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.
The OQ protocol should address the following:
• Testing HVAC (Heating-Ventilation-Air Conditioner) system operation against specified functional requirements
• Critical Alarms
• Interlock Alarms
• Critical operating parameters defined on the room data sheet
• Filter integrity tests
• Standard operation for the cleanroom
• Air speed and air flow
• Air flow patterns
• Pressure differential
The OQ phase should also address worst case scenarios. To design the worst case scenario for the operation of the cleanroom, critical operating parameters are identified from the cleanroom data sheet. Operation ranges, and extreme ranges, are set for each critical parameter and a worst case designed and documented. It should include the following:
• Maximum and minimum temperatures
• Maximum and minimum humidity
• Maintenance schedules
• Personnel contamination
The worst case scenario is usually carried out at the specified High and specified Low parameters.
The output of this phase is an OQ report addressing alarms and functional requirements of the cleanroom specified in the user requirement specifications.
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