This paper identifies an appropriate surfactant solution to improve the defect detection rate of the ISO/FDA water leak test method for condoms. A surfactant solution and concentration are identified to optimize leakage testing of condoms, considering factors of safety, cost, reproducibility, and hole detection. Defect detection rates are compared using the ISO/FDA method with and without the surfactant solution.
Micro-90® concentrated cleaning solution is selected as a suitable surfactant for water leak testing of condoms due to reliable formulation, low sudsing, low cost, and no disposal or toxicity problems. A concentration of 0.1% by volume optimizes the effectiveness of the solution while minimizing solution concentration.
Detection rates of standardized defects are quantified for four condom types tested with and without surfactant solution. Use of surfactant solution in the ISO/FDA method increases the detection rates of all defect types and sizes in all the condom types tested. This increase is statistically significant for 10 (out of 48 possible) combinations of condom type, hole diameter, and hole location.