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QuantaSep® 100 Chromatography System Specifications

System Overview

The QuantaSep® 100 pilot 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. A computer is separate from the system to provide the option of remote control up to 25 feet away. The system is compatible with 1M NaOH and 19% alcohol for CIP operations and operable at 4° C for cold room processing.

The fluid handling module contains: Dual stepper motor controlled pumps, static mixer, PTFE tubing with sanitary clamp connections, diaphragm shielded solenoid valves, UV, pH, leak, conductivity, temperature and pressure sensors, air sensor, air purge valve, sanitary inlets, outlets and column connections all enclosed in a 316 stainless steel cabinet. Total hold-up volume is approximately 7 mls from any one buffer inlet to any one fraction outlet.

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 (user defined detector input) digital display of monitor outputs, status LED’s, an emergency stop switch, cables, computer interface, fuse blocks, etc.

The system is controlled by an Pentium Personal computer which includes a minimum of 1.2GB hard drive, 32 MB RAM, 17" SVGA color monitor, 4 MB V RAM graphics card, mouse, printer port, single 3.5" floppy disk drive and QuantaSep® 100 control software. Resident DOS 6.0, and Windows 3.1, mouse drivers, etc. (computer and operating system software specifications are likely to change in line with current standards).

Flow Path Description

Sample feed and buffer tanks are connected to sanitary 0.0625" ID inlets (positioned on the system’s left side as you face the front). Inlets are arranged as follows:
  • 6 Star Configuration inlets to supply the A pump
  • 6 Star Configuration inlets to supply the B pump
Two positive displacement pumps draw the selected process fluids into the systems and deliver them at precisely controlled flow rates for accurately proportioned gradients.

A low volume static mixer combines the two flow streams to produce a single uniform binary composition gradient.

A pressure transducer detects process pressure for recording to the computer and for alarm control. A non-invasive air sensor detects air for system alarm and/or purging through the air purge valve thus forming a unique active Air/Bubble Trap with no dilution, etc.

Connections for three columns with 0.0625" ID sanitary inlet and outlet, as well as a column bypass system follow the air purge valve in sequence. Only one column or the bypass line may accept flow at a given time.

UV, pH, conductivity, and temperature sensors continuously monitor the column effluent. Flow cells are easily cleanable in place.

After the system monitors, the process stream flows out one of the 10 selectable fraction outlets; 0.0625" sanitary connections (positioned toward the front of the system). An appropriate external fraction collector (not included) can be connected to any one of the outlet ports to increase fractionation capability.

Instrumentation

Self priming, positive displacement rotating piston pumps with stepper motor drive and stall detection capability

Flow rate range: 0 ml - 100 ml/min. Maximum pressure: 100 psi.

Pressure transmitter: 0 to 100 psi +/- 1.0 psi accuracy

Non-invasive air sensor range: ultrasonic detection with adjustable purge timer 0 to 2 minutes. Detects bubbles 1/4 th the diameter of the tubing.

UV monitor

Wavelengths: 280nm

Path length: .1, .2, .5 or 1.0 cm

Range: 0-0.1; 0-0.2, 0-0.5; 0-1; 0-2.0 AUFS

Accuracy: +/-5%; of reading

Conductivity monitor: range 0-100ms

pH monitor: 2-12 +/- 0.1 pH

Alarms

The system has safeguards built into it for detecting and expelling air, detecting a leak, system over-pressure, and detecting communication error. The window flashes whenever a new alarm occurs. The icon representing active alarms is highlighted and flashes when an alarm occurs. When a severe alarm is detected the system automatically halts. The system can be restarted when the problem is corrected. Other alarms are simply logged and the system continues it’s process.

Pushing the red emergency stop button pauses the system and shuts off the pumps.

