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Implementation of modern requirements to methods of quantitative control of harmful chemical factors in the working zone air of pharmaceutical enterprises

ISSN 2223-6775 Ukrainian journal of occupational health Vol.16, No 1, 2020

Implementation of modern requirements to methods of quantitative control of harmful chemical factors in the working zone air of pharmaceutical enterprises

Zazulyak T.S.

https://doi.org/10.33573/ujoh2020.01.033

Lviv national medical university named after Danylo Halytskyy, Lviv

Full article (PDF), UKR

Introduction. Monitoring of concentrations of active pharmaceutical ingredients is an integral part of monitoring the pollution of the manufacturing area in pharmaceutical manufacturers. The requirements of the present day dictate the need for revising and improving the control methods, which has determined the purpose and objectives of this work.

The purpose of the studyanalysis of the current state of methodological support of the quantitative control of levels of air pollution in the working zone by harmful substances at pharmaceutical enterprises and search for ways of its improvement.

Materials and methods. The study was conducted by examining the national legislative base and directive acts, standards and norms implemented within the framework of the Ukraine-EU Association Agreement, which regulate the control of chemical pollution of the working zone air.

Results. The analysis of the national and European legislation show that the state policy of Ukraine and the EU Member States in the field of occupational safety against chemicals is aimed at increasing the level of industrial safety. For this purpose, standard methods for measuring concentrations of harmful substances in the air should be developed. A scheme presented for developing methods of measuring concentrations of medicinal substances in the air of the working zone at farmaceutical enterprises covers specificity of the pharmaceutical production and actual analytical requirements to the methods. An essential point is to obtain evidence of the suitability of the method, namely its validation and verification as well as implementation of DSTU ISO/IEC 17025:2017 (Standard) into practice.

Conclusions. The harmonization of the national legislation with EU normative acts puts forward new requirements to the methodological support of the process of development of methods for controlling harmful chemical factors in production conditions. The development of methods of the control of chemical pollution in the production environment of pharmaceutical enterprises should be carried out in accordance with the requirements of the EU directive acts, DSTU EN 482, 2016. It is proposed a scheme for developing methods of measuring concentrations of chemicals in the air of the working zone at farmaceutical enterprises. The implementation of this scheme into practice will help to optimize actions on hygienic regulation and controlling levels of the effect of chemical factors in conditions of production of medicinal preparations.

Key words: working zone, pharmaceutical enterprises, chemical pollution, methods of measurement, concentrations, applicability of methods

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