Managing a new PET production facility using PETra
06/07/2023
Örebro's new radiopharmacy is being built to supply PET/CT cameras with tracers radiolabelled with Fluorine-18.
Örebro University Hospital in Sweden has chosen LabLogic’s PET LIMS for its new radiopharmacy
Örebro University Hospital in Sweden has chosen LabLogic’s solutions for its new radiopharmacy which is being built to supply its current and future PET/CT cameras with tracers radiolabelled with Fluorine-18 initially and eventually Carbon-11, Gallium-68, and Oxygen-15. The radiopharmacy will compound all its radiopharmaceuticals through a GMP-compliant pharmaceutical quality system as described in the European Pharmacopoeia. The hospital’s radiopharmacy will use LabLogic’s PETra PET Laboratory Information Management System to manage the production and administration of PET radiopharmaceuticals along with LabLogic instrumentation controlled by Laura for PET™ software.
Lisa Holm will be the radiopharmacy’s Qualified Person and Head of Quality Assurance once the new site is running. Lisa previously worked at Linköping University Hospital which already uses PETra. She explained why Örebro University Hospital decided to use LabLogic to equip its new radiopharmacy.
“LabLogic’s PETra was the only available system that could provide everything we wanted.”
Lisa said, “We’ve previously procured FDG from a site in Finland, but as the number of PET scans has increased at Örebro over the years, we realised it would be beneficial to invest in a radiopharmacy and develop our own production.
“As well as my own previous experience with PETra, I have another colleague at Örebro who has also used it at Karolinska Hospital in Stockholm. Having used a digital system to manage PET radiotracers, we were very much in agreement that we did not want to use a paper system at Örebro. Our original idea was to start using paper, then apply for funding to acquire PETra in the future, but with both of us using PETra at previous sites, we were able to convince the hospital to implement a digital solution immediately, rather than creating a new paper-based system only to switch over later.
“We looked at alternative LIMS and demonstrated to our purchasing department that LabLogic’s PETra was the only available system that could provide everything we wanted. Once the hospital was convinced, we were able to submit a direct tender for PETra.”
PETra includes integrated modules for the complete management of PET production workflow. Based on Lisa’s previous experience with PETra at Linköping, Örebro have chosen all PETra’s available modules, including the SOP Module that allows users to easily manage and review SOPs, the Document Management Control for storing and accessing information, and the Deviation Module that records any instances where a deviation from an established procedure has occurred.
Laura for PET™ data collection and analysis software
Even though LabLogic's Laura for PET™ is compatible with over 200 instruments from different manufacturers, Örebro decided to standardise its equipment by choosing LabLogic’s own hardware once they had decided to implement PETra with a Scan-RAM radio-TLC scanner for radiochemical purity and Flow-RAM radio-HPLC detector for separation and analysis of compounds.
Lisa said, “We like Laura for PET’s™ direct data capture from the instruments. We don’t have to write things down only to copy them over to the LIMS. The integration with PETra allows us to remove the human interaction, eliminate transcription errors, and be GMP-compliant.”
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