Food and Drug Administration process validation activities to support 99Mo production at Sandia National Laboratories

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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 ... continued below

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4 p.

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McDonald, M.J.; Bourcier, S.C. & Talley, D.G. July 1, 1997.

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This article is part of the collection entitled: Office of Scientific & Technical Information Technical Reports and was provided by UNT Libraries Government Documents Department to Digital Library, a digital repository hosted by the UNT Libraries. It has been viewed 88 times . More information about this article can be viewed below.

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  • Sandia National Laboratories
    Publisher Info: Sandia National Labs., Albuquerque, NM (United States)
    Place of Publication: Albuquerque, New Mexico

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Description

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.

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4 p.

Notes

INIS; OSTI as DE97006937

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  • 1997 American Nuclear Society (ANS) winter meeting, Albuquerque, NM (United States), 16-20 Nov 1997

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  • Other: DE97006937
  • Report No.: SAND--97-1566C
  • Report No.: CONF-971125--2
  • Grant Number: AC04-94AL85000
  • Office of Scientific & Technical Information Report Number: 537292
  • Archival Resource Key: ark:/67531/metadc692695

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Office of Scientific & Technical Information Technical Reports

Reports, articles and other documents harvested from the Office of Scientific and Technical Information.

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  • July 1, 1997

Added to The UNT Digital Library

  • Aug. 14, 2015, 8:43 a.m.

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  • May 16, 2016, 3:53 p.m.

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McDonald, M.J.; Bourcier, S.C. & Talley, D.G. Food and Drug Administration process validation activities to support 99Mo production at Sandia National Laboratories, article, July 1, 1997; Albuquerque, New Mexico. (digital.library.unt.edu/ark:/67531/metadc692695/: accessed October 19, 2018), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.