impulse Single-Use Mixers

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DATA SHEET impulse Single-Use Mixer (S.U.M.) impulse Single-Use Mixers Standard specifications Introduction The Thermo Scientific impulse Single-Use Mixer (S.U.M.) is designed for liquid-to-powder, liquid-to-liquid, and suspension mixing.

1 DATA SHEET impulse Single-Use Mixer (S.U.M.) impulse Single-Use Mixers Standard specifications Introduction The Thermo Scientific impulse Single-Use Mixer (S.U.M.) is designed for liquid-to-powder, liquid-to-liquid, and suspension mixing. The unique design has been shown to successfully maintain homogeneity in slurries and suspensions over the entire working volume range down to empty. The variable-frequency drive unit allows the user to control the intensity of the agitation to meet specific process requirements. In addition, the unique design provides the benefits of low shear and low air entrainment for solutions of various viscosities up to and including 500 centipoises (cp). Each system comes standard with the mixing bag holding vessel and the variable-frequency drive unit and motor. A full list of options can be found on page two. Key features Variable speed: The mixing speed is variable between 0.1 to 2.0 Hertz from mild to aggressive agitation. Sizes: 30 5,000 L, the impulse mixer has proven and predicted mixing scalability through mixing studies and computational fluid dynamic simulations Superior mixing dynamics Rapid powder hydration, <5 minutes Effective at maintaining suspensions Variable speed, low shear, low air entrainment Areas of application Product intermediates Buffer and media preparation Final biological products Standard components impulse mixing vessel 304 stainless steel welded construction; 316 stainless steel is available Open top construction Patented hexagon-shaped body and hemispherical 7.5 bottom Polished interior and exterior with welds ground smooth Moveable, full-length process viewing window, L sizes

2 Latched, access door for 250 L and up, including a window and interlock to stop the mixer drive when the door is opened Three-leg supports and frame on fi xed units; available for 750 L and larger Stainless steel non-marring casters on 30 L through 1,500 L sizes with four legs and frame Disposable Liner Assembly Hex Tank Maximum Tank Volume Nominal Tank Volume impulse drive unit Non-adjustable, vertical stroke Variable mixing speed from 0.1 to 2.0 Hz 120/230 V, single phase, 50/60 Hz for 30, 50, and 100 L units, IP44 Motor 480 V, 3-phase, 50/60 Hz, 1,750 rpm TEFC, XE, IP55 Motor 250 L and larger sizes. Mixer Stroke Tank Hex Bottom Cone Volume at 20% Mixer: Top-centered Mixer: Bottom-centered Mixer, Shaft and Seal BioProcess Containers (BPCs) for impulse The Thermo Scientifi c BPCs for the impulse Mixer are made of Thermo Scientifi c ASI 26/77 polyethylene (PE) fi lm, which is produced utilizing two webs. Recirculation The tube fl uid set contact web is a 5.0 mil polyethylene (ASI 26 fi lm). The fill tube set outer web is a 5-layer, 7 mil coextrusion web (ASI 77 fi lm). BioProcess Container (BPC) control valve Two bottom-process tube ports inlet and outlet/recirculation Three top-process tube ports process fi ll, infl ate/vent, and pressure sensing inlet Powder port Vent outlet One agitator drive port One powder feed port with 3 in. or 4 in. tri-clamp for support, and clear cap to act as a sight glass Standard tube sets are available to connect impulse mixing BPCs for liquid addition, recirculation, infl ation, and vent control. The tube sets are modular and can be customized to best suit your process. Recirculation suction Recirculation return Sample PUMP ELEMENT DIRECTION OF FLOW BioProcess Container (BPC) Recirculation tube set BioProcess Container (BPC) Inflate control valve system Recirculation tube set BioProcess Container (BPC) fill tube set Downstream process/discharge Recirculation tube set fill tube set control valve control valve fill tube set inlet Powder port

3 Quality standards These systems comply with applicable ISO 13485, and FDA regulations, and are designed and manufactured following cgmp requirements. Film specification ASI 26/77 polyethylene (PE) BPCs are produced utilizing two webs. The fluid contact web is a 5.0 mil polyethylene (ASI 26 film). The outer web is a 5-layer, 7 mil coextrusion web (ASI 77 film). Property Test protocol Average values Physical data (post gamma irradiation, kgy) Tensile strength ASTM D psi 20.8 MPa Elongation ASTM D % Yield strength ASTM D psi 13.6 MPa 2% Secant modulus ASTM D psi 395 MPa Tensile toughness ASTM D lbf-in 3.0 kn-cm Puncture resistance ASTM F lbf 49 N Seam strength ASTM F88 28 lbf/in 49.1 N/cm O 2 transmission rate ASTM D3985, 0% relative humidity (RH) outside, 90% RH inside, 23 C cc/100 in 2 /day 0.64 cc/m 2 /day CO 2 transmission rate Mocon method, 0% RH outside, 100% RH inside, 23 C cc/100 in 2 /day 1.71 cc/m 2 /day Nylon Tie EVOH Tie vapor transmission rate Haze ASTM F1249, 0% RH outside, 100% RH inside, 23 C ASTM D1003 (outside dry/inside dry) g/100 in 2 /day 60% 0.34 g/m 2 /day LLDPE 77 Layer 26 Layer ULDPE Glass transition temperature ASTM E ºF 27ºC Film gauge 12 mil mm Film contact material Polyethylene 10 6 Sterility assurance level ANSI/AAMI/ISO 11137: Mrad kgy Biocompatibility data (post gamma irradiation, >45 kgy) USP Class VI USP <88> Pass Cytotoxicity USP <87> Pass Fluid contact surface Schematic cross section Bacterial endotoxin USP <85> 0.5 EU/mL Heavy metals USP <661> <1 ppm Buffering capacity USP <661> 0.10 ml Non-volatile residue USP <661> 1.6 mg Residue on ignition USP <661> <5 mg Appearance EP < > Pass Acidity and alkalinity EP < > Pass Schematic 3D view Absorbance EP < > Pass Reducing substances EP < > Pass Transparency EP < > Pass

