Home Forums General Discussion Extra freezing effect?

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  • wienui
    Participant
    Post count: 1

    Hi,
    is there any concern about super freezing (Ca.-75C) for some days for a finished IV medical device ENZYME used for calibration, which should be stored between -15–25C?
    best greetings!

    John O’Neill
    Moderator
    Post count: 75

    Greetings to you as well. Medical Device design verification/validation measures often address extremes up front, but may not address extremes of that degree for drugs and substances contained in the device. In theory, there is less degradation as you approach the substance’s glass-transition temperature, but physical changes along the way are possible. A good concern to have as well, is whether a regulatory body will ask the same question as you raise here. If possible, a stability study (say -80C) for a realistic period of time (30 days?) would give you a better justification for stating there are no concerns with “super freezing”.

    It will be interesting if other device/combination product stabilitarians can provide further input.

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