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May 2011


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Jaymit Patel <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Wed, 25 May 2011 15:03:56 +0530
text/plain (82 lines)
Dear members,


Initial Performance Qualification of Depyrogenation tunnel validation done
by 1 mL, 2 mL, 5 mL, 10 mL, 50 mL and 100 mL vial for Maximum three runs for
each vial.


Incase of revalidation, Is it correct to do Bracketing of the system like
doing revalidation by only Lower (1 mL) and Higher (100 mL) only for maximum
three runs.


If it is correct then please let me know the justification / Rational of
doing the same.




Jaymit Patel

Executive -QC (Micro)


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