What is ISO 8, ISO 7, ISO 6, ISO 5 cleanroom?

  • 08, 12, 2020

Cleanrooms are classified by how clean the air inside them is. Cleanroom class is the level of cleanliness the room has, according to the number of particles found in the air. ISO 14644-1 standard system is used for cleanroom cleanliness assessment, including ISO1 - ISO9 with ISO1 being the cleanest and ISO9 being the dirtiest class. ISO5 - ISO8 is the common range cleanroom class. 

ISO 5 is a super clean cleanroom classification. A cleanroom must have less than 3,520 particles >0.5 micron per cubic meter and 250-300 HEPA filtered air changes per hour. The equivalent FED standard is class 100. Common applications are semiconductor manufacturing and pharmaceutical filling rooms. 

ISO 6 is a very clean cleanroom classification. A cleanroom must have less than 35,200 particles >0.5 micron per cubic meter and 180 HEPA filtered air changes per hour. The equivalent FED standard is class 1000. 

ISO 7 is a common clean cleanroom classification. A cleanroom must have less than 352,000 particles >0.5 micron per cubic meter and 60 HEPA filtered air changes per hour. The equivalent FED standard is class 10.000. Common applications are pharmacy USP800 compounding rooms, electronics manufacturing and medical device manufacturing. 

ISO 8 is the least clean cleanroom classification. A cleanroom must have less than 35,200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. The equivalent FED standard is class 100.000. Common applications include plastic extrusion for medical devices, e-liquid manufacturing, and nutraceutical packaging. 

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