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Hello everyone , this is my first post to a forum that I have utilized as a resource for many years. I am glad that I found this site when I did and appreciate all of the people that make this site what it is. Enough of the praise and onto the questions.
I am working on a Shelf Life Stability study for a new pouch that is is used to package terminally sterilized medical devices. I am wondering how to quantify a significant change in material and seal properties? The vendor supplying the pouches has stated that the change in material or seal properties would have to be higher than 25% to be considered significant. Their acceptance criteria statement reads "Historical data and industry references would suggest that a change of more than approximately 25% is a guideline for the determination of a relevant change in the properties of the material."
Does anybody know where I could find these industry references?
Also, how is your company quantifying this significant change?
I have never seen anything like this in any standard or other reference material that I have read and any suggestions would be greatly appreciated.
Thanks,
Coolbreeze
I am working on a Shelf Life Stability study for a new pouch that is is used to package terminally sterilized medical devices. I am wondering how to quantify a significant change in material and seal properties? The vendor supplying the pouches has stated that the change in material or seal properties would have to be higher than 25% to be considered significant. Their acceptance criteria statement reads "Historical data and industry references would suggest that a change of more than approximately 25% is a guideline for the determination of a relevant change in the properties of the material."
Does anybody know where I could find these industry references?
Also, how is your company quantifying this significant change?
I have never seen anything like this in any standard or other reference material that I have read and any suggestions would be greatly appreciated.
Thanks,
Coolbreeze