4 Motor drive specifications FDA compliant, synthetic oil filled Vessel mounted with start-stop buttons, run indicator module, and speed adjustment control Physical specifications Working volume (L) Unit dimensions* Unit weight Nominal Max. Min. (L x W x H) Dry Wet x 63.5 x 91.4 cm 75 kg 112 kg (30 x 25 x 36 in.) (165.3 lbs) (246.9 lbs) Hardened stainless steel shafts with linear ball bearings x 76.2 x cm (31 x 30 x 40 in.) 110 kg (242.5 lbs) 167 kg (368.2 lbs) Quick-connecting agitator with clamp block OSHA compliant guard with hardwired interlock to stop the motor if removed x 88.9 x cm (31 x 35 x 52 in.) 81.3 x x cm 32 x 46 x 60 in.) 86.4 x x cm (34 x 58 x 68 in.) 223 kg (491.6 lbs) 370 kg (815.7 lbs) 432 kg (952.4 lbs) 334 kg (736.3 lbs) 673 kg (1,483.7 lbs) 1,037 kg (2,286.2 lbs) x x cm (56 x 60 x 80 in.) 503 kg (1,108.9 lbs) 1,410 kg (3,108.5 lbs) 1,000 1, x x cm (50 x 50 x 82 in.) 516 kg (1,137.6 lbs) 1,726 kg (3,805.2 lbs) 1,500 1, x x cm (52 x 53 x 88 in.) 629 kg (1,386.7 lbs) 2,444 kg (5,388.1 lbs) 2,000 2, x x cm (57 x 59 x 93 in.) 1,094 kg (2,411.9 lbs) 3,514 kg (7,747.0 lbs) 3,000 3, x x cm (63 x 66 x 104 in.) 1,730 kg (3,814.0 lbs) 5,360 kg (11,816.8 lbs 5,000 5, x x cm (70 x 76 x 125 in.) 3,251 kg (7,167.2 lbs) 9,301 kg (20,505.2 lbs) * The Unit dimensions listed are nominal and may vary depending on options selected.

5 Utility requirements 10 to 45 L/min 50 C maximum Connection: 1 in. tri-clamp Sanitary flange-style fittings with optional tube set Inflation or cover gas 30 psig process air 90 psig instrument air Ambient temperature Connection: 3 4 in. tri-clamp, sanitary flange-style fittings, inlet Connection: 1 in. tri-clamp, sanitary flange-style fittings, outlet Disposable filtration integrated with optional tube sets Vent Disposable filter if required Vessel jacket fluid (optional) or propylene glycol, 30% mixture supplied by customer Temperature: 5 to 50 C; flow rate; 10 to 45 gpm at 150 psig max; differential pressure; 10 psi Power: controls, instruments, and accessories 24 VDC with internal power supply Motor load max Size Stroke Amps Horsepower (HP) cm (4 in.) cm (4 in.) cm (4 in.) cm (8 in.) cm (8 in.) cm (8 in.) , cm (8 in.) , cm (8 in.) , cm (8 in.) , cm (8 in.) , cm (8 in.) Power supply required Size Volts (VAC) Amps Hertz (Hz) , , , , ,

6 Vessel volume turnover At a speed of two strokes per second, one vessel-volume turnover ranges from 15.5 sec at 30 L to 50.5 sec at 5,000 L. Nominal tank volume (L) Mixing disc diameter Mixer stroke Volume displacement per stroke (L) Speed, strokes per second Volume displaced per second (L) Vessel turnover (seconds) Unit weight (wet) cm (6.1 in.) 10.2 cm (4 in.) kg (246.9 lbs) cm (7.0 in.) 10.2 cm (4 in.) kg (368.2 lbs) cm (8.5 in.) 10.2 cm (4 in.) kg (736.3 lbs) cm (12.0 in.) 20.3 cm (8 in.) kg (1,483.7 lbs) cm (15.0 in.) 20.3 cm (8 in.) ,037 kg (2,286.2 lbs) cm (17.0 in.) 20.3 cm (8 in.) ,410 kg (3,108.5 lbs) 1, cm (19.0 in.) 20.3 cm (8 in.) ,726 kg (3,805.2 lbs) 1, cm (21.0 in.) 20.3 cm (8 in.) ,444 kg (5,388.1 lbs) 2, cm (24.0 in.) 20.3 cm (8 in.) ,514 kg (7,747.0 lbs) 3, cm (27.0 in.) 20.3 cm (8 in.) ,360 kg (11,816.8 lbs) 5, cm (30.0 in.) 20.3 cm (8 in.) ,301 kg (20,505.2 lbs) Find out more at thermofisher.com/sum For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. COL

impulse Single-Use Mixers

impulse Single-Use Mixers Standard specifications COL02488 Introduction The Thermo Scientific impulse Single-Use Mixer (S.U.M.) is designed for liquid-to-powder, liquid-to-liquid, and suspension mixing.