Regarding 7.5ml, 15ml & 30ml vial presentation, how many media fill run to be conducted ? Is it required to conduct 03 run for each presentation or it can be reduced through matrix/bracketing approach ?
Hello!
Yes, it can be reduced through matrix/bracketing… but the rationale to do that must come from a risk based approach understanding how these different presentations could potentially add up different risks for vial contamination.
For example: if 30ml vial has a wider neck, and a longer period of time where it is exposed to the environment until sealed… that represents a higher risk for viable particles to end up into the vial. Or 7.5ml vial may have a higher line speed that could required a higher frequency of interventions.
These are just examples, not applicable to all situations. Current regulatory expectation is that you approach this with a risk based decision to justify the presentations or define the bracket you intend to test during media fills.
You can read more about this in PDA technical reports 22 and 44; there is also a very interesting report by Tim Sandle “A Risk Matrix Approach for Media Simulation Trials”.
I hope this helps.
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