Regulatory Open Forum

 View Only

  • 1.  Manual disinfection process - Validation suggestions/experience

    Posted 27-Mar-2017 02:18
    Hi all,

    there is currently a discussion going on, how to validate a Manual disinfection process.

    Do you have any experience/suggestions on how a Manual wipe-down disinfection could be validated in a sensful manner?

    For disinfection purposes, we use disinfectants, which are listed on VAH and IHO. The Manual wipe-down is described in SOPs for each material, which needs go through this cleaning process.

    We already are using a SWAP-Test on bi-annual Basis to check the disinfected items and control the effectiveness(knowledge of staff performing this Manual process. Also, we use a UV-Light test to check on a monthly Basis the effectiveness of Manual cleaning within Areas, which are not easy to reach, while cleaning them (sure, this is not showing "disinfection" results -only mechanical effectiveness).

    Since These "checks" are not done 100% after the cleaning process, Validation is needed.

    Your Feedback is appreciating, thanks in advance.


    ------------------------------
    André Hülsbusch
    Regional QA/RA Specialist, Central Europe

    Germany
    ------------------------------


  • 2.  RE: Manual disinfection process - Validation suggestions/experience

    Posted 27-Mar-2017 08:27
    Generally the key is to run the process using an "inoculated" surface with a known level of bio-burden/biological load. Ideally you have some way you can estimate the amount and type of load possible on your surfaces and set the inoculation similar to that - though many people go 2x or more as a kind of overkill, you need to be careful because disinfectants are not sterilants and will not kill off a huge overload.

    Anyway, inoculate the surface, have operator clean it and then do your microbiological test to determine the load was eliminated and/or reduced adequately according to your criteria. Do this multiple time, preferably with multiple people doing the cleaning. If all the runs meet the critieria, you can consider it validated.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
    ------------------------------

    Original Message


Related Content