Microbiological control during the production of biological preparations is considered one of the important areas for ensuring product quality and safety. It is used to assess the sanitary condition of production facilities and to determine the risk of contamination of the manufactured product by foreign microorganisms. In addition, such control makes it possible to monitor microbiological safety at each stage of the production of pharmaceutical and biological preparations. During the study, the results of microbiological monitoring conducted at the production sites involved in the manufacture of biological preparations were compared. During the monitoring process, samples taken from the air of production rooms, work surfaces, and employees were examined, and the quantitative indicators and qualitative composition of the microorganisms present in them were determined. During the study, the morphological and cultural characteristics of microorganisms were analyzed, and several typical microbial populations were identified. The results of the study showed the predominant presence of Gram-negative bacteria, bacilli, and molds. The obtained data provide a basis for assessing the level of microbiological cleanliness of the laboratory environment, as well as for systematic monitoring of compliance with sanitary and hygienic requirements at each stage of the production of biological preparations. In addition, the introduction of microbiological control methods used in the production of biological preparations into the educational process creates conditions for combining students’ theoretical knowledge with laboratory experience. This approach enables students to acquire skills in analyzing and interpreting microbiological monitoring results and to develop research competencies.
USE OF MICROBIOLOGICAL MONITORING RESULTS FROM BIOLOGICAL PRODUCT MANUFACTURING CONDITIONS IN THE EDUCATIONAL PROCESS
Published October 2026
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Abstract
