Aerosol generator for EPTFE filter testing and method of use

摘要

Systems and methods for generating low or ultra-low concentrations of oil-based challenging compounds for filtration media are provided. Embodiments of the generators utilize bypass air in addition to the source of challenge. A HEPA filter which utilizes spunbond 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 counter. The system and configuration allows for exposure to ePTFE filtration media for certification by low or ultra-low concentrations of oil based challenging compounds.

主权项

1. A system for in situ testing of a filtration media comprising:
a filtration media for positioning within an air stream of an air stream handling system; an aerosol generator positioned upstream of said filtration media and having a substantially closed tank configured for containing a liquid therewithin and having a void space above a top surface of the liquid; said aerosol generator having a generation nozzle located in said substantially closed tank having a nozzle outlet located below said top surface of the liquid, said generation nozzle supplying a source of pressurized supply air; said aerosol generator having a bypass nozzle located in said substantially closed tank, said bypass nozzle supplying a source of bypass air; and a tank outlet for discharging an aerosol from said substantially closed tank to said air stream handling system; an upstream scanner for detection of said aerosol produced by said aerosol generator at an upstream side of said filtration media; and a downstream scanner for detection of said aerosol passing through said filtration media.