The Classified Room or Clean room is a room with environmental control defined in terms of contamination by viable and non-viable particles, with humidity, temperature and pressure control designed and used in order to reduce the introduction, generation and retention of contaminants inside.
Both rooms, clean or classified, are isolated rooms, areas or environments, completely isolated from other facilities, within a system that is regulated by standards of types of and has interactive techniques according to the established process. One clean room, or classified, controls the amount of particles existing in the controlled environment.
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Know the main standards for Clean Rooms or Classified Rooms
As Clean Rooms are classified according to the Standards, according to the purity of their indoor air and the concentration of particles per unit volume of air.
For the classification of Clean Room, standards recommended by the International Standards Organization (ISO) and the US standards of General Administration Services (known as FS209E) were adopted, in addition to the European GMP and Anvisa Resolutions, National Health Surveillance Agency.
As the need for international standards increased, ISO created a technical committee and several working groups, including a Brazilian one, to devise its own set of standards.
The Clean Room classification contained in ISO 14644 is the most used classification worldwide today, and in this standard Clean Rooms are classified into 9 classes, according to the amount of particles of specific sizes there are per cubic meter. The American FS209E contains 6 classes, while the ISO 14644-1 classification system adds two standards, cleaner and dirtier.
How is the Classification of Clean Rooms or Classified Rooms
Clean Rooms Class 1 to Class 5
They work under the laminar air flow regime and have some main characteristics, such as:
- Full air replenishment every 6 seconds
- Air flows uniformly from the ceiling at a rate of 0,45 meters per second.
- There are filters all over the lining
- There are no drafts within the controlled environment
- There is a uniform air flow through the environment without cross scattering of particles
- The air is removed from the environment only by exhaustion through the floor
Clean Rooms Class 6 to Class 9
They work under turbulent airflow regime and their following most important characteristics are:
- Air flows from diffusers in the ceiling at a rate of 0,45 meters per second.
- There are drafts within the controlled environment
- Transverse dispersion of particles is allowed within the controlled environment
- Air is removed from the environment by exhaustion through the floor or ceiling.
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with the operation Turn Key, Asmontec coordinates the entire process to ensure the delivery and assembly of your Clean Room or Classified Room on time, with the expected quality and excellent service.
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