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  • 1.  Sterile injectable puncture study

    This message was posted by a user wishing to remain anonymous
    Posted 12-Dec-2019 17:40
    This message was posted by a user wishing to remain anonymous

    All,
    How many visible particles i.e. stopper fragments are acceptable when performing a puncture study on a sterile injectable drug product?  The release/stability appearance specification is "essentially free from particles".  USP<381> defines NMT 5 fragments on 12 vials with 4 punctures each.  During the in-use puncture study, stopper fragments are visible in the vial after X punctures.  In order to state a label puncture limit, do we have to comply with the appearance specification of "essentially free from visible particles"?  If so, what is the quantity of "essentially free"?

    Thank you for the help.


  • 2.  RE: Sterile injectable puncture study

    Posted 13-Dec-2019 08:11

    First these two quality measures fundamentally different.  The requirement for essentially particle free drug applies to the filled, sealed primary container before opening or accessing the drug.  The second is a measure of fragments (septum particles) generated by the repeated access of the drug through a septum (usual a vial or cartridge).  The essentially particle free requirement is a Quality attribute that is to assessed on every lot of drug, usually resulting in a 100% visual inspection of all units.  The fragmentation requirement is a design verification that is performed once to verify compliance and not redone unless there is a change.

     

    As to the meaning of essentially particle free, it is defined/explained in USP monographs (new USP 1790) and there are a number of papers, discussions and a PDA Technical Report that might help you understand this term.

     

    Lee Leichter

    President

    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    Office: +1-239-244-1448

    Cell: +1-239-994-6488

    Email: leichter@plbiomedical.com

     




    Original Message


  • 3.  RE: Sterile injectable puncture study

    Posted 27-Dec-2019 02:09
    Hello,

    Fundamental requirement for any sterile injectable need to free from visible particles as mentioned by Lee​, however stopper fragments are also not desirable during in-use study. It is essentially done for a multi dose injectable and stopper fragments after X punctures would render product not to be used. you can also look at the stopper material and relevant data.

    ------------------------------
    Deepa Dasgupta RAC
    Director
    Hyderabad
    India
    ------------------------------

    Original Message


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