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

INEX Group has successfully completed the development of project documentation for the facility: "Capital repair of premises and supply of technological equipment for the production of sterile products (gels)" located on Varshavskoye Shosse, Moscow. The project aims to establish a comprehensive production and packaging cycle for medical-grade sterile gels for the company Medical Science.

Following a series of strategic technical adjustments to the technological flowchart, our specialists have moved to the active phase of cleanroom installation. The facility is designed to house specialized zones and technological lines with varying cleanliness classifications, including:

• Material and Primary Packaging Preparation: Ensuring the sterility of containers before they enter the production stream.

• Compounding, Filling, and Capping: An aseptic zone for the preparation of solutions and high-precision filling.

• Inspection, Labeling, and Secondary Packaging: Areas for quality control and final stage processing.

• Raw Material and Control Sample Storage: Controlled environments for inventory management and long-term stability monitoring.

[Image: Technical layout showing the segregation of process flows and air pressure cascading in a sterile facility]

The integration of these systems by INEX ensures that the entire manufacturing process—from raw materials to the finished product—is conducted in a controlled environment that eliminates the risk of contamination.

[Image: Construction team installing modular cleanroom panels for an aseptic production zone]

Regulatory Compliance (RF)

The engineering and installation works are carried out in strict adherence to the following standards:

• EAEU GMP (Good Manufacturing Practice): Specifically regarding the requirements for sterile medicinal products and medical devices.

• ISO 14644 (GOST R ISO 14644): Standards for the design and validation of cleanrooms and associated controlled environments.

• SanPiN 2.1.3684-21: Sanitary requirements for the operation of production facilities and engineering systems.

• SP 158.13330.2014: Russian design standards for buildings and premises intended for medical and pharmaceutical use.