Construction of a Prefabricated Modular Building for a Thermal Disinfection and Decontamination Station for Pathogenicity Groups III–IV Effluents

On October 30, 2023, a strategic site meeting took place between the management and engineering teams of INEX Group and representatives of JSC Schelkovo Agrokhim (Customer: Betaren Pharma LLC). The meeting focused on finalizing critical technical solutions for the production facility of the active pharmaceutical substance (API) "Ipidacrine."

A primary focus of the discussion was the organization of equipment cleaning protocols and facility maintenance in strict accordance with GOST R ISO 14644-4-2002 (Cleanrooms and associated controlled environments — Part 4: Design, construction, and start-up). These measures are essential to ensure the facility meets the GMP (Good Manufacturing Practice) standards mandated by the Order of the Ministry of Industry and Trade No. 916.

Key Technical Agenda Items:

• Water Treatment Systems: The teams finalized the configuration of the water purification and distribution system tailored specifically for the new production site's technological requirements.

• Equipment Integration: A comprehensive review of the ongoing installation of engineering and specialized technological equipment was conducted to ensure seamless integration with the building's utility networks.

• Progress Assessment: Specialists performed an on-site inspection of the construction and installation progress for the Ipidacrine API unit, verifying that the work aligns with the approved architectural and engineering designs.

Regulatory Compliance (RF)

Technical solutions and coordination are implemented in accordance with the following regulatory frameworks:

• Order of the Ministry of Industry and Trade No. 916: National GMP rules for the pharmaceutical industry.

• ISO 14644-4: Standards for the design and commissioning of cleanroom facilities.

• EAEU GMP Standards: Ensuring regional regulatory alignment for active substance manufacturing.