Hand Sanitizer Efficacy
In-vitro testing is required by the U.S. Food and Drug Administration (FDA) to substantiate the effectiveness of all hand sanitizing products. The Agency’s extensive testing requirements, summarized in the Tentative Final Monograph, can present challenges to product producers and manufacturers. The Agency requires testing to be performed on over 20 organisms including Gram negative bacteria, Gram positive bacteria and yeast organisms. The FDA also states that “…there must be no claims, either direct or by implication, that a product has any activity against an organism which it has not been tested.” As such, it is recommended that clinically-relevant pathogens be included in your testing regimen.
Accuratus Lab Services can help navigate the testing requirements for hand sanitizers and develop a streamlined testing regimen to quickly move your product from the development to the final testing stage. We provide services for hand sanitizer formulations that follow the ASTM E2315 Time Kill Assay for Antimicrobial Agents method, viral suspension assay (ASTM E1052), AOAC 955.16 Available Chlorine assay and Minimum Inhibitory Concentration (MIC) Test and Minimum Bactericidal Concentration (MBC) Tests. Refer to our microbial library for an extensive list of organisms and antibiotic resistant pathogens available for testing.