Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone,

does someone know or has someone experiences with how to use the sterile barrier system symbols acc. to  ISO 15223-1:2021 correctly?
Is it correct/allowed to use two types of sterile barrier symbols for one product or not?

The product concerned is a single use sterile product inside of a sterile barrier (primary packaging) and covered by a protective secondary packaging (carton).
Several sterile primary packaged products are inside of one protective secondary packaging.
The sterile system was validated with the secondary packaging.

So in case several symbols could be used for one product, this symbol has to be applied on the protection packaging:

And on the sterile barrier packaging (primary packaging in contact with the device) this one:



We discussed if it is required to use one sterile barrier system symbol for all packaging levels as the definition of those symbols concerns whole sterile systems.
So, in case of a single barrier system with protective packaging outside, symbol 5.2.14 shall be used on both, the protective packaging (secondary packaging) and the actual sterile barrier (primary packaging) inside of the protective packaging.

So what is correct?
Using both symbols depending on the packaging level or only one symbol which represents the whole packaging system on all packaging levels?


Thank you very much in advance!

Dear Anonymous,

On the website of the Sterile Barrier Association (SBA,) www.sterilebarrier.org , you will find some guidance documents Documents Archive - Sterile Barrier and instruction video's Videos Archive - Sterile Barrier

------------------------------
Frits Gastel
Director of Regulatory Affairs
5804AR
Netherlands
------------------------------

Original Message:
Sent: 27-Oct-2021 05:09
From: Anonymous Member
Subject: Interpretation of sterile barrier symbols of ISO 15223-1:2021

This message was posted by a user wishing to remain anonymous

Hello everyone,

does someone know or has someone experiences with how to use the sterile barrier system symbols acc. to  ISO 15223-1:2021 correctly?
Is it correct/allowed to use two types of sterile barrier symbols for one product or not?

The product concerned is a single use sterile product inside of a sterile barrier (primary packaging) and covered by a protective secondary packaging (carton).
Several sterile primary packaged products are inside of one protective secondary packaging.
The sterile system was validated with the secondary packaging.

So in case several symbols could be used for one product, this symbol has to be applied on the protection packaging:

And on the sterile barrier packaging (primary packaging in contact with the device) this one:



We discussed if it is required to use one sterile barrier system symbol for all packaging levels as the definition of those symbols concerns whole sterile systems.
So, in case of a single barrier system with protective packaging outside, symbol 5.2.14 shall be used on both, the protective packaging (secondary packaging) and the actual sterile barrier (primary packaging) inside of the protective packaging.

So what is correct?
Using both symbols depending on the packaging level or only one symbol which represents the whole packaging system on all packaging levels?


Thank you very much in advance!

This message was posted by a user wishing to remain anonymous

The SBA guidance as noted in the previous response is helpful; however, as noted in that guidance, this starts with packaging design.  Assuming you designed and tested the protective packaging as just that, then following SBA guidance, the single sterile barrier system symbol would go on the primary package, and the single sterile barrier system with protective packaging outside would go on the secondary package.  You just need to be sure your levels of packaging and their function are properly defined and tested.  There are some graphics in the SBA guidance that show point-of-use impacts  (where product can and cannot be handed off aseptically into the sterile field), which would also be part of that packaging design/usability documentation.

Good luck!
Original Message:
Sent: 27-Oct-2021 05:09
From: Anonymous Member
Subject: Interpretation of sterile barrier symbols of ISO 15223-1:2021

This message was posted by a user wishing to remain anonymous

Hello everyone,

does someone know or has someone experiences with how to use the sterile barrier system symbols acc. to  ISO 15223-1:2021 correctly?
Is it correct/allowed to use two types of sterile barrier symbols for one product or not?

The product concerned is a single use sterile product inside of a sterile barrier (primary packaging) and covered by a protective secondary packaging (carton).
Several sterile primary packaged products are inside of one protective secondary packaging.
The sterile system was validated with the secondary packaging.

So in case several symbols could be used for one product, this symbol has to be applied on the protection packaging:

And on the sterile barrier packaging (primary packaging in contact with the device) this one:



We discussed if it is required to use one sterile barrier system symbol for all packaging levels as the definition of those symbols concerns whole sterile systems.
So, in case of a single barrier system with protective packaging outside, symbol 5.2.14 shall be used on both, the protective packaging (secondary packaging) and the actual sterile barrier (primary packaging) inside of the protective packaging.

So what is correct?
Using both symbols depending on the packaging level or only one symbol which represents the whole packaging system on all packaging levels?


Thank you very much in advance!