Control de esterilidad en colirios: Identificación a nivel genérico de las bacterias aisladas

Abstract

Se ha realizado un estudio sobre el estado de esterilidad de 525 muestras de 75 especialidades diferentes de colirios comercializados en España, siguiendo la metodología de G. de Felip (1975). Han resultado contaminadas 17 muestras de 10 especialidades, lo que indica que un 13 por 100 de los colirios son rechazables, según los criterios de la U. S. P. XIX ed. El 30 por 100 de la contaminación se debió a Bacillus, el 40 por 100 a hongos y el 20 por 100 a Corinebacterias.

The sterility of 525 samples representing 75 different eye drops preparations commercially available in Spain has been examined using the method of G. de Felip (1975), employed sterile membrane filtration (pore size 0,45 ¡.Lm) and subsequent culture. Contaminating microorganisms were found in 17 samples representing 10 different eye drop preparations. The contaminants isolated were mem bers of the fo11owing genera: Bacillus, Micrococcus, Aerococcus, Alcaligenes, Lactobacillus, Nocardia y also organisms which were probably corynebac teria, actinomyces, yeats or fungi. 30 % of the :contaminans belonged to the genus Bacillus, 40 % were fungi and 20 % corynebacteria. According to the criteria established by U. S. P. XIX ed. a11 these sam pIes would have been rejected. However, according to G. de Felip only two of them contained more than 1 viable organism per mI, and accordingly, the remaining ones would be considered acceptable. The Icontamination could be due to sorne fault in sterilization or in the sealing process but, in any case, a more exhaustive control of sterilization is advisable.