How to Quantify Significant Change for a Shelf Life Stability Test

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Bev D

Heretical Statistician
Staff member
Super Moderator
#12
It's called "two-population hypothesis testing."
just to be picky the term is "two sample hypothesis test"

However, of more importance is that an alternative method may be more powerful: the matched pair test.
in a matched pair test, several test sets are developed where the materials adn processing are all the within each pair EXCEPT the thing that changed. Between 6 and 10 such pairs are created using independent set-ups/processing events. the statistical test to use would be the paired t test.
 
C

coolbreeze

#14
Hello again and thanks for clarifying.

In the context of sterile pouches seal stability - IMO the "significant change" clause is irrelevant. Even seal strength is not too relevant, though it's quite easy to measure and process, and thus tempting :) Of course seal strength has to be above an acceptable minimum, but much more important is the seal barrier (sealing) quality. The best way to demonstrate that is via biological challenge (sterility testing) but since it's a bit expensive and complicated, many start off with mechanical tests such as pressure testing (inflating and looking for pressure drops) and dye testing - each has their pros and cons. I am not aware of 1 comprehensive published standard covering this subject in a very good way - what I've seen is a combination of scattered published test methods, in-house developed test methods, and some (creative?) justifications. You could, though, make some good use of ISO 11607 (probably already are).

Cheers,
Ronen.
How does one determine the minimum acceptable seal strength when an actual failure limit cannot be determined if no failures were present during distribution testing? Although theoretical, is it typical to utilize the vendor's minimum seal strength specification?
 

Sam Lazzara

Trusted Information Resource
#15
I have a completely different angle on this topic. I am not that concerned about percent change, I am concerned about meeting the finished device performance specifications. These specifications should apply to sterilized devices throughout their labeled shelf life. I test devices post sterilization and aging to show they meet those specifications.
 

Ronen E

Problem Solver
Staff member
Moderator
#16
How does one determine the minimum acceptable seal strength when an actual failure limit cannot be determined if no failures were present during distribution testing? Although theoretical, is it typical to utilize the vendor's minimum seal strength specification?
It does make sense to set the vendor's minimum strength spec as a floor value, because there's no point in having one side of the pouch extra-strong while the other 3 are much weaker...

I think that in general focusing on seal strength is detrimental because it diverts one's attention from what's really important in that context - sealing. One could have a perfectly strong weld that is not properly sealed (=useless).
 
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