Volume 30, Issue 4 (July 2002)

    Use of Surfactants in Condom Water Leak Testing

    (Received 2 February 2001; accepted 12 March 2002)

    CODEN: JTEOAD

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    Abstract

    This paper identifies an appropriate surfactant solution to improve the defect detection rate of the ISO/FDA water leak test method for condoms. A surfactant solution and concentration are identified to optimize leakage testing of condoms, considering factors of safety, cost, reproducibility, and hole detection. Defect detection rates are compared using the ISO/FDA method with and without the surfactant solution.

    Micro-90® concentrated cleaning solution is selected as a suitable surfactant for water leak testing of condoms due to reliable formulation, low sudsing, low cost, and no disposal or toxicity problems. A concentration of 0.1% by volume optimizes the effectiveness of the solution while minimizing solution concentration.

    Detection rates of standardized defects are quantified for four condom types tested with and without surfactant solution. Use of surfactant solution in the ISO/FDA method increases the detection rates of all defect types and sizes in all the condom types tested. This increase is statistically significant for 10 (out of 48 possible) combinations of condom type, hole diameter, and hole location.


    Author Information:

    Kerr, LN
    Mechanical Engineer, Chemical Engineer, Physicist, Mechanical Engineer, Electronics Technician, Biomedical Engineer, and Computer Engineer, Food and Drug Administration, Winchester, MA

    Mailhot, SA
    Mechanical Engineer, Chemical Engineer, Physicist, Mechanical Engineer, Electronics Technician, Biomedical Engineer, and Computer Engineer, Food and Drug Administration, Winchester, MA

    Boivin, WS
    Mechanical Engineer, Chemical Engineer, Physicist, Mechanical Engineer, Electronics Technician, Biomedical Engineer, and Computer Engineer, Food and Drug Administration, Winchester, MA

    Hamilton, SL
    Mechanical Engineer, Chemical Engineer, Physicist, Mechanical Engineer, Electronics Technician, Biomedical Engineer, and Computer Engineer, Food and Drug Administration, Winchester, MA

    O'Malley, LG
    Mechanical Engineer, Chemical Engineer, Physicist, Mechanical Engineer, Electronics Technician, Biomedical Engineer, and Computer Engineer, Food and Drug Administration, Winchester, MA

    Boyd, SM
    Mechanical Engineer, Chemical Engineer, Physicist, Mechanical Engineer, Electronics Technician, Biomedical Engineer, and Computer Engineer, Food and Drug Administration, Winchester, MA

    Pierdominici, VJB
    Mechanical Engineer, Chemical Engineer, Physicist, Mechanical Engineer, Electronics Technician, Biomedical Engineer, and Computer Engineer, Food and Drug Administration, Winchester, MA

    Bushar, HF
    Statistician, Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Rockville, MD


    Stock #: JTE12321J

    ISSN: 0090-3973

    DOI: 10.1520/JTE12321J

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    Author
    Title Use of Surfactants in Condom Water Leak Testing
    Symposium , 0000-00-00
    Committee D11