Installation qualification

Initial balance AHU systems

Pressure cascade set up

VAV calibration

CAV measurement

Air velocity measurements

Supply & extract volume rates

Cleanroom ventilation rates calculation

As-built cleanroom room measurements

HEPA filter integrity testing - aerosol challenge method

Fine-tuning pressure differentials between cleanrooms

Airborne particle counting

Recovery testing - as built and at rest

Microbiological tests (air and surface) - viable and non-viable particle counting

Cleanroom classification

Lighting & sound testing

Visualisation of airflow demonstrations

Testing complies with EU GMP Annex 1, ISO 14644, DIN 1946, ISO 14698, ISPE, PIC standards

Testing of pressure differentials and airflow integrity between rooms

Measurement of air leakage rates to ISO 14644 and GMP standards

Identification of leakage paths through doors, wall penetrations, and fixtures

Use of calibrated equipment (e.g. photometers, anemometers, pressure meters)

Generation of pass/fail results with detailed reporting

Recommendations for remedial works where leakage exceeds allowable limits

Support for validation, regulatory audits, and cleanroom commissioning

Site specific protocol authoring

Data collection & analysis

Non conformance & deviation handling

Final qualification report