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

The modernization of the Solid Dosage Form (SDF) production line at the Pharmzaschita Research and Production Center (FMBA of Russia) has reached its final technical phase. Located in Khimki, Moscow Region, this project involves the complete overhaul and certification of the cleanroom module and its supporting engineering infrastructure within Building No. 2 (Rooms 114, 115, 116a, 116b).

Since the project’s inception in April 2020, INEX Group has transitioned from complex engineering design to the physical assembly of specialized environments. By mid-September 2020, the installation of the cleanroom complex and the core ventilation systems was successfully completed.

Validation and Quality Assurance: On September 18, independent validation experts arrived on-site to conduct a rigorous audit of the facility. The project underwent two critical stages of the validation V-model:

• Design Qualification (DQ): Verification that the engineering solutions fully comply with the Client's User Requirement Specification (URS) and GMP standards.

• Installation Qualification (IQ): Physical verification that all components and systems are installed correctly according to the design documents. The validators confirmed the high quality of the installation, allowing the project to proceed to the operational testing phase.

Automation and Commissioning: In early October 2020, INEX specialists initiated the commissioning of the ventilation systems. A sophisticated SCADA (Supervisory Control and Data Acquisition) system was integrated to provide centralized management. This allows dispatchers to monitor air exchange rates, pressure differentials, and filtration integrity in real-time, ensuring total control over the manufacturing environment.