GE Healthcare Data File 11-0032-71 AB Membrane systems ÄKTAcrossow automated cross ow ltration for process development ÄKTAcrossow™ is the rst fully automated system for cross ow ltration process development and is ideal for lter screening and process optimization at small-scale. ÄKTAcrossow together with UNICORN™ control software puts you in control of your cross ow process to allow consistent simulation of large-scale conditions and provide data for comprehensive analysis of results. The benets of working with ÄKTAcrossow include: • Broad range of applications that cover ultraltration and microltration • Flexible operation of either hollow ber cartridges or cross ow cassettes • Thorough and ecient process development with full TMP and ux scouting • Single familiar UNICORN interface for both chromatography and membrane separations • No disruption to proteins or cells with low shear force pumps that require no cooling • Minimum working volume of 25 ml ensures operation of complete processes using lters between 40 cm2 and 150 cm2 System design and description ÄKTAcrossow consists of the separation unit, a computer with at-screen monitor and UNICORN software (Fig 1). The compact, bench-top system is suitable for installation in laboratories, which reduces facility expenditure. The sanitary design means that it can formally qualify for use in current Good Manufacturing Practices (cGMP) processes. Fig 1. ÄKTAcrossow has a compact and sanitary design. The system is built with ÄKTAdesign™ components for reliability, scalability and exibility. ÄKTAcrossow comes complete with UV, pH and conductivity detectors, as well as air, pressure and temperature sensors. The valves and the ttings are specially developed for hygienic, leak-free operation. Electrically actuated diaphragm valves diminish hold up volumes and prevent dead volumes. A wide range of cross ow devices include GE Healthcare hollow ber cross ow cartridges for cell harvesting/ cell concentration and Kvick™ Start cassettes for product concentration/ dialtration. ÄKTAcrossow is designed to operate up to 150 cm2 of membrane area and is suitable for processing small sample volumes.

Flow Restrictor Transfer Pressure Sensor QT Transfer Valve Block 1 In 1 Air In 2 Sensor Air In 3 In 4 Transfer Valve Block 2 In 5 In 6 In 7 In 8 Transfer Pump (Module A) Transfer Purge Valve Transfer line Level & Temperature Sensor Fig 3. Sanitarily designed membrane valve. Vent Retentate Pressure Control Valve Permeate Valve Block Retentate Valve Block Permeate Pressure Sensor Feed Pump Permeate Pressure Control Valve UV Permeate Pump (Module B) The UNICORN control software allows quick, simple communication between systems and users. The software also meets the stringent control and data handling...

integral part of the permeate ow path, because it is used to control either a constant permeate ow or a constant permeate pressure. In TMP control, for example, the ow rate of the pump is regulated to maintain a constant permeate pressure set by UNICORN that continuously reports permeate ow rate. A pressure control valve (P-PCV) is situated after the permeate pump; this automatically raises the pressure to a level higher than the permeate pressure to assure ow rate accuracy by a proper function of the pump checkvalves. The ow path continues to the permeate valve block comprising four outlets....

Method wizard With the method wizard, you can easily program your ltration methods for all the steps in a typical run. For example, it is possible to rinse new lters; CIP used lters and test water ux to check lter quality and status before each run. A system sanitization method is also provided in the method wizard. Fig 7. Product step selection in the method wizard. The water ux test is a typical example of the benets when using an automated system. Water ux tests are easily included in the method, both before and after the ltration steps. From the evaluation wizard, you can gather the data...

Sanitary design System specications ÄKTAcrossow has a design that allows eective sanitization using 1 M sodium hydroxide (NaOH) as a sanitizing agent. Sanitization is the use of a chemical agent to reduce a microbial population to acceptable, predetermined level. Microbial challenge tests evaluate the eciency of the sanitizing agent. Weight, approximate: Operating temperature: 4 - 40 °C (50°C during membrane cleaning) In a study the system has been subjected to high level (1x106 Colony Forming Units CFU/ml) of microbial challenge. Two strains of bacteria that are recommended by the United States...

Hollow ber hoop cartridges Hollow ber cartridges HF Start AXM, 50 cm2, 750 kD, 1 mm UFP-750-E-2U HF Start AXM, 50 cm2, 0.65 μm, 0.75 mm CFP-6-D-2U HF Start AXM PACK, 50 cm2 Related literature Code Number UNICORN Control System Further information For the latest news and product information visit: www.chromatography.amershambiosciences.com www.bioprocess.amershambiosciences.com www.amershambiosciences.com/aktacrossow or contact your local GE Healthcare representative. www.amershambiosciences.com www.gehealthcare.com ÄKTAcrossow, ÄKTAdesign, Fast Trak Validation, Kvick, and UNICORN are trademarks...