Back to achievements

Qualification of new ventilation units


Manufacturing plant for non-sterile liquid and solid pharmaceutical products


Montreal area (Quebec), Canada


Qualification and validation


As part of its asset management program, the client had to replace obsolete ventilation units. These changes triggered a re-qualification of the ventilation systems.


Genipro was mandated to write and execute the installation and operation requalification protocols (IOQ) of the ventilation system, as well as to produce the associated reports.


The ventilation units had to be replaced and requalified during a two-week plant shutdown and then released by the QA department in time for production to resume. The new ventilation units had to supply new production rooms and the configuration of some ventilation ducts had to be modified to improve air distribution in the rooms. We used our team of experts to understand the engineering drawings and ensure the accuracy of the qualification protocols. Rigorous planning and our experience with similar projects allowed us to successfully release the units in time despite the unforeseen events encountered during the installation.
Back to achievements