机器人系统制备抗肿瘤药物过程中的环境和产品污染

I. Krämer, M. Federici, R. Schierl
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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. 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引用次数: 8

摘要

机器人系统的设计是为了在自动化制备过程中最大限度地减少抗肿瘤药物的暴露。然而,污染不能完全排除。本研究的目的是评估在使用不同版本的机器人和手动制备的自动制备过程中,抗肿瘤药物对工作表面和即用产品(输液袋和注射器)外表面的污染。方法采用擦拭取样法测定铂(Pt)和5-氟尿嘧啶(5-FU)的表面污染,用伏安法测定铂(Pt),用气相色谱-质谱法测定5-FU。在标准化测试产品制备之前和之后,在工作区域的预定义位置进行采样。对含铂或含5- fu的输液袋和含5- fu的注射器的外表面进行取样,取样后分别进行手动盖盖。结果总体而言,机器人系统工作区域的表面污染范围为Pt为0.4至114 pg/cm2, 5-FU为1.3至1,250,000 pg/cm2。在制备后,在机械臂的抓手和计量装置下面的表面检测到最高的污染水平。在大多数情况下,制备后的测量浓度更高。与人工制备的输液袋相比,机器人制备的输液袋外表面污染较少。注射器外表面的污染因所采用的程序而异。结论污染风险集中在机器人的工作区域内。产品的外表面仅受到轻微污染。工作区域的清洁程序有待进一步调查。应制定机器人工作区域的有效去污程序和灌装注射器的自动封盖,以进一步减少职业风险。
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Environmental and Product Contamination during the Preparation of Antineoplastic Drugs with Robotic Systems
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.
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