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RESEARCH PRODUCT

Environmental and Product Contamination during the Preparation of Antineoplastic Drugs with Robotic Systems

Matteo FedericiIrene KrämerRudolf Schierl

subject

PharmacyRM1-950030226 pharmacology & pharmacygas chromatography/mass spectrometryantineoplastic drugs03 medical and health sciences0302 clinical medicineMedicinePharmacology (medical)Pharmaceutical industryPharmacologyvoltammetryChromatographybusiness.industrysurface contaminationautomated compoundingContaminationwipe samplingRobotic systems030220 oncology & carcinogenesisProduct (mathematics)Antineoplastic DrugsTherapeutics. PharmacologyGas chromatography–mass spectrometryHD9665-9675businessWipe sampling

description

Abstract Background Robotic systems are designed to minimize the exposure to antineoplastic drugs during automated preparation. However, contamination cannot be completely excluded. The aim of the study was to evaluate the contamination with antineoplastic drugs on the working surfaces and on the outer surface of the ready-to-use products (infusion bags and syringes) during automated preparation with different versions of a robot and manual preparation. Methods Surface contamination with platinum (Pt) and 5-fluorouracil (5-FU) was measured by wipe sampling and quantified by voltammetry for Pt and GC-MS for 5-FU. Sampling was performed on pre-defined locations in the working areas before and after preparation of standardized test products. The outer surfaces of Pt- or 5-FU-containing infusion bags and 5-FU-containing syringes were sampled without and after manual capping. Results Overall, the surface contamination in the working areas of the robotic system ranged from 0.4 to 114 pg/cm2 for Pt and from 1.3 to 1,250,000 pg/cm2 for 5-FU. The highest contamination levels were detected after preparation on the gripper of the robotic arm and on the surface beneath the dosing device. In most cases, measured concentrations were higher after preparation. Outer surfaces of infusion bags prepared with the robotic system were less contaminated than manually prepared bags. Contamination on the outer surface of syringes varied depending on the procedure adopted. Conclusions The risk of contamination is localised inside the working area of the robot. The outer surfaces of products were only marginally contaminated. Cleaning procedures of the working area are to be further investigated. An effective decontamination procedure for the working area of the robot and automated capping of filled syringes should be developed to further minimize the occupational risk.

10.1515/pthp-2018-0018https://doaj.org/article/5151d80d431d46ffb97e435de4d28119