Establishing Benchmark Rates of Microbial and Bacterial Endotoxin Contamination for Radiopharmaceuticals Compounded in Commerical Nuclear Pharmacy Settings
International Journal of Pharmaceutical Compounding (IJPC)
Author(s): Weatherman Kara D, Augustine Samuel, Christoff Jeffrey, Galbraith Wendy
Issue: Mar/Apr 2013 – Volume 17, Number 2
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 Samples for testing were withdrawn after unit doses were dispensed.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 … Read More »
Closer inspection of the reactor in Petten
While preparing for the start-up of the reactor during the planned maintenance stop which started on 11 November 2012, NRG discovered an abnormality in the cooling water system of the reactor. Consequently, the start-up of the reactor has been postponed. An investigation has been started immediately to find out the nature, extent and cause of this abnormality. In addition to a visual inspection, a safety analysis has being conducted. The results should offer more insight in the nature of the abnormality. NRG are reporting the progress and status of the investigation to the competent authorities. There is no question of any risk to staff or the environment.
NRG is as of yet unable to indicate when the reactor will be started up again. In cooperation with AIPES, a global organisation bringing together manufacturers and … Read More »
SNMMI Press Releases
December 24, 2012
Congress Passes American Medical Isotope Production Act
SNMMI commends Sens. Jeff Bingaman and Lisa Murkowski for leadership
Reston, Va. — Congress last week affirmed its dedication to securing a sustainable, domestic supply of Molybdenum-99 (Mo-99) as it passed the American Medical Isotope Production Act of 2011 (S. 99). The bill, sponsored Sen. Jeff Bingaman (D-NM), chair of the Senate Committee on Energy and Natural Resources, and Sen. Lisa Murkowski (R-AK), was passed out of the Senate by Unanimous Consent and referred to the House Subcommittee on Energy and Environment. S. 99 was included in the Conference Agreement for the National Defense Authorization Act for fiscal year 2013. The president is expected to sign the final legislation.
The bill will establish a technology-neutral program to support the production of Mo-99 for medical uses in the United States by non-federal entities. … Read More »