ChemSwab - Real-time microbial monitoring of surfaces

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GSK receives FDA Approval

 

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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Combining Speed & Sensitivity for Surface Monitoring!

 


ChemSwab: Rapid Environment Monitoring of Surfaces


ChemSwab + ChemScan = Only 3 hours from Sampling to Results!

 


- Quantitative Real-time MonitoringFDA approved rapid monitoring of surfaces
- High Recovery and Release Capacity
- Viability Labeling enables the Enumeration of all viable Microorganisms
- Only one Single Protocol for Bacteria, Yeasts and Molds (including Spores)

 

While traditional swabs typically recover and release only about 20 % of the sample, ChemSwab, due to its unique design, recovers up to 60 % of collected microorganisms collected on surfaces. As a result, you will now be able to have better detection of microbes, especially in areas with lowlevel contamination that is difficult to detect.
With its unique combination of speed and sensitivity, represents a revolution in microbial detection. For the first time, direct cell counts down to one microbial cell can be delivered within minutes for viable micro-organisms. Even spores, stressed cells and fastidious organisms can be detected within minutes.

 

ChemSwab Nylon Flocked swab

The new flocked swab is a pre-shaped plastic applicator on

to which a thin layer of nylon fibers is sprayed by a
flocking process. The nylon-flocked swab is designed to improve sample absorption by strong capillary action and to release more than 80% of the sample. Traditionally wound fiber swabs (rayon or polyester) trap a large
percentage of the sample in the fiber matrix, retaining the sample.

 

 

 

clean room surface monitoring ChemSwab

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