27 sept 2022
MoVE: Shutdown by Prothya
Our Validation Engineers talk about the annual summer shutdown at Prothya. Read all about it on this page.
Shutdown through the eyes of an experienced colleague.
Xenia, Senior Validation Engineer
The shutdown at Prothya, formerly Plasma Industries Belgium, is a project that Normec Advipro has been handling for several years now. The scope of the assignment is impressive; with two teams of five colleagues, we revalidate the cleanrooms within just five days. One additional colleague is responsible for reviewing the work and facilitating communication between both teams. Over the years, preparation, execution, and reporting have been optimised to the point where everyone knows exactly what to do, allowing everything to run smoothly. Some colleagues have several years of experience at Prothya already, and the test forms we use to record our results are mostly prepared in advance. This means we can dedicate a lot of time to the actual testing and to knowledge sharing/training. We recently also optimised our filter integrity test, so we no longer lose time in case of edge leakage around the filter.
That said, it remains a challenging assignment! We return every year, but no two years are ever the same. This year, I took on the lead role for the day shift. It really helped that I did a lot of hands-on testing in the cleanrooms the year before, so I was able to draw on that experience. That way, I could coordinate, lead, and support the team “from the outside” this time. Together with my colleague Aline, who fulfilled the QA role and reviewed all documents, I also communicated with Prothya’s QA. The client expects regular updates on the progress... On the other hand, they also provided technical support when, for example, a leaking filter was detected by the Test Engineers in the cleanroom.
Prothya would supply a replacement, and Normec Advipro would handle the removal and installation of the new filter. As the day shift was wrapping up, the colleagues from the evening shift would arrive. A written handover document listed all completed tests, what still needed to be done, and what was most urgent. The next morning, the day shift would find an updated version of this document and could get started right away. What I love about this assignment is that although it's five very intense days, the teamwork creates an amazing atmosphere. There are definitely stressful moments, but we always have each other's backs, and everyone helps out wherever they can. The pastries and pita were the cherry on top – a well-earned reward for all the hard work! Everyone truly deserved it. In summary, it’s an incredibly educational experience for everyone involved, whether you’re testing in the cleanroom, coordinating from above, or reporting and discussing results with the necessary stakeholders. The group of great colleagues really builds a bond for the future, and a happy client at the end of it all makes the assignment complete! I won’t be taking vacation in August next year… Count me in for Prothya Shutdown 2023!
Shutdown through the eyes of a new colleague.
Pallieter, Junior Project Engineer
On my very first working day at Advipro, I was asked to support the MoVE department during the Prothya shutdown. Just two weeks later, it was time for Prothya’s major production break — and for us, our first real steps into the field.
Our first day at Prothya started with registering our trainings and receiving on-site instruction on their gowning procedures. Like ducklings following their mother, we trailed behind our more experienced colleagues. We kicked things off with airflow measurements on no fewer than 350 filters, using flow hoods to check if the air exchange rate met the requirements for each area. After about two days of working with the flow hoods, all airflow measurements were completed. With slightly sore arms, we moved on to testing the integrity of all filters.
During these tests, our phones became our best friends — we needed them to communicate with the colleague injecting smoke from the technical area outside the cleanroom. While smoke was introduced from the outside, we counted the number of particles that made it through the filter. Thanks to these tests, we found two leaking filters. Three hundred filters and two days later, it was time for particle counting. A day and a half flew by, and all measurements were completed.
With just half a day left on the clock, the final tests on the list were the recovery tests and smoke studies. For the recovery tests, we filled the cleanrooms with smoke to determine how long it would take for the particle levels in the air to drop back to baseline. For the smoke studies, we created visible smoke to observe how the air flows within the space.
Thanks to everyone’s hard work, everything was completed right on time. To wrap up the week, we were treated to a well-deserved dürüm.
In short, it was an incredibly educational, intense, exhausting, but most of all fun week.
Looking for expert support in cleanroom validation?
Meet our MoVE team. A team that analyses, tests, and validates processes, rooms, and laboratories within the pharmaceutical sector.
Normec Advipro’s MoVE team specialises in testing controlled environments and GMP-critical installations. In practical terms, they verify whether cleanrooms, operating theatres, production facilities, and more comply with the (regulatory) requirements defined by the client — such as FDA, Eudralex Annex 1, ISO, and PIC/S standards.
To do this, they use precise, validated measuring equipment. What sets us apart is our ability to provide solutions and make recommendations in line with approved procedures.
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Normec Advipro
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