Cleanroom validation offers ISO compliance and peace of mind, so you need to ensure that your cleanroom continues to perform efficiently. It needs to be validated at process-dependent intervals to demostrate that it complies with ISO 14644-1:2015 - Classification of air cleanliness by particle concentration.
Regulations state that 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 examined to ensure it is in-line with your monitoring plan and risk assessment.
The tests that need to be considered include:
• Filter integrity testing according to ISO 14644-3:2005
• Airborne particle counts
• Airflow readings
• Air changes and volumes
• Smoke visualisation testing according to ISO 14644-3:2005
• Containment leak testing according to ISO 14644-3:2005
• Recovery rate testing according to ISO 14644-3:2005
• Air pressure differentials according to 14644-1:2015
• Comfort tests such as lux, noise levels, temperature and RH readings
• Particle Counter Calibration certificates to prove instrumentation complies to ISO 21501-4:2007
• Safety cabinet testing including KI Discuss testing & Fume Cabinet Testing including Carbon Breakthrough Testing to BS7989
Once completed, the format of the report conforms with the ISO standards, there it should meet your requirements and those of any nominated regulatory body.
It's essential that Cleanroom Validations are performed on a regular basis to ensure that these environments are performing at optimal levels, and any possible disruption is minimised.
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