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

INEX has finalized the Engineering Design and Site Survey (PIR) for the Lidkor LLC facility, which includes a dedicated area for reagent preparation and packaging. The project focuses on the development of a production site for hematology analyzer solutions, the filling of reagents into vials and cartridges, and the establishment of the supporting engineering infrastructure.

During the design phase, a comprehensive analysis of technological and engineering solutions was conducted, incorporating sanitary-epidemiological safety requirements and Good Manufacturing Practice (GMP) principles. The project scope encompasses filling lines, material preparation and storage rooms, purified water (PW) generation units, sterile compressed air systems, as well as quality control zones and finished product warehouses.

The design solutions specify ISO Class 7–9 cleanrooms required for the production of reagents that do not contain pathogenic biological agents. The documentation incorporates Quality Risk Management (QRM) principles and elements of a Contamination Control Strategy (CCS) to prevent cross-contamination, manage airflow patterns, and ensure stable microclimate parameters.

Particular emphasis was placed on designing engineering systems as GMP-critical utilities, including HVAC, water treatment, and sterile air supply systems. The adopted solutions are oriented toward subsequent Qualification and Validation (DQ / IQ / OQ / PQ) of equipment and facilities, ensuring the site is ready for the construction and installation phase.

The completion of the engineering design stage allows the project to transition to the next phase—construction, installation, and equipment procurement—followed by preparations for commissioning.

Regulatory Compliance (RF and EAEU) The engineering design and site survey works were carried out in accordance with current regulatory documentation, including:

• EAEU Good Manufacturing Practice (GMP) Rules: (EEC Council Decision No. 77 dated 03.11.2016).

• Order of the Ministry of Industry and Trade of the Russian Federation No. 916: Regarding engineering infrastructure requirements.

• SanPiN 2.1.3684-21 & 1.2.3685-21: National sanitary and hygienic standards for environmental and workplace safety.

• GOST ISO 14644 (Series): Regarding the classification and operation of cleanrooms.