Validation Frequency Requirements
How often do I need to validate a cleanroom?
To ensure that your cleanroom continues to perform efficiently and enhance your business process, it needs to be validated at process-dependent intervals 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 suggested 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. However this should be assessed to ensure it is in-line with your monitoring plan and risk assessment, which is required to be reviewed on a regular basis.
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The Importance of Cleanroom Validation
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Discover the different classes within the cleanroom ISO standards and their Federal Standard and GMP...Read more