Test Method Validation requirement in 11607-2

[Luis_777]

Hello guys, new to the forum!

I'm in the process of doing a validation plan for a Tray Sealing Process (PETG and Adhesive Coated Tyvek). I'm reviewing the requirements in ISO 11607-2: 2019, section 4.4.3 indicates "All test methods used to show conformity to this document shall be validated and documented by the laboratory performing the test. NOTE Annex B of ISO 11607-1 contains a list of test methods. Publication of a method by a standards body does not make it validated in any laboratory."

We plan to do Peel Strength Test per ASTM F88/F88M−21 and Visual Inspection per ASTM F1886/F1886M−16 as acceptance criteria.

1. The way I read the standard it pretty much says that you have to perform TMV, referencing the standard is not enough, is this correct? Have you had experience in which a rationale was acceptable?
2. Does anyone have experience performing TMV for Visual Inspection and Peel Strength any examples you can provide in sample size and defects generated?, I think I need quite a little bit of guidance on the Peel Strength as this is a destructive test.

Any inputs are appreciated, thanks!

 

[chris1price]

I would recommend doing the TMV, this is probably easier than trying to argue why its not required. Whilst in principal you might be following the standard, there may be variation in the way samples are cut and how they are loaded into the tensile tester. This should be captured in a gauge R&R study. The appendix in ASTM F88 gives information on methods and sample size. If you are doing a visual inspection follow the AAIG methods for attribute measurement systems.

 

[planB]

In addition to what chris said:

- A rationale for not doing a TMV might most probably not be accepted because ISO 11607-1:2019 is very clear about this requirement especially in section 4.4.3;
- You may also want to consider performing a further "whole-package integrity" test (e.g. bubble emission) in addition to your already planned "seal integrity" test (peel strength);

HTH,