RE: bioburden validation Contribution from JD Mallet written on 9/25/2008 at 13:31
Original contribution: bioburden validation written by samatha on 9/25/2008 at 13:00) Dear Sama(n)tha,
What it a buffer ? I would consider it as raw material. Therefore depending on the further processing of that material you may set bioburden specification limits at different level but, most likely, the typical 100 cfu/ml. In case of a very fragile process I would recommend you to target the same cleanliness as WFI meaning 10 cfu/100 ml.
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