Know what goes into the cleanroom validation process so you can best prepare and successfully validate and certify your facility.
Why Validate Your Cleanroom?
Cleanroom control hinges on a number of complex factors. New cleanrooms are validated for a variety of reasons, including:
- Ensure the facility’s design is fit for its intended purpose
- Ensure the facility, equipment, and environment meet User Requirement Specifications (URS)
- Ensure the facility, equipment, and environment meet defined regulatory requirements
- Ensure the facility, equipment, and environment function together as a system to meet standards
Validation is accomplished through five phases.
1. Design Qualification (DQ).
This phase focuses on the first bullet point above, proving the fit through objective evidence. It focuses on URS, vendor documents and specifications, facility layout, POs, design documentation, factory acceptance tests, as build drawings, and datasheets.
The output involves a phase report and Standard Documentation List (SDL) file documenting the following:
- Design requirements
- Bidding requirements
- Purchasing and order documentation
- Vendor supplied documents list
- As build drawings
- Components list
- Inspection lists
- Factory acceptance tests
*Approval of the DQ phase is a pre-requisite for moving on to the next phase.
2. Installation Qualification (IQ).
This phase verifies that the equipment as installed meets user and design requirements. The following are included: HVAC calibration, P&ID loop verification, HEPA filter integrity test data review, critical equipment calibration status, Site Acceptance Tests, Installation Qualification tests, piping and welding documentation, utility verification, and system SOP and work instructions.
The SDL file will address:
- Project changes
- IQ tests performed
- Supplier supplied documents
- Equipment certificate(s)
- Installation deviations
- Site Acceptance Tests
- Consumable list
- Spare part list
- Environmental review report
- List of Operational and Instructional documents
*Approval of the IQ phase is a pre-requisite for moving on to the next phase.
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 datasheet)
- 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 datasheet. 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 & 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 Cleanrooms. We have been in the cleanroom business for 30 years. Call us at 888-628-0056 or email firstname.lastname@example.org.