Did you know that a person walking in a cleanroom at a rate of 2 mph (not exactly a brisk pace) can produce 5 million particles 0.3 microns or larger per minute? Even just standing motionless produces 100,000 particles/minute. And every one of those particles is a potential source of contamination. Cleanrooms are used in many industries where sterile, contaminant-free environments are required. This includes the usual suspects -- e.g., pharmaceutical manufacturing, biotech, semiconductors, electronics -- as well as other industries, like food processing. Let’s look at current cleanroom standards and how proper housekeeping and appropriate vacuum filtration can help you meet them.
To put these numbers in perspective, if you live in a typical city, the air outside corresponds roughly to ISO 9. Medical device packaging areas typically use ISO 7, and operating rooms must be clean to ISO 5 or better. ISO 5 is also the level mandated by the FDA’s cGMP for sterile drug products produced by aseptic processing. As you can imagine, ISO 1 facilities are rare. This one in South Carolina was built for manufacturing...wait for it...cleanroom cleaning products.
ISO 14644-1: Classification of air cleanliness
ISO 14644-1 is the most commonly used standard for cleanroom airborne particulate cleanliness. There are nine ISO classifications, based on the number of particles of different sizes allowed per cubic meter of air.ISO Class | Maximum # of particles per m3 | |||||
| 0.1 microns | 0.2 microns | 0.3 microns | 0.5 microns | 1 micron | 5 microns | |
| ISO 1 | 10 | 2 | ||||
| ISO 2 | 100 | 24 | 10 | 4 | ||
| ISO 3 | 1,000 | 237 | 102 | 35 | 8 | |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
| ISO 7 | 352,000 | 83,200 | 2,930 | |||
| ISO 8 | 3,520,000 | 832,000 | 29,300 | |||
| ISO 9 | 35,200,000 | 8,320,000 | 293,000 | |||
