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

In late May 2023, a group of INEX experts visited the Shchelkovo Agrokhim site to define the scope of a large-scale collaboration with Betaren Pharma LLC. The partnership aims to develop a comprehensive pharmaceutical complex, starting with on-site engineering surveys and the preparation of technical assignments for design and estimate documentation.

Currently, the INEX engineering department has commenced work on the Production Layout Concept. The facility is designed to house several specialized manufacturing streams, including:

Tablet Formulations: High-capacity solid dosage form production.

Granulated Products: Encapsulation in hard gelatin capsules.

Infusion Solutions: Aseptic filling in glass vials.

[Image: Schematic layout of a multi-product pharmaceutical plant showing cleanroom zoning]

In addition to primary production, the concept defines critical infrastructure and support zones:

Secondary Packaging & Warehouse Operations: Optimized logistics for finished goods.

Quality Control (QC) Laboratories: Ensuring rigorous product testing.

Support Services: Specialized gowning areas, engineering systems, and administrative offices.

The design philosophy is centered on the principle of drug compatibility, ensuring that all technological flows prevent cross-contamination and meet international safety standards. The new complex will be located in the Dubna Special Economic Zone (SEZ), Moscow Region.

[Image: 3D model of the pharmaceutical complex highlighting the integration of engineering systems]

Regulatory Compliance (RF)

The conceptual design and subsequent stages of the project are developed in accordance with:

EAEU Good Manufacturing Practice (GMP): Regarding facility design, production segregation, and contamination control.

SanPiN 2.1.3684-21: Sanitary requirements for the operation of industrial buildings and utility systems.

ISO 14644 (GOST R ISO 14644): International standards for cleanrooms and controlled environments in the pharmaceutical industry.

Regulations for the Dubna Special Economic Zone: Local construction and environmental standards for high-tech industrial sites.