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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