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

A specialized engineering team from INEX has performed a primary technical audit of the production and laboratory spaces for GEM LLC (GEM Technopolis). This audit serves as the foundation for a multi-functional project aimed at establishing several high-performance controlled environments for medical device manufacturing and diagnostics.

Based on the audit results, the design phase will cover the following key technological sectors:

[Image: Technical site survey for a medical device manufacturing facility with HVAC routing analysis]

1. Specialized Production Lines

• ISO Class 8 (Grade D) Zone: Dedicated to the production of non-sterile specialized devices, including 96-well plates for microbial identification and antibiotic susceptibility disks.

• Medical Device Assembly: A controlled environment for the precision assembly of medical equipment.

• Packaging Sector: Final packaging lines for finished medical products.

2. Laboratory & Research Infrastructure

• Microbiology Laboratory: Engineered for the safe handling and cultivation of microorganisms.

• Quality Control (QC) Laboratory: A dedicated zone for rigorous product testing and validation.

3. Specialized Logistics & Support Systems

• Cold Chain Storage: Warehouse facilities featuring controlled temperature regimes for raw materials and finished goods.

• Personnel Infrastructure: Designing specialized zones for cleanroom garment preparation and personnel airlocks.

• Auxiliary Utilities: Engineering of a water purification/treatment unit and intermediate storage areas for in-process materials.

[Image: Engineering layout of an ISO 8 cleanroom for microbiological diagnostic manufacturing]

Following the site visit and the completion of the audit, the project is moving into the active development stage in close coordination with the Client.

Regulatory Compliance (RF)

The project is engineered to meet the stringent requirements of both the medical device and pharmaceutical sectors:

• GOST R ISO 14644-1: Classification of air cleanliness for ISO Class 8 environments.

• GOST R ISO 13485-2017: Medical devices — Quality management systems — Requirements for regulatory purposes.

• EAEU GMP (Grade D): Ensuring compliance for the production of diagnostic tools and microbiological media.

• SanPiN 2.1.3684-21: Sanitary requirements for the maintenance of production territories and water supply.