Cleanliness Levels And Requirements for Different Cleanrooms

The standards for Cleanroom cleanliness operate on a scale determined by the needs of specific industrial or research activities. Different levels of cleaning quality measure air suspension particle count where lower numbers relate to better cleanliness standards. The standards set by ISO 14644-1 and Chinese GMP specify complete guidelines regarding Cleanroom cleanliness levels. The classification of cleanroom environments consists of seven stages known as ISO 1 to ISO 9 whereas ISO 1 represents the highest level of cleanliness and ISO 9 represents the lowest.

Semiconductor manufacturing demands the highest level of cleanliness because even microscopic dust particles can harm microcircuits thus diminishing product quality which is why operators adhere to ISO 3 or higher standards.

In the biomedical field organizations maintain high cleanliness standards at minimum ISO 5 in order to stop microorganisms and other pollutants from affecting pharmaceutical compounds and testing items.

The aerospace industry together with aviation needs to maintain minimum cleanliness standards at ISO 5 together with higher levels to guarantee reliable performance of important components.

Food and beverage manufacturing pathogen control requirements remain low yet the sector demands strict ISO 8 or higher classification for reducing all possible contaminants.

The correspondence between the different cleanliness standards is roughly as follows:

ISO 3 corresponds to class 1

ISO4 corresponds to class 10

ISO5 corresponds to class 100

ISO6 corresponds to class 1000

ISO7 corresponds to class 10000

ISO8 corresponds to class 100000

Grade A corresponds to ISO4 or higher

Class B corresponds to ISO5 or higher

Class C corresponds to ISO7 or higher

Class D corresponds to ISO8 or higher

Different Clean Room grades not only affect the production cost, but also directly relate to the quality and safety of the products, so each industry needs to consider the actual needs and economic benefits when choosing the cleanliness grade.

In addition, the design and operation of the Cleanroom also need to consider the temperature, humidity, pressure and other factors to ensure the stability and suitability of the environment. Through rational design and management, Cleanrooms can effectively control airborne contaminants and provide an environment suitable for specific production or research.