Water Leak Testing of Polyurethane Female Condoms

    Volume 23, Issue 6 (November 1995)

    ISSN: 0090-3973

    CODEN: JTEOAD

    Page Count: 5


    Neunaber, LM
    Mechanical engineer, Winchester Engineering and Analytical Center (WEAC), Food and Drug Administration, Winchester, MA

    Boivin, WS
    Physicist, Winchester Engineering and Analytical Center (WEAC), Food and Drug Administration, Winchester, MA

    Khatri, ZH
    Physicist, Winchester Engineering and Analytical Center (WEAC), Food and Drug Administration, Winchester, MA

    Herman, BA
    Physicist, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD

    (Received 19 March 1995; accepted 6 June 1995)

    Abstract

    This paper describes an apparatus and a technique for water leak testing of polyurethane female condoms. This test detects holes as effectively as other official FDA methods used to test barrier products such as latex male condoms and medical gloves. This rapid test simulates actual use conditions as much as possible without causing plastic deformation of the polyurethane material. Blind validation tests showed that the method detects a high percentage of holes 20 μm and larger over the entire surface of the condoms. Holes as small as 10 μm were detected with lower efficiency. Hole detection rate was highest in the bottom one third of the condom where the water pressure was greatest. The condom lubricant was shown to act as a surfactant when added to water.


    Paper ID: JTE11433J

    DOI: 10.1520/JTE11433J

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    Author
    Title Water Leak Testing of Polyurethane Female Condoms
    Symposium , 0000-00-00
    Committee E07