Cleanroom Requirements, Certification And Monitoring Per Common Accepted Standards

By Sean Birch, Applications Engineer, Lighthouse Worldwide Solutions

Cleanroom Classification and class limits are established in ISO 14644-1 , while specifications for testing and monitoring to prove continued compliance are established in ISO 14644-2.Often there is confusion regarding the definitions of certification and monitoring. This article explains the differences between monitoring and certification.

A cleanroom is a modular environment where airborne contaminants, temperature, relative humidity, differential pressure, static electricity and other factors are under strict control. There are several levels of cleanliness, called classes, that can be applied to a cleanroom. When a cleanroom is certified to a specific class, the room performs to standards that meet or exceed the performance of that class under a specific occupancy status. Certification is the general means of checking the room for various parameters to guarantee that it is built to a specific set of requirements. The room is also periodically re-tested to those same parameters to ensure that nothing has changed.

1. Ensure that the cleanroom parameters have not altered in any way. Everything in the construction and supporting equipment is 100% operational and is at the same performance level as it was when the room was certified.
2. Ensure that the process in the room is in control at all times.
3. Ensure that the cleanroom staff follows accepted procedures at all times.