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Shelf life vs Expiration date

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Rachel, Mar 17, 2016.

  1. Rachel

    Rachel New Member

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    A little back ground: we are a customize plastic tubing company we design nothing but meet necessary regulations. We take the customers Design drawing and manufacture a plastic tubing component to there specifications. We are ISO 13485:2003 cert. We supply to medical company's that are the finished product,label and assembly.

    My debate has been going on for 2 days with SALES were I needed clarification before I would let a shipment go out. Not even my boss could give me answer. I access the customer Drawing for review with sales and other management. I ask where in this customer specification does it state what the expiration date will be concluded from? They all point to the an area that states "Shelf life: receive within 12 months from date of manufacture" . Sales and management based the "EXPIRATION DATE" on that statement. I am explaining to them that shelf life and expiration date are 2 different meanings and that doesn't give me no indication how to determine what it should be. There easy answer is that they have been using a year since 2012!!! Mind you the tubing does get an etch. Shouldn't they go back to the customer for clarification. The reason I say ask customer is because my boss did state that we don't have a claimer on that ...in other words that they are not going to pay or research the evidence of how long etch is good on a part I assume! So how should this be handled moving forward. I know I am correct. I am so agitated there are a few who agreed but in the end it was getting it out the door!!! see my snap shot of the part from the CUSTOMER Drawing

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  2. MarkMeer

    MarkMeer Well-Known Member

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    You are correct that "expiration date" and "shelf life" are not necessarily the same. ...but in your situation (as a supplier), the semantics shouldn't matter.

    You (as a supplier) are only concerned with your customer requirements.
    If they specify "receive within 12 months from date of manufacture", then just make sure you're meeting this requirement... it doesn't really matter the terminology your customer uses.

    If the issue is with respect to their requirement to label the expiration date, I'd argue that there isn't one, as PTFE is pretty resilient.
    ...as such, I think it should be sufficient to just label with the manufacturing date (of course, confirm with customer first).
     
  3. Reluctance

    Reluctance Member

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    Medical isn't my particular field, but we do work with material that can have both a shelf life and an expiration date.

    Typically we view the shelf life as the duration that the product from a manufacturer's lot can be stored and used without re-verifying the specific properties that are time dependent. Once the shelf life has passed the product must be checked to determine if it has expired. If the desired properties are still effective the shelf life can then be extended for another cycle. Often this requires sampling and destructive testing.

    The material that we see this the most with is water-based polyester resin. Shelf life recommended by the manufacturer is based on when they made the product and when we first open the container. In much slower times we evaluated the shelf life several times and extended our usage. Lately though we go through enough product that this isn't a concern.
     
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  4. Miner

    Miner Moderator Staff Member

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  5. MarkMeer

    MarkMeer Well-Known Member

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    So, clearly the customer is mistaken when they spec: "Shelf Life: Receive within 12 months from date of manufacture". From all the data sheets I've seen for PTFE, its shelf life is more-or-less unlimited, as it's highly resistant to environment and aging. Given this, I'd say the appropriate business decision as far as expiration date would also be unlimited (or, in effect, not applicable).

    As such, I maintain that no expiration date needs to be labelled on the product in question. Confirm with the customer, and go from there...
     
  6. Eric Twiname

    Eric Twiname Well-Known Member

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    I am not in medical.

    Miner's statement, however, is how we use those terms....

    Certification date may be up to 6 months prior to shipment date (shelf life).
    Expiration date {of the cert} is 6 months after shipment date (related to liability).
     
  7. MarkMeer

    MarkMeer Well-Known Member

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    Huh? Quite confused.
    Are you saying that the shelf-life is certified prior to shipping, and that this certification expires (and this is defined as the expiration date)?
    What happens if a shelf-life (for a hypothetical volatile material) is determined to be 6-months, and the product is then manufactured and sits in manufacturer inventory for 4-months before it is shipped? According to what you've said, in this case the expiry date would be an additional 6-months from the shipping date? How does this make any sense if the product will have already exceeded its specified shelf-life well before the expiration date?

    My reading of the OP's concern is that their customer has specified that the expiration date be labeled (etched) on the product, but have not provided one.
    To me - unless there are extenuating circumstances - permanently etching an expiry date into a PTFE product makes no sense, and the OP should seek clarification from the customer.
     
  8. Eric Twiname

    Eric Twiname Well-Known Member

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    An "Expiration date" is a prediction into the future as to a time past which the product will no longer fit the use.
    For a driver's license or a passport, it can be a hard date.
    For a can of soup, nothing magical happens on that day.
    An expiration date in this case is a date past which the manufacturer will not stand behind the reported data or "fitness for use".

    We stand behind the data on the cert, and by extension stand behind the claim that the product meets spec, for 6months after shipping.
    Thus the "expiration date" is 6mnth from shipping. 7mnths from shipping...it's probably fine.

    How long prior to shipping the manufacturer feels OK letting it sit on the shelf...that can be called whatever...we call it "shelf life".
    Others may call the time between shipping and expiration date "shelf life"...to each his own.
    We have customers who want an "expiration date" labeled on the product. Is is put on immediately prior to shipping, and is 6mnth from shipping date.
    The shipping date can be up to 6mnth after certification date, resulting in a total storage life anywhere from 6.01mnth to 11.99mnth while under that cert.

    Hope that clears it up a bit...
     

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