Rapid Environmental Monitoring - Real-Time Microbiology Results
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GlaxoSmithKline Parma (Italy) manufacturing site has received inspection and formal approval from the FDA to use the ChemScan RDI scanning cytometer from AES CHEMUNEX, as a part of the rapid microbiological in-process monitoring of a non-sterile nasal spray product. Rapid monitoring of the manufacturing process using more sensitive tests allows accurate prediction of product quality; thus eliminating the need of final
product testing to release the prescription product to the market.
The recent work with the ChemScan RDI has delivered confidence in the speed and high sensitivity of the system to deliver accurate and early counts for the control of surfaces and product bulk solutions.
In addition to pharmaceutical waters testing, the sensitivity of the ChemScan RDI is used to deliver "real time" microbiological process controls for product bulk monitoring using bioburden application and surface monitoring using ChemSwab application.
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The Ultimate Combination of Speed and Sensitivity for Environmental Monitoring
Real-time Microbiology Results for AIR - WATER - SURFACES
Real-time Microbiology Results for Rapid Environmental Monitoring
AES CHEMUNEX unique's ScanRDI® technology enables real-time results for the microbial environmental monitoring:
- Results within hours, from sample collection to final results
- Sensitivity down to one cell
*Several users have received FDA approval to use ScanRDI® for routine analysis
AIRCoriolis® cyclonic air sampler captures biological particles in the air and provides liquid samples.
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WATERWater samples up to one liter. |
SURFACESChemSwab®, due to its unique design, recovers up to 60% of collected microorganisms collected on surfaces and has been especially designed for the ScanRDI® application
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