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21st Jan 2016

How Often Should I Validate my Cleanroom to meet ISO 14644-1:2015?

In early January 2016, ISO introduced an update to standards ISO 14644-1:2015 - Classification of air cleanliness by particle concentration and ISO 14644-2:2015 - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.

We have been asked what impact the updated standard has on validation and testing frequency and we aim to answer that question here.

To ensure that your cleanroom continues to perform efficiently and enhance your business process, it needs to be validated to prove it complies with ISO 14644-1:2015 - Classification of air cleanliness by particle concentration.

ISO 14644-2:2015 - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, recommends customers to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual processes.

It states the maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is 6 months and ISO class 6 and above is 12 months.

Test Parameter Class Maximum Time Interval
Airborne particle concentrations = ISO Class 5
> ISO Class 5
6 months
12 months
Schedule of additional tests
Airflow velocities in unidirectional airflow
Airflow volume supply in non-unidirectional
airflow
Pressure differentials

All classes
All classes

All classes

6 months
12 months

Continuously monitored


For more information, call +44 (0)1524 813020 to discuss your annual Connect 2 Cleanrooms validation service contract or email service@connect2cleanrooms.com.

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