eBook: TOC and Microbial Detection Monitoring - 19

7000RMS Analyzer

On-line Microbial Analyzer
Real-time Monitoring and Control
For pharmaceutical manufacturers, on-line measurement provides
process control and real-time monitoring of their water quality. A leading
biotechnology company reduced sanitization costs with the METTLER
TOLEDO on-line 7000RMS™ microbial detection analyzer.

Improved process efficiency with
continuous data

Optimizing sanitization cycles
reduces downtime

A leading biotechnology company
evaluated the 7000RMS analyzer as a
process monitoring tool in conjunction
with plate counts as part of a strategy
to facilitate rapid response to deterioration of their pure water system.

The company's Standard Operating
Procedure (SOP) required a weekly
heat sanitization from 00:30 am to
10:00 am. Before and during this
process, the company implemented
the 7000RMS to monitor real-time
trend data that was used to evaluate
the sanitization effectiveness and duration. There was no change in the
baseline data prior to the sanitization,
suggesting that the interval between
sanitization cycles could be increased.
This process change would result in
reduced sanitization costs and prevent
premature replacement of worn water
system components.

The 7000RMS was installed on a WFI
loop downstream from the return port
under temporary change control. Data
was captured on the Building Control
System during an evaluation period of
four months.

In addition, the company observed
baseline recovery after each sanitization, which indicated sanitization effectiveness. Using this trend data, the
company had the opportunity to optimize their sanitization cycles, thus
reducing downtime and increasing
overall productivity.

More production time
The ability to review real-time trending
data also made it possible for the
customer to reduce rinse time after
sanitization. According to the customer's SOP, a six-hour rinse time was
required. With the 7000RMS and an
established baseline, they interpreted
the trending data to conclude that the
Auto Fluorescent Unit counts (the
7000RMS' unit of measurement) were
within acceptable limits after only four
hours of rinsing (Figure 1). This provided the potential to significantly reduce rinse time and release water two
hours sooner, resulting in more production time.

Increased control, minimized risk

Figure 1: AFU trending data during sanitization and rinse. Dotted line indicates original rinse time.

METTLER TOLEDO Pharmaceutical Waters

In addition to making their processes
more efficient, the trending data provided by the 7000RMS also allowed
the customer to better comprehend
their water system dynamics. With a
more complete understanding of how
normal system events impact the microbial and biofilm environment, an

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