Bacterial survival in radiopharmaceutical solutions: a critical impact on current practices

IF 4.4 Q1 CHEMISTRY, INORGANIC & NUCLEAR
Julien Leenhardt, Luc Choisnard, Maelle Plasse, Valérie Ardisson, Nicolas de Leiris, Loic Djaileb, Pierrick Bedouch, Marie-Dominique Brunet
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Abstract

Background

The aim of this brief communication is to highlight the potential bacteriological risk linked to the processes control of radiopharmaceutical preparations made in a radiopharmacy laboratory. Survival rate of Pseudomonas aeruginosa (ATCC: 27853) or Staphylococcus aureus (ATCC: 25923) or Staphylococcus epidermidis (ATCC: 1228) in multidose technetium-99 m solution was studied.

Results

Depending on the nature and level of contamination by pathogenic bacteria, the lethal effect of radioactivity is not systematically observed. We found that P. aeruginosa was indeed affected by radioactivity. However, this was not the case for S. epidermidis, as the quantity of bacteria found in both solutions (radioactive and non-radioactive) was rapidly reduced, probably due to a lack of nutrients. Finally, the example of S. aureus is an intermediate case where we observed that high radioactivity affected the bacteria, as did the absence of nutrients in the reaction medium. The results were discussed in the light of current practices on the sterility test method, which recommends waiting for radioactivity to decay before carrying out the sterility test.

Conclusion

In terms of patient safety, the results run counter to current practice and the latest EANM recommendation of 2021 that radiopharmaceutical preparations should be decayed before sterility testing.

Abstract Image

放射性药物溶液中的细菌存活率:对当前实践的关键影响。
背景:本简短交流的目的是强调与放射性药物实验室中制备的放射性药物制剂的过程控制相关的潜在细菌风险。研究了多剂量锝-99m溶液中铜绿假单胞菌(ATCC:27853)、金黄色葡萄球菌(ATCC:55923)或表皮葡萄球菌(ATC C:1228)的存活率。结果:根据致病菌污染的性质和水平,放射性的致死作用没有得到系统的观察。我们发现铜绿假单胞菌确实受到放射性的影响。然而,表皮葡萄球菌的情况并非如此,因为在两种溶液(放射性和非放射性)中发现的细菌数量迅速减少,可能是由于缺乏营养。最后,金黄色葡萄球菌的例子是一个中间案例,我们观察到高放射性影响了细菌,反应介质中缺乏营养物质也是如此。根据无菌检测方法的现行实践对结果进行了讨论,该方法建议在进行无菌检测之前等待放射性衰变。结论:就患者安全性而言,这一结果与目前的做法和2021年欧洲药品监督管理局的最新建议背道而驰,即放射性药物制剂应在无菌检测前腐烂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
7.20
自引率
8.70%
发文量
30
审稿时长
5 weeks
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