Service
Cleanroom & Clean Air Device Validation
Cleanrooms, isolators and laminar flow devices protect products and patients from contamination. We provide independent validation and periodic requalification so you can demonstrate ongoing control of your critical environments.
What’s included
HEPA filter integrity
DOP/PAO filter integrity testing to detect leaks and confirm installed filtration performance.
Airflow & air velocity
Air velocity measurement, air change rate calculation and airflow visualisation studies.
Pressure differentials
Verification of pressure cascades between adjoining rooms to maintain containment and protection.
Particle & microbial sampling
Airborne particle counting and microbial contamination sampling against your classification.
How we deliver it
Qualification planning
We define the test schedule and acceptance criteria aligned to ISO 14644 and EU cGMP.
Testing & measurement
Calibrated instrumentation and documented methods across all in-scope rooms and devices.
Reporting & certification
Results benchmarked against acceptance criteria with clear pass/fail certification.
Ready to ensure compliance and patient safety?
Talk to an independent specialist about validation, verification and testing for your site.