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

The project at the Moscow Anti-Plague Center (MAPC) is being implemented in strict accordance with the national sanitary-epidemiological regulations of the Russian Federation. The engineering objective is to integrate robust containment systems into the facility's technical infrastructure, ensuring a reliable framework for biosurveillance and specialized public health operations.

The scope of work includes developing infrastructure for handling Pathogenic Biological Agents (PBA) of Hazard Groups I–II (as defined by Russian national classification). The project encompasses critical engineering, technological, and layout solutions tailored for anti-plague institutions, with a focus on operational stability and continuous regulatory oversight.

Technical & Engineering Controls: The design focuses on establishing clear primary and secondary containment layers:

• Effluent Decontamination Systems (EDS): Thermal inactivation units designed for the qualified treatment of biohazardous liquid waste.

• HVAC & Airflow Management: Specialized air-handling units maintaining precise pressure differentials to ensure directional airflow toward contaminated zones. The system includes integrated monitoring and alarm logic for pressure stability.

• Aerosol Containment: Exhaust air is treated through redundant HEPA (H14) filtration systems to ensure high-efficiency particulate removal before environmental discharge.

• Physical Containment Envelopes: Installation of gas-tight barriers, airtight sealing systems, and automated airlocks to provide functional segregation between high-containment areas and the external environment.

Methodology and Validation: System implementation is guided by Quality Risk Management (QRM) and Contamination Control Strategy (CCS) principles, drawing on established GMP (Annex 1) methodologies for high-containment environments. The project lifecycle includes the Qualification (IQ / OQ / PQ) of critical utilities—including HVAC, EDS, and biodecontamination systems (VHP)—to provide documented evidence of consistent operational performance.

This modernization program is a key part of the comprehensive strategy to enhance biosafety infrastructure, ensuring safe and regulated facility operation in line with industrial engineering standards.

Regulatory Framework Design and organizational solutions for the MAPC facility are developed in accordance with the following regulations:

• SanPiN 3.3686-21: Russian National Sanitary Regulations for the prevention of infectious diseases, governing the handling of pathogenic microorganisms and biohazardous waste disinfection.

• SanPiN 2.1.3684-21 & 1.2.3685-21: National requirements for occupational health and environmental safety factors.

• EAEU GMP (Decision No. 77): Utilized to establish the framework for the qualification of critical utility systems and contamination control protocols.

• Order of the Ministry of Industry and Trade No. 916: National requirements for engineering infrastructure, applied within the scope of facility technical validation.