Abstract
In December of 1989, the United States Food and Drug Administration approved 82Rb chloride in saline solution for cardiological perfusion imaging by positron emission tomography (PET). The solution is derived from a 82Sr generator system that is presently manufactured by Bristol Myers Squibb and distributed for clinical application in the United States by Bracco Diagnostics, Inc. Many years of research and development by people in several institutions led up to the approval for clinical use. Currently, there are about 15 sites in the U.S. that perform clinical myocardial perfusion imaging by PET using 82Rb chloride from the generator. In order to manufacture the generators, Bristol Myers Squibb requires about 1600 mCi of 82Sr every 30 days. The United States Department of Energy and MDS Nordion, Canada are the current suppliers with qualified Drug Master Files for the production and distribution of this nuclide for the Cardiogen® generator. These two entities have worked together over the years to assure the regular, reliable supply of the 82Sr. Here we describe the facilities and methods used by the Department of Energy in its Virtual Isotope Center to make and distribute the nuclide.
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