Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I have a question regarding the 2014 Amendment to ISO 11607 regarding packaging integrity requirements. We currently use creep-to-burst for seal strength and visual peel apart for integrity testing. As per the update to the standard, these two methods are not considered true "packaging integrity tests." The proposed updates are to change creep-to-burst to peel strength and visual peel strength to bubble leak. Can anyone clarify if the standard calls for these tests to be done as in-process tests or as a finished goods criteria?

Any information would be greatly appreciated!

Thank you.

Dear Anonymous,

I just briefly touched this topic in the past, so I am not 100% sure if the standard ISO 11607-1 calls out any specific requirement on this.
When you say 'Peel Test', I guess you refer to seal strength testing per ASTM F88/F88M or EN 868-5?

In-process testing for sealing seam strength (e.g. per ASTM F88/F88M) is something I have seen in many companies to monitor if the heat sealing process  is still in a validated state.

This requirement comes from ISO 11607-2 Section 5.6 .

You can also check AAMI TIR22 section 11.5, which states:

"Establish documented ongoing process control and monitoring. (ANSI/AAMI/ISO 11607-2, 5.6). This typically includes:

1. Monitoring and recording the critical process parameters
2. In process testing of sterile barrier systems in accordance to the quality system."

ISO/TS 16775:2014 states in Appendix A, section A.8.2 that in many cases the sealing seam strength can be used to determine if the sealing process is under control. Further measurements of the sealing seam strength can be used to monitor the manufacturing and ensure that the process is under control. (I just have the DIN version available and translated it quickly to English, so the wording may differ in the ISO version.)

I hope this helps?

Kind regards,
Michael

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Michael Hottner
Köln
Germany
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Original Message:
Sent: 02-Feb-2018 11:07
From: Anonymous Member
Subject: ISO 11607 "Packaging for terminally sterilized medical devices..."

This message was posted by a user wishing to remain anonymous

Hello,

I have a question regarding the 2014 Amendment to ISO 11607 regarding packaging integrity requirements. We currently use creep-to-burst for seal strength and visual peel apart for integrity testing. As per the update to the standard, these two methods are not considered true "packaging integrity tests." The proposed updates are to change creep-to-burst to peel strength and visual peel strength to bubble leak. Can anyone clarify if the standard calls for these tests to be done as in-process tests or as a finished goods criteria?

Any information would be greatly appreciated!

Thank you.