A cleanroom is a controlled environment that has a low level of pollutants such as dust or chemical vapors. Cleanrooms are typically used in manufacturing or scientific research labs, such as a radiochemistry laboratory, where an ISO Class 7 cleanroom is required. The cleanroom classification standard ISO 14644-1 requires specific particle counts, such as ISO 7, to be met to classify the cleanliness level of a cleanroom or area.
What Is A Cleanroom Classification?
Cleanrooms are classified based on the level of clean air in the room. This is measured according to the quantity and size of the air particles per volume of air. The ISO 14644-1 classification system classifies cleanrooms on a scale of ISO 1 through ISO 9, with one being the cleanest and nine being the dirtiest. ISO 7 is one of the most common cleanroom cases.
The Importance of ISO Class 7 Cleanrooms
ISO Class 7 cleanrooms are utilized to minimize airborne pollutants from contacting critical sites, especially in the medical field. There are critical maintenance elements to consider with an ISO 7 room. Without following the ISO 7 cleanroom guidelines, pharmaceutical or manufactured products can become contaminated by outside pollutants, reducing the product’s efficiency or ability to be used by consumers. Having a clean environment is imperative to creating safe products.
ISO Class 7 Cleanroom Considerations
When looking to achieve a class 7 cleanroom, there are a few things to keep in mind. For example, hardwall and softwall cleanrooms can both be used to achieve an ISO 7 environment. ISO 7 cleanrooms should also have a changing atrium for laboratory workers to change into cleanroom attire to reduce the risk of contaminants from entering the cleanroom. The inside surface of the cleanroom should also be considered for proper cleaning. For example, stainless steel is a recommended material to use for disinfecting pharmaceutical cleanrooms.
The importance of an ISO Class 7 cleanroom is to minimize the risk of pollutants that can contaminate and alter manufacturing or pharmaceutical results. Without following ISO standards, the production of safe and sterile products would be difficult to control.