Environmental monitoring of anti-neoplastic drug (AND) residues in workplaces is crucial to limit exposure to workers who handle with them. Although wipe sampling is the most appropriate methodology to evaluate the risk, conflicting results are also reported due to the lack of standardized and validated procedures. In this study, procedures for surface contamination of ANDs in workplaces are presented, with a focus on sampling, sample preparation and instrumentation. The analytical method validation parameters are designed to comply with requirements of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7 Good Manufacturing Practice (GMP) for active pharmaceutical ingredients. Additionally, the study provides a simple, specific, rapid and multi-component analytical method to evaluate seven ANDs that are Gefitinib, Imatinib, Dasatinib, Axitinib, Erlotinib, Nilotinib and Sorafenib at very low concentration levels, simultaneously. Quantitative, precise and reproducible results obtained from the study show that environmental monitoring procedure and analytical method validation protocol presented in the study can be used to reduce and monitor occupational exposure risk to ANDs in wokplaces.

中文翻译：

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基于清洁验证程序评估表面污染环境监测的分析方法验证协议设计：多组分 RP-UHPLC 方法

工作场所抗肿瘤药物 (AND) 残留物的环境监测对于限制接触这些药物的工人至关重要。尽管擦拭取样是评估风险的最合适方法，但由于缺乏标准化和经过验证的程序，也报告了相互矛盾的结果。在本研究中，介绍了工作场所 AND 表面污染的程序，重点是采样、样品制备和仪器。分析方法验证参数的设计符合人用药物技术要求国际协调委员会 (ICH) Q7 药物活性成分良好生产规范 (GMP) 的要求。此外，该研究提供了一个简单、具体、快速和多组分分析方法同时评估极低浓度水平的七种 AND，即吉非替尼、伊马替尼、达沙替尼、阿西替尼、厄洛替尼、尼罗替尼和索拉非尼。从研究中获得的定量、精确和可重复的结果表明，研究中提出的环境监测程序和分析方法验证协议可用于减少和监测工作场所 AND 的职业暴露风险。