Radiopharmaceutical Production Radioassay STOP

Radiopharmaceutical Production Radioassay Example STOP Radioassay Acceptance Criteria: The product label should contain information pertaining to the concentration and total radioactivity in the product vial (or the patient dose) at a specified reference time. The measurement should be completed on every batch prior to release of the product. Procedure: Using the properly calibrated measuring equipment (e.g., dose calibrator), measure the radioactivity of a known volume of the test sample (e.g., an accurately measured aliquot of the FDG batch). Calculate the radioactive concentration and record it in MBq/mL or mCi/mL. Similarly, measure the total amount of radioactivity in the container, and record it in MBq or mCi. Discussion: Radioactivity is measured in a dose calibrator which is calibrated with an appropriate reference standard such as 137 Cs (662 KeV). The product vial label should indicate total radioactivity (MBq or mCi) and also the concentration (MBq/mL or mCi/mL) of FDG at the reference time.

Radiopharmaceutical Production Radioassay Example STOP Radioassay Procedure The final FDG solution in the multi-injection vial or other container, should be placed in an ionization chamber (e.g. Capintec) calibrated for the activity range of the product. The total activity should be recorded in the batch record and on the label on the vial. The calibration of the ionization chamber should be done daily with a single point calibration using a standard traceable source. –On days that the Capintec is used, check its performance with a sealed 137 Cs source. Insert the source in each Capintec chamber being used that day and record the readings in the equipment log book. Compare the readings with the acceptable range printed on a calibration placard found in the front of the log book. Link to Demonstration

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