

Chez Solvias AG, nous souhaitons entrer dans le secteur de l'analyse et de la caractérisation des combinaisons de médicaments antibody (ADC). Le défi auquel nous sommes confrontés est que les têtes de série des ADC ont une limite d'exposition professionnelle (LEP) inférieure à 50 ng/m3. Par conséquent, nous devons respecter les exigences de laboratoire énoncées dans les directives CFST 1871, ainsi que les spécifications fournies par notre hygiéniste du travail. C'est pourquoi nous avions besoin d'un planificateur de laboratoire ayant des compétences dans ce domaine des isolateurs et du confinement, et nous avons trouvé en pixon le partenaire idéal pour ce travail.
On one hand, time was a significant factor, which presented us with a challenge. We had to make quick decisions regarding which other partner companies to collaborate with. Another challenge was the size of the room — we had limited space especially under the ceiling (piping, ventilations, filters, FFU) for such a complex setup. However, the most important factor was communication with all the companies involved. It was crucial to maintain a smooth flow of information, and Stefan Schlageter and Serena Albarello did an excellent job organizing that.
It was important to know what would be brought into this room. So, together with pixon and our operations team, we reviewed everything that would be placed in the room. We needed to determine where the sockets would go, how much space would be available in each section, and what changes would need to be made to the room itself (e.g., removing a partition wall and a door and replacing them with a window).

pixon provided us with very professional support in this area, with Simon Koch leading the effort. He did excellent work coordinating with the ventilation and control company for the building management system. The ventilation and filtration systems in the room are central to the setup. They had to meet the requirements for maintaining different negative pressures in various areas of the room (lock, laboratory, isolator). This was a significant challenge to achieve. The isolator is part of our containment system, with the primary containment being the isolator and the room itself serving as secondary containment. As a result, we conducted several tests on the ventilation and filters to ensure everything worked as expected and met the required parameters. All the companies involved maintained communication throughout this process.
Stefan Schlageter and Serena Albarello were a great help with their organization, weekly meetings, and expertise. The process was very transparent, and timelines and costs were updated regularly. This allowed us to maintain a clear overview and keep management informed about our progress. Furthermore, all additional requests and questions were considered and answered promptly.
It fully meets our expectations. The laboratory is state of the art and includes all the necessary functionalities in the right places.

The goal was for the laboratory to be easy to clean, without wasting any unnecessary space. Additionally, the plan is to allow for future laboratory equipment to be added, ensuring there is flexibility for future setups.
The excellent project team within the involved companies and the strong laboratory planning contributed significantly to the success. There was great synergy between the companies and excellent communication, which allowed us to quickly overcome our challenges. Our recommendation for other companies is clear: maintain good, friendly, and above all, open communication. These are the key ingredients for a successful outcome in such a demanding project.

Photos: ©Boris Haberthür borishaberthuer.com