Regulatory Open Forum

 View Only
  • 1.  Gamma sterilization documentation requirements

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jun-2023 08:03
    This message was posted by a user wishing to remain anonymous

    Hello everyone,

    My question is with regard to a proposed change in sterility of a reusable stainless steel surgical instrument. Currently it is being offered in the EU and the U.S. nonsterile for reprocessing by the user. We are exploring the possibility of marketing a sterile version, to be reprocessed (cleaned and sterilized) by the user after first use and after every subsequent use.

    We have been in contact with several suppliers of packaging and Gamma sterilization services, but the documentation they are willing and/or able to provide for inclusion in our TD/DHF seems to differ.

    To our understanding, we would need the following documents:

    1.       The contract packager's ISO certificate for contract packaging services for sterile devices

    2.       Summary report of cleaning validation

    3.       Summary report of packaging validation

    4.       Shelf life validation report, including a discussion of the accelerated and real-time aging procedures and testing.

    5.       The sterilization establishment's  Performance Qualification report including dosimetric results for our product and packaging and defining the validated parameters.

    6.       The packager's microbiological performance (re)qualification of the gamma radiation sterilization process.

    7.       For the FDA of course company registration and listing of both the packager and the sterilization provider.

    8.       At a later date we would require the sterilization records for each batch, including the purchase order, irradiation certificate and delivery note.

    Am I missing anything here?

    Also, would item number 6 need to be performed on our product or would the packager's routine testing report for a similar „worst case" product with identical packaging specifications suffice? And is it the packager's responsibility to provide this or should we have it done ourselves?

    Thank you for any pointers or suggestions!

  • 2.  RE: Gamma sterilization documentation requirements

    Posted 04-Jun-2023 03:07

    Hello Anon,

    There are quite a few considerations which need to be made for your example, including the specific type of device, because even reusable surgical instruments can have some differences.  In general, the list of documents you made sounds fine, but there also may be many others which need to be made available or obtained.  Sterilisation validation is a complex process with many aspects involved.  You might want to seek some expert advice to go through the process in detail to ensure all considerations have been made.  Already you are experiencing the complexity of these processes in contacting different suppliers providing differing documentation.  Sorry, for not providing more succinct information, but the information your are requesting is deep and broad which would be more than a forum response.

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

  • 3.  RE: Gamma sterilization documentation requirements

    This message was posted by a user wishing to remain anonymous
    Posted 05-Jun-2023 09:32
    This message was posted by a user wishing to remain anonymous

    Thank you Richard, for taking the time to respond! That is very helpful. 

  • 4.  RE: Gamma sterilization documentation requirements

    Posted 06-Jun-2023 13:09

    Answer to point 6 -

    For the packager's microbiological performance (re)qualification of the gamma radiation sterilization process, the general approach is to perform testing on identical items rather than the exact device that will be distributed. This means that you would typically test multiple units of the same product or packaging configuration to assess the sterilization process's effectiveness.

    The rationale behind using identical item testing is to ensure that the sterilization process consistently achieves the desired level of microbial reduction across a batch or lot of products. By testing multiple units, you can evaluate the process's performance and confirm that it consistently meets the required microbial reduction standards.

    adding some post sterilization package testing  ISO 11607. 

    • Package system performance testing / Distribution simulation
    • Stability testing / Shelf-life study
    • Package system integrity testing

    You should also be aware that testing can include:

    • Visual inspection test
    • Peel strength test
    • Burst test
    • Dye penetration test
    • Creep test
    • Bubble emission test

    I agree with Richard as this sterilisation is a important step good to engage microbial testing lab do a complete testing plan and then proceed.

    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    3470 Superior Court
    Oakville ON L6L0C4