Worst-case Sealing device selection

[erdal88]

Hello together,
We are about to produce samples for MDR.(Transport and stability tests.) But we have 4 equivalent sealing machines. 1 of them has been using for a long time(old one) but the other 3 devices are newly purchased. (3 of them are used for sealing validation, not for serial production.) So for the MDR sample production do we have to determine the worst-case sealing machine ? If so, since one of them is the old one, may I choose it as the worst-case machine? Or let's say, I produced some samples for every machine and perform seal strength test for each of them and use the data to determine if there is any difference between the sealing machines via statistical analysis.

I am looking forward to hearing your valuable feedback.

Thanks in advance.

 

[planB]

You state that you have 4 equivalent sealing machines - so actually you should not have a worst-case sealing machine, no matter how old or new your equipment is. Comparative seal-strength testing at lower, upper and nominal process parameters, as you propose, would be a way to support your conclusion on sealer equivalence.

ISO 11607-1:2019, section 8.2.2. and the note therein say the following on transport/performance testing, also with respect to newly introduced sealing equipment:

8.2.2 Performance testing shall be conducted on packaging systems comprised of the worst-case sterile barrier system as well as the worst-case protective packaging.
NOTE It is not necessary to redo performance testing when new sealing equipment with equivalent sealing technology is introduced, [...]

So for performance testing, the focus is on the "worst-case sterile barrier system", which typically implies sealing at lower process limits.

For stability testing, there is no such worst-case requirement for sealing the samples, but a similar note in section 8.3.6:

NOTE In a similar way, it is not necessary to redo stability testing when new sealing equipment with similar sealing technology is introduced, provided the sealing process is validated and capable of producing seals that meet the specifications of the packaging which was used for the prior documented stability testing.

Bottom line of these two notes: as long as your four sealers have undergone IQ, OQ, PQ and have been demonstrated to produce packages according to the very same specification, you could use either sealer for manufacturing samples for performance and stability testing. Using your "worst" sealer within this framework (if applicable) would be a conservative approach, that especially your notified body might like to see, even though the standard does not explicitly require this.

HTH,

 

[erdal88]

Hello PlanB. Your valuable feedback is highly appreciated it. Thank you very much.
Maybe I can use the seal strength data from the previous validation study for each sealer in order to see if it is possible to find a difference in regard to the "mean and also standard deviation" of the data. If I have any conclusion in terms of worst-case sealer, I can use that sealer: Lower parameter usage for transport testing and nominal parameters for stability testing.