Driving compliance, efficiency, and innovation in medical radioisotope production with PETra
7 March 2024
Arnold Spaans (inset) is BV Cyclotron's Development Manager based at Amsterdam UMC Imaging Center.
BV Cyclotron is a global manufacturer of radiopharmaceuticals and radionuclides and user of LabLogic’s LIMS, which has brought significant benefits to commercial PET production
For 15 years, LabLogic’s PETra LIMS has helped modernise radiopharmaceutical production by migrating sites from paper to an online platform. Designed to improve regulatory compliance, production efficiency, and remove human error, it has emerged as an industry-standard solution around the world.
BV Cyclotron is a leading manufacturer of radiopharmaceuticals based in Amsterdam in the Netherlands who have been using the system for several years. PETra was first installed in 2019 and was updated in 2021 following a new release, with another scheduled update again this year. During that time, PETra has introduced significant advantages to BV Cyclotron’s commercial production and how it maintains regulatory compliance.
BV Cyclotron produces a range of common and novel radiotracers for both research and clinical use. It is one of the biggest producers of 18F tracers in the Netherlands, but also produces KryptoScanTM (81Rb/81mKr) for distribution in Europe together with Curium and 89Zr for delivery all over the world together with Revvity.
“Choosing PETra was an easy choice for us.”
Arnold Spaans is BV Cyclotron’s Development Manager who originally managed PETra’s implementation with LabLogic’s support. The concept of using a digital solution to replace paper records was raised when BV Cyclotron prepared to move from its previous PET production site to its current facility at the Amsterdam UMC Imaging Center.
Arnold said, “We wanted to be as paperless as possible at our new site, so we began looking for an alternative method. Through our own investigations, we recognised that PETra was the most suitable LIMS available. It was a proven system that was already being used at many sites around the world with an excellent track record. Choosing PETra was an easy choice for us.”
Introducing meaningful change to the nuclear medicine community
“We have on occasion requested new instruments be made compatible with PETra or have asked for updates to the QMS system based on how we change our internal production methods, and LabLogic has always fulfilled our requirements.
“Being listened to is important, and LabLogic have demonstrated that they are willing to listen to their customers by developing their software based on what customers are asking for, rather than trying to dictate what the market should be doing simply because it would be convenient for them.
“This makes project implementation a nice thing to do because you’re solving these important problems together. LabLogic’s openness to feedback is a useful and convenient mechanism for introducing important changes to the way the industry works. Many of our own questions are being answered in this forthcoming update.”
“PETra is the way to move forward.”
“BV Cyclotron has three cyclotrons and eight synthesis modules, so our use of PETra is thorough and extensive. When we introduced it, we were one of the biggest users of the software compared to many existing users at smaller sites such as university hospitals, and PETra has proven itself in this upscaling. It is easy to see how its use will become commonplace in other big facilities in the future.
“PETra is the way to move forward. Everything is going digital, so why are we still using paper in medical radioisotope production? Digitisation is the way to go. Here in the Netherlands, we must retain paper records for five years. Can you imagine five years’ worth of paper? It’s a lot! We still have dozens of filing cabinets full of records from years ago before we used PETra for commercial production, and they’re just occupying space, nothing more.”
Direct data capture for quick release of batches
In addition to PETra, BV Cyclotron also uses LabLogic’s Laura radiochromatography software for direct data capture and instrument control. Laura populates PETra to deliver accurate, consistent, and valid data without the need for manual recording or transcription. Not only does this guarantee data integrity, it provides significant improvements in workflow efficiencies, as Arnold attested to.
“Releasing batches is much faster using PETra because data is captured directly, for example when using Laura, meaning our QP can watch and release during production in real-time. If there is a deviation in production, the QP has immediately direct access to all the data. This is a significant advantage over paper, because historically what would have happened is that the QP would have received the batch record only after production when it had been laboriously completed by hand. PETra shows the information live, and time will always be useful when producing short lived isotopes.”
Demonstrable compliance with regulations
“One of PETra’s biggest advantages over using paper is the data-integrity. Everything is audited with a clear trail. Everything is evident and clear. PETra reduces the reliance on people remembering the small details, such as signatures or ticking a box. The software either prompts you or does the work for you, and it won’t let you continue until you’ve completed the critical parts.
“The authorities in the Netherlands are happy with our site’s compliance and the use of PETra and how it fulfils regulations. Many sites are still not using LIMS, so it is quite novel for them to see a digital system, but when we have been inspected, they have seen its usefulness and how it applies conformance. PETra has never had any major findings at BV Cyclotron, which of course I am very happy about.”
Find out more
You can learn more about PETra by clicking the button below to speak to a product specialist directly to request a guided demonstration.