Clean Room Validation

Clean Room Validation

Cleanrooms are validated to an essential class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO14644-1:

Methods for evaluation and measurements for Certification are specified in

Standards:

• US FED STD 209 E
• ISO 14644-1
• IEST- RP-CC-002-2
It calls out for the following tests.
1. Airborne particle count test

2. Airflow test

3. Air pressure differential test

4. Airflow direction test

5. Temperature test

6. Humidity test

Once certified to a particular class the Cleanroom factors are monitored to ensure that parameters have not drifted, or changed, and that the environment is under control. A cleanroom or clean room is an environment, typically used in manufacturing, including of pharmaceutical products or scientific research, as well as aerospace semiconductor engineering applications with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors.
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