Regulatory Open Forum

 View Only
  • 1.  sterilization dose validation

    This message was posted by a user wishing to remain anonymous
    Posted 05-Dec-2022 09:19
    This message was posted by a user wishing to remain anonymous

    I have an issue here and i would like to get an idea... I conducted a sterilization validation for a product line. i determine the dose range to be 13.7kGy to 13.7kGy but when we reached out to the sterilizer they stated that they cant hold that tight tolerance  13.7on the lower limit of the i am not sure what to do in that case...

  • 2.  RE: sterilization dose validation

    Posted 06-Dec-2022 04:08
    Hello Anon,

    If you are referring to ISO 11137 for gamma sterilisation, typically there is a minimum dose which needs to be established to ensure the Sterility Assurance Level (SAL) is met.  Though during routine sterilisation processing, most sterilisation facilities will establish a range or window for the dose being applied, which of course is maintained above the minimum level dose range.  This is mostly important based on some materials, because a high enough dose can actually cause degradation or impact the materials, i.e. silicone; this is usually done during material assessment depending on the materials.  Therefore, a "range" is established with the minimum dose and maximum dose being applied.  In your situation, for the maximum dose this should really be dependent on your material type ... and yes a sterilisation facility would most likely not be able to do a range of zero (0).

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs