Are radiopharmaceuticals self-sterilizing? Radiation effect of gallium-68 and lutetium-177 on bacillus pumilus and staphylococcus succinus

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Ziel/Aim For radiopharmaceuticals, aseptic preparation in combination with filtration is the most chosen sterilizing method. In general, the production of radiopharmaceuticals needs to fulfil the requirements of good manufacturing practice. In the scope of this work, we focused on the positron emitter gallium-68 and on the therapeutically used beta- and gamma-emitter lutetium-177, as they are routinely used for in-house synthesis of radiopharmaceuticals in nuclear medicine departments. Our hypothesis is that radiopharmaceuticals might be self-sterilizing due to a high radioactivity concentration and high-energy radionuclides in the preparation for intravenous injections. Methodik/Methods Approximately 10 9 colony-forming units (cfu) out of one mL of an over-night culture of bacillus pumilus and staphylococcus succinus were transferred into an isotonic saline solution and incubated with a glass vial containing 1-2 GBq of Ga-68 or 0.8-1.4 GBq of Lu-177, respectively. After different incubation times, a dilution series was executed to estimate the concentration of remaining cfu. Bacterial growth of bacillus pumilus and staphylococcus succinus was evaluated by counting colony forming units on agar plates. Ergebnisse/Results Incubation with gallium-68 and lutetium-177 for both 30 minutes and 5 hours post-dispensing did not cause any significant effect on bacteria growth. As the theoretical dose is only 0.1-0.6 % of the Ph. Eur. recommended dose of 25 kGy, we conclude that the beta and positron energy of lutetium-177 and gallium-68 as used for standard radiopharmaceutical in-house production is not sufficient to decrease the number of colony building units compared to the control values. Schlussfolgerungen/Conclusions Based on these findings, gallium-68 and lutetium-177 labeled radiopharmaceuticals are not self-sterilizing under the tested conditions with respect to bacillus pumilus and staphylococcus succinus. Consequently, strict aseptic preparation conditions in addition to end-sterilization of the radiopharmaceutical e.g. through membrane filtration are strongly advised for in-house productions. Publication History Publication Date: 08 April 2021 (online) © 2021. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany

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