MICROBIOLOGICAL CONTROL OF WATER QUALITY FOR THE PRODUCTION OF BIOLOGICAL PRODUCTS

Abstract

One of the main requirements for the new vaccines being created is their safety in use, including their sterility, the index of hydrogen ions and the content of bacterial endotoxins (BE), which are among the main indicators of quality and safety. Compliance of these parameters to the standards of the GF RK is directly related to the quality of water used in the production line. This article presents the results of work on determining one of the main safety parameters of biological products, such as sterility, bacterial endotoxin content and hydrogen ion index.The sterility of the biological product was determined by filtration with subsequent inoculation on specific bacterial culture media. As a result, it was found that the samples of purified and injected water are free of extraneous microflora, colony growth was not observed for 5-7 days. Abundant colony growth on bacterial nutrient media is observed in tap and wastewater samples, which confirms the presence of coprophytic microorganisms. A LAL test was used to determine bacterial endotoxins. As a result of the work carried out to determine the content of BE, it was found that in samples of purified and injection water, the concentration of BE is 0.15 IU/ml, while the concentration of BE in wastewater samples is 15 IU/ml, and in tap water 1.5 IU/ml, which also does not exceed the norm. When studying the indicators of hydrogen ions in the tested samples, the pH value of injection water is 7.16, purified water – 6.84, tap water – 7.93, wastewater - 7.03. The obtained indicators indicate that the microbiological parameters of the tested water samples comply with the norms and requirements of the GF RK.