Condoms provide one of the most important means of preventing pregnancy and the spread of human immunodeficiency virus (HIV) and other sexually transmitted diseases. Pinhole defects may lead to the passage of sperm or viruses through the condom wall. Embedded particles, which may become dislodged in handling or use, may represent latent pinhole defects. Thin regions in the condom wall may lead to breakage in use. Testing for such defects in regulatory laboratories, or in the factories as part of production screening or quality assurance efforts, is a major tool for ensuring condom reliability. A new optical method for testing condoms is presented, sensitive to pinholes, thin regions, and em bedded particles. The method could supplement or replace the existing, less powerful, electrical test techniques in either regulatory testing laboratories or in the factory. The optical techniques presented provide quantitative data on the condoms tested, rather than lust accept/reject decisions. They thus support detailed monitoring of production or lot characteristics that is generally not possible with existing electrical techniques. The ability of the optical techniques to separately test for and identify not only pinholes, but also thin regions and embedded particles, which are not separately tested for with the electrical technologies, is an especially important new capability. Further, the new optical techniques allow the locations of defects found to be precisely marked, making possible a microscopic examination of defects useful in studying their structure and possible causes. The optical technique is also totally nondestructive, in that it does not alter the defects whose structures are of interest. Initial results are reported on the testing of latex condoms purchased in retail stores. Condoms identified optically as being potentially defective were subjected to industry standard leak and burst testing. Results of the various tests are summarized. The data suggest that use of the new optical test techniques could have prevented an unexpectedly large number of condoms with significant pinhole and thin region defects from reaching the public. Optical test systems could be used to support either regulatory, quality assurance, or clinical field testing of latex or nonlatex condoms. Due to their high rate capability and level of automation, they could also be applied to 100% screening testing in the factory. The new test techniques could also be used to detect defects in a wide range of other thin sheets and membranes. (C) 1999 Elsevier Science Inc. All rights reserved.
