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

Engineering specialists from INEX have successfully conducted a technical site audit for GEM LLC to support the development of a modern medical device production and storage facility. The project is situated within the Technopolis Moscow special economic zone (42 Volgogradsky Prospect), a hub for high-tech industrial modernization.

The primary objective is the design and implementation of a full-cycle cleanroom complex and dedicated technological lines for the assembly and sterile packaging of medical products.

[Image: Engineering site survey at Technopolis Moscow showing industrial infrastructure for cleanroom integration]

Key Project Components:

• Assembly Production: Establishing controlled environments for the precision assembly of medical devices arriving from existing manufacturing sites.

• Packaging Lines: Specialized zones for primary and secondary packaging to ensure product integrity and sterility.

• Storage Solutions: Designing integrated warehouse areas for raw materials and finished medical goods, optimized for logistics within the Technopolis framework.

• Technological Re-equipment: Modernizing existing spaces to meet the high-throughput demands of the medical sector.

[Image: 3D BIM model of a cleanroom layout for medical device assembly and packaging]

The facility is being designed as a turnkey solution, ensuring that every stage—from component arrival to final dispatch—complies with the latest industry regulations and manufacturing standards.

Regulatory Compliance (RF)

The engineering design for the GEM project strictly adheres to the following frameworks:

• GOST R ISO 14644-1: Standards for air cleanliness in cleanrooms and controlled environments.

• GOST R ISO 13485-2017: Quality management systems for medical device manufacturing.

• EAEU GMP Standards: Ensuring the production environment supports the safety and quality of medical products.

• Technopolis Moscow Technical Regulations: Compliance with the specific engineering and fire safety codes of the Special Economic Zone.