Cleaning Verification Case Studies

Creative BioMolecules operates a cGMP plant with 1000L mammalian cell and 1000 L bacterial fermentation capacity. The plant is used for contract manufacturing as well as for CBM’s proprietary products. These case studies will review five campaigns of five products over the last three years. In each case, the goal was to demonstrate that the equipment was properly cleaned and ready for the next campaign.


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Author(s):
David DeLucia,
Journal:
ISPE , January 1997

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