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Validation of a filtration processA Khan2007-03-06Click here to register.
Hi
I am involved in the design of a filtration process for recovery of an intracellular protein. The filtration is to be used following bacterial fermentation, and cells harvested using a large-scale cross-flow filtration set-up with CIP and SIP capabilities.
I'm a bit stuck with the design since we need to consider validation strategies. What kind of validation considerations should I be looking at in terms of scaled-down process, offline and which need to be addressed on-scale under actual processing conditions. Also, is this particular filtration step (before homogeniszation) more viable as re-usable or disposable?

Thank you very much in advance

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