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

INEX has completed the engineering design for a facility dedicated to the preparation and packaging of non-sterile medical solutions in Dubna (Moscow Region). The project was executed in strict accordance with the contract terms and approved Technical Specifications, incorporating the principles of Good Manufacturing Practice (GMP).

The project was implemented as a major renovation with the development of detailed design documentation in a single stage. Engineering solutions were formulated based on the User Requirements Specification (URS) and developed to the Design Qualification (DQ) level, ensuring process control, parameter reproducibility, and facility readiness for subsequent implementation phases.

Layout and technological solutions include functional zoning, segregated flows for personnel and materials, the organization of personnel and material airlocks, and equipment placement optimized for Quality Risk Management (QRM) and Contamination Control Strategy (CCS). The design specifies Grade C and D cleanrooms (according to GMP classification), appropriate for production profiles that do not involve pathogenic biological agents.

Engineering systems (HVAC, water and sewage, power supply, and automation) are designed as GMP-critical utilities, ensuring controlled pressure differentials, microclimate parameters, and sanitary safety. The adopted solutions are specifically oriented toward the subsequent Qualification and Validation (IQ / OQ / PQ) of both engineering systems and cleanroom environments.

Upon completion of the design phase, INEX submitted a full set of detailed engineering documentation for review and approval. The documentation was prepared in compliance with GMP requirements and is intended for use during construction, outfitting, and commissioning, including future regulatory inspections.

Regulatory Compliance (EAEU and International Standards) The engineering solutions were developed in accordance with current regulatory documentation, including:

• EAEU Good Manufacturing Practice (GMP) Rules: (EEC Council Decision No. 77 dated 03.11.2016) — regarding the design of production facilities, engineering systems, risk management, and preparation for qualification and validation.

• GOST ISO 14644 (Series): Regarding the classification of cleanrooms and the verification of air cleanliness parameters according to established classes.