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  • 1.  Sterile components-Labeling

    This message was posted by a user wishing to remain anonymous
    Posted 15-Sep-2020 09:40
    This message was posted by a user wishing to remain anonymous

    Hi there,

    If a device has components that are sterile and within a sterile barrier, but are within a final device that is not asceptically processed or terminally sterilized, how is this expressed on labeling?


  • 2.  RE: Sterile components-Labeling

    Posted 16-Sep-2020 03:10
    Hi Anon, 

    The finished product is a system that contains different parts or you combine different devices together in a single pack?
    If the device is a system which is not sterile as a whole and not packaged in a sterile barrier, then it cannot be stated as sterile on the packaging.

    If you have different packages inside the final packaging system, then maybe you can add the sterile symbol in the inner packages.

    Depending on the situation it must be clearly stated in the IFU and also in the technical documentation.

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    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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    Original Message


  • 3.  RE: Sterile components-Labeling

    Posted 16-Sep-2020 04:31
    Hello,

    Agree with what Spyros said you can not claim sterile for the whole pack or put a symbol on the whole packaging if there is only one part which is sterile.  The only way a sterile claim (and symbol) can be put on is directly on the package which is sterile.  You can have a "kit" label on the next packaging level which could indicate contents of the pack/kit/box which could indicate what is sterile.  However, it would only be on the direct sterile package/pouch where the sterility claim could be made.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Sterile components-Labeling

    Posted 16-Sep-2020 07:39

    It is not clear how this would be described without more details, but I would assume that the sterile portion has some reason for being sterile.  It may be that you need to describe the function of the component that is sterile rather than the whole device?

    The only type of product that has a qualifier that comes to mind are those product where the drug fluid path is sterile, but the entire device is not.  Infusion sets are sometime labeled as having a "Sterile fluid path". 

     

     

    Lee




    Original Message


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