Duplicate Band Sealers



Due to an audit, our company has to redo our band sealer OQs and PQs.
The previous qualifications did not include a PQ, and were missing some components for the OQ (bubble leak/dye testing).
We have roughly 15 sealers (5 of type U and 10 of type D) and many pouches that we have sorted into 5 material groups.

For the OQ I proposed we demonstrate equipment equivalence to narrow our scope.
For example:
Using historical evidence I will justify that all 5 U-type sealers are equivalent to each other and all 10 D-type sealers are equivalent to each other.
I will then pick 1 U-type sealer and 1 D-type sealer and test the high and low conditions for each 5 material groups on each sealer.

I will conclude that because the sealers are functionally equivalent, the results from U-type sealer #1 can be applied to U-type sealers # 2-5, and the results from D-type sealer #1 can be applied to D-type sealers #2-10.

I will follow the same logic for the PQ, doing 3 runs on U-type sealer #1, and D-type sealer #1 and applying the results across to the rest of the sealers.

Alternatively, some people on our team want to test the high and low conditions for all 5 materials on all 15 sealers, which increases the scope significantly.

For background, we have used these sealers for many years and have produced thousands of lots with millions of individual pouches that meet our seal strength requirements.

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