Labelling of sterile barrier systems (sterilisation pouches)

Hi all,

I was reading an article or standard some time ago that stated sterilisation pouch labels must not take up more than 20% of the paper side, if being labelled on the paper side. A customer has queried why we label the plastic side as they would prefer to have the label on the paper side.

I informed the customer of the "why" we label the plastic side but they have come back and asked for the exact text of the standard.

Question is - where did i see this referenced? I checked ISO 11607-1 but can not see it, or have overlooked it

I am not aware of a (standard) recommendation for a label size on a breathable barrier system and cannot tell you where you saw this referenced. I am assuming that you talk about pouches intended to be subjected to a gaseous sterilant, such as ethylene oxide?

As long as you successfully validate your actual product presentation (including any applied label) to the sterilisation cycle in terms of both efficacy and safety, the label's relative size compare to the pouch size is not limited.

HTH,

You can place your label on either the foil side or the paper side, as long as you provide a rationale during design testing. However, if your product undergoes ETO sterilization, you must ensure that the label does not impact the sterilization process. Additionally, if you choose to place the label on the paper side and intend to conduct a whole packaging test such as a bubble test, it's likely that bubbles may form on the paper side due to the presence of the label. Based on my experience, I recommend placing the label on the foil side of the pouch to mitigate this issue.