GE Healthcare Data File 11-0035-43 AC Process chromatography ÄKTAprocess ÄKTAprocess™ is an automated liquid chromatography system built for process scale-up and large-scale biopharmaceutical manufacturing (Fig 1). The proven design has been verified during development and can be userconfigured to meet specific process demands. ÄKTAprocess is the obvious choice of system to use when scaling up processes developed on smaller ÄKTAexplorer™ and ÄKTApilot™ systems. • Versatile user-configuration with UNICORN™ control • Post-purchase configuration increasing usability and lifespan • Traceable USP Class VI materials • Intelligent packing of AxiChrom™ columns • Full regulatory documentation and services Versatile user-configuration ÄKTAprocess is a versatile platform providing thousands of configuration possibilities (Fig 2). The system is available in three flow rate ranges that extend up to 1800 l/h for large volume manufacturing. The compact design with a built-in computer allows the system to fit neatly into a plant with a minimum of clutter. ÄKTAprocess can be constructed in either electropolished stainless steel or polypropylene depending on your process conditions and plant requirements. Stainless steel systems are recommended for use in applications where salt concentrations are low and pH is above 5. Polypropylene systems have high quality, corrosion resistant polypropylene pumps to make your more process more secure. This type of system is recommended for applications with low pH and high salt concentrations, such as in the production of monoclonal antibodies. Fig 1. The ÄKTAprocess system features versatile user-configuration possibilities. ÄKTAprocess systems can be configured to develop gradients at any flow rate with feedback loop technology. This ensures thorough mixing of liquids/solvents without air bubbles so that even challenging gradients can be created with 2% accuracy (Fig 3). The built-in computer with UNICORN software allows standalone operation or integration into any plant-wide control system. Additional configurations include, for example, the choice of extra inlets and outlets, the type and quantity of selected monitors, and isocratic versus gradient functionality.

Inle Inlets Up to ten inle inlet valves. tlet Air outlet e, valve, led controlled Air trap A liquid vortex at high flow rates allows l the system to expel air effectively during op operation and make CIP more effective. P Packing/CIP valves A Additional valves are a available for automation o of CIP and intelligent p packing of AxiChrom c columns. Pressure sensor Pumps A second pum pump i il bl for is available f gradient formation. Fil Filter Op Optional filter ho housing for pa particle or ste sterile filration. C Cond cell Air sensor Flow meter Out Outlets Up to ten out outlet valves. Pressure...

UNICORN has undergone an independent audit and is designed as a validatable control package in FDA 21 CFR part 11 and GMP compliant environments. The electronic signature and record system uses a dual password confirmation, documenting locking scheme, and traceable audit log. For integration purposes, UNICORN communicates with control systems within the plant via OLE for Process Control (OPC). OPC supports application area such as data access for real time values and security control to protect sensitive information. Reproducible results with scalability Now, with ÄKTAprocess, the ÄKTA platform...

Operating pressure and temperature System specifications Piping diameter 6 mm i.d. PP* 3/8" o.d. (7.7 mm i.d.) SS† 10 mm i.d. PP ½" o.d. (9.4 mm i.d.) SS 1" o.d. (20.4 mm i.d.) PP 1" o.d. (22.1 mm i.d.) SS System flow rate 4–180 l/h 4–180 l/h 15–600 l/h 15–600 l/h 45–1800 l/h 45–1800 l/h Single (280 nm) or multiple wavelengths Surrounding temperature Applied solutions Applied solutions NEMA 4X / IP 56 electrical cabinet Electrical standards Ingress protection 0–14 (spec. valid between 2 and 12) Conductivity range Skid size (W × D × H) 6 mm, 10 mm, 3/8", and 1/2" 850 mm × 1205 mm × 1670 mm (D...