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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
Parameters of cleanroom validation
According to the ISO classification, a cleanroom is a room where the amount of particles is controlled. This means that particle counts have to be conducted when classifying a cleanroom.
In short, cleanrooms are classified on a particle count basis set out in 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 shown that this classification is in line with the activities taking place there.
Moreover, in addition to particle counts, many other critical parameters are tested to ensure proper cleanroom conditions and hygiene. Possible parameters include:
- Microbial contamination
- Temperature
- Relative humidity
- Air flows
- Pressure
- Brightnesses
Cleanroom Validation Tests
Combine high-end calibrated test equipment from Advipro’s MoVE department with their years of expertise, and you’ll know you are safe 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
Rent Validation Equipment?
Operating within a controlled environment and (temporarily)in need of professional validation equipment ?At Advipro, you can rent high-quality validation equipment to ensure that your controlled environments comply with current regulatory standards.
