Translate process risk into design requirements
The URS and design review should define room grades, occupancy, air-change and recovery expectations, pressure relationships, filtration, temperature and humidity ranges, alarm strategy, monitoring locations and operating states.
Design Qualification confirms that zoning, airlocks, flows, controls, maintainability and capacity can support the intended process. For sterile facilities, the rationale must align with the contamination control strategy.
Installation and operational qualification
IQ verifies equipment, ductwork, filters, instruments, materials, drawings, calibration, software and utilities against the approved design. OQ challenges operating ranges, alarms, interlocks, pressure cascades and control sequences.
Cleanroom and clean-air equipment qualification commonly includes installed filter integrity, airflow volume or velocity, pressure differences, airflow visualization, microbial and particle conditions, temperature, humidity, recovery and containment leakage where relevant.
Classification is not routine monitoring
Cleanroom classification demonstrates air cleanliness against the applicable particle limits under defined states. Environmental monitoring is an ongoing process-control programme. The two activities have different purposes and should not be treated as interchangeable.
Test locations, sample volumes, occupancy state, equipment operation and acceptance criteria must be defined before execution and traceable to the governing standard and room use.
Performance and continued verification
PQ demonstrates performance during representative operations with normal personnel, equipment and interventions. Results should be evaluated together with environmental monitoring, differential pressure and deviation history.
Filters, controls and sensors require maintenance and calibration. Significant changes, repeated excursions or major repairs should trigger impact assessment and an appropriate level of requalification.
A defensible execution path
- 1Define room use and contamination risks
- 2Qualify the installed HVAC system
- 3Challenge alarms, airflow and recovery
- 4Demonstrate performance in operation
Frequently asked questions
Is cleanroom classification the same as HVAC qualification?
No. Classification is one element of cleanroom qualification. HVAC qualification also addresses design, installation, controls, airflow, filters, pressure, recovery and other intended-use requirements.
Which HEPA test is normally performed?
Installed filter system leakage and integrity testing is commonly included. The approved method, challenge aerosol, acceptance criteria and test frequency should follow the facility standard and applicable requirements.
When is airflow visualization required?
It is especially important where airflow direction protects critical operations or prevents cross-contamination. The study should cover relevant operational conditions and interventions.
Primary references
Use the current official publication and your applicable national requirements when approving a protocol or quality-system decision.
Need support applying this to your facility?
PHARPRO can scope the qualification, review your current documents or execute the work with your site team.
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