In order to produce acceptable packaging on a daily basis and throughout a determined shelf life validation, it is important to evaluate the strength characteristic. Not only does strength play a key role in a shelf life validation, but it also lets the medical device manufacturer determine that their process for sealing packages is staying consistent to their predetermined specification set in the process validation.
The main culprit for poor package strength is the sealing parameters. If a proper process validation of the sealer is not performed, the medical device manufacturer can expect failure.
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