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

Engineering work continues for the development of a state-of-the-art production unit dedicated to the purification of technical pharmaceutical substances. These active pharmaceutical ingredients (APIs) will be utilized for the manufacturing of Finished Dosage Forms (FDF) both for JSC Schelkovo Agrokhim and for supply to external pharmaceutical partners.

As the General Designer, INEX Group is collaborating closely with the State Institute of Drugs and Good Practices (SID & GP), which is responsible for the technological part of the project.

Universal Technological Framework: Specialists from both partner organizations have developed a versatile technological scheme for API production, encompassing:

• Chemical Purification & Crystallization: High-precision refinement of technical substances.

• Filtration & Drying: Removing solvents and stabilizing the active material.

• Milling (Size Reduction): Achieving the specific particle size distribution required for FDF.

• Filling & Packaging: Sterile handling and containment for distribution.

The recent tripartite conference, including the Customer's subject matter experts, allowed for the rapid resolution of facility layouts, the selection of critical technological equipment, and the distribution of tasks for related engineering disciplines.

This collaborative synergy ensures that the final design will not only be technically superior but also fully compliant with the most stringent international regulatory expectations. We thank all participants for their professionalism and deep commitment to this landmark project.

Regulatory Compliance (RF)

The project is being developed under the strict oversight of federal institutions to ensure alignment with:

• EAEU GMP (Good Manufacturing Practice): Specifically Part II, which focuses on the manufacturing of active substances used as starting materials.

• ICH Q7: International guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients.

• GOST R ISO 14644: Governing the design of cleanroom environments required for open-product handling during filtration and drying stages.

• Environmental Safety Standards: Ensuring the safe handling and recovery of chemical solvents used during the purification process.