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Cleanrooms, Laboratories & Containment Suites
Cleanroom Testing and Validation
Enbloc's experienced cleanroom validation team can carry out all routine cleanroom testing, to meet the requirements of BS EN ISO 14644 and EU cGMP.
Our in house team are experienced in the preparation, writing and execution of Operating
Procedures and test protocols for a variety of facilities, including Design Qualification,
Installation Qualification, Operation Qualification and Performance Qualification
documents. We can also assist with re-
Enbloc's Validation Team can undertake the following tests:
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.
Pressure Differential
Demonstrates that the airflow between areas in the cleanroom suite cascades in the correct direction and that the pressure differentials are correct.
Clean-up & Recovery
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
Noise
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.
Air Velocity & Uniformity
Demonstrates the effective unidirectional airflow for laminar flow workstations and rooms.
Air Volumes & Air Change
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-
