Stability Community

 View Only

  • 1.  Is punctured vial stability a requirement for multi-use vials?

    This message was posted by a user wishing to remain anonymous
    Posted 02-07-2024 17:09
    This message was posted by a user wishing to remain anonymous

    Hello everyone,

    I'm venturing into a new area: Sterile Injectables and trying to catch up on requirements.

    Curious if anyone knows for a multi-use vial: Is stability of a punctured vial a nice to have or a requirement?

    Can't seem to find anything specific so far, so appreciate if anyone can provide a reference.

    My solids background thought train says yes, but I'm getting to the point where most of the batch will be samples?

    So, I'm beginning to second guess myself, but maybe in the injectables world that is a realistic expectation?

    Thanks in anticipation.

    NOTE:  This question was initially submitted to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the questioner.



  • 2.  RE: Is punctured vial stability a requirement for multi-use vials?

    Community Leadership
    Posted 02-07-2024 17:12
      |   view attached

    Hello,

    I have attached some FDA guidance on selection of appropriate package type terms and recommendations.  There is mention here of a default 28-day use period for multi-use vials, unless data from the manufacturer is provided.  I hope this is helpful.

    ------------------------------
    Dan Willingmyre
    Vir Biotechnology, Inc.
    Associate Director, Stability & Data Analytics

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 3.  RE: Is punctured vial stability a requirement for multi-use vials?

    This message was posted by a user wishing to remain anonymous
    Posted 02-15-2024 15:10
    This message was posted by a user wishing to remain anonymous

    I worked on a multidose vial many years ago and we never did stability on punctured vials.  We did test preservative effectiveness at every timepoint where sterility was tested - this is a different CQA.

    NOTE:  This response was initially provided to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the responder.


    Original Message


  • 4.  RE: Is punctured vial stability a requirement for multi-use vials?

    This message was posted by a user wishing to remain anonymous
    Posted 02-15-2024 15:13
    This message was posted by a user wishing to remain anonymous

    I haven't used a multi-use vial in years, but I'll assume you need to have an in-use study to show stability after the first puncture to the last use.  At the very least if filing in EU or Brazil.

    Check out the EMA guidance.  Not too detailed but seems applicable.

    In-use stability testing of human medicinal products - Scientific guideline | European Medicines Agency (europa.eu)

    NOTE:  This response was initially provided to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the responder.


    Original Message