How are Cleanrooms Classified?

What is a Cleanroom?

A Cleanroom is a highly regulated facility used in specialised industries such as manufacturing of pharmaceuticals and scientific research, designed to control airborne particles and subsequently reduce the risk of contamination.

Why are Cleanroom’s Classified?

Due to the sensitive nature of materials processed in a Cleanroom, classification is required to determine the level of risk to the external environment. By measuring the concentration of airborne particles, an engineer can conduce the class a Cleanroom should be placed in and what ISO 14644:2015/CGMP guidelines it must comply with as a result.

Cleanrooms are classified based on the concentration of air particles from a range of 0.1μm to 5μm in accordance with ISO 14644-1 standards. Cleanrooms can be placed in any of the 9 ISO groups. The lower the class of the Cleanroom, the more risk of contamination from sensitive airborne particles.

The table below displays the maximum particles/ m3 each ISO class can contain.

Class maximum particles/ m3
>=0.1 µm >=0.2 µm >=0.3 µm >=0.5 µm >=1 µm >=5 µm
ISO 1 10 2
ISO 2 100 24 10 4
ISO 3 1,000 237 102 35 8
ISO 4 10,000 2,370 1,020 352 83
ISO 5 100,000 23,700 10,200 3,520 832 29
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293
ISO 7 352,000 83,200 2,930
ISO 8 3,520,000 832,000 29,300
ISO 9 35,200,000 8,320,000 293,000

Fully Independent Cleanroom Specialists

Crowthorne Group are an unbiased solution for Cleanroom services including classification and validation. Our services adhere to ISO 14644:2015, Medicines and Healthcare Products Regulatory Agency (MHRA) and Food and Drug Administration (FDA), and our experienced engineers are Certification Board (CTCB-I) qualified. Speak to one of our Cleanroom specialists to book our classification service today.

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