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

A team of engineering specialists from INEX has conducted a detailed technical inspection of the active laboratory facilities of Sistema-BioTech. As a leading developer in molecular biology, genetics, and cellular technologies, Sistema-BioTech operates over 1,000 m² of research and production space across the Mosmedpark biotech technopark, with additional manufacturing sites in Zelenograd and Obninsk.

The partnership is strategically significant as Sistema-BioTech is a member of the International Medical Cluster (IMC) in Skolkovo, where they are preparing to launch one of Russia’s largest private R&D laboratories, spanning 4,000 m² within a new innovative production complex.

Technical Scope of Work: The audit conducted by INEX focused on two critical pillars of biotechnological infrastructure:

• HVAC Systems (Ventilation): Evaluating air exchange rates, pressure cascading, and filtration efficiency to ensure absolute containment and air purity in sensitive genetic research zones.

• Chilled Water Systems (Refrigeration): Auditing the reliability and precision of cooling loads required for high-tech laboratory equipment and controlled production environments.

• Validation Services: Performing rigorous testing to verify that existing systems comply with the operational parameters required for advanced biotechnological processes.

The successful completion of this technical audit provides a baseline for the ongoing modernization and optimization of Sistema-BioTech’s infrastructure as they scale their operations.

Regulatory Compliance (RF)

The audit and validation works were performed in accordance with the following engineering and pharmaceutical standards:

• ISO 14644-3: Cleanrooms and associated controlled environments — Part 3: Test methods (for airflow and pressure validation).

• EAEU GMP (Good Manufacturing Practice): Ensuring the environmental control systems support the integrity of molecular and cellular products.

• SP 60.13330.2020: Russian federal standards for "Heating, Ventilation, and Air Conditioning."

• SP 158.13330.2014: Design and operational codes for medical and biotechnological laboratory buildings.