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精确泄漏探测器上市 - China Medical Device Manufacturer
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Wed, January 17th, 2018

2006年7/8月刊 » 技术新知
精确泄漏探测器上市

700G型泄漏探测器能检测组装医疗设备的密封性,灵敏度可达到每秒3.010-13atm-cm3

新型泄漏探测器可以探测到每秒最小3.010-13atm-cm3的细微气体泄漏。一个内充20,000cm3空气,压力2bar强的轮胎,若以该速率泄漏,大约20亿年才会泄露一半气体。该探测器是由Pernicka公司(美国科罗拉多州,Fort Collins;www.pernicka.com)提供,是世界首个利用累积型氦泄漏探测技术(cumulative helium leak detection, CHLD)判断密封性能的仪器。

Pernicka公司副总裁Bill Burkard解释道,CHLD技术适用于检查包装、组装医疗仪器的完整性,能对胰岛素泵等产品进行总量泄漏测试,不需使用CFC(氟氯碳化物)。通常检测胰岛素泵加压气室时,需在组装前分别做总量泄漏测试和细微泄漏测试,而采用CHLD技术后,只需对最终成品做一次全面测试。

此密封测试技术的精确度比其它方法高出许多,因而早就引起了美国国家航空和宇宙航行局(NASA)和美国食品药品管理局供货商的注意,希望将此用来测试卫星部件或医疗植入物。Pernicka公司新闻发言人George Grenley说,医学界应该会对CHLD探测器产生兴趣,它的测试成本低廉、精度非常高、不损坏被测部件,如果需要还可做多次重复测试。

该项测试方法是将产品或包装置于氦气加压测试系统中,让氦分子穿过十分微小的泄漏孔,然后系统充入纯氮气以排空氦气,再用低温泵降低压强同时冷冻比氦气重的气体,最后分析测试系统压力,使用质谱仪判断被测部件是否存在任何细微泄漏。

公司总裁及该产品发明人John Pernicka先生解释说:这种独特创新的泄漏探测器是一种封闭系统,它能累积和分析内部所有气体,检测极其微小,泄露速率极低的泄漏。Pernicka公司CHLD技术可让器械制造商生产安全的植入仪器。

Copyright 2006 China Medical Device Manufacturer


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