Rotational Wand Mixer LevTech Disposable Mixing System

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April 12, 2006 Rotational Wand Mixer LevTech Disposable Mixing System Contents Rotational Wand Mixing System (RWM): Overview, Specifications & Pictures RWM Disposable Mixing Bags: Description & Drawing RWM Mixing Studies 1509 Bull Lea Road, Suite 300, Lexington, KY 40511 USA Phone: +1.859.263.1135 Fax: +1.859.263.1664 Email: info@levtech.net

RWM System Overview: The RWM is an innovative disposable mixing system using patented LevTech mixing technology. The system is designed to be portable and flexible for a broad range of mixing applications at multiple scales. The RWM allows noninvasive mixing in sterile disposable mixing bags from 10L - 200L. Mixing bags may be readily customized to optimize the integration into specific processes. The RWM drive operates independently of the tank and bag so that a single wand drive can serve multiple tanks of different sizes. Jacketed tanks are available in order to control the temperature inside the bag. The RWM can be used for sterile or non-sterile mixing applications for fluids and powders. The wand drive can run at rotational speeds from 20 to 250 RPM. The RWM System consists of: 1. A top-mounted drive designed for operation with the RWM Wand and LevTech RWM mixing bags. The design of the mixer allows this portable component to be used with multiple retaining tanks of different volumes. 2. Plastic or stainless steel retaining tanks, volumes 10 200L. The retaining tank is designed to house LevTech mixing bags. These retaining tanks may be of a jacketed design for temperature control of the mxing bag contents. 3. A 316 stainless steel frame designed to support the drive and accommodate the retaining tank. 4. LevTech mixing bags or liners are manufactured to be compatible with the retaining tanks and can include customized ports to allow the insertion of temperature probes. The number, size and configuration of the ports, tubing and associated fittings in each bag or liner will be per customer s specifications. RWM Drive: The drive is mounted on a 316 stainless steel frame structure. The frame and drive are compact and are designed for bench-top mixing. One frame and drive can service multiple bags at various volumes. LevTech performs validation of rotational speed with a certified tachometer prior to shipping. In addition to the following specifications, the drive is CE compliant and conforms to several safety directives and product standards. Declaration of Conformity and other documentation is provided.

RWM Drive Specifications: INPUT VOLTAGE +/- 15% 115 VOLTS INPUT CURRENT AMPS AC 2 AMPS INPUT FREQUENCY Hz +/- 5% 50/60 RECOMMENDED OPERATIONAL SPEED RANGE 20-250 RPM SPEED REGULATION +/- 5% RPM, PLUS +/- 0.5% OF SET SPEED TIMER ACCURACY +/- 2% OF SET TIME MAX TORQUE 68 IN-OZ POWER PEAK AT MAX RPM FOR 30 MINUTES 60 WATTS CONTINUOUS POWER AT MAX RPM 25 WATTS CURRENT AT RATED TORQUE +/- 15% 1.2 AMPS CURRENT LIMIT +/- 15% 1.4 AMPS CURRENT TRIP +/- 15% 1.7 AMPS FUSES 5 X 20 mm FAST ACTING 250V 3.15 A 250T3.15 INTERNAL TEMP TRIP POINT +/- 5% DEG. C 58 DEG. C DERATING ABOVE 25 DEG. C 1.5 WATTS PER DEG. C Figure 1: The RWM drive is shown above. RWM Retaining Tank: The purpose of the tank is to retain LevTech s disposable mixing bags. Retaining Tanks The standard retaining tanks are clear polycarbonate rectangular tanks and can accommodate mixing volumes from 10L to 200L. The tank shown in the picture is 15L.

Ports of various sizes and positions can be incorporated in the tank to allow for custom bag fittings. Stainless steel jacketed tanks can be provided for temperature control. RWM Frame Specifications: Material: Stainless steel #316 Finish: Beadblast as welded with all welds shined only with no sharp edges Dimensions: 21 wide x 15 deep x 28 high Figure 2: Rotational Wand Mixing System Disposable Bags & Liners Drawings, specifications & bills of material provided separately and per customer s specifications.

Figure 3: Schematic of RWM bag.

RWM Mixing Tests: Mixing studies in 15L mixing bags (200 RPM) show complete liquid-to-liquid mixing in less than 10 seconds and complete powdered buffer mixing in less than four minutes. The system or its components are for use under or may be covered by US Patent #6,494,613. Other U.S. and foreign patents pending.