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J Nucl Med. 2008; 49 (Supplement 1):93P
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Radiopharmaceutical Chemistry: Radiopharmacy

Radiopharmacy I

Evaluation of the microbial contamination rate of compounded radiopharmaceuticals prepared in commercial nuclear pharmacy settings

Kara Weatherman1, Samuel Augustine2, Jeff Christoff3 and Wendy Galbraith4

1 College of Pharmacy, Purdue University, West Lafayette, Indiana; 2 School of Pharmacy, Creighton University, Omaha, Nebraska; 3 College of Pharmacy, Ohio Northern University, Ada, Ohio; 4 College of Pharmacy, University of Oklahoma, Oklahoma City, Oklahoma

368

Objectives: To establish a microbial contamination and pyrogenicity rate for radiopharmaceutical preparations compounded in USP <797> low risk level aseptic compounding environments within commercial nuclear pharmacy operations.

Methods: Radiopharmaceutical samples were obtained between November 2006 and December 2007 from seven commercial nuclear pharmacies. Products 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 Samples for testing were withdrawn after unit doses were dispensed.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. Limulus amebocyte lysate-based pyrogen testing was also performed on the radiopharmaceutical samples.

Results: Six hundred eighty six samples were tested from 14 different types of radiopharmaceutical kits and eluates from two types of radionuclide generators. Eleven of the samples exhibited growth in at least one of the testing media within the 14-day incubation period resulting in a contamination rate of 1.6%. The results of pyrogen testing on 668 of the samples were evaluated, with two samples that failed pyrogen testing (0.3%).

Conclusions: The microbial contamination and pyrogenicity rate of aseptically prepared radiopharmaceutical kits in this study is low. Further analysis is necessary to identify the root causes that led to specific incidences of microbial contamination and/or sample pyrogenicity.

Research Support: This project was funded by a grant from United Pharmacy Partners, Incorporated (UPPI).





This Article
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Right arrow Alert me to new issues of the journal
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Right arrow Articles by Weatherman, K.
Right arrow Articles by Galbraith, W.
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Right arrow Articles by Weatherman, K.
Right arrow Articles by Galbraith, W.