Journal of Siberian Federal University. Biology / Microbiological Status of the Pilot Production Facility for Degradable Polyhydroxyalkanoates

Full text (.pdf)
Issue
Journal of Siberian Federal University. Biology. 2025 18 (2)
Authors
Prudnikova, Svetlana V.; Kiselev, Evgeniy G.; Demidenko, Aleksey V.; Volova, Tatiana G.
Contact information
Prudnikova, Svetlana V.: Siberian Federal University Krasnoyarsk, Russian Federation; ORCID: 0000-0001-8990-3043; Kiselev, Evgeniy G. : Siberian Federal University Krasnoyarsk, Russian Federation; Institute of Biophysics SB RAS Federal Research Center “Krasnoyarsk Science Center SB RAS” Krasnoyarsk, Russian Federation; ORCID: 0000-0003-4472-7087; Demidenko, Aleksey V. : Siberian Federal University Krasnoyarsk, Russian Federation; Institute of Biophysics SB RAS Federal Research Center “Krasnoyarsk Science Center SB RAS” Krasnoyarsk, Russian Federation; Volova, Tatiana G. : Siberian Federal University Krasnoyarsk, Russian Federation; Institute of Biophysics SB RAS Federal Research Center “Krasnoyarsk Science Center SB RAS” Krasnoyarsk, Russian Federation; ORCID: 0000-0001-9392-156X
Keywords
microbiological monitoring; risk analysis; critical control points; biotechnological production; clean rooms; working area air
Abstract

Of late, high demands have been placed on the quality of biotechnological products alongside with the extremely rapid development of the biotechnology industry and ever growing demand on its products. To guarantee the safety and maintain high quality of biotechnological products, it is vital to create a microbiological monitoring framework that adheres to both Russian and international standards. This paper presents an approach to developing a monitoring system for the pilot microbial polymer (polyhydroxyalkanoate – PHA) production facility at Siberian Federal University. Based on regulatory documents, a protocol for conducting the biotechnological process under aseptic conditions has been established, along with control mechanisms for enforcing this protocol. These include sanitary monitoring of indoor air, surfaces in clean rooms, personnel hygiene, and biotechnological process from the pre- fermentation stage to the final polymer product. Evaluation of the effectiveness of these quality control measures has identified key sources and pathways of potential microbial contamination at all critical control points. A systematic risk analysis not only assesses the condition of the operational environment but also facilitates planning of the corrective actions to enhance the effectiveness of microbiological control. The findings show that the established microbiological monitoring regulations ensure strict compliance of the microbiological status of the pilot PHA production facility with the safety standards and requirements set forth by both international and Russian regulations

Pages
236–248
EDN
DWHHDI
Paper at repository of SibFU
https://elib.sfu-kras.ru/handle/2311/156632

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