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Jasun - Cleanroom Validation Services
Cleanroom validation is essential for maintaining ISO compliance and ensuring the operational efficiency of controlled environments. Cleanrooms must be validated at process-dependent intervals as dictated by ISO 14644-1:2015, which classifies air cleanliness by particle concentration. For ISO class 5 and below, the maximum recommended interval between airborne particle concentration tests is six months, while for class 6 and above, it is twelve months. It's necessary to align these intervals with your monitoring plans and risk assessments. Comprehensive validation involves various tests, including filter integrity, airborne particle counts, airflow measurements, and smoke visualization, as specified by ISO 14644-3:2005. Additional tests include containment leak testing, air pressure differentials, and comfort assessments such as lux and noise levels. Safety cabinet testing and particle counter calibration are also critical to ensure adherence to standards like ISO 21501-4:2007. These validations are vital for minimizing disruptions and ensuring compliance with regulatory demands.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.