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MICROBIOLOGICAL MONITORING OF CLEANROOMS IN THE PRODUCTION OF STERILE PRODUCTS

https://doi.org/10.58318/2957-5702-2025-24-29-34

Abstract

The study presents the results of microbiological assessment of cleanrooms during the industrial production of foot-and-mouth disease vaccine under aseptic processing conditions. The investigations were conducted in Grade A and B areas during 2024–2025. More than 1,800 samples of air, equipment surfaces, and personnel gowning were analyzed. No microbial contamination was detected in air or on production surfaces. In 1.9% of samples taken from personnel garments and gloves, single microorganisms were identified within acceptable regulatory limits. The obtained data indicate the stability of aseptic conditions and the controlled state of the production environment.

About the Authors

N. B. Yesimbekova
LLP “OtarBioPharm”
Kazakhstan

Guardeyskiy



G. K. Sheriazdan
LLP “OtarBioPharm”
Kazakhstan

Guardeyskiy



A. M. Keramatdinova
LLP “OtarBioPharm”
Kazakhstan

Guardeyskiy



B. D. Duisenbayev
LLP “OtarBioPharm”
Kazakhstan

Guardeyskiy



S. M. Myrzakhan
LLP “OtarBioPharm”
Kazakhstan

Guardeyskiy



S. S. Kubyr
LLP “OtarBioPharm”
Kazakhstan

Guardeyskiy



A. M. Kurmantai
LLP “OtarBioPharm”
Kazakhstan

Guardeyskiy



Z. D. Ershebulov
LLP “OtarBioPharm”
Kazakhstan

Guardeyskiy



References

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Review

For citations:


Yesimbekova N.B., Sheriazdan G.K., Keramatdinova A.M., Duisenbayev B.D., Myrzakhan S.M., Kubyr S.S., Kurmantai A.M., Ershebulov Z.D. MICROBIOLOGICAL MONITORING OF CLEANROOMS IN THE PRODUCTION OF STERILE PRODUCTS. Biosafety and Biotechnology. 2025;(24):29-34. (In Russ.) https://doi.org/10.58318/2957-5702-2025-24-29-34

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ISSN 2707-7241 (Print)
ISSN 2957-5702 (Online)