February 8, 2011 — The only direct National Institute of Standards and Technology (NIST) traceable dose calibrator source for Ga-68 and F-18 is now available in a 1 mCi (37 MBq) sealed source. This will help positron emission tomography (PET) manufacturers and end-users comply with all FDA, NRC, state regulations and with 21 CFR 212; cGMP for PET drugs.
RadQual LLC says its continuing study of facilities using or producing Ga-68 and F-18 worldwide indicate that they were incorrectly measuring the amount of radionuclide by as much as 19 percent and 17 percent respectively. In addition, the information reported for F-18 has shown as great as a 27 percent difference between two different brands of dose calibrators and as much as a 9 percent difference within the same brand and model. These facilities prior to receiving their F-18 standard, which were calibrated by NIST prior to shipping, were using either Cs-137 or Na-22 for daily calibration for PET radionuclides.
For more information: www.radqual.com