Inhibition of viability of microorganisms in [18F]-labeled radiopharmaceuticals

Jörg, Gerhard; Fosselmann, M.; Leis, W.; Oberdorfer, Franz; Fehsenfeld, Ch.

doi:10.1016/j.nucmedbio.2016.09.002

Cited by 3 publications

(3 citation statements)

References 28 publications

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“…Levigoureux et al had already proved the nonmicrobiologic contamination of multidose radiopharmaceuticals when the rules of hygiene are applied (11). Furthermore, the radioactive nature of radiopharmaceuticals cannot guarantee sterility (12). The study was performed under worst-case conditions: vials stored at room temperature and disinfection of the obturator cap only once for a syringe preparation.…”

Section: Discussionmentioning

confidence: 99%

Validation of an Ergonomic Method of Withdrawing ^99mTc-Radiopharmaceuticals

Blondeel-Gomes

Marie

Fouque

et al. 2017

J. Nucl. Med. Technol.

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The main objective of the present work was to ensure quality of radiopharmaceuticals syringes withdrawn with a "Spinal needle/obturator In-Stopper" system. Visual examinations and physicochemical tests are performed at T0 and T+4h for [Tc]albumin nanocolloid and T+7h for [Tc]eluate, [Tc] HydroxyMethylene DiPhosphonate and [Tc]Human Serum Albumin. Microbiological validation was performed according to European pharmacopoeia. Fingertip radiation exposure was evaluated to confirm the safety of the system. Results show stable visual and physicochemical properties. The integrity of the connector was not affected after 30 punctures (no cores). No microbiological contamination was found on tested syringes. The system could be used 30 times. The stability of syringes drawing with this method is guaranteed up to 4 hours for [Tc]albumin nanocolloid and 7 hours for [Tc]eluate, [Tc]HydroxyMethylene DisPhosphonate and [Tc]Human serum albumin.

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Section: Discussionmentioning

confidence: 99%

Validation of an Ergonomic Method of Withdrawing ^99mTc-Radiopharmaceuticals

Blondeel-Gomes

Marie

Fouque

et al. 2017

J. Nucl. Med. Technol.

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“…Our hypothesis is, that radiopharmaceuticals might be selfsterilizing due to the fact that they contain a high radioactivity concentration and high-energy radionuclides. To the best of our knowledge, this hypothesis was thus far only tested for [ 99 m Tc]radiopharmaceuticals [2,3] and [ 18 F]-radiopharmaceuticals [4]. Brown et al state, that the time lag between preparation and the sterility test of [ 99 m Tc]-radiopharmaceuticals should be as short as possible.…”

Section: Salmentioning

confidence: 99%

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

2021

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Background For radiopharmaceuticals, aseptic preparation in combination with filtration is the most commonly used 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. 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 forming units compared to the control values. 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.

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“…Our hypothesis is, that radiopharmaceuticals might be self-sterilizing due to the fact that they contain a high radioactivity concentration and high-energy radionuclides. To the best of our knowledge, this hypothesis was thus far only tested for [ 99m Tc]-radiopharmaceuticals [2,3] and [ 18 F]radiopharmaceuticals [4]. Brown et al state, that the time lag between preparation and the sterility test of [ 99m Tc]-radiopharmaceuticals should be as short as possible.…”

Section: Introductionmentioning

confidence: 99%