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Cleanroom Classification

Dec 29,2023 | Blog

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Cleanrooms are classified according to the cleanliness of their internal air. Cleanroom rating is the cleanliness of a room according to the number and size of particles per unit of air.The main organization in the United States and Canada is the ISO classification system, ISO 14644-1.

The standard includes cleanroom grades ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, where ISO 1 is the "cleanest" grade and ISO 9 is the "dirtiest" grade (but still cleaner than normal rooms).The most common categories are ISO 7 and ISO8.Old federal standard 209 (class 100,000;10000;1000;100;10;1) was withdrawn in 2001 and officially replaced by iso-14644-1 in 1999, but to this day, clean rooms must meet industry-specific and regional standards.For example, EU GGMP (a-b-c-d) is for medicines, while USP (795, 797, and 800) is for compound pharmacies.


Cleanroom standards are based on microns, or m, the size of the particles to be filtered.As mentioned earlier, clean rooms are classified according to the amount and size of particles per unit of air.

The clean room classification table below shows the maximum concentration limit (particle/m3 air) for particles of the size shown.Certain categories do not need to be tested for specific particle sizes because the respective concentrations are too low or too high, but should not be zero.


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