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

The INEX Group has achieved a critical milestone by receiving a positive conclusion from the State Expert Evaluation (Gosexpertiza) for the development of project documentation for the Armavir Biological Factory in the Krasnodar Territory. This approval serves as the green light for our specialists to commence the development of "Stage R" (Detailed Documentation).

The comprehensive project covers four key facilities within the factory’s infrastructure:

[Image: Engineering 3D visualization of the modernized production floors at the Armavir facility]

1. Sterile Liquid Veterinary Bacteriological Products (Phase 1): Reconstruction of existing capacities on the 1st floor of the Main Production Building (GPC) to achieve a production volume of 350 m³/year. The technological lines are being modernized to strictly align with Russian and European GMP standards.

2. Liquid and Lyophilized Sterile Bacteriological Products (Phase 2): Development of high-capacity lines on the 3rd floor of the GPC for the production of 44.5 million vials per year. This includes both liquid and freeze-dried (lyophilized) forms.

3. Medicinal Serum Production: New construction of a facility dedicated to the extraction and processing of albumin and globulin fractions.

4. Vivarium Building: New construction of a specialized vivarium designed to support the institute's research and testing requirements.

[Image: Technical layout of the high-capacity sterile filling line for veterinary pharmaceuticals]

The Armavir Biological Factory is a strategic site, and the integration of advanced engineering solutions by INEX ensures that the facility will operate at the highest international levels of pharmaceutical excellence and biological safety.

Regulatory Compliance (RF)

The project adheres to a dual-standard framework to ensure export readiness and local compliance:

• EU & Russian GMP (Good Manufacturing Practice): Comprehensive requirements for sterile pharmaceutical production environments.

• Decree of the Government of the Russian Federation No. 87: Ensuring the project documentation meets all federal legal requirements for industrial construction.

• SanPiN 3.3686-21: Regarding the safety of biological production and veterinary medicine.

• ISO 14644 (GOST R ISO 14644): Governing the design and validation of the cleanroom zones within the new and reconstructed buildings.