Logo

«Innovation expert clean rooms»®

Manufacturing of Cleanroom Structures

INEX carries out a full production cycle of structural elements for organizing pharmaceutical, biotechnological, food, and other cleanroom environments. The production program includes metal structures, wall and ceiling panels, profile systems, fan filter units (FFU), doors, pass-through hatches, and associated components for clean zones of all classes according to ISO 14644. All products comply with GMP requirements and are adapted for operation under conditions of strict microbiological cleanliness.

Production Facilities and Technologies

The INEX manufacturing complex is equipped with modern automated CNC machinery, including sections for metalworking, welding, precision bending, powder coating, and final assembly. This technological equipment allows for the execution of complex "turnkey" cleanroom projects — from engineering calculations and design development to the shipment of finished products.

Our production capabilities ensure the custom design of components, taking into account the specific requirements of cleanliness classes, operating conditions, and the geometric features of the premises. The implementation of both serial solutions and unique engineering developments based on the client's technical assignment is carried out using multi-level quality control: incoming inspection of materials, in-process control of production stages, and final inspection of finished products.

The qualification of production personnel is maintained through regular training and certification for working with GMP equipment, which guarantees compliance with technological requirements at all stages of manufacturing.

Types of Structures

  • Wall Panels: Sandwich structures filled with polyurethane foam (PUR), polyisocyanurate (PIR), or mineral wool, with external coatings of painted metal, HPL plastic, or stainless steel. These panels provide the airtightness and surface smoothness required to maintain the necessary cleanliness class.

  • Ceiling Systems: Airtight suspended and load-bearing structures integrated with ventilation and lighting systems. The ceilings are designed to accommodate HEPA filters and ensure uniform air distribution.

  • Cleanroom Doors: Manufactured in swing and sliding configurations with airtight seals; they can be equipped with glass inserts and automated control systems. The designs are adapted for integration with access control and interlock systems.

  • Profiles and Coving: Made of aluminum and steel alloys, ensuring an airtight fit for all joints and minimizing the number of areas difficult to clean.

  • Pass-through Hatches: Produced in mechanical and electronic versions with the option to integrate UV-disinfection and HEPA filtration to prevent cross-contamination between zones of different cleanliness classes.

  • Air Diffusers: Available in turbulent and laminar modifications with H14 class HEPA filters, providing the required airflow parameters and filtration efficiency.

  • Fan Filter Units (FFUs): Equipped with airflow velocity control systems and integrated into the overall HVAC system to maintain specified microclimate parameters.

  • Laminar Flow Zones: Create localized Grade A work areas with vertical or horizontal unidirectional airflow for performing critical technological operations.

  • Ceiling Lighting: Airtight LED modules for integration into suspended ceiling systems, providing uniform illumination without shadows or inaccessible areas.

  • Air Locks: For personnel and materials, equipped with automatic or mechanical interlocking systems to prevent simultaneous door opening and pressure differential breaches.

  • Flooring: Features antistatic, easy-to-clean coatings with seamless jointing to eliminate contamination buildup in connections.

Regulatory Requirements

Cleanroom structures are developed and manufactured in accordance with current international and national standards:

  • ISO 14644-1: The international standard governing the classification of air cleanliness by particle concentration.

  • ISO 14644-4: Specifies the general principles for the design, construction, and integration of cleanrooms.

  • GOST R 56640–2015: The Russian standard adapted to domestic practice, establishing requirements for cleanroom design and construction (fully compatible with ISO 14644-4).

  • GMP Annex 1 (2022): The current EU regulation governing sterile manufacturing, including clean zone layout and filtration systems.

  • SanPiN 1.2.3685–21: Hygienic standards for environmental factors in workspaces, including microbiological safety parameters.

All materials used in the structures are resistant to disinfectants and UV radiation, ensuring the airtightness and smoothness of surfaces necessary for controlled environment operation.

Industrial Reliability and Import Substitution

The structures are designed and manufactured within the Russian Federation using domestic materials and components, complying with import substitution policies and ensuring independence from foreign supplies. The manufactured equipment is applicable for pharmaceutical enterprises, analytical laboratories, medical equipment plants, and research centers requiring microbiological cleanliness standards.