Health Effects Laboratory Division (HELD), Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), Chemical and Biochemical Monitoring Branch (CBMB), Alice Hamilton Laboratories, Cincinnati, Ohio, United States of America.
PLoS One. 2021 Nov 4;16(11):e0258425. doi: 10.1371/journal.pone.0258425. eCollection 2021.
A system to differentiate and quantify liquid and headspace vapor leaks from closed system drug-transfer devices (CSTDs) is presented. CSTDs are designed to reduce or eliminate hazardous drug (HD) exposure risk when compounding and administering HDs. CSTDs may leak liquid, headspace, or a mixture of the two. The amount of HD contained in liquid and headspace leaks may be substantially different. Use of a test solution containing two VOCs with differences in ratios of VOC concentrations in the headspace and liquid enables source apportionment of leaked material. SIFT-MS was used to detect VOCs from liquid and headspace leaks in the vapor phase. Included in this report is a novel method to determine the origin and magnitude of leaks from CSTDs. A limit of leak detection of 24 μL of headspace vapor and 0.14 μL of test liquid were found using Selected Ion Flow Tube Mass Spectrometry (SIFT-MS).
本文介绍了一种用于区分和定量密闭式药物传输装置（CSTD）的液体和顶空蒸气泄漏的系统。CSTD 的设计目的是在配制和使用高毒性药物（HD）时降低或消除 HD 暴露风险。CSTD 可能会发生液体泄漏、顶空泄漏，或者两者混合发生泄漏。液体和顶空泄漏中所含的 HD 量可能有很大差异。使用含有两种挥发性有机化合物（VOC）的测试溶液，这两种 VOC 在顶空和液体中的浓度比值不同，可用于对泄漏物质进行来源分配。使用选择离子流管质谱法（SIFT-MS）检测蒸气相中液体和顶空泄漏的 VOCs。本报告中包含一种确定 CSTD 泄漏源和程度的新方法。使用选择离子流管质谱法（SIFT-MS）发现，顶空蒸气的泄漏检测下限为 24 μL，测试液体的泄漏检测下限为 0.14 μL。
