Cleanroom Validation Tests
A critical component in production within life sciences? Undoubtedly, it's cleanrooms. They play a crucial role in the safe and sterile production of ointments to vaccines. Depending on the requirements of the process, a cleanroom must belong to a class or grade and meet the associated criteria.
Parameters of Cleanroom Validation
According to the ISO classification, a cleanroom is a space where the quantity of particles is controlled. This always presupposes that particle counts are performed when classifying a cleanroom.
In summary, cleanrooms are classified based on particle counting according to standards, the most common of which are ISO 14644-1 and GMP grades, as described in Eudralex Volume 4 Annex 1. During an inspection, it must be demonstrated that this classification meets the requirements of the activities taking place there.
Furthermore, in addition to particle count, many other critical parameters are tested to ensure the proper conditions and hygiene in the cleanroom.
Possible parameters include:
- Microbial contamination
- Temperature
- Relative humidity
- Airflow
- Pressure
- Light intensity
- CO2
- Vapourized Hydrogen Peroxide (VHP)
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“Want to know what parameters our Advipro team tests in those cases? It depends on which variables are critical to your company's processes. In any case, it is a fact that our experts test whether all parameters meet the predefined requirements.”Nathan - Project Manager MoVE
Cleanroom validation– Advipro @ your service
Combine Advipro's high-end calibrated testing equipment from the MoVE department with their years of expertise, and you'll know you're in safe hands with our team for qualifying and validating your cleanroom
- Environmental monitoring:
- Viables: micro-organisms
- Non-viables: particle counting
- Temperature, pressure, sound & light measurements
- Filter integrity testing
- Recovery testing
- Air changes
- Testing of flow cabinets
- LAF-cabinets
- Biosafety cabinets
- Powder extraction cabinets
- Fume hoods
- Cleanroom training @ the GxP Academy
Need assistance with cleanroom measurements?
Our MoVE team has the expertise
