RE: Aseptic Process
Contribution from Mike Edgington written on 7/11/2006 at 14:19
Original contribution: Aseptic Process written by Sudhir Kulkarni on 6/21/2006 at 17:32)
It is rceognised that some filling process do generate particles. This is sufficient justification to ommit non-viable particle monitoring during filling. See section 5 of annex 1 the example given is for live virus vaccines but it may be applicable to other products.
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