Cleanroom validation

An essential part in production for life sciences? Undoubtedly the cleanrooms. Indeed, they play an important role in the safe and sterile production from ointments to vaccines. Depending on the process requirements, a cleanroom should have a certain purity class or grade and meet the corresponding criteria.

The 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

“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

What tests does Advipro perform?

Essential for cleanrooms are HEPA filters, a specific type of air filters that allow only a small number of particles to pass through and are therefore partly responsible for controlling and minimising the number of particles in the cleanroom. Very important: HEPA filters are checked regularly for any leaks using integrity tests. In addition, recovery time and the number of air changes per hour also contribute to elimination and minimal particle retention. Using mappings, we also map the temperature and pressure in the room.

What support does Advipro offer?

Mobile validation experts (MoVE)

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.