DOI: https://doi.org/10.22263/2312-4156.2023.4.78
N.I. Miklis, I.I. Burak, T.M. Krasovskaya, A.B. Yurkevich
The effectiveness of ethanol-containing products for hygienic hand antiseptics
Vitebsk State Order of Peoples’ Friendship Medical University, Vitebsk, Republic of Belarus
Vestnik VGMU. 2023;22(4):78-87.
Abstract.
Objectives. To study chemical-analytical and microbiological quality indicators, as well as indicators of microbiological efficacy and toxicological safety of ethanol-containing hygienic hand antiseptics.
Material and methods. For the research under aseptic conditions, agents with an ethyl alcohol content of 70% (1), 77.93% (2), 80.23% (3) and 82.01% (4) were obtained. 3 series of experiments were carried out in the educational establishment “Vitebsk State Order of Peoples’ Friendship Medical University” by means of organoleptic, physical and chemical, toxicological and microbiological methods in accordance with standard modern techniques.
Results. In terms of physico-chemical and organoleptic parameters, all manufactured agents are of high quality, in terms of microbiological purity – microbiologically clean. In a laboratory study, in terms of acute toxicity, medicinal products belong to class IV, in terms of the irritating properties severity – to the zero class with no irritating effect. In a clinical and laboratory study on volunteers with primary open and closed epicutaneous tests, these agents do not lead to erythema of the skin, repeated applications do not cause subjective and objective symptoms of sensitization. Ethanol-containing agents 2-4 completely inhibit the growth of standard test cultures of microorganisms in the qualitative suspension test tube method without the protein load during 0.5 min. In the quantitative suspension method without the protein load at the exposure of 0.5 min and when applied to E.coli-contaminated hands skin of volunteers medicinal products 2-4 have a high bactericidal efficiency against standard strains with a reduction factor above 4 lg.
Conclusions. Manufactured ethanol-containing products meet the regulatory toxicological safety indices and microbiological indicators of efficacy and can be recommended for registration as medicinal agents for hygienic hand antisepsis and further industrial production.
Keywords: ethanol-containing products, toxicological safety, microbiological efficacy, hygienic antiseptics.
Acknowledgements. The authors express their gratitude to the head of the Chair of Clinical Microbiology of VSMU, Professor Generalov Igor Ivanovich.
Information about the source of support in the form of grants, equipment, medicinal agents. The work was carried out within the frames of the research “Development and improvement of methods for diagnosing, treatment and prevention of human infectious diseases”, SR No. 20191502. The research has been approved by the Local Ethics Committee.
References
1. Shestopalov NV, Akimkin VG, Tutelyan AV, Khrapunova IA, Shestopalova TN. Hygienic hand hygiene of health care workers - the most important condition for the prevention of infections associated with the provision of medical care (evaluation of the pilot project implementation). Dezinfekts Delo. 2020;(1):12-9. (In Russ.)
2. Kampf G. Hand hygiene in health-care organizations. Fundam Klin Meditsina. 2018;3(4):60-72. (In Russ.)
3. Wang HP, Zhang HJ, Liu J, Dong Q, Duan S, Ge JQ, et al. Antimicrobial resistance of 3 types of gram-negative bacteria isolated from hospital surfaces and the hands of health care workers. Am J Infect Control. 2017 Nov;45(11):e143-47. doi: http://dx.doi.org/10.1016/j.ajic.2017.06.002
4. Hand hygiene a key defence in Europe’s fight against antibiotic resistance. Available from: https://www3.paho.org/hq/index.php?option=com_content&view=article&id=13231:la-higiene-de-manos-clave-para-una-atencion-segura-y-para-prevenir-la-resistencia-a-los-antibioticos&Itemid=0&lang=en#gsc.tab=0 [Accessed 28th July 2023]
5. Decontamination of health care workers' hands and patients' skin when providing medical care: metod. ukazaniya 3.5.1.3674-20: utv Federal sluzhboi po nadzoru v sfere zashchity prav potrebitelei i blagopoluchiya cheloveka 14 dek 2020 g. Moscow, RF; 2020. 16 р. (In Russ.)
