HR

CLEAN ROOMS

A cleanroom or clean room is an environment, typically used in manufacturing or scientific research, with a low level of environmental pollutants such as dust, aerosol particles, and chemical vapors. A cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. The ambient air outside in a typical urban environment contains 35,000,000 particles per cubic meter in the size range 0.5 μm and larger in diameter, corresponding to an ISO 9 cleanroom, while an ISO 1 cleanroom allows no particles in that size range and only 12 particles per cubic meter of 0.3 μm and smaller. In the pharmaceutical industry, clean rooms play a crucial role in the manufacturing of pharmaceutical products which are required to be free from microbial and particulate contamination and protected from moisture. Such pharmaceutical products are manufactured and manipulated in cleanrooms, which are fitted with HEPA and, if required, ULPA filters as well as dehumidifier systems.

Cleanrooms are classified according to the number and size of particles permitted per volume of air.

ISO 14644-1 cleanroom standards:

GMP EU classification

Class Maximum particles per cubic meter FED STD 209E equivalent
≥ 0.1 µm ≥ 0.2 µm ≥ 0.3 µm ≥ 0.5 µm ≥ 1.0 µm ≥ 5.0 µm
ISO 1 10 2.37 1.02 0.35 0.083 0.0029 -
ISO 2 100 23.7 10.2 3.5 0.83 0.029 -
ISO 3 1 000 237 102 35 8.3 0.29 class 1
ISO 4 10 000 2 370 1 020 352 83 2.9 class 10
ISO 5 100 000 23 700 10 200 3520 832 29 class 100
ISO 6 1.0 x 106 237 000 102 000 35 200 8 320 293 class 1 000
ISO 7 1.0 x 107 2.37 x 106 1 020 000 352 000 83 200 2 930 class 10 000
ISO 8 1.0 x 108 2.37 x 107 1.02 107 3 520 000 832 000 29 300 class 100 000
ISO 9 1.0 x 109 2.37 x 108 1.02 x 108 35 200 000 8 320 000 293 000 room air

EU GMP guidelines are more stringent than others, requiring cleanrooms to meet particle counts at operation (during manufacturing process) and at rest (when manufacturing process is not carried out, but room AHU is on):

Class Maximum particles per cubic meter
At rest At rest In Operation In Operation
0.5 µm 5 µm 0.5 µm 5 µm
grade A 3 520 20 3 520 20
grade B 3 520 29 35 200 2.93
grade C 352 000 2 930 3 500 000 29.30
grade D 3 520 000 29 300 not defined not defined

Besides, meny more references from our partner Imgrad can be found on their web adress.