RE: Biological Indicator Strip Contribution from JD Mallet written on 7/16/2008 at 09:59
Original contribution: Biological Indicator Strip written by Lisa Nathalie on 7/15/2008 at 09:15) Please could you precised what is the objective ? I don't understand exactly why you wish to do so.
To my knowledge strips are not put directly into a medium. This because strips are usually "calibrated" for the number of spores they content. There will be no valuable indication of the biological load. It is not for sure that the medium to be sterilized will support the growth of the spores / and when. Moreover the thermal resitance of a spore is higher than the one of the viable form and if you put the strip into the medium you could have that kind of artefact. In the real conditions do you think that your medium could be contaminated with spores ?
Usually what is checked is the final sterility of the medium to be sterilized taking into account the worst case (maximum holding time before sterilization, most favorable temperature for micro growth during that holding time).
Last, please remember that the validation of a process should mimic as close as possible the actual process. So it is the actual volume of medium to be sterilized in routine that should also be used for the validation runs.
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