Background and Importance Continuous occupational exposure to hazardous drugs (HD) poses significant risks to healthcare personnel. Robotic compounding systems have been introduced in pharmacies to enhance patient and staff safety. These systems operate within enclosed ISO Class 5 environments with negative pressure, which effectively minimising personnel exposure to HD during critical operations. However, there is a concern that surfaces in the compounding area may get contaminated, potentially exposing hospital personnel to these hazardous substances.

Aim and Objectives The primary objective of this study was to evaluate the risk of occupational exposure to HD when utilising robotic compounding systems for the preparation of antineoplastic sterile medications. Specifically, we aim to assess the levels of HDs present on the surfaces of ready-to-use preparations and on the gloves worn by personnel involved in the compounding process.

Material and Methods This study was conducted over a period of 3 days during routine production at KIRO Oncology (Kiro Grifols, Mondragon, Spain). Each day, we collected wipe samples from the surfaces of 20 HD preparations and from the gloves of the operator engaged in the compounding process using Cytoxlab sampling kits (CYTOXLab, Geneva, Switzerland). Our analysis included the detection and quantification of 25 anticancer molecules commonly used in hospital pharmacies.

Results Throughout the study, 19 different drugs were compounded by the robot, including 5-fluorouracil, bevacizumab, carboplatin, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, etoposide, gemcitabine, irinotecan, nivolumab, oxaliplatin, paclitaxel, panitumumab, pembrolizumab, pemetrexed, trastuzumab, and vinorelbine. We observed only a negligible amount of gemcitabine, which fell below the quantification limit (<0.005 ng/cm²), on the surfaces of two out of the 20 bags and on two of the operator’s gloves.

Conclusion and Relevance The results of this study demonstrate that levels of HD surface contamination in robotic compounding are exceedingly low and, in most cases, undetectable. Occupational exposure to HD remains consistently below 0.1 ng/cm², a threshold deemed ‘safe’ according to certain studies. This finding assures the safety of the compounding personnel and other hospital staff members involved in cancer treatment.

References and/or Acknowledgements This research was partially supported by Kiro-Grifols.

Conflict of Interest No conflict of interest.