WATER LEAK TESTING OF POLYURETHANE FEMALE CONDOMS

This paper describes an apparatus and a technique for water leak testi ng of polyurethane female condoms. This test detects holes as effectiv ely as other official FDA methods used to test barrier products such a s latex male condoms and medical gloves. This rapid test simulates act ual use conditions as much as possible without causing plastic deforma tion of the polyurethane material. Blind validation tests showed that the method detects a high percentage of holes 20 mu m and larger over the entire surface of the condoms. Holes as small as 10 mu m were dete cted with lower efficiency. Hole detection rate was highest in the bot tom 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 .