Evaluation of the ScanRDI solid phase laser cytometer with the Coriolis cyclonic air sampler for real time microbial control of the air (Pfizer, St-Louis, USA)

AES CHEMUNEX and Bertin Technologies have developped a novel method enabling  the microbial air monitoring of clean rooms within 3 hours - from sampling to results

(pfizer USA  - Extrract from RMUG 2009 présentation)

"The Coriolis® system is an easy to use portable air sampler that collects air samples into liquid media. This allows quick icrobial detection when coupled with RMM technologies as demonstrated into this study.
The feasibility study conducted in Saint-Louis Micro Lab indicates that Coriolis® system collects airborne microorganisms in comparable amount to the impaction system does. ScanRDI can be used as Rapid Microbiology Method coupled with Coriolis® collection in order to give rapid results (around 3 hours from sampling to result). It is also shown here that the amount of microorganisms detected with the ScanRDI is higher than with the traditional method as far as it is not based on cultivability but on viability; appropriate alert and action limits may thus need to be re-evaluated for ScanRDI results. This couple of innovative methods fits for the Environmental Monitoring application and could be implemented for investigation and routine monitoring in production sites and in critical areas and cleanroom environments."

Pfizer study Team: Dr Lin Chen (responsible of the study), S. Fennell, W. Snapp

Download the Pfizer study on real-time microbial air monitoring

(first log in the customer area)

SPI Pharma validation of BactiFlow ALS (extract from Salles Propres)

"The performance qualification study performed at SPI PHARMA shows that the results obtained with the rapid technique using flow cytometry of BactiFlow are equivalent to the results obtained with the reference method.
The equivalence tests carried out over 6 months of production
showed a sensitivity equivalent to the reference method. In only one analysis, the implementation of this qualitative method allows to control the production within 24 hours, by also confirming the absence of the specific germs. In this precise case, the validation of this new approach showed that a qualitative test did not penalise to release the products compared to a quantitative analysis. The release of the finished products, thus validated in 24 hours, allows a reduction of the storage costs and an increase of the just in time production. In
addition, if BactiFlow is validated here within the framework of a qualitative analysis, it allows direct enumerations available for certain matrices according to their background. This aspect was used also at the time of this validation to estimate the stocks solutions necessary
to the inoculums preparation or to validate the neutralization
effectiveness and the control of the residual inhibiting capacity."

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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.