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June 01, 2006 (Vol. 26, No. 11)

Maintaining Biocontamination Control

Firms Must Demonstrate to Both the FDA and the Public that Processes are Safe and Effective

  • Common wisdom holds that bacteria and viruses are everywhereexcept, of course, in bioprocesses. Keenly aware of this, biomanufacturers have numerous approaches to limiting biocontamination upstream and eliminating it to undetectable levels downstream. Processes stay clean mostly by assuring that microbes never enter the picture. Well-known techniques, such as clean-in-place, ...

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