RE: bioburden validation Contribution from Archana written on 9/27/2008 at 17:09
Original contribution: bioburden validation written by samatha on 9/25/2008 at 13:00) You should definitely consider the storage condition and the hold-time as well as the expiry date of the in-process buffers.
If your product prone to some kind of protease activity then bioburden specification for in-process buffers should be eqvivalent to WFI.
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