Background The use of robotic systems is expected to significantly decrease the risk of operators being exposed to cytotoxic substances, as the most critical operations are performed in a closed area under negative pressure. Although robotic systems are already in use in several international centres, very few systematic studies on workplace contamination, comparing manual and robot-assisted drug preparation have been performed.
Purpose To compare environmental contamination with cyclophosphamide (CP) during one week of drug compounding by the manual procedure in a biological safety cabinet (BSC) and automated preparation with an APOTECAchemo robot.
Material and methods Over four consecutive days, similar numbers of infusion bags containing cyclophosphamide were prepared by both techniques in a cross-over design. Wipe samples (49 for BSC, 50 for APOTECAchemo robot) were taken at several locations (gloves, infusion bags, trays, BSC-benches, floor) in the pharmacy and analysed by GCMSMS (LOD 0.2 ng/sample).
Results We detected contamination in 70% of samples in BSC versus 15% in robotic samples. During manual preparation, contamination with CP was below 0.001 ng/cm2 at most locations, but significant on gloves (0.0004–0.0967 ng/cm2) and the majority (70%) of infusion bags (<0.0004–2.89 ng/cm2). During robotic preparation, gloves (1 of 8: 0.0007 ng/cm2) and infusion bags (3 of 20: 0.0005, 0.0019, 0.0094 ng/cm2) were considerably less contaminated. Residual contamination was found on the surface under the dosing device in the compounding area (0.0293–0.1603 ng/cm2) inside the robotic system.
Conclusion Compared to outcomes from other studies, our results underline the good manufacturing procedures in this pharmacy with low contamination for both techniques. However, comparison of the two procedures confirmed that the overall CP contamination was lower when the production was carried out by the robotic system inside a closed and controlled system. This was also underlined by minimally or even non-contaminated external surfaces of compounded bags and gloves when the APOTECAchemo robot was used.
References and/or acknowledgements No conflict of interest.
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