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开发一种用于验证微流体系统中泄漏检测的工具

Ali Bozorgnezhad¹, Luke Herbertson¹, Suvajyoti Guha¹

¹Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

|March 6, 2025

概括

一个新的工具准确地测量了微流体设备的泄漏率,从0.1%到10%. 该方法有助于验证微流体泄漏检测系统,防止医疗器械故障.

科学领域:

生物医学工程生物医学工程
材料科学材料科学材料科学
流体动力学流体动力学

背景情况:

微流体设备越来越多地提交给监管机构,如食品和药物管理局 (FDA).
泄漏是微流体系统中普遍存在且具有挑战性的故障模式,影响设备的可靠性和安全性.
准确检测和量化微流体泄漏对于医疗器械开发至关重要.

研究的目的:

开发和验证一种用于测量和验证微流体泄漏的敏感工具.
建立一个测试方法,用于评估微流体系统的0.1%至10%的泄漏率.
为微流体医疗器械开发人员提供验证工具,以检测流媒体泄漏故障.

主要方法:

开发了一个分析模型,将水力动力学阻力原理应用于流体接触元件 (管道,接口,连接器).
泄漏率根据特定应用的接受标准进行调整.
三种聚合物基的微流体系统 (PEEK,PEEKsil,COC) 用于准和实验验证大约0.1%,1.0%和10%水平的泄漏.

主要成果:

PEEKsil管道系统表现出高精度,在目标泄漏率中,实验不确定性为0.00%至1.59%.
聚乙 (PEEK) 管道的不确定性较高,在1.16%到23.08%之间.
循环烯酸共聚合物 (COC) 微流体芯片表现出7.69%和5.05%的特定目标泄漏的误差.

结论:

拟议的试验台试验方法为微流体设备的泄漏检测提供了一种灵敏而可靠的方法.
该方法允许精确调整泄漏率,有助于验证泄漏检测系统.
该工具可以显著帮助设备开发人员评估和减轻微流体医疗应用中的泄漏相关故障.

关键词:

失效模式的故障模式泄漏测试泄漏测试泄漏测试泄漏测试医疗器械医疗器械医疗器械微流体学在微流体学方面验证验证验证验证验证验证验证验证验证验证验证验证

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