A cleanroom is a controlled environment where products are manufactured. It is a room in which the concentration of airborne particles is controlled to specified limits.
Eliminating sub-micron airborne contamination is really a process of control. These contaminants are generated by people, process, facilities and equipment. They must be continually removed from the air. The level to which these particles need to be removed depends upon the standards required. The most frequently used standard is the Federal Standard 209E. The 209E is a document that establishes standard classes of air cleanliness for airborne particulate levels in cleanrooms and clean zones. Strict rules and procedures are followed to prevent contamination of the product.
The only way to control contamination is to control the total environment. Air flow
rates and direction, pressurization, temperature, humidity and specialized filtration all need
to be tightly controlled. And the sources of these particles need to controlled or eliminated
whenever possible. There is more to a clean room than air filters. Cleanrooms are planned
and manufactured using strict protocol and methods. They are frequently found in
electronics, pharmaceutical, biopharmaceutical, medical device industries and other critical
It only takes a quick monitor of the air in a cleanroom compared to a typical office
building to see the difference. Typical office building air contains from 500,000 to 1,000,000
particles (0.5 microns or larger) per cubic foot of air. A Class 100 cleanroom is designed to
never allow more than 100 particles (0.5 microns or larger) per cubic foot of air. Class 1000
and Class 10,000 cleanrooms are designed to limit particles to 1000 and 10,000
A human hair is about 75-100 microns in diameter. A particle 200 times smaller (0.5 micron) than the human hair can cause major disaster in a cleanroom. Contamination can lead to expensive downtime and increased production costs. In fact, the billion dollar NASA Hubble Space Telescope was damaged and did not perform as designed because of a particle smaller than 0.5 microns.
Once a cleanroom is built it must be maintained and cleaned to the same high standards. This handbook has been prepared to give professional cleaning staff information about how to clean the cleanroom.
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