Contact Lens Regimen Test
The contact lens regimen test is used to qualify contact lens solutions as part of a lens disinfectant regimen. This procedure is used for contact lens solutions which may include the steps of cleaning, rinsing and soaking. This test uses the solution in the manner and quantity recommended in the manufactures instructions for use. This test uses a panel of 5 microorganisms, which include 2 gram negative bacteria, 1 gram positive bacteria, a yeast and a mold. This test is uses lenses, organic soil and the manufactures instructions for use to evaluate disinfecting solutions.
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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|DIS850||Disinfection: ISO-FDA Regimen Test for Disinfection of Contact Lenses||Add|
DIS850 - Disinfection: ISO-FDA Regimen Test for Disinfection of Contact Lenses
TAT: 75 days
Study OutlineThe Contact Lens Regimen test should be performed using lens types that are representative to which the regimen is intended to be used.
The test is performed by placing the test lenses concave up in a sterile petri dish. The challenge organism is prepared and adjusted to assure that each lens is inoculated with 2 x 105 - 2 x 106 CFU/lens. Each individual lens for each organism is inoculated with approximately 0.01 mL of the challenge organism. The inoculum is allowed to adsorb onto each lens for 5 – 10 minutes.
After allowing the inoculum to adsorb, the lenses are cleaned and disinfected using the manufacture’s instruction for use. After cleaning and disinfecting the lens, the lens is placed into a lens case containing the disinfecting solution and allowed to soak for the manufacture’s minimum soak time.
At the conclusion of the soak time, the lens solution and lens are membrane filtered and rinsed with a neutralizing broth. The lens is then assayed by casting in agar. The membrane is placed in a petri dish containing agar. The recovery plates are incubated at the appropriate temperature for the challenge organism. At the conclusion of the incubation period, the number of CFU observed are counted and recorded.
Finally, a neutralization study is completed for each of the test organisms and solutions to demonstrate that the media, method and dilutions used were able to effectively neutralize the active antimicrobial to support acceptable organism recovery.