Performance equivalence and validation of a rapid microbiological method for detection and quantification of yeast and mold in an antacid oral suspension

Abstract

ABSTRACT: Alternative and rapid microbiological methods are effective and profitable technologies that can be safely use in the pharmaceutical industry. This report studies the efficacy of the Soleris® direct yeast and mold automated method for the quantitative detection of C. albicans and A. brasiliensis at three different microbial bioburden. Validation testing was carried out using an antacid oral suspension (aluminum hydroxide 4% + magnesium hydroxide 4% + simethicone 0.4%). Equivalence of data between detection time vs. colony-forming units was established for both, alternative and conventional methodologies. Using probability of detection, linear Poisson regression, Fisher's test, and multifactorial analysis of variance ANOVA, all results from the rapid method were prove to be in statistical agreement with the reference plating procedures. The limits of detection and quantification were statistically similar for both methods (Fisher's exact test, P >0.05), showing that the alternative method was not inferior in performance to the reference method. Essential validation parameters such as precision (standard deviation < 5, coefficient of variance < 35%), accuracy (>70%), linearity (R2 >0.9025), and ruggedness (ANOVA, P <0.05) were determined. It was proved that all test results obtained from the alternative method were in statistical agreement with the standard plate count method. Thus, this new technology was found to meet all the validation criteria needed to be considered as an alternative method for yeast and mold quantification in the antacid oral suspension tested.