eBook: TOC and Microbial Detection Monitoring - 34

Biofilm, Endotoxins and Their Relationship

Theoretically, if the plate count method gave a true picture of the bioburden of the water, then a 0 CFU test result
would be evidence of there being no microorganisms in
the system. But, as previously discussed and exhibited
in the picture of the pressure sensor, biofilm will adapt
and can survive in Hot WFI.
In several pharmaceutical facilities, it has been observed that plate count results are normally 0 CFU with an
occasional 1 CFU, but the facilities have frequently failed
the LAL test. This LAL test failure further demonstrates
the limitations of the traditional test method, the ability
of biofilm to adapt and survive in Hot WFI loops and the
need for real-time microbial detection.

7000RMS Microbial Detection Analyzer
Improve Process Control and Production Efficiency
Continuous monitoring with results every two seconds
allows optimization of system processes.

The METTLER TOLEDO Thornton 7000RMS™ is an
on-line microbial detection analyzer. It provides the realtime data and information necessary for monitoring a
water system and determining if it is under control.
In addition, its measurement technology identifies the
presence of bioburden in situations where plate count
methods are unreliable.

Control Product Quality with High Sensitivity
Count individual microorganisms down to 0.3 µm
in size.
Minimize Risk and Reduce Cost
Real-time monitoring eliminates waiting period for
results. Trending data enables ability to react prior to
an out of specification event.

The 7000RMS can confidently be used for ascertaining if
water system sanitization procedures are sufficient and
effective, and if the maintenance cycle is frequent enough
to maintain the required water quality and therefore,
reduces risk to product.

Global Compliance
Regulatory agencies encourage the use of alternative,
rapid microbiological methods.

www.mt.com/7000RMS

www.mt.com/thornton
For more information

METTLER TOLEDO Group
Process Analytics Division
Local contact: www.mt.com/pro-MOs

http://www.mt.com/7000RMS

eBook: TOC and Microbial Detection Monitoring

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