It is utilized to determine the effectiveness of preservatives added to nonsterile/sterile aqueous pharmaceutical products. These preservatives aid in preventing microbes that may inadvertently be introduced through the process of production or repeatedly withdrawing individual doses. The AET is also useful in determining whether the product’s preservative will maintain effectiveness throughout the shelf life or until expiration.
Completing the test requires inoculation of the product with a known quantity of various microorganisms. Effectiveness of the preservative is measured at varying times over the course of the next 28 days by comparing the known quantity of microorganisms introduced to the recorded quantities over the course of the testing period. We provide analysis for injections housed in multi-dose packaging, and for samples containing antimicrobial preservatives. Our scientists complete all analysis according to the processes and guidelines outlined within USP <51>, to ensure that all regulatory requirements are met for your product.