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  • 1.  leachables and extractables

    This message was posted by a user wishing to remain anonymous
    Posted 03-Sep-2019 09:53
    This message was posted by a user wishing to remain anonymous

    Hi

    I would like to know if there are is any specific guideline or guidance that provides cut off limits for leachables and extractables?  I am aware of the GUIDELINE ON PLASTIC IMMEDIATE PACKAGING MATERIALS, however this does not provide any limits. 

    ICH  Q3D also does not cover all relevant formulations such as ocular systems. 

    The only guideline I found was BP, Appendix XIX E. Rubber Closures for Containers for Aqueous Parenteral Preparations.

    Any advise on this would be appreciated. Thank you

    Zara 

    ​


  • 2.  RE: leachables and extractables

    Posted 03-Sep-2019 14:34
    Dear Zara,

    are you concerned with pharmaceuticals r medical devices?

    regards

    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------

    Original Message


  • 3.  RE: leachables and extractables

    Posted 03-Sep-2019 14:38

     

     

    Hi Zara,

     

    You do not say if you are interested in drugs/drug packaging, or in medical devices.  Regarding the latter, I can say that acceptable limits are typically established based on a toxicological risk assessment, so the limit varies according to the toxicity of each substance identified in extractables studies.  ISO 10993-17 is currently being revised to describe the tox risk assessment process.  The concept of TTC (threshold of toxicolocial concern) has been developed for those substances for which no tox data exist, or those substances that cannot be identified (assuming there is a reasonable expectation that nothing from the cohort of concern is present).  The level for TTC is usually taken from ICH M7.

     

    My understanding is that the drug container/packaging processes are much the same, though there are some differences in the approaches to extraction and study design.

     

    Please feel free to connect directly with me if you have further questions.  I have chaired the working group for ISO 10993-18 for several years.

     

    Ted

     

    --

    THEODORE HEISE, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute

    1330 Win Hentschel Blvd.

    West Lafayette, IN 47906

    765.463.1633 ext. 4444

    http://medinstitute.com/

     

     

     

     




    Original Message


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