GE Healthcare Life Sciences Data file 18-1167-90 AD Chromatography Systems ÄKTApilot™ ÄKTApilot is a high-performance, automated liquid chromatography system designed for process development, process scale-up, scale-down and small-scale production. The system has the capacity to purify from milligrams to tens of grams of product and is biocompatible, hygienic and sanitizable. • Hygienic design – Enables purification of microbiologic- and contaminantfree products. – For convenient Cleaning Validation. • High dynamic capacity – Flow capacity 4-400 ml/min with 0-100% gradient. – 4-800 ml/min flow with limited gradient. – Possible to purify 10 g product per cycle. • Fast and convenient start to every purification – Method wizard for easy programming. – Preprogrammed cleaning method and column lists. – Pressure regulation of flow rate at sample application and column packing. • Validation support – IQ/OQ documentation available. – UNICORN™ supports FDA 21 CFR part 11 for Electronic signature and Electronic records. • Wetted parts easily changeable for – Convenient product change when campaigning. – Simplified cleaning validation. • Bench-top design – Fits in small areas. – Easily moved and serviced. The system consists of the ÄKTApilot separation unit, a computer including a flat-screen monitor and UNICORN control system (Fig 1). UNICORN ensures quick, simple communication between systems and users and meets the stringent control and data handling procedures of modern production and laboratory facilities. Method wizards provide easy method generation. Optimized methods are transferred easily from laboratory to production scale. System design and description The ÄKTApilot components are based on our ÄKTA™ platform of reliability, scalability and flexibility. The UNICORN control system is the most current platform used in our research and production scale systems. ÄKTApilot comes complete with multi-wavelength UV, pH and conductivity detectors, and multiple air and pressure sensors. The valves and the fittings are specially developed for hygienic, leak-free operation. Electrically actuated diaphragm valves, set together in blocks of four, minimize hold up volumes and prevent dead volumes. An air trap and optional filter ensure protection of the columns.

AKTApilot contains all the fluid handling components required to perform eluent delivery and mixing, sample application, and in-line monitoring. All the control and mechanica components are located inside an easily cleaned cabinet. The flow path consists of two sets of four inlets on the main pump and four inlets on the sample pump. The latter has the same capacity as the system pump, 400 ml/min. The in-line mixer ensures high accuracy of the high-pressure gradient. The air trap is connected in parallel for easy actuation. It is possible to use two columns in series or one column at a time. Pressure...

Robust and hygienic design External valve blocks The ÄKTA platform now offers a system with sanitizable components. All wetted parts can be easily changed to simplify cleaning validation and eliminate cross contamination when the system is used in a multipurpose, campaignbased situation. ÄKTApilot can be modified by adding up to six additional external valve blocks (EVB) on a rack that fits neatly on the side of the instrument (Fig 5). A setup of four additional outlet valve blocks (EVB988) gives 16 outlet valves that allow the collection of 22 peak fractions that can be selected in the wizard....

All three system pumps have high resistance seals that withstand 20 bar and are solvent resistant. Excess pump pressure is monitored by a rapid response pressure sensor and is relayed to a preset alarm function in UNICORN. The sample pump, P-908, is identical to the system pump but only has one pump module (Fig 6). It is also equipped with a pressure sensor. Pressure and air sensors The system has four pressure sensors for measurement of the pressure. Two of the sensors are placed just before and after the column to read the pressure differential across the column. The two remaining pressure...

The Method Wizard, together with a flexible system configuration, allows fast and easy purification or column packing. The system supports you in process development, scale-up/-down and pharmaceutical production. The Scouting feature gives automatic support in process development and optimization. Scaling up to production with ÄKTApilot and optimized methods from UNICORN UNICORN cuts preparation times to a minimum whilst maintaining accuracy and assuring reproducibility. This allows quick and simple transfer from one stage of a project to the next. For example, purification of Protein Tyrosine...

Validation documentation & services ÄKTApilot – Technical specifications Regulatory authorities expect companies that produce therapeutic or diagnostic products to qualify equipment before use. Fast Trak Validation™ services can supply validation documentation to help simplify and speed these procedures. System pump and sample pump specifications Fast Trak also supplies installation and operational qualification (IQ/OQ) packages for formal qualification required by current Good Manufacturing Practices (cGMP) and inspection by regulatory authorities. Fast Trak IQ/OQ packages consist of professionally...

Ordering information Additional items AKTApilot Tubing Kit Column 18-1167-68 Cond. Cell I.D.2.5 mm AKTApilot 18-1169-00 AKTApilot Valve Membrane CPL 18-1169-10 AKTApilot Elbow 90 TC25 Short 18-1169-19 Inline filter house 18-1171-06 Connector M6 fern. - 5/16 fern. 18-1169-17 Connector M6 fern. - 5/16 male 18-1169-16 Connector 5/16 fern. - 5/16 fern. 18-1173-51 ^referred UNICORN version should be ordered on separate code number

For local office contact information, visit www.gelifesciences.com/contact www.gelifescience.com/akta GE Healthcare Bio-Sciences AB Björkgatan 30 751 84 Uppsala Sweden GE, imagination at work, and GE monogram are trademarks of General Electric Company. ÄKTA, ÄKTAexplorer, ÄKTApilot, BioProcess, Fast Trak Validation, Sephadex, Sepharose, SOURCE, and UNICORN are trademarks of GE Healthcare companies. © 2006-2012 General Electric Company—All rights reserved. First published Mar. 2006. All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare...