Cleanrooms are a man-made and controlled environment where the concentration of airborne particulates and other contaminating elements is made very low. Therefore, the concentration of particulates varies from one ISO Cleanrooms to another, depending on their use. Although, these actively cleansed engineered spaces are commonly used for scientific research, biotechnology, pharmaceuticals industries. And also for the making of different medical devices.
The personnel entering the cleanroom have expertise in contamination control. They are specifically instructed to enter or exit through airlocks and air showers. The rules before their entry differ from one cleanroom to another. Some may require specifically designed boots, coats, gloves, face masks, and even the beard cover, whereas, in others, the work can be done only using some of them like lab coats and boots.
Special clothing is designed for cleanrooms personnel to trap the contaminants that are naturally generated by the skin and the body. Extensive training and special clothing are required to prevent the contaminants that may get released due to a bit of carelessness.
How do we classify ISO Cleanrooms?
The quantity and size of particles allowed per cubic of air are used to classify ISO Cleanrooms.
To put it another way, categorization is based on how pure the air is. Before 2001, clean room classification was based on US General Services Administration criteria. Federal Standard 209E is another name for it (FS 209E). According to this international standard, the number of particles equal to or higher than 0.5 micrometers in one cubic foot of air is measured. In this way, they are classified into six classes: class 100000, class 10000, class 1000, class 100, class 10, and class 1. The “cleanest” class is called class 1, and the “dirtiest” class is termed class 100000.
In November 2001, the FS 209E classification was replaced by the new classification standards set by International Standard Organisation (ISO). It is commonly termed ISO 14644-1. ISO classification system includes nine Cleanrooms classes. These range from ISO 1 to ISO 9.
According to this classification, the “cleanest” clean room falls in class 1, and the “dirtiest” class falls in class 9. Going by this standard, most Cleanrooms are classified as ISO 7 and ISO 8.
The equivalent for different ISO classes can be found in the FS 209E. For example, the FS 209E equivalent for the ISO 7 and 8 are Class 10000 and 100000, respectively.
Why is this classification necessary?
ISO Cleanrooms are classified into different classes according to the above-discussed international standards. These classifications become important depending on their intended applications. On the other hand, it cannot be made in ISO 8 Cleanrooms as the required reactions or processes will not take place in this environment.
Why is ISO certification required?
If you want to start a business in the pharmaceutical industry or something similar, it is vital to get ISO Cleanrooms installed. Since Cleanrooms stop microbes and other particles from entering the environment, it is crucial to install these rooms, especially in the places where a lot of virus research takes place. On the other hand, a cleanroom ensures that nothing escapes the room as well. It ensures complete protection from foreign particles as well as keeps the space safe at the same time. This comes in handy when it comes to handling nuclear work or even in virology.
Conclusion
ISO Cleanrooms are classified according to FS 209E and ISO 14644-1 international standard into six and nine classes, respectively. To ensure the safety of the environment, it is vital to install these rooms. To know more about these clean rooms, contact an expert today.