ISO Cleanroom Requirements & Classifications
ISO classifications are based on international standards that regulate acceptable cleanliness standards in a cleanroom. International Organization for Standardization ISO 14644-1 provides guidance for acceptable air quality levels within the specific clean room ISO classes. A cleanroom’s class is determined by the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air.
What is an ISO Cleanroom?
A cleanroom is a specially engineered enclosed area within a manufacturing or research facility. These rooms allow for precise control, monitoring, and maintenance of an internal environment. ISO classifications are specifically designed to regulate:- Temperature
- Humidity
- Airflow
- Filtration
- Pressure
Clean Air Products is Your Source for Cleanroom ISO Classification Information
At Clean Air Products, we manufacture softwall cleanrooms and hardwall cleanrooms that comply with various ISO classifications, fs209e, and ISO cleanroom standards. From Class 4 cleanrooms that maintain meticulous cleaning standards to less strict Class 7 cleanrooms, Clean Air Products manufactures cleanrooms that will meet your application’s specifications.Contact us for more information regarding clean room ISO classes, standards, and the advantages of each type of ISO class of clean room. Or call us at 888-985-7307, and we will be happy to discuss your cleanroom needs and answer any questions.
Table 1 – Maximum number of particles in air by ISO class of cleanroom
Cleanroom Industry Requirements & Classifications
Cleanroom requirements are classified according to the number and size of particles permitted per volume of air in a specific amount of time. Our engineers can provide guidelines and ISO class code descriptions for the class of cleanroom required for your specific application. The government requires many industrial businesses to maintain specific cleanroom standards. For example, government regulation USP 797 outlines the requirements for pharmaceutical product manufacturing.Cleanroom industry requirements are classified according to ISO 14644-1 cleanroom standards, which specify basic requirements for cleanroom operations. Federal Standard 209E is still also used (see Table 1).
ISO cleanroom classifications are rated according to how much of a particulate of a specific size exists per cubic meter within a given enclosure (see second chart). Cleanroom classifications are based on an eight-class rating system, with an ISO class 1 cleanroom being rated the most particle-free and ISO class 8 allowing the most particles. Most cleanrooms fall into the class 6,7 or 8 categories.
