Verificación de la aptitud del método microbiológico para tres matrices farmacéuticas (sólida, semisólida y líquida) del laboratorio Neofarmaco del Ecuador Cía. Ltda.

Abstract

This degree project describes the verification of the suitability of the microbiological method for non-sterile products, which includes tests for the presence and absence of the most common specific microorganisms such as: Escherichia coli, Pseudomonas aeruginosa, Salmonella enterica, Staphylococcus aureus, Candida albicans; and total aerobic (Bacillus subtilis) and mold-yeast (Aspergillus niger) count tests with certified ATCC strains. The results of the microbiological analyzes were evaluated according to the criteria established by USP and AEFI for each of the three pharmaceutical matrices: solid (chewable tablets), semi-solid (vaginal cream) and liquid (pediatric drops). For the verification of the method, it was evaluated under certain parameters, where it is highlighted that it is exact since it yielded percentages greater than 70 and that it was found within the range established by the USP, not less than 50 nor greater than 200 percent of microbial recovery; accurate because the data was less than 20 percent and robust. In addition, in the robustness test, factors such as temperature, incubation time and type of plate that can influence the growth of the counting microorganisms were compared. According to the results, it is shown that the verified microbiological method is reliable and appropriate for the determination of pathogenic microorganisms and the count of total aerobes and molds-yeasts in the three pharmaceutical matrices of the Neofarmaco Laboratory of Ecuador Cía. Ltd.