Hello, I am wondering if anyone has experience with the Storage and Distribution challenge testing required for package validation work. Is there any specific testing required to comply with package validation requirements of the QSR?

We have been running new products through the ASTM D 4169-05; Performance Testing of Shipping Containers and Systems. I am often asked whether this kind of rigorous testing is necessary or whether it is really necessary to be compliant.

Any thoughts?

Hello, I am wondering if anyone has experience with the Storage and Distribution challenge testing required for package validation work. Is there any specific testing required to comply with package validation requirements of the QSR?

We have been running new products through the ASTM D 4169-05; Performance Testing of Shipping Containers and Systems. I am often asked whether this kind of rigorous testing is necessary or whether it is really necessary to be compliant.

Any thoughts?

Our understanding is that such validation is required for both FDA and 13485/MDD, for sterile-barrier-packaged medical devices. Our largest worldwide customer shares that view, and so does our NB. The FDA has applied that requirement since at least 1983 via older guidances. Within the timeline of the current version of 21CFR820, Section 130 states: "Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling and distribution." The FDA recognizes ISO 11607 as a Consensus Standard for that aspect of product and process control.

We spend a lot of money with a particular packaging performance test lab, implementing those aspects of ISO 11607 validation that we are unable to perform in-house, or for which third party evidence is appropriate. We also devote a lot of engineering hours to in-house aspects of this validation work.

Thank you for the reply, and thank you for the second opinion. That's exactly how I read it too, but it's good to know I'm not alone when the question keeps coming up.

Part of the problem is that we occasionally have failures in package integrity testing following the rigorous distribution simulation so of course, the development team may ask "well is that kind of distribution testing really necessary." To which my answer has always been YES!

Another question though along those lines, what is your acceptance for the package integrity testing (we use dye penetration). Do you accept any failures or is 1 failure enough to fail validation.

Any other thoughts on using this test method? Anyone do something different to fulfill this portion of the QSR? :confused:

Another question though along those lines, what is your acceptance for the package integrity testing (we use dye penetration). Do you accept any failures or is 1 failure enough to fail validation.
The extensive list of ASTM standards "methods" listed in ISO11607 Appendix B often contain guidance on acceptance criteria. Obviously if your packaging is also your sterile barrier system your acceptance range is going to change quite markedly.
:soap:<sanctimonious sermon warning>
IMHO you should never detect a sterile packaging seal failure using routine testing (failure should be gross failure), and if you do, you have to look at reprocessing the batch as the implications of loss of sterility are too great (packaging also has to support the SAL of 10 x-6, so one failure in a million maximum).

If you are testing to destruction then you need to set your acceptance based on realistic handling conditions, and try to ensure that "damaged" packaging is self-evident in its failure mode (11607: 5.1.10) that way there is no risk of your customer receiving and using an breached package in error.

jimmy