Package Testing Q&A
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Asked October 8th, 2009
Unfortunately, there is no guidance on a minimum specification required for the strength of a package. The underlining criterion is whether the sterility has been breached or not. Your most economical package design will probably be the lowest achievable peel strength value that does contribute to the breaching of the package’s sterility.
It is left up to the medical device manufacturer to determine the acceptable minimum value. Some things to consider when determining this minimum value are the weight and shape of product itself and the material substrate of the package.



