Stand Alone Test
The contact lens solution stand alone test is used to evaluate the ability of contact lens disinfecting solutions to significantly reduce a panel of 5 microorganisms, which include 2 gram negative bacteria, 1 gram positive bacteria, a yeast and a mold. This test is used to evaluate disinfecting solutions without using an efficacy regimen (rub/rinse procedure) or the lens.
Nelson Laboratories, Inc. can perform testing based on ISO/FDIS 14729. We have numerous years of contact lens solution testing experience and have tested a broad range of products.
- ISO/FDIS 14729
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DIS860 - Disinfection: ISO-FDA Stand-Alone Test for Disinfection of Contact Lenses
Study OutlineFor the Stand Alone test procedure, test intervals are calculated using the manufactures recommended minimum disinfection time. The ISO standard specifies the following intervals: 25 percent, 50 percent, 75 percent, and 100 percent, for bacteria as well as 400 percent for yeast and mold, of the manufacture’s recommended minimum disinfection time.
Individual test samples and positive controls are set up for each organism. At 0 hour, the test samples and positive controls are individually inoculated with the organisms to reach a final concentration of 1.0 x 105 – 1.0 x 106 CFU/mL. The volume of the inoculums used is less than 1.0% of the volume of the product. The positive controls are assayed and the starting concentration of organism is determined by serial dilution and standard plate count procedure.
After inoculation, the samples are stored in a 20 – -25°C incubator for the duration of the test. At the individual test intervals, the samples are removed from the incubator and assayed for growth. At each of these time points, an aliquot is removed from the samples and the concentration of organism remaining in the sample is determined by standard plate count procedure.
Finally, a neutralization study is completed for each of the test organisms and solutions to demonstrate that the media, method and dilutions used was able to effectively neutralize the active antimicrobial to support acceptable organism recovery.