Microbiological control of water quality for the production of biological p

Abstract

one of the main criteria for the biological safety of immunobiological preparations is their sterility. This article presents the results of the evaluation of two methods of direct seeding and membrane filtration. The results of sterility control of the inactivated vaccine against Covid-19 «QazCovid-in®, series № 0400721, № 0410721, № 0420721 are also presented. Evaluation of the sterility of the tested samples of the three vaccine series showed that after incubation, the nutrient medium remained clean both in direct seeding samples and membrane filtration samples, as well as accounting and evaluation of the obtained research data in accordance with the State Pharmacopoeia of the Republic of Kazakhstan. To assess the sensitivity of two methods for determining sterility, samples of immunobiological preparations were experimentally infected with cultures of test strains of St. aureus, C. albicans and C. sporogenes. As a result, the methods of membrane filtration and direct seeding showed the same sensitivity when detecting yeast and anaerobic organisms in all studied concentrations of test strains (10, 1, 0.1 CFU/ml). And for the detection of aerobic microorganisms, the membrane filtration method turned out to be more sensitive compared to the direct seeding method, which is proved by positive results in all samples of test strains with membrane filtration (3/3 in all concentrations) and negative results when setting the direct seeding method (in concentrations of 1 and 0.1 CFU/ml). Thus, the purpose of this study was to evaluate these two methods used to determine the sterility of immunobiological preparations using two methods: direct seeding and membrane filtration