QCNW undertake microbiological and physical monitoring of pharmaceutical clean rooms.
Sessional settle plate, contact plate and finger dab samples are incubated, enumerated and any growth identified.
Monitoring to demonstrate compliance with EU GMP Annex 1 and ISO 14644 can be undertaken via the following testing:
- Active air samples
- Air velocities
- Airborne particles (at rest and in operation)
- Contact plates
- End of session media fill
- Filter integrity testing (DOP)
- Pressure differentials
- Room air change rates
- Settle plates
- Universal operator broth tests