ASTM E2315 Time Kill Assay for Antimicrobial Agents
Purpose of Test
The ASTM E2315 Time Kill Assay for Antimicrobial Agents test is a suspension-based method which can be used to provide general rate-of-kill information for a variety of water soluble or liquid products against almost any pathogen. In addition to serving as a screening tool during the development stages, this method is commonly used to evaluate hand sanitizers as recommended by the U.S. FDA’s Tentative Final Monograph for Healthcare Antiseptic Drug Products.
Summary of Test
In this method, a sample of the product is inoculated with a suspension of a representative test organism. After a series of pre-selected exposure times, a sample is removed, neutralized and quantitatively assayed for surviving test organism. The resulting plates are incubated, the survivors are enumerated and percent and log10 reductions are determined for each time point as compared to a population control. Common test organisms used to evaluate hand sanitizers as recommended by the Tentative Final Monograph include but are not limited to: Staphylococcus aureus, Acinetobacter baumanii, Klebsiella pneumoniae, Streptococcus pyogenes, Pseudomonas aeruginosa, Burkholderia cepacia, and Serratia marcesens.