic nature. No drug radiolysis was observed even after dilution of the radiopharmaceuticals (appearance, pH, and radiochemical purity were unchanged). No impurity from medical devices (cartridge or syringe) was observed, and microbiological aspects remained in specification of the current European Pharmacopoeia., Conclusion: These radiopharmaceuticals repackaged in plastic medical devices retained their quality after dispensing and prolonged storage., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

(99m)Tc-macroaggregated albumin is widely used to diagnose pulmonary embolism. To control the radiochemical purity of this radiopharmaceutical, three rapid control methods using filter, thin layer chromatography or centrifugation, are described in the academic literature. In this paper, the interactions between impurities and (99m)Tc-macroaggregated albumin were presented. For each control method, the influence of these interactions on the determination of the radiochemical purity of labeled macroaggregated albumin was evaluated. Then, a comparison of radiochemical purity obtained by these three methods was performed in normal condition and with different addition of pertechnetate. Finally, a correlation between these three methods was investigated. The results show a specificity difference between these three control methods. However in practice, this difference has no impact on the evaluation of the radiochemical purity of (99m)Tc-macroaggregated albumin by these three methods. In additions, methods are still correlated with pertechnetate additions in (99m)Tc-macroaggregated albumin suspension. Thus, this study demonstrates that these three control methods are exchangeable in radiopharmacy.