What is a cleanroom? Norm ISO 14644.
In construction sites or scientific research, a clean room (or cleanroom) is a low level of contamination environment (dust, microbes, particles, and aerosol or chemical fumes).
Specifically, a cleanroom is a space designed to control the contamination levels to a specific amount per cubic meter.
What is a cleanroom?
A cleanroom is an area built specifically to reduce the contamination particles in the air. In addition, we control parameters such as humidity, pressure, or the temperature.
The cleanroom will be classified according to the particle size required by the industry and will follow specific regulations accordingly. Therefore, cleanrooms are classified according to the cleanliness level.
However, contamination control is not only carried out in the cleanroom where the work is done. To avoid the entrance of particles in the controlled areas, it is necessary to follow a strict protocol of cleanliness and separation between cleanrooms and contaminating areas.
At STE Engipharm, we believe that a good design is essential, so we offer customized solutions for your cleanroom environments to adapt to your plant or project’s needs.
At STE Group, we have developed SICH products for cleanroom areas. Our SICH Clean Rooms modular system is self-supporting and totally self-contained. We use high-quality materials which have excellent thermo-acoustic properties. They are easily assembled and cleaned, and do not release particles. A cleanroom is an area built specifically to reduce the contamination particles in the air. In addition, we control parameters such as humidity, pressure, or the temperature. The cleanroom will be classified according to the particle size required by the industry and will follow specific regulations accordingly. Therefore, cleanrooms are classified according to the cleanliness level.4
Practically, all the sectors whose production process or development could be affected negatively by the existence of small particles in the environment will require a customized cleanroom. In other words, cleanrooms are specifically designed for the industries which focus on an extreme hygiene and foresee environmental conditions.
The use of cleanrooms in the pharmaceutical industry, biotech or labs is commonly acknowledged. The aim is to assure an environment free from bacteria, virus, or other pathogens. However, there are a lot of sectors which need controlled spaces, such as the food sector, to produce electronic components.
Types of ISO cleanrooms according to regulations
Cleanrooms are classified according to the air cleanliness; in other words, depending on the amount and size of particles per cubic meter. The International Organization of Standardization (ISO) is the organism that establishes the regulations in this matter. Thus, the regulation for cleanrooms is ISO 14644.
According to this classification, ISO class 1 would be the “cleanest” and ISO class 9, the “dirtiest”.
At STE Engipharm, we help you carry out the layout and construction of pharmaceutical production plants and cleanroom areas. Our team of experts work according to the GMP/FDA regulations and carry out all the previous analysis to successfully execute each project.
Our technical team is at your disposal to solve any issue. If you have any cleanroom project in mind and need consultancy, do not hesitate to contact us.