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Establishing Benchmark Rates of Microbial and Bacterial Endotoxin Contamination for Radiopharmaceuticals Compounded in Commerical Nuclear Pharmacy Settings

Author(s):  Weatherman Kara D, Augustine Samuel, Christoff Jeffrey, Galbraith Wendy

Issue:  Mar/Apr 2013 - Volume 17, Number 2
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Abstract:  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 Samples for testing were withdrawn after unit doses were dispensed.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 the 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 of 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.

Related Keywords: Kara D. Weatherman, PharmD, BCNP, FAPhA, Samuel Augustine, PharmD, FAPhA, Jeffrey Christoff, PhD, Wendy Galbraith, PharmD, BNCP, microbial contamination, bacterial endotoxins, radiopharmaceuticals, nuclear pharmacy, nuclear medicine, compounded sterile preparations, drug safety, United States Pharmacopeia Chapter <797>, USP


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