Abstract
Manufacturers, consumers, and regulators use various water test methods to test the integrity of the barrier offered by natural rubber latex condoms. The purpose of this study is to analyze three alternative water test methods and determine which is the best method for detecting holes in condoms. Three types of holes (laser, acupuncture, and 28 gage insulin needles), approximating defects that occur in condoms, were placed in condoms and then into equal size test sets for testing by six laboratories for the purpose of evaluating the three alternative methods: the ASTM method, the ISO/FDA method, and the CSI/FHI method. Each method shares a hang portion for 1 min., and then uses a different form of manipulation; either elevate (ASTM), roll (ISO/FDA), or squeeze (CSI/FHI). The interlaboratory study data indicate the CSI/FHI is the most sensitive method for locating holes in condoms, becoming more sensitive as the defect approaches the closed end.
Keywords:
condoms, holes, latex condoms, natural rubber latex, water test methods
Paper ID: JTE11933
DOI: 10.1520/JTE11933
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Author Thomas, LC Affiliation Custom Services International, Las Vegas NV 89118
Author Kerr, LN Affiliation U.S. Food and Drug Administration, 109 Holton Street, Winchester, MA 01890
Author Andersen, PC Affiliation Church and Dwight Company, 469 N. Harrisno Street, Princeton, NJ 08543
Author Carter, EJ Affiliation Family Health International, Research Triangle Park, NC 27713
Author McIlvain, LD Affiliation Ansell Healthcare, 1500 Industrial Road, Dothan AL 36303
Author Thomas LC, Kerr LN, Andersen PC, Carter EJ, McIlvain LD
Title Water Testing Natural Rubber Latex Condoms: A Comparison of Surveillance Test Methods
Symposium ,
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