EN 868-5:2018 Annex E - Peel Test

[erdal88]

Hello together,

According to EN 868-5:2018;
Slowly and carefully peel the seal apart by hand. Visually check that the seal extends along the total width and length of the intended seal area and that there is no splitting of the paper outside the seal area towards the inside of the pouch and/or reel.

So the question is; the sealing seam which stated below can be accepted or rejected according to the standard ? (Only downside of the seal is sterile area.) There are tiny tyvek residuals observed after the sealing process onto upside and downside of the seal seam. The seal is intact and passed from the tests.(Seal strength, seal seam measurement, dye penetration etc.)

Thanks in advance.

 

[planB]

erdal,

some questions:
1) Do you observe particles at sealing ("tiny tyvek residuals observed after the sealing process") or at peeling the seal open (related to the standard clause you cite)
2) What does your photo actually show: a sealed or a peeled area?

Generally
- particles generated when opening a sterile barrier system should be avoided.
- if particles cannot be avoided you have to demonstrate that these do not adversely affect the safety and performance of your packaged device.

HTH,

 

[erdal88]

Hello,

Thank you for the reply.
I did not observe any tyvek residuals on the sealing area. The picture shows the peeled area and red-lighted area on the seal kept after peeling off the seal. And the tiny Tyvek residuals are embedded in the foil so they are not classified as particles technically.

 

[Zero_yield]

This looks like extremely minor delamination. Especially if you're passing dye penetration testing, there's no risk to the sterility of the product, assuming you're sterilizing after sealing. Small fibers (a few mm) are completely normal. Are you sealing at >270 degrees F?

I'm assuming this seal is not the one opened by the customer (i.e., there's a chevron at the other end sealed by the pouch vendor)?

 

[erdal88]

Hello,

In the normal processes in production, ETO sterilization is performed on the products after the sealing. The pouch type is stated below. The chevron side is sealed by the supplier and the bottom of the pouch is sealed by our company. The pouch is the foil to Tyvek.(CR2773/35721-K) As the sealing device, I used HAWO HM-8000. The sealing parameters are:

 

[Zero_yield]

If I was doing this peel test, I would pass this seal without question.

 

[erdal88]

Thank you for the feedback.