The Evolution of Quality Systems in Human Bone Banking: The U.S. Experience |
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| Authors: | Paul E. Kostiak |
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| Affiliation: | (1) Pennsylvania Regional Tissue Bank, 1232 Midvalley Drive, Jessup, Pennsylvania, 18434 |
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| Abstract: | This paper illustrates the evolutionary changes that have taken place in human bone banking in the United States since the 1970s to the present, with an emphasis on quality control systems. Specific examples of quality controls are outlined, along with their intended purposes. Particular importance is placed on the gradual change in emphasis from bacteriological concerns to viral concerns and quality control systems. |
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| Keywords: | bone banking lyophilization process validation quality systems sorrogate historian Tissue Transplant |
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