Validation Frequency Requirements
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.
How often do I need to validate a cleanroom?
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.
This table details the air cleanliness classes by particle concentration within ISO 14644-1.
| Test Parameter | Class | Maximum Time Interval |
|---|---|---|
| Airborne particle concentrations & filter integrity testing |
≤ ISO Class 5 ≥ ISO Class 6 |
6 months 12 months |
| Schedule of additional tests | ||
| Airflow velocities in unidirectional airflow | All classes | 6 months |
| Airflow volume supply in non-unidirectional airflow | All classes | 12 months |
| Pressure differentials | All classes | Continuously monitored |
BOOK A VALIDATION APPOINTMENT
Our cleanroom validation documentation is detailed and auditable. You will receive an interim report on the day of testing, followed by the full report within 10 working days. Reporting is aligned with ISO standards and GMP guidelines to meet your requirements and those of any nominated regulatory body, (e.g. the MHRA).
You can choose from one of our testing packages, or we can build a custom schedule based on your requirements.
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