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ETO Sterilisation

Discussion in 'EU Medical Device Regulations' started by Jo Campbell, Nov 13, 2015.

  1. Jo Campbell

    Jo Campbell Member

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    Hi All,

    We include a paper IFU booklet in our consumable packs for sterilisation by ETO. If we were to add another language to the IFU, increasing the number of pages, would we need to revalidate our sterilisation process, or is there a tolerance on the mass? The consumables are packed 10 units per carton (each with an IFU), 8 cartons per shipper and 12 shippers per pallet.

    Regards,

    JoCam
     
  2. Vintage Goose

    Vintage Goose Active Member

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    The "easy" answer is to refer to your risk analysis. Ideally it would be considered as part of the worst case during sterile load validation. Do you have any other validated loads you can compare against?

    I have never seen a tolerance given in a guidance document, although in a previous company, we allowed 5% over or 10% under nominal load weight.
     
    Jo Campbell likes this.
  3. Jo Campbell

    Jo Campbell Member

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    Thank you Vintage Goose,

    We only have the one item requiring sterilisation, so don't have any other validated loads to compare against.
     

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