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

Specialists from INEX Group and experts from the State Institute of Drugs and Good Practices (SID & GP) have officially transitioned to the project documentation stage for the new pharmaceutical production facility of JSC Schelkovo Agrokhim.

This collaboration leverages the engineering excellence of INEX and the regulatory and technological expertise of SID & GP—Russia’s primary body for GMP inspections and pharmaceutical standards.

Site Audit & Preliminary Assessment As part of the initial phase, a joint field survey was conducted at Schelkovo Agrokhim’s production site. The team evaluated existing vacant areas within the plant’s industrial buildings to determine their suitability for pharmaceutical conversion.

Key activities during the field audit included:

• Infrastructure Assessment: Evaluating the structural integrity and utility capacities for cleanroom integration.

• GMP Gap Analysis: A preliminary evaluation of current production workflows against Good Manufacturing Practice (GMP) requirements.

• Flow Optimization: Identifying the most efficient layouts for material and personnel movement to prevent cross-contamination.

A Long-Term Strategic Alliance This project is significant not only for its industrial scale but also as the foundation of a long-term partnership program between INEX and the SID & GP. By combining specialized cleanroom construction with federal-level research expertise, the partnership aims to elevate the standards of pharmaceutical and medical manufacturing infrastructure across the Russian Federation.

The development of the design documentation is now underway, ensuring that every technological solution is "validated by design" to meet both local and international regulatory expectations.

Regulatory Compliance (RF)

The project is engineered under the direct supervision of federal experts to ensure adherence to:

• EAEU GMP: The primary standard for pharmaceutical production quality and safety within the Eurasian Economic Union.

• ISO 14644 (GOST R ISO 14644): Governing the design, construction, and testing of cleanrooms.

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

• SanPiN 2.1.3684-21: Sanitary requirements for industrial manufacturing environments.