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bioburden

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bioburden,
n the number of bacteria living on a surface before it is sterilized.


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The investigating team found that MedImmune had not maintained appropriate control over bioburden during manufacture of vaccines.
FDA investigators Mihaly Ligmond, Omotunde Osunsanmi and Steven Rubin found that MedImmune had not maintained appropriate control over bioburden during manufacture of vaccines.
The company did not perform bioburden determination in the 2005 ethylene oxide (EO) validation study as specified in its protocol.
 
 
 
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