Cleanroom Validation

Validation and Qualification of Cleanroom and Cleanzones

CruinnCal, a division of Cruinn Diagnostics offers testing and validation of Cleanrooms, clean zones, positive or negative containment rooms.

All testing is carried out in accordange with ISO 14644 and/or EU GMP Annex 1 etc, or to customer specific criteria. We specialise in developing validation plans that are fully compliand with the requirements of GMp and can provide customised documentation subject to customer approval. Alternatively, testing can be carried out in accordance with the customer’s in-house SOP (Standard operating Procedure).

Typical testing include but is not limited to:
– Airflow/Air volume tests (Including air change calculation)
– Room pressure differential tests
– Installed filter leakage test
– Airborne particle count test
– Airflow visualisation test
– Airflow direction test
– Room recovery test
– Other non critical tests such as Temperature/Humidity/Sound Level/Lux Level tests can be carried out.

We also specialise in testing and validating Category III rooms which is carried out in accordance with the Advisory Committee of Dangerous Pathogens (ACDP) guidelines and in conjuction with our in-house procedures.

Contact Cruinn for details.