The key difference between the Quantum and other methods is the use of fluorescence detection which, Millipore claims, reduces the time required to incubate the microbes for detection five fold.
In the Quantum approach a substrate is passed through each sample which, if taken up by contaminant organisms, is broken down to a fluorescent dye that accumulates in the cell, enabling detection.
The system also combines a reader, camera, with existing Milliflex plus pump, filtration devices and media cassettes, is designed for raw ingredient, in-process and environmental analysis.
This approach, said company VP of process monitoring Roland Heinrich, “provides results faster than traditional testing methods…[and help] customers to release product to the market sooner and avoid line shutdowns.”
Heinrich went on to say that the combination of technologies means that: “The validation process is streamlined because it involves only minimal changes to the compendial tests currently used.”
Rapid detection
Demand for rapid detection technology has been growing as, increasingly, the drug industry recognizes that delays due to contamination can have a significant impact on a pharmaceuitcal’s earning potential.
Clearly this is a trend that Millipore has recognized and responded to with Milliflex Quantum being the second rapid identification product, behind its MilliPROBE Mycoplasma detection tool, to be launched this year.
The expansion of the offering will also be of interest prospective new owner Merck KGaA, which tabled a bid €5.3bn ($7.2bn) earlier this month, citing Millipore’s strength in bioprocessing as a key motivation for the deal.