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QuantaSep® 10000

Benefits and Features | Brochure | Pictures

*General QuantaSep Information: Specifications | FAQ | Presentation


The QuantaSep® 10000 process chromatography system is mobile, compact and capable of providing an operating flow range of 100ml – 10 liters/min. This sanitary system consisting of disposable tubing can process a 3000+ liter cell culture batch in one shift! It is ideal for GMP manufacturing.

The integrated system has two positive displacement pumps, 8 buffer selection valves, inline mixer, filters and 6 fractions collection valves. It has capabilities of buffer switching, gradient formation, feed pre-filtering, air ejection, conductivity and pH sensing pre and post column, forward and reverse flow in powerful easy-to-use software package. The software enable buffer and fraction switching based on process conditions and alarms in the event of overpressure, air or leaks. All events are logged and archived. Precision pumping and mixing enables on-line dilution from buffer concentrates.

The QuantaSep® 10000 hardware is composed of a fluid handling and control modules integrated into a single ergonomically designed counter high cabinet. The mobile unit is mounted on plastic castors with brakes for easy mobility. The computer that houses the control software is separated from the system to provide the option of remote operation. The system is compatible with 1M NaOH and alcohol for CIP operations and is operable at 4oC for cold room processing.

Hardware Features

The system is a 42”x 30”X 28” mobile unit which can be easily moved around. It runs on standard 110//220V power and 90 psi instrument air. It is PC controlled for easy operation, data storage, report generation and analysis.

The system has the following salient features:

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

(B) Two precision positive displacement pumps - Each at 100-10000 ml/min are used to allow one to purify small and large amounts using the same unit. Gradients can be easily run.

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

(D) Inline prefiltering capability - A manifold of sanitary valves with DP sensors enables the attachment of a prefilter for debris or particular removal pre-column

(E) Optional pre- column 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.

(F) 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.

(G) 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.

(H) 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.

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

Fluid Handling Module

The fluid handling module contains: 2 pump assemblies consisting of four (4) positive displacement metering pump heads, static mixer, and silicone tubing. These are connected with sanitary clamp connections to diaphragm shielded pneumatic 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 is attached a leak detector.

Controls Module

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.

Software Features

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 v 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, 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.

Click here for Software Slide Show.

 
Overview

QuantaSep Family Details

QuantaSep® 100

QuantaSep® 1000

QuantaSep® 1000LX

QuantaSep® 1800

QuantaSep® 5000

QuantaSep® 10000

Custom QuantaSep®

QuantaSep® Single Use


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