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Quantasep 1000 SU, Single Use Flow-path System Launched

April, 2010, Hayward, CA ... Sepragen Corporation announces that it has developed the world’s first bench top, single-use flow path chromatography system, Quantasep 1000 SU. The Quantasep 1000 SU enables users to perform chromatography runs in the flow rate range of 30ml/min up to 1000 ml/min with the ability to change out the product contact surface or flow-path which includes the integrated tubing set, UV, Conductivity and pH flow cell, pressure sensor and mixer. The patent pending design consists of innovative pinch valve manifolds and flow cells that make the flow- path swap easy and reproducible. The Quantasep 1000 SU enables biotech companies greatly needed flexibility in minimizing:

  1. The need for cleaning validation when making pre-clinical or early clinical product
  2. Potential for carryover from one step to the next in by performing multiple chromatography steps on the same system
  3. Changeover time from one batch to the next
  4. Potential cross contamination from one product to the next in a multi-product facility.
The Quantasep 1000 SU features six inlets, a peristaltic pump, auto air ejection capability, column forward, reverse and bypass capability and six manifold fraction valves. The system is rated for 50 psi or 3 bar. It has a pressure sensor, air sensor, uv, conductivity and pH sensors all of which are removable. Air is removed automatically from the system.

The Quantasep 1000 SU features the user friendly Quantasep software with the ability to operate the system by simple point and click on a P&ID screen. Excel like menus can enable automated runs where step changes can be programmed based on standard chromatography parameters like time, volume, bed volume, UV, UV slope, conductivity, pH etc. The 21 CFR part 11- compliant software also has peak analysis, overlays, zoom, asymmetry, peak area and HETP calculations available at the click of a mouse. The data which consists of the run log, method used, operator history, alarm summary, chromatogram and related analysis is available in the form of batch reports for compliance purposes.

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The statements in this release that relate to future events or performance, statements about growth, future regulatory clearances, levels of sales and market size and future manufacturing capacity and efficiencies are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to the development of markets for and commercial acceptance of the company's products and services, the availability of components, competitors' product introductions and other risks identified in the company's SEC filings. Actual results may differ from those described in these forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.


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