Email this article Aspects of microbiological monitoring of the production environment in pharmaceutical and biotechnological manufacturing
- Authors: Bogdanova O.Y.1, Chernykh T.F.1, Bukovskaya J.A.1
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Affiliations:
- Saint Petersburg State Chemical and Pharmaceutical University
- Issue: Vol 6, No 2 (2024)
- Pages: 10-17
- Section: Pharmaceutical Sciences
- URL: https://journal-vniispk.ru/PharmForm/article/view/263073
- DOI: https://doi.org/10.17816/phf630427
- ID: 263073
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Abstract
This research is devoted to the pressing issue of improving the microbiological monitoring of the production environment and quality control of products in the pharmaceutical and biotechnological industries. It is emphasized that these industries are currently among the most profitable sectors of the Russian economy, but their manufactured products are subject to particularly high quality requirements. The modern operating conditions of these enterprises give rise to certain problems that require a standardized approach to their solution. In this regard, the task of improving the microbiological monitoring of the production environment, as well as quality control of products, becomes particularly relevant in order to optimize production processes and increase the level of safety of the manufactured goods. The paper proposes an approach to the identification and analysis of critical points of production, depending on the sources of potential microbial contamination. For each of the identified critical points, an analysis of potential problems has been carried out, the solution of which will make it possible to increase the effectiveness of the microbiological control system.
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##article.viewOnOriginalSite##About the authors
Olga Yu. Bogdanova
Saint Petersburg State Chemical and Pharmaceutical University
Author for correspondence.
Email: olga.bogdanova@pharminnotech.com
Ph.D. in Biological Sciences, Associate Professor, Associate Professor of the Department of Microbiology
Russian Federation, Saint PetersburgTatiana F. Chernykh
Saint Petersburg State Chemical and Pharmaceutical University
Email: ode9gova.t@yandex.ru
D.Sc. in Pharmaceutical Sciences, Professor, Professor of the Department of Microbiology
Russian Federation, Saint PetersburgJulia A. Bukovskaya
Saint Petersburg State Chemical and Pharmaceutical University
Email: ybukovskaya@mail.ru
Applicant for the Department of Microbiology
Russian Federation, Saint PetersburgReferences
- Gosudarstvennaya farmakopeya Rossiiskoi Federa tsii. MZ RF. XIV izd. T. 1. Moskva, 2018. / [Elektronnyi resurs] // GARANT: [sait]. – URL: https://base.garant.ru/72230404/. (In Russ.).
- Vorob’ev A. Razvitie farmatsevticheskogo rynka Rossii 2023 v novoi real’nosti: klyuchevye igroki i rezul’taty [Elektronnyi resurs]. – Rezhim dostupa: https://delprof.ru/press-center/open-analytics/razvitie-farmatsevtichesk ogo-rynka-rossii-2023-v- novoy-realnosti-klyuchevye-igroki-i-rezultaty/. (In Russ.).
- Analiz rynka biotekhnologii (BioTech) v Rossii v 2018–2022 gg, prognoz na 2023–2027 gg. [Elektronnyi resurs]. – Rezhim dostupa: https://businesstat.ru/images/demo/biotech_russia_demo_businesstat.pdf. (In Russ.).
- Bogdanova O. Yu. Study of the role of hand treatment influence on the quantitative and qualitative composition of microbiota / O. Yu. Bogdanova, T. F. Chernykh, I. T. Tairov, A. B. Tairova // International Journal of Applied and Fundamental Research. – 2023. – No. 2. – P. 5–9. (In Russ.).
- Postanovlenie Glavnogo gosudarstvennogo sanitarnogo vracha RF ot 28 yanvarya 2021 g. N3 “Ob utverzhdenii sanitarnykh pravil i norm SanPiN2.1.3684-21” “Sanitarno-epidemiologicheskie trebovaniya k soderzhaniyu territorii gorodskikh i sel’skikh poselenii, k vodnym ob’’ektam, pit’evoi vode i pit’evomu vodosnabzheniyu, atmosfernomu vozdukhu, pochvam, zhilym pomeshcheniyam, ekspluatatsii proizvodstvennykh, obshchestvennykh pomeshchenii, organizatsii i provedeniyu sanitarno-protivoepidemicheskikh (profilakticheskikh) meropriyatii” (s izmeneniyami i dopolneniyami) / [Elektronnyi resurs] // GARANT: [sait]. – URL: https://base.garant.ru/400289764/. (In Russ.).
- Natsional’nyi standart RF GOST R ISO 14644-1-2017 “Chistye pomeshcheniya i svyazannye s nimi kontroliruemye sredy. Chast’ 1. Klassifikatsiya chistoty vozdukha po kontsentratsii chastits” (utv. i vveden v deistvie prikazom Federal’nogo agentstva po tekhnicheskomu regulirovaniyu i metrologii ot 18 oktyabrya 2017 g. N1442-st) / [Elektronnyi resurs] // GARANT: [sait]. – URL: https://base.garant.ru/72101886/. (In Russ.).
- Aslam B, Wang W, Arshad MI, Khurshid M, Muzammil S, Rasool MH, Nisar MA, Alvi RF, Aslam MA, Qamar MU, Salamat MKF, Baloch Z. Antibiotic resistance: a rundown of a global crisis. Infect Drug Resist. 2018 Oct 10;11:1645–1658. doi: 10.2147/IDR.S173867.
