|The ability to measure the conductivity and TOC levels in pharmaceutical water systems on-line has a multitude of advantages. Real-time release of waters, monitoring CIP processes and instant notification of out-of-spec conditions are just a few.|
But for measuring microbial contamination, almost all pharmaceutical facilities have relied on laboratory plate count tests (colony forming unit counts). The practice of growing microorganisms on agar plates has existed for over a hundred years and during that time has remained largely unchanged.
|The need for real-time measurement|
Unfortunately, culture-based, cfu count methods are slow, prone to errors and are poor for identifying certain microorganisms. Rapid microbiological methods offer reduced measurement times, but off-line analyzers require additional steps and use of reagents/stains, and are not able to detect low levels of contamination. Therefore, the development of an on-line, real-time and continuous bioburden analyzer delivers significant benefits to pharmaceutical companies.
The application of laser-induced fluorescence (LIF) technology and Mie scattering analysis in the 7000RMS allows the analyzer to accurately quantify microorganisms as well as inert particles. When used at various points in a water loop, the 7000RMS instantly recognizes an increase in microbial count, making troubleshooting significantly easier.
Real-time and historical data from the 7000RMS enables thorough trending analysis of a water loop for identifying the need for loop maintenance much earlier than other methods.
On-line measurement of the conductivity and TOC levels in pharmaceutical water systems