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CHEMUNEX announced today the confirmed
news that the GLAXOSMITHKLINE (GSK) site at Worthing, West Sussex, UK, will use the CHEMUNEX
system, ChemScanRDI® for the microbiological analyses of their pharmaceutical water systems.
Recent work with the ChemScanRDI® has
delivered confidence in the speed and sensitivity of the system to deliver accurate and
early counts for the waters used in manufacturing.
The sensitivity of the ChemScanRDI® will
be utilised to rapidly deliver "Real-Time" microbiological trending of pharmaceutical waters.
The ChemScanRDI® system delivers counts
of viable microorganisms without the requirement for a growth phase. Laser scanning of a filter
membrane containing labelled organisms delivers sensitivity to a single cell inside
two hours from sample.
Internal requirement and external
regulatory bodies increasingly monitor the absolute requirement for water quality control
in all aspects of product, production and cleaning processes.
The introduction of the specific
elements of speed and sensitivity, inherent in the ChemScanRDI® protocol, will offer further
confidence and control to the pharmaceutical microbiologist.
Typically the standard growth plate
method takes between 48 to 72 hours (TSA) or 5 to 14 days (R2A) allowing counts of culturable
organisms. Such methods do not afford early detection of, or response to, excursions from
approved limits within the water system, any such response being retrospective to the production
process.
The discussed ChemScanRDI® protocol enables
real time counting and the consequent ability to react to any out-of-specification excursion,
to then take early and remedial steps to return the water system to production, the plant to
profitability, and to reduce the expensive risk of contaminated product.
Recent multi-site studies have shown the
ChemScanRDI® to offer further scientific, production and commercial benefits in the introduction
new water system, biofilm characterisation and water system trending.
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