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R.P. Stone, R.A. Rosenthal, S.L. Buck, B.A. Schlech; Microbiology Assessment of a Multi–Dose Preservative Free Tear Product . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2041.
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Purpose:Preservatives are added to products to prevent contamination. Multi–dose products are required to meet preservative efficacy standards. But sometimes these useful preservatives cause irratation to the eye, and a preservative–free product may be desirable. A new preservative free product in a multi–dose container (MDPF product) was developed to meet these needs. The purpose of this study was to show that a new preservative free product is capable of controlling and preventing contamination under extreme microbial conditions. Methods:The new preservative free product was repeatedly challenged with Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus niger throughout a 6–month period. Additionally, multiple lots of the new formulation were stored at elevated and room temperatures for over 6 months. Results:The results consistently showed that the new product is capable of preventing contamination of the product. The new product showed greater than a 3 log reduction of the challenge bacteria. Conclusions:Though the MDPF product contains no preservatives, it is formulated with a unique blend of ingredients that allow it to maintain efficacy when exposed to extreme microbial conditions.
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