The QuantaSep® 3000 SU hardware is composed of control modules and a fluid handling combined into a single ergonomically-designed countertop cabinet. The bench top unit can be cart-mounted for easy mobility. The computer that houses the control software can be integrated with or separated from the system to provide the options of local and remote operation. The system is compatible with 1M NaOH and alcohol for CIP operations and is operable at 4°C for cold room processing. At the same time, the flow path design of the system is flexible and can be disassembled, which is convenient for cleaning and sanitizing, and easily solves the problem of cross-contamination in replacing columns or products.

The controls module contains all power supplies, transformers, valve activation pneumatics, 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 included as well.

The fluid handling module contains: 2 pump assemblies consisting of two peristaltic pumps, static mixer, and silicone tubing. These are connected with sanitary clamp connections to pinch valves, UV, pH, leak, conductivity, temperature and pressure sensors, air sensor, air purge valve, sanitary inlets, outlets, and column connections. The components are mounted inside an enclosed stainless steel cabinet with a trough to which a leak detector is attached.

Figure1

(A)  8 selectable buffer ports - Manifold of four pneumatically actuated diaphragm valves on each pump to provide flexibility.

(B)  Two precision positive displacement pumps - Each at 30-3000 ml/min are used to allow one to purify small and large amounts using the same unit.

(C) 1) Inline DP sensors - The discharge of both pumps is manifolded together to a static mixer for effective gradient formation.

2) Inline pre-filtering capability - A manifold of sanitary valves with DP sensors enables the attachment of a pre-filter for debris or particular removal pre-column.

(D) Optional pH and conductivity sensors - Can monitor pre-column pH and conductivity of buffers or load material. This helps prevent loading of wrong buffers and hence loss of product.

(E) 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.

(F) Column forward/reverse 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 for flexibility in your product.

(G) Post column sensors - Consist of a single flow cell capable of UV dual-wavelength (280 and 254 nm) detection and pH and conductivity detection. Minimize hold up volume of sensor lag time.

(H) 6 user selectable fraction ports - Fractions can be collected via a manifold compromising of 6 pneumatically actuated valves.

(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 (Figure 1) 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) 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(Figure 2), 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!

Figure2

(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 used, all alarms and events, chromatogram data and analysis can be printed or archived as part of the batch log (Figure 3). The Instant Data Analysis helps do a quick check of an ongoing process against baseline data hence preventing possible losses.

(4) 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.

Figure3