Federici Matteo, Raffaelli Jacopo, Paolucci Demis, Schierl Rudolf, Krämer Irene
a Department of Pharmacy , University Medical Center, Johannes Gutenberg-University Mainz , Germany.
b Loccioni Deutschland GmbH , Calw , Germany.
J Occup Environ Hyg. 2019 Jan;16(1):6-15. doi: 10.1080/15459624.2018.1526384. Epub 2019 Jan 18.
The automated aseptic preparation of ready-to-administer antineoplastic drug solutions with robotic systems reduces the risk of occupational exposure. However, the surfaces in the preparation area of the robot are to be cleaned by wiping with an appropriate cleaning solution. The aim of the study was to evaluate the cleaning efficacy of four cleaning solutions on four surface materials installed in the APOTECAchemo robot. Predefined amounts of cisplatin (Cis), 5-fluorouracil (5-FU), and cyclophosphamide (CP) were intentionally spread on test plates made of stainless steel, aluminium, polyoxymethylene, and polycarbonate just as installed in the robotic system APOTECAchemo. After drying, the plates were cleaned with 0.2% ethanolic NaOH, 0.23% isopropanolic sodium dodecylsulfate (SDS-2P), 0.5% sodium hypochlorite (NaOCl), and 0.1% benzalkonium chloride (BZK) solutions following a standardized wiping protocol. Residual contamination was recovered with wipe tests, Pt was quantified by voltammetry, and 5-FU and CP was quantified by gas chromatography-tandem mass spectrometry (GC-MSMS). The mean residual contamination after cleaning and the cleaning efficacy (CE) rates were calculated and aggregated on different levels. The CE rates varied between 81.5% and 100% and lay in the majority of cases above 90%. The lowest CE rates were registered for Pt contamination. Especially on aluminium surfaces the residual contamination was high. The overall CE rates of the three different drugs and four different surface types amounted to 98.3% for NaOCl, 97.9% for SDS-2P, 96.9% for ethanolic NaOH, and 96.5% for BZK. The tested cleaning solutions proved to be higher than 90% in most cases, but none of them was able to eliminate 100% of the intentional surface contamination of three antineoplastic drugs on the test plates. The cleaning efficacy varied according to the different surface types and antineoplastic drug. Results could be used in the daily clinical practice to develop and implement effective cleaning procedures.
使用机器人系统自动无菌配制即用型抗肿瘤药物溶液可降低职业暴露风险。然而，机器人制备区域的表面需用适当的清洁溶液擦拭进行清洁。本研究的目的是评估四种清洁溶液对安装在APOTECAchemo机器人中的四种表面材料的清洁效果。将预定义量的顺铂（Cis）、5-氟尿嘧啶（5-FU）和环磷酰胺（CP）故意涂抹在如安装在APOTECAchemo机器人系统中的由不锈钢、铝、聚甲醛和聚碳酸酯制成的测试板上。干燥后，按照标准化擦拭规程，用0.2%乙醇氢氧化钠、0.23%异丙醇十二烷基硫酸钠（SDS-2P）、0.5%次氯酸钠（NaOCl）和0.1%苯扎氯铵（BZK）溶液清洁测试板。通过擦拭试验回收残留污染物，通过伏安法对铂进行定量，通过气相色谱-串联质谱（GC-MSMS）对5-FU和CP进行定量。计算清洁后的平均残留污染物和清洁效果（CE）率，并在不同水平上进行汇总。CE率在81.5%至100%之间变化，大多数情况下高于90%。铂污染的CE率最低。特别是在铝表面，残留污染物含量很高。三种不同药物和四种不同表面类型的总体CE率分别为：NaOCl为98.3%，SDS-2P为97.9%，乙醇氢氧化钠为96.9%，BZK为96.5%。测试的清洁溶液在大多数情况下证明高于90%，但它们都无法完全消除测试板上三种抗肿瘤药物的故意表面污染。清洁效果因不同的表面类型和抗肿瘤药物而异。研究结果可用于日常临床实践，以制定和实施有效的清洁程序。
