Validación secundaria del método de filtración por membrana para la detección de microorganismos indicadores de contaminación en muestras de agua de uso farmacéutico

Abstract

Purified water is supplied in the manufacture of non-parenteral products in the pharmaceutical industry. This input requires a microbiological analysis due to the susceptibility of microbial contamination in the distribution process, thanks to the presence of biofilms, among other factors. The filtration by membrane allows detecting the causes of said contamination and for this reason it is important to verify this methodology in the industry so that it can be used as a method of quality control in the plant located in the urban area of Cali. The present work was carried out in the pharmaceutical company Sanofi Cali, where the challenge organisms used in each stage of the process were evaluated, respectively the strains ATCC (American Type Culture Collection) Escherichia coli ATCC 8739, Staphylococcus aureus ATCC 6538 and Pseudomonas aeruginosa ATCC 9027. The stages of the process were a) inoculum standardization, b) productivity and selectivity tests of the culture media (Plate Count Agar, Chromocult and Cetrimide), c) development of the secondary validation technique of the membrane filtration method. The comparison of the results obtained by two analysts was included during the validation process. The effectiveness of validation for S. aureus and E. coli and non-effectiveness in P. aeruginosa was demonstrated.