December 6, 2018
FDA invites Single Use Support to present MITS.2D!
In November, Single Use Support GmbH Founder Johannes Kirchmaier presented the company’s newest development, the MITS.2D at the U.S. Food and Drug Administration (FDA) headquarters in Washington to more than 60 industry experts. MITS.2D is a mobile integrity test system for single use bags and thanks to its innovative functions it constitutes an absolute novelty for the industry.
Single Use Support’s announcement of the launch of a mobile integrity testing system compatible with all standard single use bags caused a stir as early as at the beginning of 2018.
So it did not take long for the Tyrolean start-up to be invited to contribute to the international ASTM study group. This format initiated by the “American Society for Testing and Materials” comprises various industry representatives such as single-use bioprocess container and single-use bag protection manufacturers, users and processors from the pharmaceutical sector with the aim to develop new guidelines for the entire industry and to improve the standards.
“From the first release of the MITS.2D and its operational performance indicators, the phone has basically not stopped ringing,” according to founders Thomas Wurm and Johannes Kirchmaier.
FDA representatives are permanent members of the study group and they quickly recognized the potential of MITS.2D.
The initial USP was mobility thanks to the compact measurements and light weight of the device. Now it is the use of helium, the precision and the compatibility with all assembly groups. These are real milestones and make the device more precise than any other established integrity testing system for single use bags, which are all permanently installed and thus stationary. But MITS.2D manages to tackle more than that issue alone.
In less than 60 seconds (at a maximum bag volume of up to 50 liters) material deficiencies up to a detection level of 2 microns can be detected thanks to the use of helium and a patented measuring technique, ruling out the infiltration with bacteria as well as the leakage of possibly very valuable substances.
Furthermore, MITS.2D warrants completely germ-free handling, which significantly reduces contamination caused by bioburden and the development of endotoxins.
But not only the more than 60 international experts in Washington showed real interest – according to founders Thomas Wurm and Johannes Kirchmaier their phones have not stopped ringing since the first release of the MITS.2D and its operational performance indicators.
Single Use Support GmbH can be proud to have tackled more than one issue – MITS.2D has the potential to raise processes and standards for an entire industry to the next level.
Single Use Support GmbH’s mission in Washington was clearly defined by the FDA: Keep going and keep us updated about any new developments!