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Setting flexible packaging specification limits

#1
We are using a heat sealed flexible pouch to vacuum package a product. We're using ASTM testing standards to characterize puncture strength, tear strength, and abrasion resistance.
How does one set / justify a specification limit for a heat sealable metallized film material? for instance, for the puncture resistance, is there a rule of thumb that for certain applications (this one is a medical device) the material should resist X newtons at puncture failure? tear strength should be R newtons for ease of opening? abrasion resistance >N cycles rub testing?

I'm looking for a way to draw a link between real world transport and use and the standards. I am appreciative of any feedback.
 
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indubioush

Quite Involved in Discussions
#2
You need to tie this back to your risk analysis. What would be the sequence of events and hazard associated with a punctured pouch? Is this even a foreseeable event? What do you expect your pouch to undergo in the real world in a worst case scenario?
 
#3
We have a pretty comprehensive risk analysis we're working from. these will be carried in the field and will also need to test to MIL-STD shipping standards.
I am trying to draw some correlation between real world handling and how that relates to ASTM testing. for instance, the pouches are vacuum sealed and form fitting, so how can I relate that to results that come from a standardized puncture test fixture and similarly for other tests.
 

indubioush

Quite Involved in Discussions
#4
I am trying to draw some correlation between real world handling and how that relates to ASTM testing.
Exactly. If you can't draw a correlation between what happens in the real world and the testing you will be doing, you need to ask yourself whether the testing is value added.
What ASTM testing standards are you referring to? Also, when you characterize something, that does not necessarily mean you will be developing a specification right away. You need to determine and document your product requirements based on customer requirements and regulations, not some "rule of thumb" that you heard from somewhere.

For example, like you stated, you could have a requirement regarding the ease of tearing open a pouch. Your design input truly can be "pouch must be easily opened by users." So then you do a characterization study where you test the tear strength of various materials and evaluate the ease of tearing each, both by hand and by measuring the force on an instrument. This could lead to the design output that describes the material to be used for your pouch. Hope that helps.
 

Tidge

Trusted Information Resource
#5
In the case of ASTM standards, you can reach out to the members of the responsible committee to discuss with them the applicability of any particular standard. It is possible that a member may direct you to other (more appropriate) standards.

If there is a "standards gap" relating to a material, process or product... standards committees can get very excited!
 
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