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

As part of an ongoing partnership involving the Chumakov Institute of Poliomyelitis and Viral Encephalitides, INEX has completed a comprehensive scope of work to secure accreditation and sanitary-epidemiological conclusions for Biolife NIRC LLC.

The project focuses on the organization of three specialized facilities within the Biolife complex in Moscow (1st Kuryanovskaya St.), where INEX developed the architectural layouts and workflow optimizations for the 6th and 7th floors.

[Image: Interior of a newly certified microbiology laboratory with biosafety cabinets and seamless cleanroom finishes]

Certified Laboratory Facilities:

• Vivarium: Engineered to maintain precise environmental conditions for the housing, feeding, and experimental study of laboratory animals in a controlled research setting.

• Microbiology Laboratory: Dedicated to testing raw materials, excipients, finished drugs, medical devices, and purified/injection-grade water, as well as environmental monitoring of production zones.

• Physicochemical Laboratory: Designed for high-precision analysis of the physical and chemical properties of research materials and components.

Regulatory Milestones: The Vivarium, Physicochemical, and Microbiology laboratories have officially received accreditation and sanitary-epidemiological approval for microbiological research involving:

• Group IV Bacteria

• Groups III-IV Fungi

Work is currently underway to prepare documentation for the next tier of accreditation, targeting Pathogenicity Groups I-II. This project significantly elevates the standards for quality and safety confirmation of pharmaceuticals, medical equipment, supplements, and in-vitro diagnostics.

[Image: Technical documentation and certificate of accreditation for high-containment laboratory operations]

Regulatory Compliance (RF)

The certification and engineering of the Biolife complex comply with the highest federal safety standards:

• SanPiN 3.3686-21: Mandatory requirements for working with Pathogenic Biological Agents (PBA).

• GOST R ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories.

• GLP (Good Laboratory Practice): Ensuring the quality and integrity of non-clinical safety studies.

• ISO 14644: Standards for controlled environments and cleanrooms within the microbiological blocks.