Saturday, 9 March 2013

Cleanroom Validation

David Muchemu has authored an article of interest for Controlled Environments. The article concerns the essential requirements for validating a cleanroom and certifying it to a particular class before it is used for process operations.

The introduction reads:

“A cleanroom is a modular environment in which the following environmental factors are kept under control; temperature, airborne particulates, microbes, relative humidity, differential pressure, and air flow.

Cleanroom Validation is performed for a variety of reasons. To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS); to ensure that the facility, equipment, and environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards.

Cleanrooms are validated and then certified to a chosen class of ISO 14644-1. Each class of ISO14544-1 has its unique requirements that must be made for a facility to be classified in the specified classification.”

The article is free to view on line at Controlled Environments

Posted by Tim Sandle