Equivalent Sealing Technology Argument - ISO 11607-1

[Portico]

We run two (2) form-fill-seal lines for sterile barrier packaging. The two machines are of the same manufacturer, but different models (older vs newer). We have packaging performance data (per ISO 11607-1) on pouches from Machine 1. We used the NOTE in ISO 11607-1 8.2.2 that states that it is not necessary to repeat performance testing for equivalent sealing technology to justify not performing performance tests on pouches from Machine 2. We have an auditor who is asserting that the NOTE does not apply because of a slight difference in the nominal sealing temperature between Machine 1 and 2. The sealing temperature parameter tolerance ranges actually overlap. Apparently the different temperatures were derived based on idealization of Cpk for each machine.
I have drafted a response that justifies equivalent sealing technology based on the following:

• Same top/bottom films
• Same tooling / die used interchangeably on both machines (depending on line schedules)
• Same process sequence on each machine
• All other parameters for sealing are identical between the machines
• OQ and PQ met the same specifications for seal strength, seal width, forming dimensions, visual inspection, etc...

In my mind this should be enough to establish equivalent sealing technology in the spirit of ISO 11607-1. Is there anything I might be overlooking / misinterpreting?

 

[Chrisx]

It would seem to me that the difference in nominal sealing temperature is not what is important here. What is important is whether there is a significant difference in seal strength between the two machines. If machine 2 is significantly weaker then it might fail performance testing. An ANOVA or t-test might be additional data to support the machines are equivalent. I can't guarantee this rationale will convince the auditor, but it makes sense to me.

 

[Ronen E]

Side note - It's possible to get a very strong seal with poor sealing properties. Sterile barrier strength testing with no/minimal leak testing is inferior for establishing seal performance.

 

[Portico]

Side note - It's possible to get a very strong seal with poor sealing properties. Sterile barrier strength testing with no/minimal leak testing is inferior for establishing seal performance.

Good point.. we have an in-house validated dye leak test for seals that can be added to the visual inspection for seal integrity.