Clean Room Validation

Clean Room Validation

We are specialists in the validation of positive pressure cleanrooms to the ISO 14644 series of classification. The report you will receive following your test meets the requirements of the ISO standards.

We offer a full range of Clean Room Testing

  • Air flow readings ISO 14644-1:2015
  • Airborne particle counts ISO 14644-2:2015
  • Filter integrity testing ISO 14644-3:2005
  • Airflow (Smoke visualisation testing) ISO 14644-3:2005
  • Containment leak testing ISO 14644-3:2005
  • Recovery rate testing ISO 14644-3:2005
  • Differential air pressure ISO 14644-1:2015
  • Lux levels (lighting) 
  • Db levels (Noise) 
  • Temperature and humidity
  • To keep your ISO 14644 status, you must have the cleanroom validated regularly.

Frequency of cleanroom validity according to ISO 14644-1:2015

Required test Classification Maximum time interval Test procedure
Particle count <= ISO Class 5 6 months ISO 14644-2:2015
  >ISO class 6 12 months ISO 14644-2:2015
Air pressure All ISO classes 12 months ISO 14644-1:2015
Airflow All ISO classes 12 months ISO 14644-1:2015
Filter integrity All ISO classes 24 months ISO 14644-3:2005
Containment leak  All ISO classes 24 months ISO 14644-3:2005
Recovery All ISO classes 24 months ISO 14644-3:2005
Airflow visualisation All ISO classes 24 months ISO 14644-3:2005

The ISO validation test can be performed in 3 distinct states;

  1. As-built. The bare bones of a cleanroom, an empty room not yet populated with any equipment and not in use. 
  2. At-rest. The cleanroom has now been populated with any equipment required but is not in use, ie no moving parts and no personnel in the room during the test.
  3. Operational. The cleanroom is now fully operational and operating in accordance with the defined process. 

The validation is ordered in these stages so that any problems can be identified before adding more variables.

A new cleanroom should go through all 3 stages of testing. 

  1. Your installer will test your cleanroom in an ‘As built’ state to prove the installation but you may want to consider a third-party validation. 
  2. Most cleanrooms are tested ‘at rest’ which is important data but the state that most customers are interested in of course is ‘in operation’.
  3. Validation is not to be confused with the monitoring of the cleanroom which must take place at a regularity to suit your process. We are able to provide assistance in formulating your monitoring plan if required.

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