Regulatory Open Forum

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  • 1.  Justification for reducing sterilization dose audit frequency

    Posted 06-Nov-2017 09:19
    Hi all,

    I am presently looking into reducing the frequency of sterilization dose audits for a Class II sterile (gamma) device from quarterly to twice per year.  According to ISO 11137 the frequency can be reduced if:
    1. At least four consecutive sterilization dose audits, whose outcomes have required neither dose augmentation nor sterilization dose re-establishment, have been performed at the previously selected interval of time (3 months for this product);
    2. Data are available that demonstrate the stability of bioburden within the bioburden specification over the same period of time as item a.:
    • bioburden determination performed at least every three months
    • characterization of biodurden
    3. The manufacture of the product in relation to bioburden is controlled and the effectiveness of this control is demonstrated through the implementation of the elements of a quality management system identified for sterile medical devices in ISO 13485.

    Can anyone give me more details on what is ''characterization of bioburden''.  Is it simply knowing how many aerobes and fungi-yest-mold CFU per device?

    Thank you in advance for your input

    Marie-C Messier
    Quality Manager

  • 2.  RE: Justification for reducing sterilization dose audit frequency

    Posted 06-Nov-2017 10:00
    ​May I suggest you have a look at ISO 11737-1:2006 "Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products", § 6.2 "Characterization of bioburden" ? With kindest regards,

    Ary Saaman
    Director, Regulatory Affairs
    Debiotech S.A.