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«Innovation expert clean rooms»®

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

08.03.2022

Customer: Medical Science

The design and engineering survey phase for the Medical Science pharmaceutical cleanroom facility has been successfully concluded. The completed project documentation was delivered to the Client in full compliance with the established schedule, marking the transition from conceptual planning to technical readiness.

The technological solutions were developed based on the core requirements of GMP GOST R 52249-2009 ("Rules for the Production and Quality Control of Medicinal Products") and currently applicable national technical regulations.

Specialized Functional Zoning: The project documentation provides a detailed layout for a high-performance production site, including:

  • Preparation & Primary Packaging: Areas dedicated to the handling of raw materials and primary containers.

  • Aseptic Core: Specialized rooms for solution preparation, filling, and sealing (capping).

  • Finishing Zones: Dedicated spaces for inspection, labeling, and secondary (group) packaging.

  • Storage Infrastructure: Controlled environments for raw materials and quarantine/control storage.

Environmental Control & Safety: To eliminate the risk of harmful substance accumulation and ensure a sterile environment, the INEX engineering team integrated several critical safety measures:

  • Advanced HVAC: General exchange ventilation systems designed for precise pressure cascading.

  • Hermetic Integrity: Equipment sealing protocols to prevent cross-contamination.

  • Dual-State Monitoring: Systems for environmental control designed to meet standards in both "at-rest" (equipped) and "in-operation" states.

The technological solutions adopted in this project ensure that the working zone air quality remains well within permissible limits, safeguarding both the product and the personnel.