Charity

Phase Three: Operation Qualification
The objective for this Operational Qualification (OQ) phase is to show through objective evidence that the cleanroom operates in conformance with design requirements and user defined requirements, and that it consistently operates within a defined range of conditions.

Phase Four: Performance Qualification
The purpose of Performance Qualification (PQ) of the cleanroom is to demonstrate with objective evidence that the cleanroom consistently operates within defined parameters to produce the defined, desired environmental outcome. Cleanroom performance qualification involves testing and monitoring of the following:

Phase Five: Monitor & Control
A constant monitoring program is required after certification. 

Specifying lighting systems for cleanroom facilities requires considerations beyond energy and maintenance savings. While lighting for cleanrooms should be energy efficient and provide proper illumination for the task at hand, it is crucial that lighting coordinates with air-supply systems and minimizes any chances for contamination.

Contamination control is the primary design goal of any cleanroom. Any potential source of contamination into the cleanroom must be thoroughly evaluated and minimized. Lighting fixtures should be subjected to contamination evaluation. Unfortunately, there are no established standards to prequalify fixtures for a particular cleanroom class. The National Sanitary Foundation (NSF) does provide listing and testing of materials used in food, pharmaceutical, medical or other FDA applications. Fixtures used in these applications should be required to carry the NSF listing mark. Manufacturers often advertise fixtures as being suitable for cleanroom use with no data or standard qualifications to substantiate their claims.