Extended application of dose-response models of infection on injectable insulin products in vials

Abstract

Microbial contamination from in-use application of multidose pharmaceutical products constitutes health hazard to the consumer especially when considering injectable medicines. In the present study, an attempt has been made to integrate dose-response models of infections with pharmacopeial preservative efficacy test (PET) in a single simulation study that supposed accidental reuse of hypodermic syringe. Probability risk ratio of infection from assumed equal doses of two types of microbes by two routes of infection was greater than 1300 at most equivalent administration doses when considering the same reduction factor for both bacteria in the antimicrobial efficacy test (AET). The probability of infection would diminish much more rapidly for Staphylococcus aureus rather than Pseudomonas aeruginosa. The short interval of product administration increased the risk of infection with regular-type of Insulin vials. The current quantitative study provided extension and made the best use of the standard AET but also highlighted its limitations.