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Updated: Jul 12, 2025
Optimization of Radiochemical Reactions using Droplet Arrays
Published on: February 12, 2021
Bacterial survival in radiopharmaceutical solutions: a critical impact on current practices
Julien Leenhardt1, Luc Choisnard2, Maelle Plasse3
1Univ. Grenoble Alpes, INSERM, CHU Grenoble Alpes, LRB, 38000, Grenoble, France. JLeenhardt@chu-grenoble.fr.
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.
Insights
Radiopharmaceutical preparation sterility testing may pose risks. Radioactivity does not always kill bacteria like Pseudomonas aeruginosa, challenging current safety practices for technetium-99m solutions.
Area of Science:
- Nuclear pharmacy
- Microbiology
- Radiopharmaceutical quality control
Background:
- Radiopharmaceutical preparations require stringent process control to mitigate bacteriological risks.
- Assessing bacterial survival in multidose technetium-99m solutions is crucial for laboratory safety.
Purpose of the Study:
- To evaluate the bacteriological risk associated with radiopharmaceutical preparation processes.
- To determine the survival rates of specific pathogenic bacteria in technetium-99m solutions.
Main Methods:
- Studied the survival rates of Pseudomonas aeruginosa, Staphylococcus aureus, and Staphylococcus epidermidis.
- Investigated bacterial survival in multidose technetium-99m solutions under varying conditions.
Main Results:
- Radioactivity's lethal effect on bacteria varied; Pseudomonas aeruginosa was affected, while Staphylococcus epidermidis survival was limited by nutrient availability.
- Staphylococcus aureus showed intermediate sensitivity, affected by both high radioactivity and nutrient deprivation.
- Bacterial reduction was observed in both radioactive and non-radioactive solutions, often due to nutrient scarcity.
Conclusions:
- Current practices recommending decay before sterility testing may not be universally protective.
- Findings challenge the 2021 European Association of Nuclear Medicine (EANM) guidelines regarding sterility testing of radiopharmaceuticals.
- Patient safety may be compromised if radioactivity's variable bactericidal effect is not fully considered.
