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药物结合型密闭系统转移装置中细胞毒性药物蒸汽 containment 的 28 天评估。 注:“containment”此处结合语境推测可能是“遏制、控制”等意思,但由于原文未完整准确表达,所以翻译中保留英文,以待进一步明确其确切含义来完善译文表述。

A twenty-eight-day evaluation of cytotoxic drug vapor containment in drug-binding closed-system transfer device.

作者信息

Navarro Dekel, Epstein Daniel

机构信息

Nextar Chempharma Solutions Ltd., Ness Ziona, Israel.

出版信息

Front Public Health. 2025 Jun 2;13:1400571. doi: 10.3389/fpubh.2025.1400571. eCollection 2025.

Abstract

OBJECTIVE

Several studies have demonstrated that hazardous drugs can evaporate even at ambient temperature during their preparation in healthcare facilities, potentially posing a health risk for clinicians. The National Institute for Occupational Safety and Health (NIOSH) has defined closed system transfer device (CSTD) performance as preventing the release of hazardous drugs in the form of vapor, aerosol, or droplets. Most CSTDs can be used to store drugs for up to 7 days after their preparation. However, as some drugs are stable for more than 7 days, the CSTD usage period represents a limiting factor leading to residual drug waste. We investigated whether the Chemfort CSTD with the ToxiGuard system, an activated carbon matrix, minimizes the exposure to hazardous drug vapors or aerosols that may be released for 28 days after drug preparation.

METHODS

Cyclophosphamide, a cytotoxic drug with relatively high vapor pressure was chosen as the representative drug to demonstrate vapor escape prevention. Testing was performed using intact vial adaptors (with ToxiGuard) after incubation for 28 days, intact vial adaptors (with ToxiGuard) without incubation, a vial adaptor from which the carbon matrix was removed (positive control) and a vial adaptor containing only water (negative control). After each test, the components were rinsed or swabbed to test for cyclophosphamide contamination.

RESULTS

No escaped cyclophosphamide was detected in the tests performed using Chemfort with intact ToxiGuard. In the system tested without ToxiGuard, 110.3 ng of escaped cyclophosphamide were detected.

CONCLUSION

The intact ToxiGuard, as part of the Chemfort vial adaptor, prevents release of hazardous cyclophosphamide from the vial into the environment for up to 28 days. This result supports potential extension of its usage period and potential drug waste prevention with associated cost savings.

摘要

目的

多项研究表明,在医疗机构制备危险药物时,即使在环境温度下这些药物也会挥发,这可能对临床医生构成健康风险。美国国家职业安全与健康研究所(NIOSH)将封闭系统转移装置(CSTD)的性能定义为防止危险药物以蒸气、气溶胶或液滴的形式释放。大多数CSTD可用于在药物制备后储存药物长达7天。然而,由于一些药物的稳定性超过7天,CSTD的使用期限成为导致残留药物浪费的限制因素。我们研究了带有ToxiGuard系统(一种活性炭基质)的Chemfort CSTD是否能将药物制备后28天内可能释放的危险药物蒸气或气溶胶的暴露降至最低。

方法

选择环磷酰胺(一种具有相对较高蒸气压的细胞毒性药物)作为代表性药物来证明防止蒸气逸出的效果。在孵育28天后使用完整的小瓶适配器(带有ToxiGuard)、未孵育的完整小瓶适配器(带有ToxiGuard)、去除了碳基质的小瓶适配器(阳性对照)和仅装有水的小瓶适配器(阴性对照)进行测试。每次测试后,对组件进行冲洗或擦拭以检测环磷酰胺污染情况。

结果

在使用带有完整ToxiGuard的Chemfort进行的测试中未检测到逸出的环磷酰胺。在没有ToxiGuard的测试系统中,检测到110.3纳克逸出的环磷酰胺。

结论

作为Chemfort小瓶适配器一部分的完整ToxiGuard可防止危险的环磷酰胺从小瓶中释放到环境中长达28天。这一结果支持了其使用期限的潜在延长以及预防相关药物浪费并节省成本的可能性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a59/12171236/4606bc37aa73/fpubh-13-1400571-g001.jpg

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