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

 INEX continues to expand its collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry (IBCH). As part of this partnership, engineering solutions are being developed for three functional modules and a complex of laboratory equipment designed for research, experimental, and production activities.

The project is structured according to User Requirements Specification (URS) with subsequent Design Qualification (DQ). It is focused on creating a controlled laboratory and production environment that meets stringent biosafety and sanitary-epidemiological requirements. The design ensures the functional and engineering segregation of modules, providing process control, separation of personnel and material flows, and the mitigation of cross-contamination risks.

The planned complex includes zones for research and the aseptic production of medicinal forms, specifically for the development and future scaling of a unique oncology therapeutic. The engineering solutions allow for critical operations to be performed under controlled conditions, utilizing local zones of enhanced cleanliness (Grade A/B) and technical measures to ensure process stability and reproducibility.

INEX specialists are performing a comprehensive study of layout solutions, laboratory and process equipment arrangement, and the integration of modules into the Institute's existing engineering infrastructure. Particular attention is given to GMP-critical utilities, including HVAC systems, pressure cascade management, and the optimization of personnel, material, and waste movement routes.

Design solutions are being developed using Quality Risk Management (QRM) principles and elements of a Contamination Control Strategy (CCS). This approach ensures the facility's readiness for subsequent Qualification and Validation (IQ / OQ / PQ) stages and regulatory inspections under pharmaceutical and sanitary oversight.

The engineering work is conducted in close coordination with IBCH representatives, ensuring that scientific program specifics, aseptic process requirements, and future expansions of the laboratory-production base are fully integrated.

Regulatory Compliance (RF and EAEU) Design solutions are formulated in accordance with current regulatory and methodological documentation, including:

• EAEU Good Manufacturing Practice (GMP) Rules: (EEC Council Decision No. 77) — regarding facility design, engineering systems, aseptic processing, risk management, and process validation.

• Good Laboratory Practice (GLP) Guidelines: Regarding the organization of laboratory research, documentation, and results reproducibility.

• SanPiN 3.3686-21: National sanitary-epidemiological requirements for facilities handling biological agents.

• SanPiN 2.1.3684-21 & 1.2.3685-21: National standards for occupational health, environmental factors, and engineering system operation.

• GOST ISO 14644 (Series): Utilized as the technical standard for cleanroom classification and environmental air control.