Cleanroom Certification

Cleanroom Certification has been the backbone of Clevair since its inception.

Cleanrooms, by definition, are designed to control airborne particulate and environmental conditions. Cleanrooms can be positive or negative pressure environments that sweep a specified area with HEPA or ULPA filtered air. Critical pharmaceutical, microbiological, and nanotechnological areas require adherence to exacting performance requirements.

Clevair certification programs verify that your facilities perform to appropriate international standards and client specifications. Included with all testing is complete documentation of the test results and certification of the rooms and devices tested. An optional, customized formal report detailing test procedures, test results, and comprehensive conclusions of the testing performed can be included to suit your needs. All cleanroom testing is performed in accordance and compliant with Current Good Manufacturing Practices [cGMP] and International Organization for Standardization [ISO].

Clevair trained Validation Team can perform the following tests:

Air Volumes & Air Change Rates

It demonstrates 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.

Air Velocity and Uniformity

Shows the effective unidirectional airflow for laminar flow workstations and rooms.

Differential Pressure

Demonstrates that the airflow between areas in the cleanroom suite cascades in the correct direction and that the pressure differentials are correct.

HEPA Filter Integrity

The filter media and the housing are checked to ensure that no airborne contamination passes into the cleanroom as a result of bypassing the filter installation. The test is performed with an aerosol photometer or a discrete particle counter (DPC), an aerosol generator and a positive injection pump according ISO 14644 – 3.

Recovery Test

Demonstrates the ability of the room to remove particulates by purging the area with filtered air and to change from a “dirty” to “clean” state within the specified time.

Airflow Visualization

This test, usually monitored by video, shows the airflow patterns and movements within the cleanroom. It demonstrates good coverage of critical operator and/or machine areas, and also highlights zones with poor air movement.

Non Viable Particle Count Test

It proves the classification of the area has been achieved with regards to the concentration of airborne particulate. The classification can be provided to any Standard required by the Client, e.g. EU cGMP, ISO 1464, FED STD 209E.

NOTE: We have ISO 21501-4 compliant equipment available.

Optional tests include:

Recovery performance testing
Temperature & Relative humidity monitoring
Lighting, vibrating and noise levels checks
Pressure and flow gauge calibration

Do not hestitate to contact us anytime at (+30) 222.111.81.80 or at This email address is being protected from spambots. You need JavaScript enabled to view it., or directly at our office, to discuss your specific controlled enviroment needs and to schedule services.