CLEANROOM VALIDATION

  • 1-Air Supply and extract quantities (Air Balance): In case of turbulently ventilated Cleanrooms the air supply and extract volumes should be measured. In case of unidirectional flow the velocity should be measured in addition.
  • 2-Air movement control between areas: To demonstrate that the airflow between areas is in the correct direction i.e. from the pressure differences between areas are correct.
  • 3- Filter installation leak test (DOP test): The high efficiency air filter and it’s housing should be checked to ensure that no airborne contamination passes into the cleanroom through. (a) a damaged filter. (b) between the filter and its housing. (c) any other part of the filter installation.
  • 4-Airborne particles (particle Account): If the above tests are satisfactory then final measurements will be carried out to ascertain that the concentration of particles and where appropriate, micro-organisms comply with the design specification laid down for the room.
  • 5- De-contamination (Recovery) time test: The airborne particle count should be measured and at regular intervals. A useful endpoint is one –hundredth of the original concentration, and the time taken to reach there, which can be used as an index of efficiency.
  • 6- Additional tests: 
    -Temperature. 
    -Relative Humidity. 
    -Heating and cooling capacities. 
    -Sound Level. 
    -Lighting Level.