"We currently provide programs for feasibility, method development and validation together with regulatory support. Once regulatory approval is obtained, technology and method can be transferred to the manufacturing site, if decided to insource.

Alternatively, Rapid Microbiology testing can be provided by Toxikon.

Toxikon runs a GMP state-of-the-art laboratory, designed to meet the most stringent microbiological environmental conditions. Our laboratory is equipped with a sterility Isolator (La Calhène/Getinge), a solid phase cytometer and an automated fluorescence microscope, needed for direct detection of single microorganisms, without requiring a time-consuming growth stage (14days) in order to render culture media turbid.

The AES Chemunex technology, together with our experienced staff, allows us to provide same day sterility results."

Kevin Breesch, MSc
Program Manager
Pharma & Biotech Services

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.