6. Regulatory indicators of safety and effectiveness of disinfectants: SanPiN 21-112-99: utv postanovleniem glav gos sanitar vracha Resp Belarus' ot 6 yanv. 1999 g. Minsk, RB; 1999. 28 р. (In Russ.)
7. Dubel' EV. New requirements for healthcare workers' hand hygiene and patient skin decontamination. Sanepidkontrol' Okhrana Truda. 2021;(3):103-19. (In Russ.)
8. Sanitary and epidemiological requirements for organizations providing medical care, including the organization and conduct of sanitary and anti-epidemic measures to prevent infectious diseases in these organizations: SanNiP № 73: utv postanovleniem M-va zdravookhraneniya Resp Belarus' ot 05 iyulya 2017 g. Minsk, RB; 2017. 34 р. (In Russ.)
9. Shestopalov NV, Panteleeva LG, Sokolova NF, Abramova I.M., Lukichev SP. Federal Clinical Recommendations on the Selection of Chemical Disinfection and Sterilization Products for Use in Medical Organizations. Moscow, RF; 2015. 67 р. (In Russ.)
10. WHO guidelines on hand hygiene in health care. Available from: https://www.who.int/publications/i/item/9789241597906 [Accessed 28th July 2023].
11. Occupational safety standards system. Harmful substances. Classification and general safety requirements: GOST 12.1.007-76. Vved. 1977-01-01. Moscow, RF: Standartinform; 2007. 7 р. (In Russ.)
12. A Guide to the Implementation of the WHO Multimodal Hand Hygiene Improvement Strategy. Geneva, 2009. 48 р.
13. Händehygiene in Einrichtungen des Gesundheitswesens. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2016;59(9):1189-220.
14. Shestopalov NV, Fedorova LS, Skopin AYu. Antimicrobial activity and minimum effective concentrations of chemical compounds in disinfectants. Gigiena Sanitariya. 2019;98(10):1031-6. (In Russ.)
15. Ethanol, solution for external use, 70%: instruktsiya po med primeneniyu lekarstv sredstva № 715: soglasovano M-vom zdravookhraneniya Resp Belarus' 01.07.2014. Minsk, RB; 2014. 2 р. (In Russ.)
16. Miklis NI, Burak II. Characterization of microbiological indicators of the effectiveness of alcohol-containing products. Zhurn GrGMU. 2022;20(3):321-9. (In Russ.)
17. Kampf G, Ostermeyer C, Werner HP, Suchomel M. Efficacy of hand rubs with a low alcohol concentration listed as effective by a national hospital hygiene society in Europe. Antimicrob Resist Infect Control. 2013 Jun;2:19. doi: http://dx.doi.org/10.1186/2047-2994-2-19
18. Instruction for use of disinfectant "AHD 2000-special" (skin antiseptic) No. 0708-03 dated 07 Aug 2003. Moscow, RF; 2003. 8 р. (In Russ.)
19. Vsemir organizatsiya zdravookhraneniya. WHO recommended formulations of handrub antiseptics: a guide for the organization of field production [Elektronnyi resurs]. Rezhim dostupa: https://life4me.plus/bundles/hivresources/pdf/covid/guide_local_production_ru.pdf Data dostupa: 28.07.2023.
20. Instructions on disinfection measures for prevention of diseases caused by coronaviruses: pril k pis'mu Rospotrebnadzora ot 23.01.2020 g. № 02/770-2020-32 [Elektronnyi resurs]. Rezhim dostupa: https://www.consultant.ru/document/cons_doc_LAW_347527/7e6b83cb214335768ad6ec8c218e6066b627547b///. Data dostupa: 28.07.2023. (In Russ.)
