Food and Drug Administration process validation activities to support 99Mo production at Sandia National Laboratories
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.
Year of publication: |
2009-11-12
|
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Authors: | McDonald, M.J. ; Bourcier, S.C. ; Talley, D.G. |
Subject: | chemistry | biology and medicine, basic studies | MOLYBDENUM 99 | RADIOPHARMACEUTICALS | ISOTOPE PRODUCTION | RADIATION SOURCES | RADIOISOTOPE GENERATORS | VALIDATION |
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