Organization of Hygienic Monitoring of Working Area Air Pollution by Particulates in Pharmaceutical Industries (Review)

• Published in: Razrabotka i registraciâ lekarstvennyh sredstv (Online) Vol. 11; no. 1; pp. 165 - 173
• Main Authors: Pozharnov, I. A., Simakov, A. S., Shatilina, A. A., Ramenskaya, G. V.
• Format: Journal Article
• Language: English; Russian
• Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 24.02.2022
• Subjects: воздух рабочей зоны; гигиенический мониторинг; охрана труда; предельно допустимая концентрация; фармацевтические предприятия
• ISSN: 2305-2066; 2658-5049
• DOI: 10.33380/2305-2066-2022-11-1-165-173

Introduction. The use of highly active substances of various origins in the pharmaceutical industry exposes employees working directly with active pharmaceutical substances (APS) in manufacturing facilities to risks. Although pharmaceutical companies follow occupational safety requirements, such as the use of personal protective equipment (PPE), the manipulation of highly toxic substances in specially dedicated indoor facilities, etc., the impact of risk factors on the health of workers must be regularly assessed and monitored. Therefore, hygienic monitoring of working area air is obligatory in activity of pharmaceutical enterprises. A range of normative documents (orders, State standards, methodological guidelines, manuals) are currently in force in the Russian Federation defining uniform requirements for the organization and monitoring of working area air pollution by particulates. At the same time, the development of appropriate adjusted methodologies for determining the content of a specific substance in working area air is a mandatory requirement for all manufacturing enterprise by legislation. Text. The article provides a review of the Russian regulatory framework and relevant literature sources relating to the order of organization and performance of hygienic monitoring of working area air, including foreign ones. On the basis of a comparative analysis of the aforementioned literature completed in order to reveal common provisions, the comprehensive methodology for the monitoring of the content of harmful substances in the working area air at pharmaceutical enterprises is described. Conclusion. As a result of a comparative analysis of the literature reviewed, a detailed comprehensive methodology for the monitoring of the content of harmful substances in the working area air is presented, including a description of the equipment and materials required for sampling, sampling strategies, recommendations for monitoring protocols, procedures for storage and transport of samples, and procedure for sample analysis. This article may serve as a possible reference for pharmaceutical enterprises to develop individual methodologies for determining the concentration of a specific substances in working area air.