Monitoring of occupational exposure to hazardous medicinal products in robotic compounding.

Abstract

Objective: This study aims to evaluate the risk of occupational exposure to hazardous medicinal products (HMPs) when utilising robotic compounding systems for the preparation of antineoplastic sterile medications. Specifically, it assesses the levels of HMPs present on the surfaces of ready-to-use preparations and on the gloves worn by personnel involved in the compounding process.

Methods: The study was conducted over three consecutive days during routine production with a robotic compounding system. Each day, wipe samples were collected from the surfaces of 20 HMPs preparations and from the gloves of the operator involved in the compounding process. Analyses were performed using an Ultra-High Performance Liquid Chromatography (UHPLC) system to detect and quantify 25 commonly used anticancer molecules in hospital pharmacies.

Results: Throughout the study, the robot compounded 60 bags of 19 different drugs, including 5-fluorouracil, bevacizumab, carboplatin, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, etoposide, gemcitabine, irinotecan, nivolumab, oxaliplatin, paclitaxel, panitumumab, pembrolizumab, pemetrexed, trastuzumab, and vinorelbine. Only negligible amounts of gemcitabine, below the quantification limit (<0.0025 ng/cm²), were detected on the surfaces of 10 out of the 60 bags and on two of the operator's gloves.

Conclusion: The results demonstrate that surface contamination levels of HMPs in robotic compounding are exceedingly low and, in most cases, undetectable. Occupational exposure to HMPs remains consistently below 0.1 ng/cm², a threshold deemed safe according to various studies. These findings assure the safety of compounding personnel and other hospital staff involved in cancer treatment.