What is DQ?
The first step in a cleanroom validation process is the design qualification (DQ). It provides documented verification that the facility design, systems, and equipment are suitable for the cleanroom requirements. The most crucial activity is checking the structural suitability of the cleanroom. In this case, the primary consideration will be whether the capacity is sufficient and if there are design elements for efficient workflow and prevention of contamination. That means checking if the layout, connecting corridors, and ventilation systems will make the environment meet standard cleanroom requirements.
What is IQ?
Once the DQ and the installation is completed, qualification is crucial to confirm that the installation is consistent with the specified user requirement documentation. To run a practical installation qualification (IQ), you need equipment data sheets, installation guides, and technical personnel to oversee the activity. The objective is to compare standard installation procedures with installation records. This comparison helps to identify any mishaps that could be challenging in the operational step of the cleanroom.
What is OQ?
The operational qualification (OQ) process involves identifying and inspecting equipment and systems under worst-case scenarios. The first step is setting the maximum temperature and observing how long it takes for the room to recover. Additionally, you can set up a worst-case personnel contamination scenario and observe how long it takes for the system to clear the contaminating elements.
What is PQ?
The performance qualification (PQ) process proves that under normal operating conditions and with the expected load, the cleanroom and all associated equipment will work as expected. The simulated process starts by setting the cleanroom under normal conditions, preferably at 60 percent humidity and above workload. Then you can test the equipment performance, monitor contamination levels, and check workflow and staff flow efficiency.