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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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William55401

Quite Involved in Discussions
#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.
 

SylvieS

Starting to get Involved
#3
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?

... did you have an answer - I am facing the same issue currently. My initial assumption is that counting each cavity as a sample will not provide me sufficient confidence of quality within a batch - but I can't seem to explain it statistically.
 
#4
I never got a satisfactory answer, but the approach I took was to base the sample sizing on the number of sealer runs, but then to sample tray/peel locations randomly from within each run (I did three, but somewhat arbitrarily). That gave us an overall peel strength sample size of 59 * 3 = 177 rather than the 59 * 4 * 8 = 1888 samples it would have taken to measure every location of every cavity.

The idea with the approach we took being that if all the stats pass, then the cavities must be similar enough (or at least not different enough relative to the spec limits). I don't know for certain that it is statistically kosher, but it kind of makes sense in my head and hasn't raised any flags with auditors so far. If it didn't pass, we would have then supplemented with a peel strength test from one randomly sampled location from each cavity of each run and analyzed each cavity in isolation.

I also did an on the side analysis for my personal amusement to see if I could map strength values across the whole nest. I did find (weakly at the number of samples I had) that one area of one cavity generally had the highest seal strength, and a particular position in two cavities tended to have the lowest peel strength across each sealer run. Based on that, I rolled out control charts using those 3 locations plus 2 more randomly as our ongoing process monitoring samples. So far so good on that front as well.
 
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