New Dose Calibrator Reference Standard for Ga-68 and F-18
WEARE, N.H., Feb. 9, 2011 /PRNewswire/ — RadQual, LLC is pleased to announce that the only direct 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 provide the PET manufacturers and end users in complying with all FDA, NRC, State Regulations and with 21 CFR 212; cGMP for PET Drugs. Keith Allberg, Director of Manufacturing and Regulatory Affairs states that RadQual’s continuing study of facilities using or producing Ga-68 and F-18 worldwide were incorrectly measuring the amount of radionuclide by as much as 19% and 17% respectively. In addition the information reported for F-18 has shown as great as a 27% difference between two different brands of dose calibrators and as much as a 9% 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.
Peter Ouimette RadQual, LLC Weare, NH 508-833-1005
SOURCE RadQual, LLC