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What Is Clean Room?

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.

Also See

ISO 14644-1 Clean room standards

BS 5295 clean room standards

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 manufacturing environments.

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 respectively. 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.

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 and What Is Contimination?

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What Is Contamination?

Source Of Contaamination.

Key Elements Of Contamination Control.

Cleaning Process For Cleanrooms.

General Cleanroom Regulations.