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    • 5. 发明授权
    • ePTFE filter for aseptic pharmaceutical use and method of using
    • 用于无菌药用的ePTFE过滤器和使用方法
    • US09457301B2
    • 2016-10-04
    • US13462017
    • 2012-05-02
    • Michael W. Osborne
    • Michael W. Osborne
    • B01D39/16G01M3/20B01D63/14B01D65/10B01D69/12B01D71/36
    • B01D39/1692B01D63/14B01D65/102B01D69/12B01D71/36B01D2239/0627B01D2239/0654B01D2273/18B01D2323/42G01M3/20
    • A HEPA filter which utilizes spun bond scrim material and ePTFE membrane for use in an aseptic pharmaceutical filtration air handling system for installation and testing is provided. The installation and testing configuration includes the ePTFE filter with a low or ultra-low concentration of challenging aerosol in the upstream side of the filter along with a scanning device for determining the upstream concentration, all completed in situ within a pharmaceutical air handling system. At the downstream side of the ePTFE filter is positioned another scanner which may be a discrete particle scanner for calculating the penetration percentage of the aerosol through the filtering media of ultra-low concentrations. The system and configuration allows for exposure to ePTFE filtration media for certification by low or ultra-low concentrations of oil based challenging compounds.
    • 提供了一种利用纺粘稀松布材料和ePTFE膜用于无菌药物过滤空气处理系统进行安装和测试的HEPA过滤器。 安装和测试配置包括在过滤器的上游侧具有低或超低浓度的具有挑战性的气溶胶的ePTFE过滤器以及用于确定上游浓度的扫描装置,所有扫描装置全部在药物空气处理系统内原位完成。 在ePTFE过滤器的下游侧设置另一扫描器,其可以是用于计算通过超低浓度的过滤介质的气溶胶的穿透百分比的离散粒子扫描器。 该系统和配置允许暴露于ePTFE过滤介质,以通过低或超低浓度的基于油的具有挑战性的化合物进行认证。