Radiochemical purity testing for GMP and research PET tracers
26 April 2023
LabLogic’s Scan-RAM is being used by Edinburgh Imaging Facility’s radiochemistry unit for F-18, C-11, and O-15
LabLogic’s Scan-RAM radio-TLC scanner is being used at Edinburgh Imaging Facility’s radiochemistry unit at the University of Edinburgh, which houses a cyclotron with supporting radiochemistry suites to produce research PET radiotracers including F-18, C-11, and O-15. This allows EIF to conduct PET imaging experiments, develop fully translational tracers, and adopt existing radiotracers to GMP standards for clinical studies.
EIF has four imaging facilities, including ones at the Queen’s Medical Research Institute, Royal Infirmary of Edinburgh, and the Royal (Dick) School of Veterinary Studies for the imaging of large and small animals.
The Scan-RAM was procured during a refurbishment that expanded the facility to increase capacity for GMP radiopharmaceutical delivery and replaced an older radio-TLC scanner. We spoke to Kenneth Wilson, the radiochemistry unit’s QC Manager, to see how he was getting on.
Kenneth said, “The Scan-RAM TLC is simple-to-use but comprehensive. The TLC plate support beds allow for consistent placing of plates and provide an easy-to-handle method of securing plates prior to positioning on the scanner, and the system of sprung pins ensures correct positioning. The unit itself is compact and easily positionable on the lab bench.”
A single software solution for radiochromatography analysis
EIF uses LabLogic’s Laura for PET software for the collection and analysis of PET radiochromatography data. Specifically designed to meet internationally-recognised regulatory compliances such as FDA 21 CFR Parts 11 and 212, Annex 11 and MHRA, Laura allows PET production sites to maintain GxP practices.
Kenneth said, “All instrument control is via Laura software with full audit trails and electronic signatures available for GMP compliance. It offers comprehensive control of instrument parameters with saved methods and individual password-protected user logins with configurable access permissions ensuring validated methods remain safeguarded against unauthorised changes.”
Find out more
You can learn more about the Scan-RAM by clicking the button below to request a guided demonstration with a product specialist.