A cleanroom is any room in which measures are taken to protect products, processes or applications from contamination. However, not every cleanroom is equally clean – this is where the cleanroom classifications come into play.
What is a cleanroom classification?
The classification of a cleanroom determines how many particles are allowed per cubic meter of air. The lower the particle concentration, the higher the cleanliness – and the lower the ISO class number.
An ISO class 5 cleanroom is therefore significantly cleaner than an ISO 7 cleanroom.
In the pharmaceutical industry, GMP cleanroom classes A to D are also used. They are based on the ISO standards, but also take into account limit values for microbiological contamination.
Cleanroom classification according to ISO 14644-1
The international standard ISO 14644-1 defines nine ISO cleanroom classes (ISO 1-9):
ISO 1 is the highest purity class with a maximum of 10 particles ≥ 0.1 µm per m³ of air.
ISO 5 meets the requirements of semiconductor production, for example (max. 100,000 particles ≥ 0.1 µm).
ISO 9 describes almost normal indoor air conditions.
Typical applications:
ISO 8: Automotive industry
ISO 7: Medical technology
ISO 6: Optical industry
ISO 5: Electronics and semiconductor manufacturing
However, the actual classification always depends on the individual process and product specifications.
GMP cleanroom classes A-D
The Good Manufacturing Practice (GMP) guidelines apply to pharmaceutical applications.
GMP A: highest purity (sterile production)
GMP B: Background for zone A
GMP C: less critical areas
GMP D: preparatory zones with higher particle counts
This classification also takes into account the number of microbiological germs such as bacteria and spores in the air.
Cleanroom class table - ISO & GMP in comparison
The Cleanroom classes table shows the permissible particle counts per ISO and GMP class. It is the basis for the qualification and validation of cleanrooms and is used for planning, acceptance and documentation.
Here you can download our current pdf of the cleanroom classes – ideal for technology, quality management and cleanroom planning.
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