From Cyclotron to Patient: How We Produce F-18 Radiopharmaceuticals at Positron Diagnostics
Most people who come for a PET/CT scan at Positron Diagnostics do not realise that the radioactive tracer they receive was made on-site, that same morning. This is not the case at other imaging centres in Europe, which rely on external suppliers and long delivery chains. At Positron Diagnostics, we have built the entire production pipeline in-house, from the physics of the particle accelerator to the final patient dose. Here is how it works.
Why In-House Production Matters
Fluorine-18, the radioactive component of the radiopharmaceutical product, has a half-life of only 110 minutes. This means it loses half its radioactivity roughly every two hours. A dose produced in the morning and delivered by courier would be significantly less potent by the time it reaches the patient, or in some cases, unusable altogether. Producing it on-site means maximum purity, maximum precision, and no dependency on external supply chains.
Step 1: The Cyclotron — Making the Radioactive Component (Fluorine-18)
The process begins in our GENtrace cyclotron, a compact particle accelerator. The cyclotron works by bombarding an enriched water target (¹⁸O-water) with high-energy protons. This nuclear reaction converts oxygen-18 into fluorine-18.
The entire bombardment process takes up to 2 hours, producing a small but precisely calculated quantity of fluorine-18 solution.
Step 2: Synthesis — Making the Radiopharmaceutical
The fluorine-18 solution is automatically transferred, without human exposure, into our GE FASTlab2 synthesizer, where it is chemically bonded to a glucose molecule through a series of automated reactions, producing the radiopharmaceutical product such as the most robustly used, 18F-FDG (fluorodeoxyglucose). The entire synthesis is fully automated, ensuring consistency and safety for every batch.
Following synthesis, the radiopharmaceutical is automatically transferred to an automated dispensing unit to be dispensed into sterile glass vials.
Both the synthesizer and the automated dispenser are housed inside a lead-shielded hot cell located in our GMP (Good Manufacturing Practice) certified cleanrooms, maintaining aseptic conditions for the drug product and radiation protection for the operators.
Step 3: Quality Control — Nothing Leaves Without Passing
Before any dose reaches a patient, it must fully pass comprehensive quality control testing in compliance with the European Pharmacopoeia standards. These tests verify the identity, purity, quality, safety, sterility and efficacy of the radiopharmaceutical product.
The precise dose is been calculated for each individual patient based on the person’s body weight and transferred inside syringes. These syringes are handled exclusively inside lead-lined containers that shield staff from radiation at every step.
Our trained nursing team then administers the dose to the patient via a small cannula, and the 45–60 minute uptake period begins.
Why This Matters for Your Safety
Every step of this process is designed around two priorities: the quality of the diagnostic image, and the safety of the patient. Producing 18F-FDG in-house under strict pharmaceutical GMP standards means every dose is traceable, quality-assured, and administered at exactly the right time for optimal results.
To learn more about our facility or to refer a patient, visit www.positron.health or contact us: +357 22 053 555