Wetted Materials of Construction

  • Inlet/Outlet ports and manifolds PTFE
  • Valve diaphragms PTFE
  • Pump Head Ceramic
  • Pump Body PVDF
  • Sanitary gaskets Silicone
  • pH electrode Glass
  • System tubing, mixer Polypropylene/Silicone
  • UV monitor flow cell windows Quartz
  • UV, pH, conductivity flow cells PVDF
  • Pressure sensor 316 L S.S.
  • Tubing PTFE

System Operation and Control

This version of QuantaSep® 100 software runs under the Windows 3.11 operating environment and therefore employs a graphical user interface based on objects and pop-up windows. It is generally mouse-driven for selection and keyboard-driven for data entry. The QuantaSep® 100 software runs under a multiple-document interface that uses one main window from which all others are displayed. The main program window displays a menu-bar and tool-bar. Commands are executed by selecting the desired function on a drop-down menu or a button on the tool bar. The toolbar contains the following functions: automatic run, manual run, method editing, chromatogram display, alarms, pause\resume, reports, login, and logout.

Some of the screens that can be displayed from the main window include: the process display, the method editor, the security screens, the chromatogram display and the alarm display. The process display screen is the main system screen that graphically displays the instrument configuration with 3D icons and shows the process in operation and the state of all components. This movable, expandable screen provides real-time control of all system components in the manual run mode via single click mouse button action. The method editor screen displays the steps of the method controlling the process. The currently running step is highlighted and displayed in the center of the screen.. The chromatogram display shows the currently running chromatogram along with the ability to overlay a historical plot. The password security screen prompts the user to logon, it also allows administration and gives a user the ability to change his/her own password. The active alarm display screens reflect the currently active alarms. Selecting an alarm category displays the details of the specific alarms.

Manual control is actuated via a mouse by simply clicking valves and pumps ‘on’ and ‘off’, or from the keyboard. For example, to open an inlet valve select the desired valve by using the tab key or position the cursor on the screen symbol denoting the desired valve, and subsequently activate the valve by depressing the spacebar or left mouse button. The valve screen color changes from red to green to indicate the valve is open. The pump is turned on/off in the same manner. Pump flow rate is entered by highlighting the appropriate screen sector under the pump symbol and entering the desired value using the keyboard. Flow rate can also be increased/decreased by increments using the right button on the mouse.

The system can be run automatically by creating a 'method' of buffer and fraction steps along with the appropriate running and switching conditions. The method could be a simple time-based equilibrate, load, wash, elute sequence with time-based step changes. Alternately, it may be run with detector-based switching of buffer and fraction steps. Column sanitization steps that bypass the column can also be executed. Several methods can be stored into the machine and any method may be run by connecting the buffer and fraction reservoirs to the QuantaSep® 100 as described in the method. For a large batch, several cycles may be programmed to run automatically.

The password security system, under the main category of USER has four sub-categories: Login, Logout, Admin., and Lockup. The login or logout panels are used to enter or exit a user name and password. The administration panel has several check boxes and allows the password administrator full administration control. There are two available methods for assigning an access level to a user. The numeric level can be keyed in directly, or the administrator can check on the functions to be granted. As each function is checked the user level will change to reflect its current status. Each combination of selected access functions will have a unique numeric level.

Unattended operation is programmed via protocol generation using the ‘method editing’ feature of QuantaSep® 100 software. A method is a file that contains steps that describe instrument operation such as gradients, inlet valve openings, fraction valve openings, alarm limits, audit tracking information, and other information that describes an automated run. Several methods may be linked together allowing enough programming capacity to automate all of the steps involved in multiple step chromatography runs. Steps within a method may be advanced based on time, total volume, column volume, air sensor or the level of any monitor’s ascending or descending signal. The software allows the looping capability to cycle a method or a portion of a method a number of times.

Process run data and alarm/event information are continuously recorded as they occur. During the run, the system keeps a log of all significant events, any manual intervention, changes in the process parameters, such as valve and flow rate changes by operation personnel, and alarms and events. The system stores all chromatogram data in numerical format, which can be displayed and printed for documentation, review and analysis purposes. Thus, a set of batch records comprised of the method set-up, the event summary and chromatography data can be generated either automatically or on-demand. The data file gives a user, with the required security level, the flexibility to change scales, or add or remove from immediate view any monitor outputs. (The data is however, not erased from the file). The real-time and a historical chromatogram can be combined on the same plot. This feature gives the user the ability to scroll back and forth on the historical plot while the real time data is being updated on the overlay. The pen scale on the chromatogram display is changeable and adjustable at run time. All data is stored in a database, and can be exported into other software packages for further data analysis such as integration.

