ISO 11607-1 Packaging System - Temperature and shipping conditioning

#1
We are preparing samples for a packaging system validation. Packages will be produced at worst case settings. Subjected to 2X sterilization (shipped to a contract sterilizer on a pallet). Then packaged for distribution and subjected to temperature and shipping conditioning. Afterwards we'll perform package testing on real time and accelerated aged samples.

The question I was asked and and what I am looking for feedback on is should we perform temperature and shipping conditioning on the sterilization load and well as the final shipper?

thanks
 
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Ronen E

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#2
Any conditioning should be representative of real-life conditions. You need to analyse the risks first.

Cheers,
Ronen.
 

normzone

Trusted Information Resource
#3
UPS and FedEx are the shock-and-vibe of the real world - If it passes those tests that's a good sign. I've seen products pass mil-spec tests and fail to survive common carriers.
 

Ronen E

Problem Solver
Staff member
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#4
UPS and FedEx are the shock-and-vibe of the real world - If it passes those tests that's a good sign. I've seen products pass mil-spec tests and fail to survive common carriers.
The problem with this approach is that you never know what they actually went through on any given run. Was it the worst case? Was it the average? Maybe neither?

If “mil spec” is not representative (of either average or worst-case) then it is a matter of choosing a stricter standard, and if no published standards are sufficient maybe a custom designed test is called for.

And, most important, it’s not a one-size-fits-all situation. A given test may be extreme or adequate for one product and totally irrelevant for another. That’s why the main point is to first understand the vulnerabilities of the product (or the packaging, depends what you’re trying to validate, but the principle is the same); then asses the risk factors concerning the identified vulnerabilities (and not some other “standard”, maybe irrelevant factors) while the product is en-route, then try to simulate either a “representative” or a worst-case test-scenario, without introducing other factors that aren’t in the real-life scenario(s).
 
#5
Let's assume that one needs to test worst case environment and transportation conditions to the sterilizer. What about the return trip? Is there anyone out there that is subjecting their sterilization loads to D4169 (or ISTA) one or two times then testing their shippers to D4169 again?

Say I tested a pallet to DC 6 with no stacking, and a shipper to DC 13. There is a lot of overlap in the testing. Does the testing to DC 13 sufficiently cover it all?
 
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