- Metodicheskie rekomendatsii MR3.5.1.0109-16 “Dez infektsionnyi rezhim v meditsinskikh organizatsiyakh v tselyakh profilaktiki likhoradki Zika” (utv. Federal’noi sluzhboi po nadzoru v sfere zashchity prav potrebitelei i blagopoluchiya cheloveka, Glavnym gosudarstvennym sanitarnym vrachom RF 9 marta 2016 g.) / [Elektronnyi resurs] // GARANT: [sait]. – URL: https://www.garant.ru/products/ipo/prime/doc/71248586/. (In Russ.).
- Rukovodstvo R4.2.2643-10 “Metody laboratornykh issledovanii i ispytanii dezinfektsionnykh sredstv dlya otsenki ikh effektivnosti i bezopasnosti” (utv. Federal’noi sluzhboi po nadzoru v sfere zashchity prav potrebitelei i blagopoluchiya cheloveka, Glavnym gosudarstvennym sanitarnym vrachom RF 1 iyunya 2010 g.) (s izmeneniyami i dopolneniyami) / [Elektronnyi resurs] // GARANT: [sait]. – URL: https://base.garant.ru/4192979/. (In Russ.).
- Smirnova I. A. Economic consequences of the COVID-19 pandemic for Russia / I. A. Smirnova, E. Yu. Onopyuk, E. V. Zakharova // Economy of Russian regions: current state and forecast prospects: Collection of articles based on the materials of the III All-Russian scientific and practical conference of teachers, graduate students, and master’s students of the Ivanovo branch of G.V. Plekhanov Russian University of Economics, dedicated to the Year of Science and Technology – 2021, Ivanovo, April 13–15, 2021. – Ivanovo: Ivanovo branch of the Federal State Budgetary Educational Institution of Higher Education “Plekhanov Russian University of Economics”, 2021. – P. 160–164. (In Russ.).
- Gladkov E. L. Development of information support for distance education technologies in the era of a pandemic / E. L. Gladkov // Young scientist. –2021. – No. 17 (359). – P. 97–100. (In Russ.).
- Mizintseva M. F. Transformation of the Russian labor market in the context of a pandemic: main problems and trends / M. F. Mizintseva, A. R. Sardaryan // Bulletin of Volgograd State University. Economics. – 2021. – Vol. 23, No. 1. – P. 102–109. – doi: 10.15688/ek.jvolsu.2021.1.8. (In Russ.).
- Akhmadeev A. M. The structure of the innovation process and features of innovation implementation / A. M. Akhmadeev // Economics and Management: scientific and practical journal. – 2021. – No. 6 (162). – P. 45–48. (In Russ.).
- Shumakova Yu. S. Mikrobiologicheskii monitoring proizvodstvennoi sredy na farmatsevticheskom proizvodstve / Yu. S. Shumakova. – Tekst: neposredstvennyi // Molodoi uchenyi. – 2024. – № 14 (513). – S. 46–48. – URL: https://moluch.ru/archive/513/112180/. (In Russ.).
- Sandle T. Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control / T. Sandle. – Woodhead Publishing, 2015. – 316 p. – ISBN978-0-08-100044-1.
- Belykh A. A. Microbiological control in the conditions of production of medicines / A. A. Belykh, M. I. Vasilenko // Actual aspects and prospects for the development of modern biotechnology: Collection of reports of the All-Russian scientific conference with international participation, Belgorod, March 22–24, 2023. – Belgorod: Belgorod State Technological University named after V.G. Shukhov, 2023. – P. 26–29. (In Russ.).
- Babaeva E. V. Microbiological control as a tool for quality assurance in the production of medicines / E. V. Babaeva, D. A. Orlova // Current state of economic systems: management, development, security: Collection of scientific papers of the IV International scientific and practical conference, Tver, December 08–11, 2023. – Tver: Tver State Technical University, 2024. – P. 154–159. (In Russ.).
- Ananyeva E. P. Multifactorial experiment in determining the optimal ranges of microwave radiation that activate yeast growth / E. P. Ananyeva, O. Yu. Bogdanova, S. V. Gurina // International Journal of Applied and Fundamental Research. – 2022. – No. 1. – P. 12–17. – doi: 10.17513/mjpfi.13339. (In Russ.).
- Zhou T., Reji R., Kairon R.S. and Chiam K.H. (2023) A review of algorithmic approaches for cell culture media optimization. Front. Bioeng. Biotechnol. 11:1195294. doi: 10.3389/fbioe.2023.1195294
- Chernykh T. F. Changes in growth and morphological parameters of microorganisms under the influence of a new disinfectant / T. F. Chernykh, O. Yu. Bogdanova, L. V. Alekseeva // Problems and prospects for the development of science and education: Proceedings of the All-Russian (national) scientific and practical conference, Tver, February 14, 2023. – Tver: Publishing House of Tver State Agricultural Academy, 2023. – P. 281–283. (In Russ.).
- Kuznetsova A. A. Selection of disinfectants in veterinary medicine / A. A. Kuznetsova, O. Yu. Bogdanova, T. F. Chernykh // Problems and prospects for the development of science and education: Proceedings of the All-Russian (national) scientific and practical conference, Tver, February 14, 2023. – Tver: Publishing House of Tver State Agricultural Academy, 2023. – P. 278–281. (In Russ.).
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