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

01.02.2022

The INEX R&D and production division is proud to announce the successful completion of the certification and validation testing for the UTOS-1 effluent decontamination station. This system is a complex engineering solution designed for the collection, sterilization, cooling, and safe discharge of treated wastewater into external sewage networks.

To ensure the highest levels of operational reliability and biological safety, the system underwent a rigorous multi-stage qualification process:

1. Factory Acceptance Testing (FAT)

The FAT phase involved a comprehensive audit of all equipment parameters prior to shipment. Key checks included:

  • Technical Compliance: Verification against technical descriptions and P&IDs (Piping and Instrumentation Diagrams).

  • Certification Audit: Review of instrumentation and GMP certificates to ensure all components meet industry standards.

  • Mechanical & Electronic Inspection: Physical inspection of dimensions, finishes, and the integrity of electronic components.

  • Accuracy Testing: Determination of sensor measurement tolerances and test result output verification.

  • Note: The FAT protocols serve as critical foundational documents for the subsequent IQ/OQ stages.

2. Installation Qualification (IQ)

This stage confirmed that the UTOS-1 was delivered and installed correctly. Specialists verified:

  • Documentation Alignment: Ensuring the physical installation matches the approved drawings and specifications.

  • Installation Accuracy: Checking the integrity of connections, utility hookups, and component placement according to technical requirements.

3. Operational Qualification (OQ)

The OQ phase focused on the "functional health" of the system.

  • Core Functionality: Verification that the system and its software perform all intended sequences correctly.

  • Operational Stability: Testing the performance of the equipment under various load conditions to ensure it maintains the required sterilization parameters.

Commitment to Import Substitution: The UTOS-1 (and its high-capacity counterpart, the UTOS-6000) represents a significant milestone in Russian engineering. The system is assembled entirely from domestic components and assemblies. By transitioning to full import substitution, INEX provides Russian pharmaceutical and research enterprises with high-tech equipment that is independent of foreign supply chains and fully compliant with state industrial policies.