ISO room classifications are used to categorize cleanrooms and other controlled environments based on their level of cleanliness. These classifications are defined by the International Organization for Standardization (ISO) and are widely used in a variety of industries. The ISO defines standards for the maximum allowable particle counts and microbial concentrations in the air, as well as other factors such as temperature, humidity, and airflow. The classification system includes six classes, ranging from Class 1 (the cleanest) to Class 9 (the least clean), with each class having specific requirements and guidelines for maintaining a clean environment.
ISO Class 1: The cleanest classification, with a particle count of no more than 10 particles per cubic meter of air that are 0.1 microns or larger in size. This class is typically used in microelectronics and semiconductor manufacturing.
ISO Class 2: Requires a maximum particle count of no more than 100 particles per cubic meter of air that are 0.1 microns or larger in size. This class is also used in microelectronics and semiconductor manufacturing.
ISO Class 3: Allows for a maximum of 1,000 particles per cubic meter of air that are 0.1 microns or larger in size. This class is used in advanced electronic and semiconductor manufacturing, as well as some pharmaceutical applications.
ISO Class 4: Maximum particle count of 10,000 particles per cubic meter of air that are 0.1 microns or larger in size. This class is commonly used in pharmaceutical manufacturing, as well as in some biotech and electronics applications.
ISO Class 5: Allows for a maximum particle count of 100,000 particles per cubic meter of air that are 0.1 microns or larger in size. This class is used in many pharmaceutical and medical device manufacturing applications.
ISO Class 6: Maximum particle count of 1,000,000 particles per cubic meter of air that are 0.1 microns or larger in size. This class is used in some pharmaceutical and medical device manufacturing, as well as in food processing and other industries where lower levels of cleanliness are required.
ISO Class 7: Allows for a maximum particle count of 352,000 particles per cubic meter of air that are 0.5 microns or larger in size. This class is commonly used in some pharmaceutical manufacturing processes and research laboratories.
ISO Class 8: Maximum particle count of 3,520,000 particles per cubic meter of air that are 0.5 microns or larger in size. This class is commonly used in some industrial manufacturing processes, such as metalworking and plastics.
ISO Class 9: Allows for a maximum particle count of 35,200,000 particles per cubic meter of air that are 0.5 microns or larger in size. This class is used in applications where levels of cleanliness are less critical, such as warehouses or storage areas.
It's important to note that different industries may have specific requirements for their cleanrooms beyond the ISO classifications, depending on the products being manufactured or the materials being used. Additionally, other factors such as temperature, humidity, and airflow must also be controlled to prevent microbial growth and maintain product quality. Overall, the ISO classification system is an important tool for ensuring that cleanroom environments meet necessary standards and produce high-quality products.
ISO Clean Room Classifications