Hello Anon,
When applying the symbols for sterile barriers, always look at it from the users perspective. As in your example, if the carton box has a solid line that would indicate the carton is the sterile barrier. The label should have the symbol directly on the packaging levels where the sterile barrier is applied. This is a fairly newer symbol so many single barrier packaging does not yet have this symbol. There are some white papers and other information provided by sterilisation industry groups which explains further how these symbols can be applied to different packaging configurations.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 10-Jul-2023 10:31
From: Dan O'Leary
Subject: New labeling for sterile barriers
The problem is that in opening a package with multiple levels of packaging, one must stop, initially, at the sterile barrier. Without the symbol, the package opener doesn't know where to stop.<o:p></o:p>
<o:p> </o:p>
Consequently, the symbol should appear on the sterile barrier only. Putting it on the outer packaging implies that the outer packaging is the sterile barrier.<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 10-Jul-2023 05:05
From: Anonymous Member
Subject: New labeling for sterile barriers
This message was posted by a user wishing to remain anonymous
The new labeling standard includes detailed icons for showing the sterile barrier configuration (solid lines and dashed lines as appropriate).
It is very clear that the sterile barrier itself should have an appropriate icon detailing the configuration, but what about the outer package?
For example, if the sterile package includes a single barrier in the form of a blister with Tyvek (i.e. requiring an icon of a single solid line), should the carton box holding it present an icon of a single solid line too? No icon at all (just stating that it is sterile)?
Thanks in advance for your help!