Robotic compounding systems reduce the frequency of contamination when compared to manual compounding in an isolator, a new study examining the chemical contamination of cancer drugs has found.
However, robotic processing generated larger amounts of contaminants when contamination occurred.
Corrective measures such as daily cleaning significantly reduced contamination, highlighting the need for cleaning protocols to minimise contamination by cytotoxics in robotic compounding systems.
The study examined contamination by cytotoxics inside and outside the RIVA robot. Using risk analysis, the researchers identified 10 sites inside and seven outside the robot to monitor for contamination. All sites were wet swabbed before cleaning the robot in 10 sampling campaigns, which consisted of 10 samples per campaign.
The researchers analysed samples for 10 cytotoxic drugs compounded in the robot using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and measured the percentage contamination rates (CR) inside (CRin) and outside (CRout) the robot. If a site was contaminated, corrective action, such as cleaning with sodium dodecyl sulfate or isopropyl alcohol, was implemented.
Contamination levels were much higher inside the robot (mean CRin 40%) than outside (mean CRout 2%), with a high significance level of p < 10−4, suggesting the difference between the inside and outside contamination did not occur by chance.
The researchers found gemcitabine and cyclophosphamide to be the most common cytotoxic contaminants. After corrective action, the CRin fell from 60% to 10%.
Robotic compounding of cytotoxic drugs showed less frequency of contamination compared to manual contamination. When contamination occurred in the robot, larger mean amounts of contaminant were generated by incidents such as splashing during syringe disposal.
The researchers concluded that cleaning strategies were highly effective in reducing contamination inside the robot, but they would like to see further long-term studies confirm these results.
Reference
Bouchfaa, M et al. Assessment of chemical contamination by cancer drugs during use of the RIVATM compounding robot: A pilot study. Journal of Oncology Pharmacy Practice 2024; Aug 26: DOI: 10.1177/1078155224127653.