QuantaSep - Model 1000 -Fully Integrated and Completely Automated Chromatography System

The entire flow path is sanitary and consists of polypropylene manifolds and reinforced silicone tubing. All components are housed in the a compact bench top system and uses standard power. The salient features are labeled above in the Process Flow Diagram and referenced below:

(A) 12 selectable buffer ports –Manifold of six solenoid actuated diaphragm valves on each pump provide ample sample and buffer connections. Single piece construction minimizes

(B) Two precision positive displacement rotary piston pumps - Each at 0-1800ml/min are used to provide accurate flow with low pulsation with turn down ratio of 100:1. Precision gradients are possible.

(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) Multiple Columns and forward/reverse/bypass capability - 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. Three columns steps or UF/DF can be run sequentially.

(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. 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.

The controls module contains all power supplies, transformers, valve activation electronics, brainboards, sensor controls and circuit boards, alarm controls, sensor electronics including A/D and D/A converters and fuse assembly. The external chart recorder interface, status LED`s, an emergency stop switch, cables, computer interface, fuse blocks, etc are all included.

The Right Combination of Simplicity and Power

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.

Intuitive Protocol Design

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!

Security

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.

CGMP Documentation and Data Analysis

All events manual or automatic (including deviations) are recorded to the batch log. Reports consisting of the method, buffers used, 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.

The QuantaSep® 100 pilot/production chromatography system for fluid handling and control is composed of three modules, integrated into a single cabinet with dimensions of 30" width x 24" depth x 18" height and weighing 125 lbs.

• Automates buffer delivery, column switching, fraction collection, based on UV, pH and conductivity
• Graphical, intuitive software "dashboard" for easy operating and training
• Automated GMP reports
  Complete batch reports
  Event and alarm logs
  Chromatograms and calibration history
  Data Archival and Security
• Sanitary Flow Path
  Low system volume
  Minimal dead legs
  Precision Hardware
  Wier diaphragm valves
  Positive displacement pumps
  Large dynamic flow range
  100:1 turndown ratio for accurate gradients
• Sensors
  UV, pH, and conductivity sensors
  Integrated flow cell
  Optional precolumn pH, and conductivity sensors
  Optional second 254 nm UV capability
  Pressure, temperature, air, leak
• Safety features
  "Active air trap" minimizes "bubble trap dilution"
  Optional precolumn filter with differential pressure sensors
  Leak and pressure alarms
  Built in safety interlocks
  Software method checks
  Software security prevents unauthorized operation and tampering

The QuantaSep® Family

To meet the growing need for cGMP compatible sanitary purifications, Sepragen has developed a family of 6 systems designed to provide purification capability at different scales. All systems are scalable, and use the same design philosophy and software. They all automate many routine tasks so that mission critical project deadlines can be met. Clinical production capacity can be scaled up quickly within existing space and headcount limitations.

• QuantaSep® 100: Automated chromatography with a flow range of 1-100 ml/min
• QuantaSep® 1000: Automated chromatography with a flow range of 10-1000 ml/min
• QuantaSep® 100LX: A fully automated dual flow range chromatography system
• QuantaSep® 1800: Automated chromatography with a flow range of 20-1800 ml/min
• QuantaSep® 5000: Automated chromatography with a flow range of 50-5000 ml/min
• QuantaSep® 10000: Automated chromatography with a flow range of 100-10000 ml/min NEW!