Limit of Detection of Microorganisms in Drug Sterility Testing

Abstract

The use of compendial and alternative methods for drug sterility testing, the most important characteristic of which is the limit of detection (LOD), i.e., the minimum amount of viable microorganisms that can be found in the examined sample, is currently regulated abroad. The goal of the research was to determine experimentally and compare the LODs of microorganisms by direct inoculation and using a BacT/ALERT 3D Microbial Detection System automated bacteriological analyzer. Statistically significant differences between the results obtained by the different methods were not found.