Reports will be generated at the end of a run based on selections from the report generation screen. The selections on this screen are made by checking on/off check boxes to select/deselect various preprogrammed reports. These reports include; batch run reports, alarm/event summary reports, user password matrix reports, and method listing.

Documentation

The system is delivered with one user manual and the system calibration document. Comprehensive validation documentation is available on request at an additional cost.

Installation and Service

Installation and system start-up is included in the system purchase price and will be scheduled by a Sepragen representative at time of system delivery or at the system user’s convenience.

Warranty

Warranty period Sepragen Corporation warrants that all standard components of its instrument workstations (excluding items replaceable by the user, such as lamps, flow cells, seals, fittings, tubing, and filters) will be free of defects in materials and workmanship for a period of one (1) year. Sepragen will repair or replace, at its discretion, all defective components during this warranty period. After this warranty period, repairs and replacement components may be purchased from Sepragen at its published rates.

Sepragen Corporation guarantees all optional accessories supplied with its instrument workstations, such as fraction collectors, printers and special monitors, will be free of defects in materials and workmanship for a period of ninety (90) days. Sepragen will repair or replace, at its discretion, all defective accessories during the warranty period. After this warranty period, Sepragen will pass on to the buyer, to the extent that is permitted to do so, the warranty of the original manufacturer for such accessories.

Sepragen Corporation warrants that all user-replaceable items, including lamps, flow cells, fittings, tubing, and filters are free of defects in materials and workmanship when received by the buyer, but not thereafter. Sepragen also warrants all deuterium lamps to be free of defects in materials and workmanship and to operate above one half (1/2) of the original light intensity for a period equal to the lesser of one year or 1/000 hours of use. Sepragen will repair or replace, at its discretion, all defective replaceable items during the applicable warranty period.

Sepragen Corporation warrants that the software designated for use with the instrument will execute its programming instructions when properly installed on the product. Sepragen does not warrant that the operation of the instrument or software will be uninterrupted or error free. Sepragen Corporation will provide any software corrections or "bug fixes", if and when they become available, for a period of one (1) year after installation.

Warranty period effective date Any applicable warranty period under these sections will begin on the date of installation for hardware and software installed by Sepragen personnel, or technician authorized by Sepragen, unless that date has been delayed at the buyer’s request. In that case, and for all hardware and software installed by the buyer, the applicable warranty period begins the date the component is received.

Warranty exceptions The above warranties shall not apply to defects resulting from misuse, negligence, or accident, including without limitation: operation with incompatible solvents or samples in the system; operation outside of the environmental specifications of the instrument or accessories; performance of improper or inadequate maintenance by the user; installation of software or interfacing not supplied by Sepragen; and modification of the instrument or the software not authorized by Sepragen.

The foregoing provisions set forth Sepragen’s sole and exclusive representations, warranties, and obligations with respect to the products, and Sepragen makes no other warranty of any kind whatsoever, express or implied, warranties of merchantability and fitness for a particular purpose, whether arising from a statute or otherwise in law or from a course of dealing or usage of trade. Such limited warranty is given only to a buyer of any third party in the event of use of products furnished hereunder by any third party.

Warranty limitations The remedies provided herin are buyer’s sole and exclusive remedies. Without limiting the generality of the foregoing, in no event shall Sepragen be liable, whether in contact, in tort or on any other basis, for direct, indirect, punitive, incidental, consequential, or special damages sustained by the buyer or any other person, whether or not foreseeable and whether or not Sepragen is advised of the possibility of such damage, including without limitation, damage arising from or related to loss of use, loss of data, failure or interruption in the operation of any equipment or software, delay in repair or replacement, or for loss of revenue or profits, loss of good will, loss of business or other financial loss or personal injury or property damage.


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