Successful Factory Acceptance Test (FAT) for UMC Utrecht
At Von Gahlen in Zevenaar, the Factory Acceptance Test (FAT) was conducted for the new radiopharmaceutical hot cells developed for the Radionuclide Pharmacy of the UMC Utrecht. This project marks an essential step toward advancing the production of radiopharmaceuticals for both clinical care and research.
A new generation of hot cell suites
UMC Utrecht aims to modernize and expand its production capabilities for diagnostic and therapeutic radionuclides, including Gallium-68, Zirconium-89, Lutetium-177, and alpha-emitters. The new facility will be located adjacent to the current facility and replace the existing production line. Through a tender process, Von Gahlen was awarded the contract for this project.
The project involves five hot cell suites spread across two laboratory facilities, containing two production hot cells and three dispending suites equipped with:
- Shielded glove boxes
- Solid waste vaults
- Preparation boxes
- Shielded airlocks
- Product retrieval ports
- Automated HPV system
- Integration monitoring system
These hot cell suites follow the latest industry and GMP guidelines.
FAT: thorough testing and verification
Project Manager Theo Bouwman explains: “For Von Gahlen, this is the first custom made Hot cell line in the Netherlands featuring a Full HPV automatic hydrogen peroxide system, fully compliant with the new Annex I. The new design includes a narrower shielded glove box with a Classified C cell, including a redesigned full, cleanable sliding tray system. We have already integrated the automated HPV decontamination system at various locations internationally and are satisfied with the collaboration with this party.”
The FAT focused on verifying key elements, including:
- Test instrument data
- System documentation
- Construction design
- Equipment specifications
- Main equipment Specification Verification
- Functionality and interlock systems
The team described the two-day FAT as smooth, complete, and comprehensive. In addition to checking the physical product, the software, including individual user logins and audit trails, was also tested. The UMC team thoroughly tested every function, including elements that are often taken for granted, and expressed satisfaction with the results. The demonstration of the HPV system, a new feature for UMC Utrecht, drew particular interest.
Strong collaboration and preparation
The project team, including Theo Bouwman, Lucas Lössbroek, Dennis Oonk, Zachary Lo Sie Sen (Mechanical Engineering), Mustapha Bendoumou (Electrical Engineering), and Renze Hoevers (Software Engineering), worked closely with UMC representatives Dr. Alex Poot (Associate Professor / Head of Radiopharmaceutical Sciences) and Dr. Tessa Ververs (Head of Pharmacy), Berthilde van de Bospoort Akkerman (Project Leader Radiology).
The preliminary process was very comprehensive. Extensive discussions during the design qualification (DQ) phase ensured a smooth FAT process without significant adjustments.
According to Dr. Poot: “I was already familiar with the hot cell market and worked with Jaap and Alex Duiker before. Von Gahlen is a great company to work with that sets very high standards for GMP hot cells.”
Tessa Ververs: “We couldn’t have imagined doing this without Von Gahlen. The cooperation, even with external partners, went very well and kept the project on schedule.”
Next steps
After successful completion, the systems will be dismantled and prepared for shipment. Installation at UMC Utrecht is scheduled for the beginning of 2026. The second hot cell line is in production in Zevenaar, followed by a second FAT in January 2026. From mid-February, a team of four specialized technicians will install for eight weeks at UMC Utrecht.
With this project, the Radionuclide Pharmacy of the UMC Utrecht and Von Gahlen strengthen their long-term partnership, built on a shared commitment to research, safety, and innovation in nuclear medicine.
