QuantaSep® FAQ

1. Are Quantaseps research, pilot or production systems?
   There are 7 standard off the shelf Quantasep systems that are used for process development, preclinical, clinical and commercial manufacturing.
2. How do you choose what configuration you want to for the Quantasep?
   The Quantasep systems are integrated and pre-configured with certain options. They all contain buffer selection, fraction collection and column direction valves, air, pH, conductivity UV and pressure sensors. The software to make manual or automated runs with necessary reports is all included. For production custom configurations are available.
3. How do these systems compare with the Akta Systems from GE?
   The Quantasep systems have many superior features (check out comparison chart): easy to use software, greater flow rate range and 100:1 turn down ratio, accurate gradients auto air removal air and leak detection, small footprint and of course, better price.
4. Can we get IQ/ OQ, Validation documentation with all traceability and material certifications and Preventative maintenance on the systems?
   Yes, all of these are available at added cost.
5. Are any systems being used in GMP production?
   Yes, there are several hundred Quantasep systems in use in development and cGMP production.
6. Are the Quantasep systems CE certified and the software 21CFR pt 11 compliant?
   The Quantasep systems are CE certified and the software is 21 CFR Pt11 compliant.
7. In automated methods can the Quantasep software switch buffers and fractions based on UV or air besides time and column volumes?
   The Quantasep software can switch steps based on a lot of parameters like air, pressure, time, volume, column volume, UV, UV slope, % peak max, conductivity and pH.
8. Can the software do cycling?
   Yes it can
9. Can the software calculate HETP, Peak Asymmetry, % areas etc.
   Yes the software provides these features including dynamic overlays in real time.
10. Can Sepragen make custom skids for explosion proof environments?
    Yes, Sepragen has made systems certified for use in Class1 DivII and Class 1 Div1 environments.
11. Can your system back up data or connect to a DCS?
    The software operating system is WIN XP and hence data can be backed up on a Window server. Data can be transferred to a DCS via the OPC server.
12. What are the utility and power requirements?
    All Quantasep Systems can be run on normal power 110V/ 120V or 220V. Quantasep 5000 and larger require pneumatic air at 90 psi in addition.
13. Can you make Quantasep systems with single use flow-paths to enable quick "change-over" and eliminate cleaning validation?
    Yes, Sepragen has introduced the first single use Quantasep system that has a removable flow- path.
14. Can the software enable running of multiple column steps sequentially?
    Yes, the Quantasep software is designed to automate a multi column or column + concentration/ uf-df steps.
15. Can the Quantasep software reduce flow of the pumps to run at constant pressure?
    Yes, it can enable both a ramp up and ramp down of the flow to maintain pressure.