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  • 1.  sterile barrier labeling

    This message was posted by a user wishing to remain anonymous
    Posted 31-May-2022 09:50
    This message was posted by a user wishing to remain anonymous

    Hello,

    We have a sterile product which packed with two Tyvek pouches and outer carton box. Both pouches are considered sterile barrier.
    Is it mandatory to label of three levels of packaging?
    The outer carton box will be labeled but we are not sure regarding the pouches, can we label only one sterile barrier, if so which one?

    Thanks!


  • 2.  RE: sterile barrier labeling

    Posted 01-Jun-2022 03:45
    Hello Anon,

    For some medical device products have a double-barrier packaging or pouch is needed or warranted depending on the product type and how it is introduced into the operating theatre or sterile zones.  So it is quite common some products are double-pouched or have two layers of sterile barriers.  In my experience, only the outer packaging would need a label as the inner pouch is used for that introduction into the sterile condition/zone and would not be separated in some other sequence.  What we did in my experience was document in the technical information the packaging configuration (including labelling) clearly describing how it was configured, why it was done that way, and the relationship with the labelling.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: sterile barrier labeling

    Posted 01-Jun-2022 09:20

    The sterile barrier symbol tells the person opening the package when to stop so as not to break the sterile barrier by mistake.

    The standard on symbols has some variations for single and multiple sterile barriers. Make your labeling decision based on providing information for safety to the user.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 4.  RE: sterile barrier labeling

    Posted 01-Jun-2022 11:14
    In scenarios where there is a double Tyvek pouch for the sterile barrier, my understanding is that there is some chance that the inner Tyvek pouch alone isn't wholly sufficient to meet all of the needs for a sterile barrier.  Accordingly, that generally means that the outer Tyvek is the ultimate sterile barrier.

    To understand the labeling requirements for that level of packaging, one needs to be cognizant of the applicable regulatory requirements.  For example regarding Europe's Union, the EU MDR Annex I.23.3 lists various specific information that needs to be on that level of packaging, i.e., on the "packaging which maintains the sterile condition" ('sterile packaging'), a.k.a., the 'sterile barrier'.

    As long as you've clearly justified precisely which packaging level is the one that ultimately maintains the sterile condition, then that becomes a defensible basis for so labeling only that one of the Tyvek pouches, specifically the one that represents the ultimate sterile barrier.

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 5.  RE: sterile barrier labeling

    Posted 02-Jun-2022 03:51

    The Sterile Barrier Association has established guidelines for the use of the symbols

     https://sterilebarrier.org/wp-content/uploads/2021/10/SBA-Box-scaled.jpg

     https://sterilebarrier.org/wp-content/uploads/2021/06/QA-Symbols-document-for-healthcare-professionals-210521-v2.0.pdf

     Videos Archive - Sterile Barrier



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    Frits van Gastel
    Director of Regulatory Affairs
    5804AR
    Netherlands
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    Original Message


  • 6.  RE: sterile barrier labeling

    Posted 02-Jun-2022 11:10
    Edited by Kevin Randall 02-Jun-2022 11:11
    Many thanks Frits for providing the Sterile Barrier Association (SBA) documents.  They are very helpful and informative, especially their demonstration and reminder about the various barrier system symbols prescribed by EN ISO 15223-1 (as amended) (hereinafter "15223-1").  That said, I'd like to add a few observations:

    1. Sterile barrier labels may be required to contain additional information not included in the SBA models, and/or that might not be appropriate for conveyance as a symbol(s).  Accordingly, I advise everyone not to limit the content of a sterile barrier label to just a symbol(s).  For example, Europe's EU MDR requires that the sterile barrier label include a description of the device, whereas the SBA models and 15223-1 don't appear to address such additional required information or symbology.
    2. Certain 15223-1 symbols shall be accompanied by corresponding information.  For example, the 'Batch code' symbol shall be accompanied by the batch code adjacent to the symbol; the 'Date of manufacture' symbol shall be accompanied by a date; the 'Use-by date' symbol shall be accompanied by a date; the 'Lower limit of temperature' symbol shall be accompanied by an indication of the lower limit of temperature adjacent to the lower horizontal line; and so on.  Consequently, if the symbols are used in the floating/orphaned manner illustrated in the SBA documents, then that would constitute a nonconforming label.  Therefore, I would advise everyone to be sure that the 15223-1 symbols are used in the way prescribed by 15223-1 rather than in the way modeled by the SBA documents.
    3. The SBA models don't include all of the symbols that would be required by 15223-1.  For example, the SBA models don't yet include the 'Manufacturer' symbol required, for example, by the EU MDR.


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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 7.  RE: sterile barrier labeling

    Posted 03-Jun-2022 02:42

    Thanks for the addition, Kevin.

    Indeed, the SBA documents are only about the symbols to identify the sterile barrier and not about the other labeling requirements.

    The symbols have been developed to meet the related identification requirements of the European Medical Device Regulation (EU) 2017/745.



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    Frits van Gastel
    Director of Regulatory Affairs
    5804AR
    Netherlands
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    Original Message


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