The objective of this study was to establish benchmark rates for microbial and bacterial
endotoxin contamination rates for
radiopharmaceutical preparations compounded in commercial nuclear pharmacies.
Radiopharmaceutical samples were obtained between November 2006 and June 2010 from seven commercial nuclear pharmacies. Preparations were compounded per the compounding protocols of each radiopharmacy, and each kit was used for unit-dose dispensing of patient-specific doses. Samples for testing were withdrawn after unit doses were dispensed.
Sterility testing was performed on each
radiopharmaceutical sample and incubated at appropriate temperatures for 14 days. A sample of the
radiopharmaceutical was also used to complete limulus amebocyte lysate-based bacterial
endotoxin testing. Over the course of the study, 1516
radiopharmaceutical samples from 16 different
radiopharmaceutical preparations, including eluates from
radionuclide generators, were tested for
sterility and bacterial endotoxicity. For
sterility testing, 13 of the 1516 samples (0.86%) showed evidence of growth in the testing media, indicating the presence of microbes in the tested sample. For bacterial
endotoxin testing, 4 or 1492 samples (0.27% showed formation of gel clots, indicating the presence of bacterial
endotoxins in the sample. The microbial and bacterial
endotoxin contamination rates of aseptically compounded
radiopharmaceuticals compounded in a commercial nuclear pharmacy environment are extremely low. The results of this study show the high level of safety and quality that is provided when obtaining
radiopharmaceutical doses that are compounded and dispensed from a commercial nuclear pharmacy.