Questions and Answers

What are cleanrooms?

A cleanroom is a specially designed room in which the concentration of airborne particles is controlled. It is constructed and operated in a manner to minimize the introduction, generation, and retention of particles inside the room. A particle is defined as a microscopic object of solid, liquid, or other structure, or microorganisms, with sizes ranging from 0.005 to 100 micrometers. If necessary, cleanrooms can also control and monitor temperature, humidity, pressure differentials with adjacent rooms of different cleanliness classes, and other parameters. The correct organization of airflows is the fundamental factor ensuring the proper operation of a cleanroom.

There are two fundamentally different types of airflow organization:

• Unidirectional airflow, or laminar flow;

• Non-unidirectional airflow, or turbulent flow. High-cleanliness class rooms require unidirectional airflow. Modern requirements for cleanrooms involve laminar movement of air masses, where no turbulence occurs. Under these conditions, all particles generated by personnel and equipment surfaces do not disperse into the atmosphere but are kept near the floor and removed from the room by the airflow. Cleanrooms are used in high-tech industries: pharmaceuticals, medicine, microelectronics, research laboratories, and more.

What is the GMP standard?

The international GMP (Good Manufacturing Practice for Medicinal Products) standard is considered one of the world's primary standards defining requirements for the production of pharmaceutical, biopharmaceutical, and veterinary drugs, medical devices, diagnostic products, dietary supplements, and food products. Compliance with the GMP standard guarantees a high level of product quality. Cleanrooms with appropriate certification are used for production in accordance with GMP. In the Russian Federation, the equivalent of GMP is the state standard GOST R 52249-2009 "Rules for the Production and Quality Control of Medicines."

What is GLP?

Good Laboratory Practice (GLP) is an international system of requirements for obtaining laboratory test results and for the laboratories where these results are produced. Compliance with these requirements ensures the reliability of the results and the ability to compare them with global standards. This approach to obtaining reliable research data is recognized in many countries. The GLP system has been in place for over 20 years, and since March 1, 2010, it has been an approved national standard in the Russian Federation — GOST 33044-2014 "Interstate Standard: Principles of Good Laboratory Practice."

What is BIM modeling?

BIM (Building Information Modeling) involves creating an information model that integrates architectural, planning, structural, and engineering solutions, reflecting all technical and economic indicators. Practical experience using BIM identifies several main stages in project implementation: planning, design, construction, operation, and reconstruction of the facility. All these stages undergo digital modeling, cost estimation, economic benefit evaluation, and risk assessment.

What are the requirements for cleanroom materials and equipment?

Structures, components, and materials for cleanrooms must meet the following requirements:

• Correspond to the cleanroom class and its specific requirements;

• Ensure surface smoothness and absence of roughness;

• Be wear-resistant and able to withstand mechanical loads related to processes in the room;

• Be resistant to detergents and disinfectants;

• Be resistant to corrosion and chemicals;

• Not provide conditions for the growth of microorganisms;

• Possess electrostatic and conductive properties;

• Not emit harmful substances;

• Comply with fire safety requirements based on the room category. Requirements for cleanroom materials are detailed in GOST R ISO 14644-4-2002 "Cleanrooms and associated controlled environments. Part 4: Design, construction, and start-up. Annex E: Construction and materials."

What are modular cleanrooms?

Modular cleanrooms are one of the most popular types of such equipment worldwide. The principle of a modular cleanroom is that manufacturers design and fabricate modular enclosure elements with various integrated engineering systems—ventilation, electrical, medical gas supply, and others. Building modular systems allows for zoning a facility into local areas with different cleanliness classes without erecting separate cleanrooms, significantly reducing equipment costs. An expanded modular component base allows for the integration of any medical and engineering equipment into the structure.

What are the advantages of modular cleanrooms produced by INEX?

• Individuality: Modular cleanrooms are created in strict accordance with the tasks, standards, and individual wishes of the clients;

• Speed: The modular nature of the structures allows for the manufacture and commissioning of the required systems in a very short time;

• Cost: Modular cleanrooms are significantly cheaper to manufacture and assemble than standard cleanrooms;

• Transformability: Modular cleanrooms can be modified in design, expanded, or supplemented with new types of equipment as the client's business needs develop;

• Mobility: Modular cleanrooms can be moved and reinstalled in a new location.

What is an automation and dispatch system (SCADA)?

Cleanrooms designed and manufactured by INEX are equipped with a modern SCADA (Supervisory Control And Data Acquisition) software package—a universal system integrator. It serves to automate, supervise, and provide real-time data collection, processing, display, and archiving of information regarding cleanroom operations. SCADA systems are well-known today in industry, thermal power engineering, and the management of municipal engineering networks.

What is cleanroom validation?

Validation (Qualification) is the final and critically important stage in cleanroom construction, aimed at confirming that the cleanrooms comply with specified requirements and state/international standards. During and after installation, an agreed-upon set of cleanroom tests must be performed and documented. These tests must be completed before the cleanroom is put into operation. Cleanroom testing is a mandatory part of the qualification procedure for built and commissioned cleanrooms. There are three types of cleanroom qualification:

1. As-built Qualification: To ensure every cleanroom element meets the design requirements through commissioning, inspections, and testing.

2. At-rest Qualification: A set of checks and tests to ensure the equipped room meets accepted cleanroom standards.

3. In-operation Qualification: Monitoring the installation quality of all structures and all operational parameters during actual use. The qualification of the specialists performing these procedures and the availability of specialized technical equipment are of paramount importance. At INEX, cleanroom validation is conducted by top-tier engineers with years of experience not only in testing but also in fine-tuning cleanroom parameters to meet required standards. As a result, the client receives a high guarantee that the cleanroom is fully ready for operation, with all characteristics verified and documented.