Laboratory and Production Biosafety When Working With Bioobjects: Regulatory and Organizational and Technical Aspects




biosafety, labor protection, biological object, biological agent, biosafety level, risk management


The use of pathogenic and opportunistic biological agents in research and production processes should be accompanied by risk management in the context of biosafety and biosecurity. These issues are regulated differently depending on the industry orientation, including organizational and technical support. To provide a safe environment for working with biological threats of various levels of risks is one of the urgent tasks of our time. Our article is an analytical review of modern approaches to biosafety management in laboratories and industries when working with hazardous biological objects, pollution, including issues of occupational safety management and organizational and technical support of biosecurity. We analyzed the current state of the problem on the implementation and provision of proper working conditions in biotechnological or related industries, as well as in laboratories and research centers operating with biolo­gical objects of various hazard classes. To achieve biosafety, the basic principle is to limit or prevent the spread of potentially hazardous or harmful biological agents. The article describes the classification of hazardous biological agents, the current requirements for ensuring biosafety for workers of biotechnological and biopharmaceutical enterprises, laboratories and research centers when working with biological material. Ensuring the appropriate level of biosafety in Ukraine is governed by a number of regulations concerning all areas and activities related to work with biological objects of various hazard levels. Adherence to strict regulatory requirements at all levels of the organization of work in laboratories, research institutions, and industries dealing with biological objects will ensure safe conditions for staff.


Coelho AC, García Díez J. Biological risks and laboratory-acquired infections: a reality that cannot be ignored in health biotechnology. Front Bioeng Biotechnol. 20015;3:56. DOI: 10.3389/fbioe.2015.00056

Hambleton P, Melling J, Salusbury TT, editors. Biosafety in industrial biotechnology. Dordrecht: Springer Netherlands; 1994. 302 p. DOI: 10.1007/978-94-011-1352-6

Artika IM, Ma'roef CN. Laboratory biosafety for handling emerging viruses. Asian Pac J Trop Biomed. 2017 May;7(5):483-91. DOI: 10.1016/j.apjtb.2017.01.020

Laboratory biosafety manual. 3rd edition. Geneva: World Health Organization; 2004. 184 p.

Gradova NB, Babusenko ES, Panfilov VI. Biological safety of biotechnological industries. Moscow: Delhi Print; 2010. 136 p.

Sacadura-Leite E, Mendonça-Galaio L, Shapovalova O, Pereira I, Rocha R, Sousa-Uva A. Biological hazards for healthcare workers: occupational exposure to vancomycin-resistant staphylococcus aureus as an example of a new challenge. Port J Public Health. 2018:36(1):26-31. DOI: 10.1159/000487746

Biosafety in microbiological and biomedical laboratories. 5th edition. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institutes of Health; 2009. 604 p.

Wilson DJ. NIH guidelines for research involving recombinant DNA molecules. Account Res. 1993;3(2-3):177-85. DOI: 10.1080/08989629308573848

Nambisan P. Laboratory biosafety and good laboratory practices. In: An introduction to ethical, safety and intellectual property rights issues in biotechnology. Elsevier; 2017. p. 253-71. DOI: 10.1016/B978-0-12-809231-6.00011-9

Andrup L, Nielsen B, Kolvraa S. Biosafety considerations in industries with production methods based on the use of recombinant deoxyribonucleic acid. Scand J Work Environ Health. 1990 Apr;16(2):85-95. DOI: 10.5271/sjweh.1812

Ermishin AP, Podlisskih VE, Voronkova EV, Anoshenko BYu, Zarkov VM. Biotechnology. Biosecurity. Bioethics. Minsk: Technology; 2005. 430 p.

Zhou D, Song H, Wang J, Li Z, Xu S, Ji X, et al. Biosafety and biosecurity. J Biosaf Biosecur. 2019;1(1):15-8. DOI: 10.1016/j.jobb.2019.01.001

Rim KT, Lim CH. Biologically hazardous agents at work and efforts to protect workers’ health: a review of recent reports. Saf Health Work. 2014 Jun;5(2):43-52. DOI: 10.1016/

On approval of state sanitary standards and rules "Organization of work of laboratories in the material study, which contains pathogenic biological agents of I-IV groups of pathogenicity by molecular-genetic methods". Order of the Ministry of Health of Ukraine № 26. 2008.

Urumova LA. Biosafety Levels 1, 2. Requirements for laboratory furniture and laboratory equipment. Personnel access. Remedies. Medical surveillance of the health of laboratory personnel. In: Proceedings of Сonference on Biological Safety Principles in Microbiology Laboratories. Novosibirsk; 2013.

Danilovа VV, Dekhtiarenko NV, Gorshunov YV, Galkin AY. Biosafety in the context of labour protection. biotechnological and regulatory aspects. Naukovi Visti NTUU KPI. 2016;3:20-9. DOI: 10.20535/1810-0546.2016.3.71114

Kruse RH, Puckett WH, Richardson JH. Biological safety cabinetry. Clin Microbiol Rev. 1991;4(2):207-41. DOI: 10.1128/CMR.4.2.207

On ensuring sanitary and epidemic wellbeing of the population. Act of Ukraine Act of Ukraine № 1103-V. 1994.

On state biosafety system while creating, testing, transportation and use of genetically modified organisms. Act of Ukraine № 1103-V. 2007.

Hygienic classification of labor according to indicators of harmfulness and danger of factors of the production environment, severity and intensity of the labor process. State sanitary norms and rules. 2014.

Medicines. Good manufacturing practice. Ordinance of the Ministry of Health of Ukraine ST-N 42-4.0:2016. 2016.

Povodzinskiy V, Shybetskiy V, Ramazanova-Stepkina E. Biosafety in the methodology of room design for industrial and laboratory practice. Sci Messenger Lviv Nat Univ Vet Med Biotechnol Ser Agricult Sci. 2010;12(2):246-9.

Clean rooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration, ISO 14644-1:2015.

Clean rooms and associated controlled environments – Part 4. Design, construction and start-up. ISO 14644-4:2001.

Clean rooms and associated controlled environments – Part 2. Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. ISO 14644-2:2015. DOI: 10.3403/30152882

Povodzinskiy VM. Safety and technological hygiene in production of active pharmaceutical ingredients. Technol Audit Prod Reserv. 2013;3(2):11-4.

Feshina MO, Bespalova OYa, Besarab OB. Biosecurity and bioethics as elements of a professional worldview. Biomed Eng Technol. 2020,4:36-50. DOI: 10.20535/2617-8974.2020.4.221853

Tsinyk MI, Besarab OB, Motronenko VV. Biosafety and work safety. Biomed Eng Technol. 2021,5:52-8. DOI: 10.20535/2617-8974.2021.5.231250

Gryb IO, Mironenko VI, Motronenko VV. Bioethics in the context of socio-economic, socio-political and cultural development of society. Biomed Eng Technol. 2021,5:76-86. DOI: 10.20535/2617-8974.2021.5.231333

Zubik PR, Motronenko VV, Besarab OB. Technologies of genetic material use restriction: types, molecular-genetic base and ethical analysis of their application. Biotechnologia Acta. 2021;14(2):19-27. DOI: 10.15.407/biotech14.02.019



How to Cite

Khablenko A, Besarab O, Motronenko V. Laboratory and Production Biosafety When Working With Bioobjects: Regulatory and Organizational and Technical Aspects. Innov Biosyst Bioeng [Internet]. 2021Jun.30 [cited 2024Jun.13];5(2):125-34. Available from: