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Raw materials expiry date

Six Sigma – iSixSigma Forums Old Forums Healthcare Raw materials expiry date

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  • #25822

    Raphael
    Participant

    Hi,
    I am currently working in an In vitro diagnostic company and I am doing a study about expiry date of raw materials after package opening.I try to extrapolate informations from existing datas. I deduced 3 options to consider:
    “1.  Contact the vendor for data;2. Perform your own accelerated ageing, and concurrently, set aside product (the RM and/or the finished product) for real-time studies; sufficient qty to  pull and test samples at several intervals up to the max. period desired;3.  Industry standards / practices (supported by 2.).”
    I am presently contacting vendors for information about my study but some of them do not actually have the answer and we can not perform big stability studies because of the large range of our production.
    Hence, could you please tell me, as you may know, how/where can I find “Industry standards/practices” about that kind of expiry date or maybe the standards for some kinds of “product families” which may have the same assignated expiry date because of their similarities.
    Thank you, Best regards
    Raphael,
    Support Quality Process

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    #62550

    cxg174
    Participant

    I came across this by accident- cleaning out old emails. You have probably made progress by now. I find this a very interesting topic. You basically have two issues- contamination and decomposition of products in opened packages. In healthcare some items can be used after opening for varying amounts of time, often up to 24 hours. This is a safety issue related to contamination. Some critical items can only be used once. Some items particularly pharmaceuticals normally have vendor data to support their useful life once opened.
    Your industry is a specialized one. The industry I most see as a similar product family would be pharmaceuticals. I am sure that they have extensive data in this area.

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