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The ChemScan
RDI microbial analyser from Chemunex is being extended to real
time environmental monitoring of air, and later to personnel and
surfaces, as announced at the recent annual Parenteral Drug Association
meeting in Basle, Switzerland.
The addition
of environmental monitoring to the already well established ChemScan
RDI water testing methods will, for the first time, provide the
pharmaceutical industry with a unique capability to implement
real time monitoring of all critical areas subject to risk of
microbial contamination. This will allow companies to minimise
risks before manufacturing products and to detect contamination
early enough to minimise subsequent losses and plant downtime.
Current environmental
monitoring procedures use traditional plate culture, which provides
results only after several days and therefore prevents any proactive
monitoring. The ChemScan RDI microbial analyser, produces sensitive
results down to a single micro-organism within 90 minutes for
filterable products. The extension of ChemScan RDI's capabilities
to the this critical process control step means that manufacturers
will be able to control all areas for potential microbial contamination
using a single analytical platform with enhanced detection sensitivity
and very short response time.
Chemunex R&D
developed a unique approach to overcome the challenge of collecting
micro-organisms from the environment and transferring them on
to ChemScan RDI for analysis without damaging their viability.
The technology developed, for which a patent protection has been
filed, uses a water-soluble polymer which, in its solid form,
collects the micro-organisms and is subsequently solubilised prior
to analysis on ChemScan RDI. This new development, which was originally
started in collaboration with British scientists, is supported
by leading pharmaceutical companies, such as Glaxo Wellcome, SmithKline
Beecham, Astra Zeneca.
Environmental
monitoring represents a critical process control step in the manufacture
of pharmaceutical products, especially those manufactured within
highly controlled clean room conditions. The test includes monitoring
of air, personnel and surfaces and, to meet regulatory authority
requirements, must be capable of detecting one single micro-organism.
As it represents around one third of the number of microbial tests
performed in an average production plant, the volume of environmental
testing is high.
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