Heat seal strength test
ISO11607-2 (Validation requirements for forming, sealing and assembly processes), requires Performance Qualification (PQ) of packaging devices to be carried out and documented. During PQ proof must be provided after sterilization that the process is under control and produces optimally sealed or closed sterile barrier systems.
Verification is being done by means of a heat seal strength test as per EN 868-5. The heat seal strength test is a test which validates the sealing process. By testing the sealed pouches one tests the combination of the packaging material and the heat sealing process. If the results are good, then it can be concluded that he sealing process went well too.
From each seal that needs to be tested, a length of 15mm is being cut. At least one sample of a produced seal seam must be taken from each packaging. In case the length of a seal is more than 500mm, additional samples may be
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