发明公开
EP2637772A2 EPTFE FILTER FOR ASEPTIC PHARMACEUTICAL USE AND METHOD OF USING
有权
对无菌药物用途EPTFE过滤器及其使用方法
- 专利标题: EPTFE FILTER FOR ASEPTIC PHARMACEUTICAL USE AND METHOD OF USING
- 专利标题(中): 对无菌药物用途EPTFE过滤器及其使用方法
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申请号: EP11839618.3申请日: 2011-11-08
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公开(公告)号: EP2637772A2公开(公告)日: 2013-09-18
- 发明人: OSBORNE, Michael, W.
- 申请人: Aaf-McQuay Inc., D/b/a Aaf International
- 申请人地址: 10300 Ormsby Park Place Suite 600 Louisville, Kentucky 40223 US
- 专利权人: Aaf-McQuay Inc., D/b/a Aaf International
- 当前专利权人: Aaf-McQuay Inc., D/b/a Aaf International
- 当前专利权人地址: 10300 Ormsby Park Place Suite 600 Louisville, Kentucky 40223 US
- 代理机构: Schwabe - Sandmair - Marx
- 优先权: US411279P 20101108
- 国际公布: WO2012064751 20120518
- 主分类号: B01D65/10
- IPC分类号: B01D65/10 ; G01M3/04 ; B01D46/54 ; A61L9/00
摘要:
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.
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