Rapid microbiological methods have begun to appear in pharmaceutical and other industries
for applications in aseptic operations. An introduction of real time monitoring methods
for water and air and principle of operations will be presented.
Several studies for water monitoring will presented to show the capability of this technology
as a process verification tool for process optimization and real time feedback
process control analyzer for trouble-shooting and suggestion how to set new alarm limits
for monitoring online water quality.
Several new instruments based on new technology, i.e. real time microbial sensor using
optics for particle detections, are available:
Instantaneous Microbial Detection (IMD) of Azbil BioVigilant, Inc. for air applications
BioLaz Real-Time Microbial Monitor (BioLaz) of Particle Measuring Systems, Inc.
for air applications and
Real-Time Microbial Monitoring Systems (RMS) of Instant BioScan for water applications
These instruments detects microbes by using a Mie scattering sensor for measuring the size
of particles. The microbes are differentiated from inert particles using detection of intrinsic
fluorescence of metabolites (NADH and riboflavin) inside the microbial cells. The microbial
detection is carried out in real time, and no reagents nor sample preparation is needed.
The real time microbial measuring capability of RMS can be useful as a process verification
tool for process optimization and as a real time feedback process control analyzer for
trouble-shooting (Figure 3). The sampling of surface and cleaning validation are important
parts in aseptic operations and a sensitive, real-time analyzer e.g. RMS can be beneficial
in visualizing sampling results and timely validation. In Figure 4 aseptic swabbing was
used as sampling method. The samples were analyzed using RMS for sampling swab
rinses. The RMS is screening the results in less than one minute.
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