21. On Circulation of Medicines: Zakon Resp. Belarus', 20 iyulya 2006 g, № 163-Z: v red ot 14.10.22 g, № 213-Z. V: Nats tsentr pravovoi inform Resp Belarus' Etalon [Elektronnyi resurs]. Minsk, 2023. (In Russ.)
22. Yurkevich AB, Burak II. Pharmaceutical technology for the pharmacy manufacture of medicines: posobie dlya studentov vuzov. Vitebsk, RB: VGMU; 2014. 418 р. (In Russ.)
23. M-vo zdravookhraneniya Resp Belarus', UP «Tsentr ekspertiz i ispytanii v zdravookhranenii»; Sheryakov AA, red. State Pharmacopoeia of the Republic of Belarus: in 2 vol. T 1: General methods of quality control of medicinal products. Molodechno, RB: Pobeda; 2012. 1220 р. (In Russ.)
24. On approval of Instruction No. 4.2.10-22-102-2005 "Determination of microbiological purity of disinfectants and antiseptics": postanovlenie M-va zdravookhraneniya Resp Belarus', 30 dek 2005 g, № 283. V: OOO «YurSpektr», Nats tsentr pravovoi inform Resp. Belarus'. Konsul'tant plyus: Belarus' [Elektronnyi resurs]. Minsk, RB; 2023. (In Russ.)
25. M-vo zdravookhraneniya Resp Belarus'. Requirements for setting up experimental studies for primary toxicological assessment and hygienic regulation of substances: instruktsiya 1.1.11-12-35-2004. Minsk, RB; 2004. 42 р. (In Russ.)
26. Perfumery and cosmetic products. Methods of determination and evaluation of clinical and laboratory indicators of safety: GOST 33483-2015. Vved 2016-09-01. Minsk, RB: Gosstrandart; 2016. 16 р. (In Russ.)
27. Gudkova EI, Krasilnikov AP, Adarchenko AA, sost. Methods for testing the antimicrobial activity of prophylactic antiseptics: metod ukazaniya № 11-13-1-97 M-va zdravookhraneniya Resp Belarus'. Minsk, RB; 1997. 11 р. (In Russ.)
28. Methods for testing and evaluating the antimicrobial activity of disinfectants and antiseptics: instruktsiya po primeneniyu № 11-20-204-2003: utv gl gos sanitar vrachom Resp Belarus' 22 dek 2003 g. Minsk, RB; 2003. 41 р. (In Russ.)
29. Disinfectants. Suspension method for determination of antimicrobial activity: GOST R 59072-2020. Vved 2021-02-01. Moscow, RF: Standartinform; 2020. 15 р. (In Russ.)
30. Zhiltsov IV, Semenov VM, Zenkova SK. Fundamentals of medical statistics. Biomedical research design: prakt ruk. Vitebsk, RB: VGMU; 2014. 154 р. (In Russ.)
31. Update on European Standards for Hand Disinfection. Chistye Pomeshcheniya Tekhnol Sredy. 2013;(3(47)):4-6. (In Russ.)
Information about authors:
N.I. Miklis – Candidate of Medical Sciences, associate professor, head of the Chair of Environmental and Preventive Medicine, Vitebsk State Order of Peoples’ Friendship Medical University, https://orcid.org/0000-0001-6496-4472
e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра. – Natalia I. Miklis;
I.I. Burak – Doctor of Medical Sciences, professor of the Chair of Environmental and Preventive Medicine, Vitebsk State Order of Peoples’ Friendship Medical University, https://orcid.org/0000-0002-7204-3056
T.M. Krasovskaya – lecturer of the Chair of Environmental and Preventive Medicine, Vitebsk State Order of Peoples’ Friendship Medical University, https://orcid.org/0000-0003-2182-9670
A.B. Yurkevich – Candidate of Pharmaceutical Sciences, associate professor of the Chair of Environmental and Preventive Medicine, Vitebsk State Order of Peoples’ Friendship Medical University, https://orcid.org/0000-0002-1044-1577
