Vice President Quality Assurance and Regulatory Compliance, Custom Services International Inc., Las Vegas, NV
Mechanical Engineer, Winchester Engineering and Analytical Center, Winchester, MA
Manager, Quality Engineering, Church and Dwight Co. Inc, Princeton, NJ
Director, Family Health International, NC,
Quality Assurance/Regulatory Manager, Ansell Healthcare Inc., Dothan, AL
(Received 10 April 2003; accepted 6 November 2003)
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.
Paper ID: JTE11933