Validation
Cleanroom Validation
ISO 14644 Performance Testing & Documentation
A cleanroom is not complete when construction is finished. It must demonstrate that the installed system performs according to its specified requirements.
- As-Built → At-Rest → Operational
- Particle counting & classification
- Final qualification dossier
Validation activities
Typical Validation / Qualification Activities
ISO 14644-3:2019 provides test methods for cleanrooms and clean zones in different occupancy states, including as-built, at-rest and operational conditions.
Activities
- Airborne particle counting
- Cleanroom classification
- Airflow volume measurement
- Air velocity measurement
- HEPA filter integrity/leak testing
- Differential pressure testing
- Airflow visualization
- Recovery testing
- Temperature mapping
- Relative humidity verification
- Air-change verification
- Noise measurement
- Illumination measurement
- Equipment suitability assessment where applicable
- Validation documentation
Validation States
- As-Built
- At-Rest
- Operational
Documentation
Documentation
Deliverables
- Test protocols
- Calibration certificates
- Test reports
- Room data sheets
- HEPA integrity reports
- Particle count reports
- Airflow reports
- Pressure differential reports
- Temperature/RH reports
- Final qualification dossier
Standards positioning
ISO 14644 framework
Designed, commissioned and tested in accordance with applicable ISO 14644 requirements.
ISO 14644-1
Classification of air cleanliness
The principal standard for classification by airborne particle concentration.
ISO 14644-3
Cleanroom test methods
The test-method framework for cleanrooms and clean zones.
ISO 14644-4
Design, construction and start-up
Addresses the process of creating cleanrooms from requirements through design, construction and start-up.
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Whether you are establishing a medical-device manufacturing unit, CAR-T cell therapy facility, MSC laboratory, BMT center, IVF laboratory, or injectable biopharma facility, our engineering team can develop a complete cleanroom solution around your process.
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- Approximate area
- Process description
- Required cleanroom classification
- Existing architectural drawing
- Equipment list
- Target completion date
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