Buy online at Cleanroomshop.com

General Cleanroom Information

What is a cleanroom?

The most accurate way of answering this question is by quoting the ISO standard definition of a cleanroom. This is the standard which all cleanrooms must conform to and the following explanation gives the defining parameters of a cleanroom -

A cleanroom is a "room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room".

Ref: BS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration

Cleanroom Classification Table

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 GMP - - A/B - C D
Air changes / hour 360-540 300-540 240-480 150-240 60-90 5-48

ISO Classes of air cleanliness by particle concentration

For cleanrooms and clean zones shown in ISO 14644-1:2015 
ISO Classification Number Maximum allowable concentrations (particles/m3) for particles equal to and greater than the considered sizes, shown below
≥0.1µm ≥0.2µm ≥0.3µm ≥0.5µm ≥1µm ≥5.0µm
ISO Class 1 10b d d d d e
ISO Class 2 100 24b 10b d d e
ISO Class 3 1,000 237 102 35b d e
ISO Class 4 10,000 2,370 1,020 352 83b e
ISO Class 5 100,000 23,700 10,200 3,520 832 d,e,f
ISO Class 6 1,000,000 237,000 102,000 35,200 8,320 293
ISO Class 7 c c c 352,000 83,200 2,930
ISO Class 8 c c c 3,520,000 832,000 29,300
ISO Class 9g c c c 35,200,000 8,320,000 293,000

Cleanroom Limits for Airborne Particulate Contamination

Clean room and clean air device classification, in relation to GMP (2008). 
Cleanroom Standard Maximum permitted number of particles /m³
EU GMP Grade ISO EN 14644-1 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

Find about more about our cleanrooms.

Contact us»