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This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room.
The cleanroom classification standards FS 209E and ISO 14644-1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. In the UK, British Standard 5295 is used to classify cleanrooms.
Cleanrooms have specific ISO class code descriptions that provide secure environments through controlled air filtration and protective guidelines. That reduces the possibility of large particulates interfering with critical process manufacturing or the possibility of product contamination.
The ISO cleanroom classes are identified by the numbers 1-9. An ISO 1 cleanroom is considered to be the cleanest possible room, while an ISO 9 cleanroom corresponds to almost normal room air. So if you want to achieve the cleanest of all cleanrooms, you need an ISO 1 classification.
The International Standards Organization (ISO) has established a classification system specifically for cleanroom environments. The ISO 14644-1 cleanroom standards are composed of nine classifications for cleanrooms based on the maximum number and size of particulates that exist per cubic meter.
Cleanrooms and associated controlled environments are classified for air cleanliness by particle concentration ( ISO 14644-1 ). Cleanliness attributes relating to chemicals, nanoscale particles and viable particles (microorganisms), as well as cleanliness of surfaces, can also be considered.
The main classification standards for cleanrooms are ISO14644-1:2015, US FED STD 209E and GMP Annex European Community Cleanroom Standards. The level of contamination in each standard is based on the number of particles in a defined particle size range that is allowed in the air.
