19 Nov Test to be Performed in validation
HEPA Filter Integrity
The filter media and the housing will be checked to ensure that no airborne contamination passes into the cleanroom as a result of bypassing the filter installation.
Demonstrates that the airflow between areas in the cleanroom suite cascades in the correct direction and that the pressure differentials are correct. Air Velocity &Uniformity Demonstrates the effective unidirectional airflow for laminar flow workstations and rooms. Air Volumes &Air Change Rates Shows that the correct volume (turbulent ventilated cleanroom) or the velocity unidirectional cleanroom) is entering the clean area. This information is then used to calculate the number of air changes within the area to ensure compliance with specification. Containment Leak Test Demonstrates that airborne contamination cannot enter adjacent areas by means of leaks in the room fabric. This is typically performed on negative pressure containment suites. Airborne Particulate Counts Proves the classification of the area has been achieved with regards to the concentration of airborne particulate. See table below for selected BS EN ISO 14644-1 cleanroom classifications. The classification can be provided to any Standard required by the Client, e.g. EU cGMP.
Demonstrates the ability of the room to remove particulate by purging the area with filtered air and that the room can change from a “dirty” to “clean” state within the specified time. Airflow Visualisation and Smoke This test, usually with video evidence, will show the airflow patterns and movement within the cleanroom, to show good coverage of critical operator and / or machine areas and highlight any zones with poor air movement.
Other tests include:
- Temperature and Humidity &Mapping
- Lighting Level
A full comprehensive validation report will be issued to the Client following each visit which will include current calibration certificates, drawings detailing test locations and all the raw data taken during the attendance.