To meet the high industry standards with low limitations of bioburden, large volumes need to be evaluated for microbial contamination to enable reliable analysis. Each microbial method used should be highly sensitive, applicable for larger volume testing, rapid and reliable.
These requirements often imply complex methods and are time-criticals, as time has a direct effect on production efficiency and costs. Results should be available the same day.
The Sieve-ID method with MuScan analysis meets these requirements.
Example of linearity of both the compendial method and the Sieve-ID method for Escherichia coli. No significant difference is observed between both methods (Based on non-linear Poisson distribution in statistical analysis).
A comparison of a direct rapid method like the MuScan method with a reference growth-based method requires additional statistical needs and experimental approaches. As a growth-based method measures the counts in CFU (Colony Forming Units), the number of counts is highly dependent on growth parameters like pH, nutrients, temerature etc. Next to that, a microbe might be dormant or as so-called VBNC (Viable but Non Culturable) and will thus not form a colony. This is in high contrast with a direct microbial method, as these measure in FFU (Fluorescense Forming Units). All microbes that are viable are detected, including VBNCs. As of this contrast, during validation studies good care should be taken in experimental design to avoid misinterpretation of either methods.