Aziz,
Your reference to "bugs don't lie" pretty much answers many of your own
questions. The growth of the two BI's needs to be investigated with the
focus on the BI placement and the configuration of the item that was being
sterilized. I think all of us who have done extensive sterilization
studies have come across this same scenario. Sometimes placement of the BI
itself creates a situation that impedes full steam penetration to the BI
also the adjacent thermoucouple tip location to the BI sometimes might
reflect good temperatures but 1/4 to 1 inch away a portion of the BI could
be sitting in a pool of condensate. An air pocket could also be present as
a result of the configuration of the item that is being sterilized the
temperatures are fine but there is no steam penetration. I remember a
postive BI at a location where I had 320 Fo. A filter in the steam path
was not allowing steam p enetation however temps were 128°C for an hour.
So look at your set up and configuration of your load. The study will
obviously need to be repeated as a full validation of that load and cycle.
But you will have to show that you changed something from the the previous
study.
Peter Cardinal
CardinP@labs.wyeth.com
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