Cleanroom Requalification
Cleanroom requalification involves conducting a series of tests to make sure your cleanroom is operating within the desired parameters of your risk assessment.
Ongoing Performance Qualification requires a repeat of the initial testing on the cleanroom to ensure that its operation continues to meet initial requirements as the facility ages. This is also described as requalification or re-validation. Ongoing Performance Qualification provides an ongoing assurance that facilities and equipment continue to meet their original specifications.
ISO 14644-2 recommends to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual processes. 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.
| Test Parameter | Class | Maximum Time Interval |
|---|---|---|
| Airborne particle concentrations & filter integrity testing | ≤ ISO Class 5 | 6 months |
| > ISO Class 5 | 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 |
What does Cleanroom Requalification testing Involve?
Tests may include but not be limited to:
- As built/At rest Particle Counts
- Air Volumes and Air Change Rates
- Filter Integrity Testing
- Pressure Differentials
- Temperature and Humidity Levels
- Recovery Rate Testing
- Smoke Visualisation Airflows
- Containment Leak Testing
- Light (Lux) Level Testing
- Sound Level Testing
- Door interlocks Testing
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.
REQUEST A VALIDATION APPOINTMENT