Characterization and Creation of Defects in Condoms
L.N. Kerr, M.P. Chaput, S.M. Boyd, E.A. Galevi and P.A. Millward, WEAC, FDA, Winchester, MA 01890
Condom defects were characterized and compared with defects made using various creation techniques. Eighty-five percent of the condom defects examined were classified as either a hole (void in material) or a slit (puncture). Laser drilling and puncturing with a 160 um diameter acupuncture needle artificially introduced similar types of defects. Microscopic examination of the created defects, before and after water leak testing, showed that using the FDA water leak method does not increase the size of pre-existing microscopic defects. Examination also showed that these creation techniques produce reproducible defects within a condom type, with the size of acupuncture needle defects varying less than laser drilled defects. Results of water leak testing showed that the leakage characteristics of defects are affected by: the material type, the condom shape and size, the type of defect and the defect size, and the presence of lubricant.