Analysis of the range of disinfectants used in pharmaceutical manufacturing enterprises
- 作者: Bukovskaya Y.A.1, Chernykh T.F.1, Volkov N.I.1, Narkevich I.A.1
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隶属关系:
- Saint Petersburg State Chemical Pharmaceutical University
- 期: 卷 74, 编号 3 (2025)
- 页面: 43-49
- 栏目: Organization and economy
- URL: https://journals.eco-vector.com/0367-3014/article/view/680115
- DOI: https://doi.org/10.29296/25419218-2025-03-06
- ID: 680115
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详细
Introduction. Maintaining cleanliness of pharmaceutical manufacturing facilities is a requirement of Good Manufacturing Practices (GMP). According to the GMP standards of the Russian Federation and the GMP standards of the Eurasian Economic Union, the procedure for using detergents and disinfectants, developed by the organization independently, must be based on microbiological control and ensure rotation of different types of preparations.
Objective: analysis of the trade names of disinfectants used at 4 enterprises for treating premises of different cleanliness classes from A to D was carried out.
Material and methods. The evaluation parameters were chosen: belonging of the active ingredient to one or another group according to the modern classification of disinfectants; country of origin; price range of the offer from open sources; scope of application and processing modes in accordance with the instructions for use.
Results. Despite the differences in the number of items in each pharmaceutical enterprise, it has been revealed that the drugs contain active substances of different chemical natures, ensuring the destruction of any microorganisms and preventing the development of their resistance. Combined disinfectants dominate the range of disinfectants used. More often, concentrates or solid forms are used to prepare working solutions, followed by antiseptics intended for sanitizing the hands of personnel and disinfecting small, hard-to-reach surfaces and equipment. Most disinfectants are domestic. The instructions for use of some drugs do not clearly state that they are intended for use in pharmaceutical or other drug manufacturing facilities. Prices for the studied titles published in open popular sources show significant fluctuations.
Conclusion. The analysis of the range of disinfectants used at four pharmaceutical manufacturing enterprises demonstrated the use of drugs of different groups according to the active ingredient, which allows for effective disinfection, development of individual treatment modes for rooms of purity classes A, B, C, D, while rotating drugs, as required by the GMP standard.
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作者简介
Yulia Bukovskaya
Saint Petersburg State Chemical Pharmaceutical University
Email: ybukovskaya@mail.ru
ORCID iD: 0009-0001-9461-6281
Candidate of the Department of Microbiology
俄罗斯联邦, Saint PetersburgTatyana Chernykh
Saint Petersburg State Chemical Pharmaceutical University
Email: tatiana.odegova@pharminnotech.com
ORCID iD: 0009-0000-1539-8013
Doctor of Pharmaceutical Sciences, Professor, Head of the Department of Microbiology
俄罗斯联邦, Saint PetersburgNikita Volkov
Saint Petersburg State Chemical Pharmaceutical University
Email: volkovnikita2006@yandex.ru
ORCID iD: 0009-0001-0986-5284
Candidate of the Department of Microbiology
俄罗斯联邦, Saint PetersburgIgor Narkevich
Saint Petersburg State Chemical Pharmaceutical University
编辑信件的主要联系方式.
Email: igor.narkevich@pharminnotech.com
ORCID iD: 0000-0002-5483-6626
Dr. Sci. (Pharm), professor, Rector
俄罗斯联邦, Saint Petersburg参考
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