MODERN SCIENTIFIC AND TECHNICAL APPROACHES TO PROVIDING CLEANLINESS OF PRODUCTION PREMISES IN THE PHARMACEUTICAL INDUSTRY

Abstract

The article considers modern scientific and technical approaches to ensuring the cleanliness of production facilities in the pharmaceutical industry. The work summarizes the regulatory framework and analyzes traditional and modern technologies for controlling cleanliness, evaluates innovative solutions (automation, digitalization, robotics), and identifies practical areas for improving cleanroom management systems. The purpose of the study is to analyze modern approaches to ensuring the cleanliness of production facilities in the pharmaceutical industry in accordance with GMP and ISO requirements. The regulatory requirements (GMP, ISO) and international standards for organizing cleanrooms are analyzed. Traditional and innovative methods of pollution control are summarized, such as ventilation and air filtration systems, disinfection technologies, monitoring of microbiological and mechanical particles. A criterion-comparative assessment of traditional and modern solutions for ensuring the cleanliness of production facilities is given, taking into account the role of personnel, filtration equipment, pollution monitoring, and compliance with current standards. The effectiveness of filtration systems as a key factor in ensuring cleanliness in pharmaceutical production facilities, in particular HEPA and ULPA filters, is analyzed. An integrated generalized assessment of the effectiveness of the implementation of modern solutions in pharmaceutical enterprises is provided, which highlights the priority of the latest technologies (ULPA, ATP tests, IoT) in ensuring the cleanliness of production facilities by significantly increasing the speed, sensitivity and reliability of control in clean rooms. It is shown that modern scientific and technical approaches – from multi-level filtration and disinfection to digital monitoring and automation systems – significantly increase the efficiency of control and minimize risks. Further development in this area is associated with the introduction of robotic technologies, the expansion of the use of IoT solutions and the harmonization of national standards with international GMP and ISO requirements.