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  • 1.  Aging studies

    This message was posted by a user wishing to remain anonymous
    Posted 18-Feb-2021 08:42
    This message was posted by a user wishing to remain anonymous

    Hi

    Could anyone recommend how to determine a sample size for aging studies, using AQL seems to bring very high quantities and I'm not sure I need that many testing for this.

    Thanks


  • 2.  RE: Aging studies

    Posted 21-Mar-2021 01:05
    Hi,

    I am not an expert.  I thought there was a table for sampling in a standard; however, I could not find it.  Here's what I found, "In most cases, determination of sample size is left for each company to decide and justify following a statistically valid rationale (reference ISO 11607-1, Section 4.3)."  Below is the excerpt from ISO 11607-1.  I hope this helps.  


    Kind regards,

    ------------------------------
    Alyssa Thomas RAC
    Principal Consultant
    Beaverton OR
    United States
    ------------------------------

    Original Message


  • 3.  RE: Aging studies

    Posted 22-Mar-2021 07:34

    Dear Anon,

     

    You do not mention whether this is a Medical Device or a Medicinal product (drug of biologic).  You also do not mention the attribute of function that is to be tested at the end of aging.  Is it only sterile barrier (such as in ISO 11607) or some other device function or attribute, or is it a degradation profile for some chemical or biologic test to predict expiration (as for many drug critical to Quality attribute)?

     

    I believe the sample size is dependent on the number of products needed to establish success (which would be the same sample size at release) for the function tested or attribute measured at each timepoint, or at least at the end of shelf life.  For those attributes where you are looking for trends, it is at least the number of product needed to perform duplicate or triplicate tests at each time point to plot the degradation profile and confirm or predict the shelf life.

     

    As such, it is dependent on what you need the device to do or be at the expiration date.

     

    I hope that help answer, or lets you refine your question.

     

    Lee

    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


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