Focus - Bioburden Viable Microbes

The amount and type of viable microbes on a medical device must be known to set adequate sterilization measures.  Since microbial contamination can be sporadic, bioburden is determined on replicate lots of product, with replicate units from each lot.  Typically a medical device is submerged in a rinse fluid and shaken, stomached, sonicated or treated in some other fashion that will rinse the microbial off the device.  The rinse is then evaluated for microbial bioburden, according to methods