QuantaSep®1000LX adopts a unique radial flow chromatography technology, which makes the product more flexible, and has outstanding advantages such as low operating pressure, easy linear scale-up, high separation efficiency and large sample processing capacity. The system pump adjustment ratio of 100:1 supports gradient elution of 5%-95%, making product separation more accurate; there is also a unique automatic exhaust function and leakage monitoring function, which can reduce unnecessary product loss; Simple and intuitive operation page, easy to use and learn; QuantaSep software complies with 21CFR, Part11, and automatically generates GMP reports.

Hardware Features:

The entire flow path is sanitary and consists of polypropylene manifolds and reinforced silicone tubing for the high flowrate flow path and polyethylene tubing for the low flowrate flow path. All components are housed in a r compact bench top system that complies with cGMP and uses a standard power supply.

QuantaSep®1000LX has four pumps and two flow paths, with flow rates ranging from 1 to 100 ml/min and 10 to 1000 ml/min. Just click Qsep 100 or Qsep 1000 on the operation screen to run in either mode, and easily realize the conversion from 5 ml~500 ml process development to 500 ml~20 L pilot/small scale cGMP production .

The Product Features:

(A)  For each flow path there is a manifold of six solenoid actuated diaphragm valves on each pump which provide ample sample and buffer connections. Single piece construction minimizes hold up volume and makes sanitization easy.

(B)  Two precision positive displacement rotary piston pumps – For each flow path either a 0-100ml/min or 0- 1000 ml/min pumps are used to provide accurate flow with low pulsation with turn down ratio of 100:1. Precision gradients are easily achieved between 5 -95%.

(C)  In-line mixer with a pressure sensor

(D)  Auto air eject - An "active air trap" consisting of an air sensor and three-way air ejection valve continuously detects and removes unwanted air before the column thus preventing loss of raw material and valuable production time.

(E)   For each flow path, the flow is directed to the column through a valve manifold, which can route flow to the column in a forward, reverse or bypass mode.

(F)   Post column multi-mode flow cell- Consist of a single flow cell capable of UV dual-wavelength (280 and 254 nm) detection, pH, conductivity and temperature detection. Improves sensor response and synchronicity and minimizes hold up volume.

(G)  10 user selectable fraction ports - Fractions can be collected via a manifold compromising of 10 valves for each flow path. The components are mounted inside an enclosed stainless steel cabinet with a trough to which is attached a leak detector which detects and alarms in the event of a leak in a seal or fitting in the fluid path.

Software Features:

1) The simplicity of the QuantaSep® interactive graphical user interface gives the system its efficiency and power by making it easy to use and learn. The main screen below displays a flow diagram of the system with all the main components and their real time status quickly and easily. By simply clicking the mouse, you can open or close a valve, stop or start a pump, set new flow rates, collect fractions and perform other system operations all from your work station.

2) Programming is simple. Open the method editor by clicking on the icon on the tool bar. Then key in steps in the table, stepping through different buffers and changing buffer or fraction steps based on UV, conductivity, pH or air. Simply click on the gradient box and choose your gradient profile. Click on the event box and zero the UV baseline before you load your product or program in a pause before you start eluting your product!

3) CGMP Documentation and Data Analysis. All events manual or automatic (including deviations) are recorded to the batch log. Reports consisting of the method, buffers, all alarms and events, chromatogram data and analysis can be printed or archived as part of the batch log. The Instant Data Analysis helps do a quick check of an ongoing process against baseline data hence preventing possible losses.

4) The multi-levels of password protection restrict access to the system. For instance, an operator may have provision to run a method but not change the parameters; only the supervisor may be given that responsibility. In another instance, only the QA or metrology group may have access to setting calibration parameters. The security administrator in the software can enable all this and more.

5) Control and Power Module Contents. The control and power modules contain: All power supplies, sensor controls and circuit boards, alarm controls, sensor electronics including A/D and D/A converters, the external fraction collector interface, external chart recorder interface, external (e.g., user defined detector input) interface, digital display of monitor outputs, status LED’s, an emergency pause button, cables, computer interface, fuse blocks, etc.

6) Computer and Software. The system is controlled by a personal computer running a recent MicroSoft operating system.