What are clean rooms?

Cleanroom (Cleanroom) - a special specially designed and built room in which the presence of scattered microparticles in the air is minimized or completely excluded - microscopic objects of solid, liquid and other structures, or microorganisms, the size of which is within 0.005-100 micrometers. If necessary, in clean rooms, temperature conditions, humidity, pressure and other parameters can be set and controlled. Modern requirements for clean rooms imply the organization of a unidirectional, laminar movement of air masses, in which the effect of turbulence does not occur. If these conditions are met, all particles generated by humans and the surface of equipment do not scatter in the surrounding atmosphere, but are located near the floor and are removed from the room by means of an air stream. Clean rooms are in demand in high-tech areas - in pharmaceuticals, medicine, microelectronics, and a number of scientific research.

Where are they used?

Today clean rooms are an integral part of production and research complexes of various specializations, where increased requirements are imposed on the purity of air, water, and production environments. These are medicine, pharmaceuticals, microelectronics, production of optical and laser technology, food industry, perfumery and cosmetics, space industry, work in the field of precision mechanics, hydraulics, pneumatics, veterinary medicine, biotechnology.

What is GMP Standard?

The international GMP (Good Manufacturing Practice for Medicinal Products) standard is considered one of the main standards in the world that defines the requirements for the production of pharmaceutical, biopharmaceutical and veterinary drugs, medical devices, medical devices for diagnostics, dietary supplements and even food. It ensures a high level of product quality. For the production of products in the GMP standard, clean rooms with a corresponding certificate are used. In the Russian Federation, the analogue of GLP is the standard GOST R 53434-2009 "Principles of Good Laboratory Practice".

What is GLP?

Good Laboratory Practice (GLP) is an international system of requirements for obtaining laboratory test results and for laboratories in which these results are obtained. Compliance with these requirements ensures the reliability of the result and the ability to compare it with international standards. This approach to obtaining reliable research results is recognized in many countries. The GLP system has been in operation for over 20 years and since March 1, 2010 it has been an approved national standard of the Russian Federation - GOST 33044-2014.

What is BIM Modeling?

BIM modeling - Building information modeling - means the creation of an information model that combines architectural, planning, structural and engineering solutions, reflecting all technical and economic indicators. The practical experience of using BIM distinguishes several main stages in the implementation of the project - planning, design, construction, operation and reconstruction of the facility. All these stages undergo digital modeling, cost estimation, economic benefits and possible risks..

What are the requirements for materials and equipment for clean rooms?

Structures, materials and elements of premises with a controlled concentration of suspended particles must correspond to the class of the cleanroom and its purpose. Requirements for materials for "clean" rooms are set out in GOST R ISO 14644-4-2002 "Clean rooms and associated controlled environments. Part 4. Design, construction and commissioning. Appendix E Construction and materials". The required characteristics are the tightness of structures, the absence of emission of harmful substances, antistatic properties, coplanarity (evenness and smoothness) of surfaces, resistance to treatment with disinfectants and detergents.

What are modular cleanrooms?

Modular clean rooms are one of the most popular types of such equipment around the world. The principle of a modular cleanroom is that manufacturers design and manufacture modular elements of enclosing structures with integrated various engineering systems - ventilation, electrical, medical gas supply and others. The construction of modular systems allows you to zone the premises into local areas with different classes of cleanliness, without resorting to the construction of separate clean rooms, which significantly reduces the cost of equipping production. The extended modular element base makes it possible to integrate into the construct of any medical and engineering equipment.

What are the advantages of INEX modular clean rooms?

- individuality: modular clean rooms are created in strict accordance with the tasks, standards and individual wishes of customers;

- speed: the modular nature of the structures allows the manufacture and commissioning of the required structures in a very short time;

-cost: modular clean rooms are much cheaper to manufacture and assemble than standard clean rooms;

- transformability: modular clean rooms can be changed in design, expanded, supplemented with new types of equipment, depending on the development of the customer's business needs;

- mobility: modular clean rooms can be moved and reinstalled in a new location.

What is SCADA system?

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 for automation, dispatch control and real-time operation of systems for collecting, processing, displaying and archiving information about the operation of the cleanroom. Today SCADA systems are well known in industry, heat power engineering, management of utility networks of cities and territories.

What is cleanroom validation?

Certification (validation) is the final and extremely important stage in the construction of clean rooms, the purpose of which is to confirm the compliance of clean rooms with specified requirements and state and international standards. The certification procedure includes quality control of installation of all cleanroom structures and all parameters of its functioning. In the certification procedure, the qualifications of specialists who carry out all the necessary procedures and the availability of special technical equipment are of paramount importance. At INEX, the certification of cleanrooms is carried out by highly qualified engineers who have many years of experience not only in conducting validation tests, but also in setting the parameters of the cleanroom to the required level. As a result, the customer receives a high guarantee that the cleanroom is completely ready for use and all its characteristics have been verified and documented.