Sensitivity of Water Leak Tests for Latex Condoms

Abstract

As part of quality assurance testing, latex condoms are often screened for pinholes using water leak tests. This report analyzes the seasitivity of two similar tests, both requiring that a condom be filled with 300 mL of water and then examined visually for leakage. One test, a Food and Drug Administration protocol, specifies that the condom be filled vertically, the open end pinched off, and then rolled horizontally on a towel. The second test, developed by the American Society for Testing and Materials, is the same, except the condom is not rolled, merely placed in a horizontal position and examined. Detectability of a defect is dependent on the pressure developed within the condom, wettability of the condom surface by the water, thickness, and expansion of the condom. Three brands and nine different models were studied to determine the range of values for these variables and the sensitivity of the tests were then calculated. Sensitivity (minimum hole size detectable) varies from approximately 100 μm radius to 3 μm radius. Note that the smallest defect observable is larger than the HIV virus.

pH Effects on the Bio-Permeability of Polymers Used in Prophylactics

“…Prior to use, prophylactics are tested using visual inspection and a "water leak test", approved by the Food and Drug Administration (FDA) and the American Society for Testing [10]. While these detect gross physical defects in the materials, they are not an adequate measure of integrity.…”