Publications

Prior to 1989 {sup 99}Mo was produced in the US by a single supplier, Cintichem Inc., Tuxedo, NY. Because of problems associated with operating its facility, in 1989 Cintichem elected to decommission the facility rather than incur the costs for repair. The demise of the {sup 99}Mo capability at Cintichem left the US totally reliant upon a single foreign source, Nordion International, located in Ottawa Canada. In 1992 the DOE purchased the Cintichem {sup 99}Mo Production Process and Drug Master File (DMF). In 1994 the DOE funded Sandia National Laboratories (SNL) to produce {sup 99}Mo. Although Cintichem produced {sup 99}Mo and {sup 99m}Tc generators for many years, there was no requirement for process validation which is now required by the Food and Drug Administration (FDA). In addition to the validation requirement, the requirements for current Good manufacturing Practices were codified into law. The purpose of this paper is to describe the process validation being conducted at SNL for the qualification of SNL as a supplier of {sup 99}Mo to US pharmaceutical companies.

Sandia National Laboratories operates two reactors which fall under US Environmental Protection Agency regulations for emission of radionuclides to the ambient air. These reactors are: (1) the Annular Core Research Reactor, a pool-type reactor and (2) the Sandia Pulsed Reactor III, a Godiva-type reactor. The annual radioactive air emissions from these two reactors had been estimated based on engineering calculations and used in the facility Safety Analysis Report. The calculated release rates had never been confirmed through measurements. The purpose of this work was to obtain confirmatory radioactive gas and aerosol concentration measurements for radionuclides in exhaust stacks of these reactors during normal operation; however, the measured production rate of argon-41 was significantly different from the engineering calculations for both reactors. The resolution of this difference is discussed.