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Validation Sample Size for Tray Seal

#1
I'm working on a tray seal validation for a sterile medical device. We have already qualified this packaging system on a single nest sealer, but we are moving it to a multi-cavity sealer and it is causing quite a debate about sample sizing.

We are taking 8 peel strength samples from defined locations around the tray and have a nest that can process 4 trays simultaneously. The debate is whether each peel location of each tray should count as 1 sample, or if due to lack independence between sample locations, each "run" of 4 trays really only counts as 1 sample, or somewhere in the middle.

What have you all done to address validation of multiple units per machine cycle and with multiple measurements per unit?
 
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#2
Do you have very good existing variable data on the capability of your existing process? Can you leverage these variable stats to minimize sample size? IMHO: If you sampled 4 locations on your one up sealer and had a sample size for that, you need to do the same on each 4 up. The opportunity here is if you can leverage variable stats to perform a difference test (t test) on the 4 up version. Hope this helps.

Said differently... you should have the same (or better) statistical confidence / reliability in the 4 up as the 1 up. Leverage your experience to get there and potential reduce sample size from the initial one up qualification.
 
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