Part two wraps up the final three phases of the 5-part validation process. Understand the process to validate your cleanroom
In part one, we introduced the first two of five validation phases. Understanding what goes into this complex process will help you better prepare and continue to remain compliant. Each phase revolves around a specific purpose of the validation process. Following Design Qualification and Installation Qualification are:
3. Operation Qualification. This phase proves the cleanroom operates in conformance with both design and user defined requirements. It also shows that the cleanroom consistently operates within a defined range of conditions. Protocol will address:
- Testing the HVAC
- Critical alarms
- Interlock alarms
- Critical operating parameters (defined on the room data sheet)
- Filter integrity tests
- Standard operation
- Air speed/flow
- Air flow patterns
- Pressure differential
The other piece to this phase is to address worst-case scenarios. Worst cases are designed using operation ranges and extreme ranges from the critical operating parameters on the cleanroom data sheet. It will include: maximum and minimum temperatures, maximum and minimum humidity, maintenance schedules, and personnel contamination.
The output is a report addressing alarms and functional requirements of the cleanroom as specified in the user requirement specifications.
4. Performance Qualification. This demonstrates that the cleanroom consistently operates within defined parameters to produce the defined/desired environmental outcome. Testing and monitoring includes:
- Airborne particulate levels
- Surface particulate levels
- Viable microbial particulates
- Relative humidity
- Differential pressure
The output report analyzes the performance of the cleanroom against specified equipment parameters. This is a pre-requisite for certification.
At this point, a validated cleanroom is certified. Following successful certification, we move to the final phase.
5. Monitor and control. After certification is complete, you need a constant monitoring program.
If you need your cleanroom validated or certified, or if you have questions about either, contact Gerbig Engineering Company. We have been in the cleanroom business for 30 years. Call us at 888-628-0056 or email firstname.lastname@example.org.