GE Healthcare Life Sciences Data file 29-0483-67 AA Single-use mixing systems Xcellerex™ XDM Quad Mixing System GE Healthcare Life Sciences’ disposable mixing systems are designed for convenient and efficient mixing of buffer, media, intermediates and product, as well as other process fluids. The single-use system eliminates the hassle of timeconsuming and costly clean-in-place (CIP), steam-in-place (SIP) procedures, and cleaning validation. The result is efficient processing and rapid batch-to-batch turnover time. The Xcellerex XDM Quad Mixing System is available in singlewall stainless steel (Fig 1), jacketed stainless steel (for heating and cooling applications), or polypropylene (Fig 2). The system comprises an integrated rigid container, complete with an agitation system and controls that use an irradiated USP Class VI single-use ULDPE fluid contact layer bag. The system delivers flexibility with the availability of two standard bag types that include varying numbers of tubing lines and connections, and sampling and sensing capabilities to accommodate a wide array of applications (Fig 3). Custom bag configurations are also available on request. Key features of the bag and rigid container also permit seamless transitioning between powder-liquid and liquid-liquid mixing applications. Fig 1. Xcellerex XDM Quad Mixing System is available in 50L, 100 L , 200 L, 500 L, and 1000 L sizes. A disposable impeller is welded into the bottom of the bag assembly (Fig 4). The engagement between motor and disposable impeller is via a robust magnetic coupling, imparting high torque and rapid mixing capability to the system. Key features and benefits: • Powerful, integrated magnetic agitator with compact VFD and AC motor • Square configuration offers enhanced mixing efficiency through natural baffling effect • Workable heights and low center of gravity increase level of safety • Bottom is slanted on two planes for minimal low bag hold-up volume • Fitted square bag minimizes bag wrinkles imagination at work Fig 2. Xcellerex XDM Quad Mixing System is available in various materials including polypropylene (pictured here), single-wall stainless steel (Fig 1), or jacketed stainless steel (for heating and cooling applications). • Real-time sensing and sampling capability via mixer window and bag probe ports, sampling port and thermowell for non-invasive temperature sensing • 500 and 1000 L systems equipped with removable door for easy bag loading • All mixers are CE and UL approved and GMP compliant System specifications1 Xcellerex XDM QUAD-S (stainless steel) Mixing System Dimensions 50 L 100 L 200 L Exterior (W × H × D) 848 × 1067 × 544 mm 851 × 1067 × 610 mm 940 × 1067 × 673 mm 1227 × 1443 × 897 mm 1405 × 1443 × 1100 mm (33.4 × 42 × 21.4 in) (33.5 × 42 × 24 in) (37 × 42 × 26.5 in) (48.3 × 56.8 × 35.3 in) (55.3 × 56.8 × 43.3 in) 102 × 51 mm (4 × 2 in) Jacket volume Weight System weight (empty) Construction material Container NA 68 kg (150 lbs) 82 kg (181 lbs) 140 kg (309 lbs) Acrylic Casters SS/polyurethane (non-marring) Type AC motor HP 0.26 Power rating 197 W RPM 0 to 200 Power requirement 115 V or 230 V: (50/60 Hz) Functionality Run/stop, forward/break/reverse Power cord 3.05 m (10 ft) Washdown Motor is IP66, CE certified/drive is IP65 NEMA 4×, CE certified Xcellerex XDM QUAD-T (jacketed stainless steel) Mixing System 50 L 100 L 200 L Exterior (W × H × D) 848 × 1067 × 544 mm 940 × 1067 × 681 mm 978 × 1067 × 681 mm 1280 × 1443 × 975 mm 1488 × 143 × 1207 mm (33.4 × 42 × 21.4 in) (37 × 42 × 26.8 in) (38.5 × 42 × 26.8 in) (50.4 × 56.8 × 38.4 in) (58.6 × 56.8 × 47.5 in) Jacket volume System weight (empty) 102 × 51 mm (4 × 2 in) 1.2 L 2L 2.65 L 5.8 L 9.1 L 91 kg (200 lbs) 107 kg (236 lbs) 173 kg (381 lbs) 