pharmjournalРазработка и регистрация лекарственных средствDrug development & registration2305-20662658-5049LLC «CPHA»10.33380/2305-2066-2022-11-1-165-173pharmjournal-1175Research ArticleРЕГУЛЯТОРНЫЕ ВОПРОСЫREGULATORY ISSUESОрганизация гигиенического мониторинга загрязненности воздуха рабочей зоны твердыми частицами на фармацевтических предприятиях (обзор)Organization of Hygienic Monitoring of Working Area Air Pollution by Particulates in Pharmaceutical Industries (Review)https://orcid.org/0000-0002-5721-1883ПожарновИ. А.PozharnovI. A.

119991, Россия, г. Москва, ул. Трубецкая, д. 8, стр. 2

8/2, Trubetskaya str., Mosсow, 119991, Russia

https://orcid.org/0000-0002-3076-0030СимаковА. С.SimakovA. S.

119991, Россия, г. Москва, ул. Трубецкая, д. 8, стр. 2

8/2, Trubetskaya str., Mosсow, 119991, Russia

https://orcid.org/0000-0001-9910-9097ШатилинаА. А.ShatilinaA. A.

Шатилина Анастасия Андреевна

119991, Россия, г. Москва, ул. Трубецкая, д. 8, стр. 2

Аnastasia А. Shatilina

8/2, Trubetskaya str., Mosсow, 119991, Russia

shatilina_a_a@staff.sechenov.ruhttps://orcid.org/0000-0001-8779-3573РаменскаяГ. В.RamenskayaG. V.

119991, Россия, г. Москва, ул. Трубецкая, д. 8, стр. 2

8/2, Trubetskaya str., Mosсow, 119991, Russia

ФГАОУ ВО Первый МГМУ им. И. М. Сеченова Минздрава России (Сеченовский университет)I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)202224022022111165173Copyright © Пожарнов И.А., Симаков А.С., Шатилина А.А., Раменская Г.В., 20222022Пожарнов И.А., Симаков А.С., Шатилина А.А., Раменская Г.В.Pozharnov I.A., Simakov A.S., Shatilina A.A., Ramenskaya G.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmjournal.ru/jour/article/view/1175Введение

Введение. Использование высокоактивных субстанций различного происхождения на предприятиях фармацевтической промышленности подвергает риску персонал, работающий непосредственно с активными фармацевтическими субстанциями (АФС) в производственных помещениях. Несмотря на выполнение фармацевтическими предприятиями требований по охране труда, в частности использование средств индивидуальной защиты (СИЗ) и проведение манипуляций с высокотоксичными веществами в специально предназначенных для этого помещениях, влияние факторов риска на состояние здоровья операторов необходимо регулярно оценивать и контролировать. В связи с этим гигиенический мониторинг воздуха рабочей зоны является обязательным мероприятием в деятельности фармацевтических предприятий. В настоящее время на территории Российской Федерации действует ряд нормативных документов (приказов, государственных стандартов, методических указаний, руководств), определяющих единые требования к организации и проведению контроля загрязненности воздуха рабочей зоны твердыми частицами. Вместе с тем, на законодательном уровне обязательным требованием для всех производственных предприятий является разработка соответствующих индивидуальных методик для определения содержания конкретных веществ в воздухе рабочей зоны.

Текст

Текст. В данной статье приведен обзор российской и зарубежной нормативной базы по вопросу порядка организации и проведения гигиенического мониторинга воздуха рабочей зоны. На основе сравнительного анализа приведенной литературы, с целью выявления общих положений, описан подход к проведению контроля содержания вредных веществ в воздухе рабочей зоны на фармацевтических предприятиях.

Заключение

Заключение. В результате сравнительного анализа рассмотренных литературных данных представлен общий подход к контролю за содержанием вредных веществ в воздухе рабочей зоны, включающий в себя описание необходимого оборудования и материалов для отбора проб, стратегию проведения пробоотбора, рекомендации по оформлению протоколов мониторинга, порядок хранения и транспортировки проб, а также процедуру проведения анализа проб. Данная работа может служить в качестве возможного опорного материала для разработки фармацевтическими предприятиями индивидуальных требований к методике определения концентрации конкретных веществ в воздухе рабочей зоны.

Introduction

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

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

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.

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The authors declare that there are no conflicts of interest present.