Successful FAT for PET Labs South Africa
Just before the summer started, PET Labs’ Chief Quality Officer, Johannes van Tonder, visited our headquarters in Zevenaar for the Factory Acceptance Test (FAT) of the first of two hot cell radiopharmaceutical production lines.
Johannes assessed the quality during our FAT test, which involved various components following the GMP regulations. The project involves two lines: one, fully assembled in May 2025 and FAT-tested in early June, and a second line planned for September 2025.
PET Labs Pharmaceuticals in Pretoria, South Africa, is currently providing PET isotopes for diagnostic scans across South Africa.
Project Scope and Features
PET Labs required a flexible production line for common liquid isotopes used primarily for diagnostic purposes. Previous experience with a Von Gahlen Hot cell, installed 20 years ago in a different facility, has proven the high quality and long product life cycle of our products.
The new design features an HPLC cabinet with a clear door, allowing for direct synthesis work with multiple modules and our semi-automatic dispensing systems (CVDD). The Product Retrieval Port (PRP) was specially adapted for single-patient doses and various vial and syringe sizes, including an extra hot cell with an automatic dose divider (ADD) for precise portioning. This technological solution enables the dispensing of multiple vials and one set per patient as well. The PRP facilitates the transfer of final shielded products to the packaging and logistics location, allowing further transportation to operate efficiently.
Customer Experience
This was Johannes’s second visit to Von Gahlen. On his first visit, he was impressed by another live production line. This time, he could see his project taking shape, discuss every detail, and understand how our team brings the system to life.
On the final day of his visit, he even had the opportunity to demonstrate the system’s performance during an NKRV group visit, the Dutch branch organization for radiology.
The downflow filter test, with the smoke machine visibly pushing the smoke downwards in seconds, showcased the hot cell’s reliable safety features. Johannes: “I have had a good impression and first exposure to the product, and I am looking forward to working with this line at our location.”
Long-Term Partnership
The founder of PET Labs, Gerdus Kemp, has been collaborating with Von Gahlen for over twenty years. This latest project started with an on-site visit to Pretoria and informal workflow concepts and discussions with our Area Sales Manager, Sjors van Es and our Sales engineer, Nynke Vredenbrecht. From there, it evolved into a comprehensive design and engineering project.
The team successfully completed the FAT test, and the line is now ready for dismantling by the assembly team and transportation. To be assembled again at the final location on-site for the customer. We look forward to the next steps and continuing to support PET Labs’ mission of safe and efficient isotope production in South Africa.
If you have any hot cell inquiries, please contact our sales team at: sales@vongahlen.com