228 kg (503 lbs) 359 kg (792 lbs) Container 304 L stainless steel Insulation Insulation is non-asbestos, chloride free, and coated with Thurmalox™ mastic material Acrylic Casters SS /polyurethane (non-marring) Type AC Motor HP 0.26 Power rating 197 W RPM 0 to 200 Power requirement 115 V or 230 V: (50/60 Hz) Functionality Run/stop, forward/break/reverse Power cord 3.05 m (10 ft) Washdown Motor is IP66, CE certified/drive is IP65 NEMA 4×, CE certified Xcellerex XDM QUAD (polypropylene) Mixing System 50 L 100 L Exterior (W × H × D) 686 × 1143 × 572 mm 838 × 1041 × 699 mm 965 × 1016 × 826 mm 1029 × 1219 × 1181 mm (27 × 45 × 22.5 in) (33 × 41 × 27.5 in) (38 × 40 × 32.5 in) (40.5 × 48 × 46.5 in) Weight System weight (empty) Construction material Container Insulation Lid Casters Type HP Power rating RPM Power requirement Functionality 838 × 838 × 838 mm (33 × 33 × 33 in) ~ 41.7 mm (1.64 in) per meter (3.28 ft) 102 × 51 mm (4 × 2 in) Jacket volume NA 52 kg (115 lbs) 65 kg (143 lbs) 83 kg (183 lbs) 138 kg (304 lbs) Polypropylene NA Acrylic SS/polyurethane (non-marring) AC motor 0.26 197 W 0 to 200 115 V or 230 V: (50/60 Hz) Run/stop, forward/break/reverse Power cord 3.05 m (10 ft) Washdown Motor is IP66, CE certified/drive is IP65 NEMA 4×, CE certified All specifications are subject to change without notice. 29-0483-67 AA 500 L 394 × 394 × 394 mm 508 × 508 × 508 mm 635 × 635 × 635 mm (15.5 × 15.5 × 15.5 in) (20 × 20 × 20 in) (25 × 25 × 25 in) Slope to drain 2 200 L Container interior (W × H × D) Caster dimensions (ø × W) 1 838 × 838 × 838 mm 1041 × 1041 × 1041 mm (33 × 33 × 33 in) (41 × 41 × 41 in) ~ 41.7 mm (1.64 in) per meter (3.28 ft) Lid Motor/VFD 1000 L 394 × 394 × 394 mm 508 × 508 × 508 mm 635 × 635 × 635 mm (15.5 × 15.5 × 15.5 in) (20 × 20 × 20 in) (25 × 25 × 25 in) Caster dimensions (ø × W) Dimensions 500 L Container interior (W × H × D) Slope to drain Motor/VFD 275 kg (606 lbs) NA Lid Construction material 180 kg (397 lbs) 304 L stainless steel (SS) Insulation Weight 838 × 838 × 838 mm 1041 × 1041 × 1041 mm (33 × 33 × 33 in) (41 × 41 × 41 in) ~ 41.7 mm (1.64 in) per meter (3.28 ft) Caster dimensions (ø × W) Dimensions 1000 L 394 × 394 × 394 mm 508 × 508 × 508 mm 635 × 635 × 635 mm (15.5 × 15.5 × 15.5 in) (20 × 20 × 20 in) (25 × 25 × 25 in) Slope to drain Motor/VFD 500 L Container interior (W × H × D) Single-use bag specifications1 50 L 100 L 200 L 394 × 369 × 394 mm (15.5 × 14.5 × 15.5 in) 508 × 483 × 508 mm (20 × 19 × 20 in) 635 × 609 × 635 mm (25 × 24 × 25 in) Maximum 55 L 125 L 246 L 571 L 1019 L Nominal 50 L 100 L 200 L 500 L 1000 L Minimum (for mixing) 17 L 28 L 44 L 76 L 117 L < 20 mL < 20 mL < 20 mL < 20 mL < 20 mL Dimensions Dimensions (W × H × D) Volume Hold up Film Fluid contact layer 1000 L ULDPE (USP class VI) Pressure rating (max. operating) Impeller 500 L 839 × 813 × 839 mm 1041 × 940 × 1041 mm (33 × 32 × 33 in) (41 × 37 × 41 in) 2 psi (1 psi) Number of blades 3 Diameter 191 mm (7.5 in) Blade height × width 107 × 64 mm (4.2 × 2.5 in) Blade pitch 57º Construction material Molded HDPE impeller with ceramic bearing Temperature range 2°C to 60ºC (May vary due to specific process conditions) Powder port dimensions 76 mm (3 in) TC Sterilization Gamma irradiated Single-use bag assemblies1 Basic bag assembly Port description A Fill port: 3" tri-clamp powder addition port, capped B C-flex™ tubing, 4’ with clamp, plugged (ID indicated) Plus bag assembly 50 L 100 L 200 L 500 L 1000 L 50 L 100 L 200 L 500 L 1000 L × × × × × × × × × × 12.7 mm 12.7 mm 12.7 mm 12.7 mm 19.1 mm 19.1 mm 19.1 mm 19.1 mm 19.1 mm 19.1 mm (1/2 in) (1/2 in) (1/2 in) (1/2 in) (3/4 in) (3/4 in) (3/4 in) (3/4 in) (3/4 in) (3/4 in) C ½" ID C-flex tubing, 4’ with clamp, female MPX connector, plugged NA NA NA NA NA × × × × × D 1/8" ID C-Flex tubing (36”) Luer lock connection NA NA NA NA NA × × × × × E, F Probe Port: Female Kleenpack™ Connector port for probe connection NA NA NA NA NA × × × × × F Female Kleenpack Connector port for probe connection NA NA NA NA NA × × × × × G Thermowell: for non-invasive temperature sensing NA NA NA NA NA × × × × × × × × × × × × × × × H Sample Line: 1/8" ID sample line with clamp, and Luer lock connection I Harvest/Drain: C-flex tubing, 6’ with clamp, plugged (ID indicated) 1 12.7 mm 12.7 mm 12.7 mm 12.7 mm 19.1 mm 12.7 mm 12.7 mm 12.7 mm 12.7 mm 19.1 mm (1/2 in) (1/2 in) (1/2 in) (1/2 in) (3/4 in) (1/2 in) (1/2 in) (1/2 in) (1/2 in) (3/4 in) All specifications are subject to change without notice. Bag assembly details Xcellerex XDM Quad Mixing System options and accessories The following options are available for Xcellerex XDM Quad Mixing systems: • Dual pH/conductivity monitoring System • pH probe • Conductivity probe Fig 3. Xcellerex XDM Quad Mixing System available with two standard bag assembly types: Basic and Plus. • RTD probe • Probe sheath assemblies • Weight monitoring1 (load cells for stainless steel units) • Temperature control unit for heating and cooling of jacketed stainless steel systems • Temperature monitoring1 • Hopper for powder addition 1 Not available in polypropylene mixers. Fig 4. The disposable impeller assembly is welded to the bottom of the bag. 29-0483-67 AA 3 Applications and performance data The mixing systems effective mixing of common cell culture media (Fig 7). 11.5 100 11.0 80 Corn syrup dissolved (%) Conductivity (mS/cm) Xcellerex XDM Quad Mixing System units demonstrate rapid mixing of common salt solutions (Fig 5). The systems demonstrate effective mixing even at high viscosities (Fig 6). 10.5 10.0 9.5 9.0 60 75% corn syrup, 274 cp 85% corn syrup, 561 cp 90% corn syrup, 1000 cp 40 20 0 60 120 180 240 0 300 0 20 40 Time (s) Fig 5. Xcellerex XDM500: mixing trend 6 g/L for NaCl. (B) 10 L-glutamine (L-Gln) 9 Component concentration 80 100 Fig 6. Xcellerex XDM200: mixing trend for 1% NaCl in 75%, 85%, and 90% corn syrup. 90 Glucose (g/L) 8 100 (mmol/L) Component concentration (mmol/L) (A) 60 Time (min) 7 6 5 4 3 2 1 + Na (mmol/L) 80 70 60 50 40 30 20 10 0 0 0 60 120 180 Mix time (s) 0 300 240 60 120 180 240 300 Mix time (s) (C) (D) 10 400 + K (mmol/L) Osmo (mOsm/kg) 350 8 300 7 Osmolarity (mOsm/kg) Component concentration (mmol/L) 9 6 5 4 3 250 200 150 100 2 50 1 0 0 60 120 180 240 0 300 0 60 Mix time (s) 120 180 240 300 Mix time (s) Fig 7. Xcellerex XDM500: glucose and l-Gln trends for DMEM/F-12 cell-culture medium (A), sodium trends for DMEM/F-12 (B), potassium trends for DMEM/F-12 (C), and osmolarity trend for DMEM/F-12 (D). For local office contact information, visit www.gelifesciences.com/contact GE, imagination at work and GE monogram are trademarks of General Electric Company. Xcellerex is a trademark of Xcellerex, Inc., now part of GE Healthcare. C-Flex is a trademark of Saint-Gobain Performance Plastics. Kleenpak is a trademark of Pall Corporation. Thurmalox is a trademark of Dampney Company, Inc. © 2013 General Electric Company—All rights reserved. First published June 2013. www.gelifesciences.com/xcellerex GE Healthcare Bio-Sciences AB Björkgatan 30 751 84 Uppsala Sweden All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information. GE Healthcare UK Limited Amersham Place Little Chalfont Buckinghamshire, HP7 9NA UK GE Healthcare Europe, GmbH Munzinger Strasse 5 D-79111 Freiburg Germany GE Healthcare Bio-Sciences Corp. 800 Centennial Avenue, P.O. Box 1327 Piscataway, NJ 08855-1327 USA imagination at work GE Healthcare Japan Corporation Sanken Bldg., 3-25-1, Hyakunincho Shinjuku-ku, Tokyo 169-0073 Japan 29-0483-67 AA 06/2013