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  • 1.  Sterilization via filtration and aseptic fill

    This message was posted by a user wishing to remain anonymous
    Posted 14-Feb-2020 14:01
    This message was posted by a user wishing to remain anonymous

    Reg Ex Community,

    Can you tell me how I demonstrate by objective fact that my finished antimicrobial wound cleanser is sterile, and I can support the sterility claim in my FDA 510(k) filing?  The manufacturing method uses filtration and subsequent aseptic fill into a BFS container.

    Do I measure the CFUs after bulk blend then USP <71> on the final, finished device?  Can I use USP <61> to potentially show 6-log reduction?  

    Any advice would be appreciated.

    Thank you!

    Anon


  • 2.  RE: Sterilization via filtration and aseptic fill

    Posted 17-Feb-2020 05:20
    Check out standards ISO13408 parts 1 & 2. Demonstrating sterility assurance levels is a bit more complicated for aseptic filling than for terminal sterilisation methods. I haven't had experience of submitting data for 510(k) for aseptic products so aren't sure exactly what is required by the FDA (my experience is more EU-based) but these standards should tell you all you need to know on how to validate this process correctly.

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    John Walters
    Wells
    United Kingdom
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    Original Message


  • 3.  RE: Sterilization via filtration and aseptic fill

    Posted 17-Feb-2020 09:06
    Good morning,

    The FDA has a guidance on aseptic filling for drugs/biologics - https://www.fda.gov/media/71026/download.
    While I recognize that your product is a device, it would seem most likely that the same principles would apply.  There is discussion there about what sampling and testing should be performed to demonstrate suitability of process and sterility.

    Good luck!

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    Bobbi Drais RAC
    Owner, Principal
    Fort Worth TX
    United States
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    Original Message


  • 4.  RE: Sterilization via filtration and aseptic fill

    Posted 18-Feb-2020 02:58
    Hi Anon,

    Please check ISO 13408-1 & 2. You have to validate the sterilizing filtration method according to these standards (filterability, extractables, integrity, bacterial challenge etc).
    PDA have also issued a guidance which can help you.
    Sterility testing is not reliable. You have to prove the effectiveness of the sterilizing method.

    Hope that helps

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


  • 5.  RE: Sterilization via filtration and aseptic fill

    Posted 18-Feb-2020 04:04
    Hi,

    USP<61> is about microbial quality of non sterile products and microbial enumeration tests, so may not be of much use here.
    Wherever BFS technology is used for aseptically treated products, a summary of the validation data should be provided to confirm that the container produced is sterile. Validation data using a biological indicator of suitable resistance to demonstrate a SAL of ≤10-6 for the surface of the container.

    End product has to be checked for sterility for sure, but to prove process effectiveness, achieved SAL should be provided.

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    Deepa Dasgupta RAC
    Director
    Hyderabad
    India
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    Original Message


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