Understanding Cleanroom Glove Classifications
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Cleanroom gloves look a lot like exam gloves.  They’re available in nitrile, latex or vinyl materials.  They’re thin, ambidextrous and disposable.  But they have something extra – an ISO number or Class number.  What does this mean?

To understand cleanroom gloves, we need to understand why they are needed.  A “cleanroom” is an environment with a controlled level of contamination – dust, microbes and aerosol particles – to prevent damage to a product during manufacturing.  Think microelectronics, semiconductors, and biotechnology, where a particle 200 times smaller than a human hair can lead to expensive failures and downtime.

Cleanroom contamination is measured by the number of particles by volume of air at a particular particle size.  The air you breath contains about 35 million particles sized 0.5 µm and larger per cubic meter.  The air in a cleanroom will have much less, making the environment “cleaner.”

The First Cleanroom Standards

US FED STD 209E set the first cleanroom standards.  Airborne contaminates were measured as maximum particles per cubic foot. So a “Class 100” environment meant there was an upper limit of 100 particles/ft3, size 5 µm or smaller.  A “Class 10” meant no more than 10 particles/ft3.

US FED STD 209E Cleanroom Standards
Class maximum particles/ft3 ISO
equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm
1 35 7.5 3 1 0.007 ISO 3
10 350 75 30 10 0.07 ISO 4
100 3,500 750 300 100 0.7 ISO 5
1,000 35,000 7,500 3000 1,000 7 ISO 6
10,000 350,000 75,000 30,000 10,000 70 ISO 7
100,000 3.5×106 750,000 300,000 100,000 700 ISO 8

The New Standard

In 1999, the US Department of Commerce introduced a new classification system called ISO 14644-1.  This document established the certification requirements for air cleanliness areas, and airborne particulates are measured as particles per cubic meter rather than cubic foot.  So a Class 100 became ISO 5, and a Class 10 became ISO 4. While this new standard officially replaced the old Federal Standard 209-e in 2001, both classification terms are still in use.

ISO 14644-1 Cleanroom Standards 
Class maximum particles/m3 FED STD 209E
equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥1 µm ≥5 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 3,520 832 29 Class 100
ISO 6 1.0×106 237,000 102,000 35,200 8,320 293 Class 1,000
ISO 7 1.0×107 2.37×106 1,020,000 352,000 83,200 2,930 Class 10,000
ISO 8 1.0×108 2.37×107 1.02×107 3,520,000 832,000 29,300 Class 100,000
ISO 9 1.0×109 2.37×108 1.02×108 35,200,000 8,320,000 293,000 Room air

Glove Classifications

While there are no published standards that designate gloves as “ISO 5,” for instance, glove manufacturers understand the importance of maintaining specified particulate levels in cleanrooms.  Gloves are carefully laundered, dried, tested and packaged to ensure a particle count that is compatible with the cleanroom environment where they will be used. So a glove listed as Clean Class 10 or ISO 4 is compatible with a Class 4 cleanroom and up.  A “Controlled Environment” or Clean Class 1000 glove is suitable for ISO 6 and up environments.

 

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