Construction of a Prefabricated Modular Building for a Thermal Disinfection and Decontamination Station for Pathogenicity Groups III–IV Effluents
01.06.2023
Customer: Federal State Unitary Enterprise SPbNIIVS FMBA of Russia, St. Petersburg
Designing industrial-grade buildings for the pharmaceutical sector involves navigating a complex landscape of stringent technical and safety requirements. At INEX, our recruitment of top-tier industry specialists ensures that even the most complex projects are executed with high precision and minimal revisions.
Currently, the project for the technical re-equipment of the Research Laboratory and Quality Control Laboratory at SPbNIIVS FMBA Russia has reached the documentation analysis phase. Consolidated feedback from the Customer's experts regarding the "Stage R" (Detailed Documentation) has been received and accepted for processing.
The documentation is now undergoing final technical refinements. This collaborative process between INEX and SPbNIIVS FMBA Russia ensures that every engineering solution—from airflow patterns in the Laboratory Building Lit. A to the integration of analytical equipment—is perfectly aligned with both operational needs and regulatory mandates.
Regulatory Compliance (RF)
The refinement of the engineering documentation strictly adheres to the regulatory framework of the Russian Federation and EAEU:
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EAEU GMP (Good Manufacturing Practice): Specifically regarding the documentation and qualification requirements for production-related laboratory zones.
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Decree of the Government of the Russian Federation No. 87: Governing the composition and content of project documentation sections.
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ISO 14644 (GOST R ISO 14644): Standards for cleanrooms, ensuring that all architectural and HVAC modifications maintain the required cleanliness classes.
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SanPiN 3.3686-21: Ensuring biosafety protocols are fully integrated into the revised technological solutions.



