Cleanroom information

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What is a cleanroom?

A cleanroom is an environment with high cleanness and is designed to reduce or even eliminate contamination (pollution) of product, process or examination within that space. Contamination can consist of large and fine particles present in the air, as well as fibres, micro-organisms and chemical vapours. The degree of contamination in a cleanroom is specified on the basis of the amount of particles of a certain size per cubic metre.

All cleanrooms must meet an international standard ISO14644-1. A new version of this standard has recently been released: the ISO 14644-1:2015 (replacing the old 14644-1:1999). The definition of a cleanroom according to the current ISO standard:

“Cleanroom – Room in which the concentration of airborne particles is controlled and classified, and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the area.”

Ref. International standard ISO14644 first edition 2015.

Cleanroom Standard Cleanroom Classification Guidelines
ISO 14644-1 Class 3 Class 4 Class 5 Class 6 Class 7 Class 8
Federal Standard 209E 1 10 100 1.000 10.000 100.000
EU GGMP A/B C D
Air changes / hour 360-540 300-540 240-480 150-240 60-90 5-48

Selected Airborne Particulate Cleanliness Classes

For cleanrooms and clean zones shown in ISO 14644-1:2015

ISO Classification Number Maximum concentration limits (particles/m³ of air) for particles equal to and larger than the considered sizes shown below
≥0.1µm ≥0.2µm ≥0.3µm ≥0.5µm ≥1.0µm ≥5.0µm
ISO Class 1 10
ISO Class 2 100 24 10
ISO Class 3 1.000 237 102 35
ISO Class 4 10.000 2.370 1.020 352 83
ISO Class 5 100.000 23.700 10.200 3.520 832
ISO Class 6 1.000.000 237.000 102.000 35.200 8.320 293
ISO Class 7 352.000 83.200 2.930
ISO Class 8 3.520.000 832.000 29.300
ISO Class 9 35.200.000 8.320.000 293.000

Cleanroom Limits for Airborne Particulate Contamination

Relating to GGMP

Cleanroom Standard Maximum permitted number of particles /m³
EU GGMP Grade ISO14644-1:1999 At rest ≥0.5µm At rest ≥5.0µm In operation ≥0.5µm In operation ≥5.0µm
A 5 3.520 20 3.520 20
B 5 3.520 29 352.000 2.900
C 7 352.000 2.900 3.520.000 29.000
D 8 3.520.000 29.000 not defined not defined

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