After the Cyclotron and Radiochemistry Program receives a request for a PET radiotracer, we produce the radioisotope in the cyclotron, and deliver it to our radiochemistry laboratory. There, we synthesize the requested PET radiotracer.
We then send a sample of the radiotracer to our Quality Control Laboratory. After a radiotracer passes QC, we transport the appropriate dose to the preclinical PET imaging laboratory or clinical PET center for imaging studies.
All procedures involving human use of radiotracers comply with 21 CFR part 212, the U.S. Food and Drug Administration’s cGMP guidance for production of PET drugs, and/or the U.S. Pharmacopeia's Chapter 823 standards for PET drug production and compounding.
CRP operations are monitored by UT Southwestern's Radiation Safety Office to ensure compliance with the radiation safety regulations of the U.S. Nuclear Regulatory Commission, and the Texas Department of State Health Services.