Cleanroom validation, Cleanroom testing, Cleanroom monitoring.
Cleanrooms and Associated Controlled Environments
CruinnCal offers testing and validation/qualification of Cleanrooms, Clean zones and positive or negative containment rooms, (e.g. Category 111 containment suites).
Testing is carried out in accordance with relevant standards, e.g. ISO EN 14644, EU GMP annex 1 etc, or to specific customer criteria. We specialise in developing Validation Master Plans (VMP) that are fully compliant 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’s.
Typical tests carried out as part of this service are:
- Airflow/Air Volume Tests, (including air change rate calculations)
- 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 can be carried out, such as: Temperature, Humidity, Sound and Light Level.
Environmental Monitoring
To ensure compliance with regulatory requirements we can provide environmental monitoring to Annex 1 of EU GMP or ISO 14698 as appropriate.
Our services include:
- Risk Assessment
- Validation Plan Generation
- Settle Plate, Contact Plate, Air Sampling and Swaps, (where applicable).
- Off-site Laboratory Incubation
- Detailed reporting of results
Category III Rooms
Testing and validation Category III rooms is carried out in accordance with the Advisory Committee on Dangerous Pathogens (ACDP) guidelines and in conjunction with our in-house procedures. Testing and Validation can also be carried out to specific customer requirements or using customer’s in-house SOP’s.
Typical tests carried out as part of this service are:
- Airflow/Air Volume Tests, (including air change rate calculations)
- Room Pressure Differential Tests
- Installed Filter Leakage Test
- Biological Safety Cabinet Testing (including an Operator Protection Test – Ki Discus test)
- Room integrity/leak test
