USD2952a1 LevMixer® System Ideal for buffer preparation and product contact mixing Highlights and Benefits True superconductive levitation technology: no mechanical shear and no particle generation to ensure product integrity No shafts, seals or bearings inside the mixing system Scalability; from 6 L to 2,000 L using one portable, ergonomic and universal drive unit. This feature helps lower capital costs and improve process efficiency Powerful mixing technology capable to suspend powders and other solids without clogging or shearing Applications Product homogenization Suspension/re-suspension Final formulation Media, buffer preparation Overview The LevMixer system is specifically designed to fulfill the needs of the bioprocess industry. This system is a mobile, flexible mixing system that allows efficient and reproducible single-use mixing of a wide range of volumes in a broad series of applications ranging from buffer preparation to final formulation. The LevMixer system is engineered for use with Pall Life Sciences single-use mixing systems in cGMP certified cleanrooms. The LevMixer system consists of an interchangeable superconducting drive unit and proprietary levitating-impeller-based single-use mixing system fitted into into either plastic tanks located on a trolley or stainless steel tanks. Once charged and coupled with the single-use system, the superconducting drive unit induces levitation and rotation of the impeller (Figure 1) resulting in effective mixing action inside a closed mixing system. Coupling of the impeller with the drive motor requires no dynamic seals or shaft penetration inside the single-use system. The drive motor is enclosed on a portable cart that can be easily disconnected from the single-use system and reconnected to another mixing system, allowing mixing in multiple single-use mixing systems of various sizes with a single drive unit. The LevMixer system includes a real-time reading of the impeller speed and an process monitoring/ alert capability. In case of any process disruption, the user is alerted. End users may access a detailed activity report during on-going applications to monitor the mixer either on site, or remotely from a different location. Figure 1 The levitating impeller rotates inside a sterile single-use mixing system 2 Additionally, the mixer may either be controlled on site or remotely, based on user preference. When operating onsite, users will benefit from an easy-to-use touchscreen PLC that features access to the mixing recipe in use. The LevMixer system utilizes disposable mixing biocontainers made from Allegro™ TK8 bioprocess film. The product-contacting layer of Allegro TK8 film is blow-extruded in-house by Pall Life Sciences under cleanroom conditions using medical-grade ultra low-density polyethylene resin. It is then laminated to create a gas barrier film of exceptional cleanliness, strength, and clarity that is animal derived component free (ADCF) and complies fully with USP Class VI requirements. Figure 2 Mobile and flexible, the LevMixer system allows efficient mixing in a wide range of volumes Principle of Operation The mixing technology of the LevMixer system is based on non-contact magnetic coupling between conventional permanent magnets in the impeller and superconducting material in the drive (Figure 3). Superconducting material has the ability to trap the magnetic field generated by the permanent magnets and “lock the magnetic field in memory” in an equilibrium position. The trapped magnetic field behaves like mechanical springs; if the magnet is moved up, down or sideways by outside forces (e.g., gravity or angular torque) it will tend to be pulled back to an equilibrium position. The peculiar nature of magnet-superconductor interaction ties the two bodies together resulting in a very stable magnetic coupling with finite equilibrium separation. This system is housed in a universal drive unit (Figure 4). Figure 3 The magnet-superconductor interaction results in a very stable magnetic coupling Technical Specifications Parameter LevMixer Drive Unit Power Input Wattage Drive Unit Footprint Drive Unit Height Material of Construction Interface Type Control Box Rating Single phase 100V–230V AC, 50/60 Hz < 350 Watts 40 cm x 112 cm (16 in. x 44 in.) 92 cm to top of control box (36 in.) 304 L Stainless Steel, at least 35 µin. Ra Touchscreen PLC IP 65 Parameter Single-Use Impeller Type Number of Blades Material Maximum Speed Impeller Bag Location 6.25 in. diameter radial flow Four (4) USP Class VI, ADCF, gamma stable HDPE 210 RPM Center, off-center Ordering Information Drive Unit for Use with LevMixer System Part Number Description LT- DBTL300 LevMixer 3 Universal Drive Unit Tanks for Use with LevMixer System Part Number Description Figure 4 LevMixer universal drive unit. LEV30PR LEV30NJ420SLC LEV50PR LEV50NR LEV50NR420SLC LEV50JR LEV50JR420SLC LEV50NC LEV50NC420SLC LEV50JC LEV50JC420SLC LEV100PR LEV100NR LEV100NR420SLC LEV100JR LEV100JR420SLC LEV100NC LEV100NC420SLC LEV100JC LEV100JC420SLC LEV200PR LEV200NR LEV200NR420SLC LEV200JR LEV200JR420SLC LEV200NC LEV200NC420SLC LEV200JC LEV200JC420SLC 30 L, Round, MDPE 30 L, Round, Stainless Steel, Load Cells 50 L, Round, MDPE 50 L, Round, Stainless Steel 50 L, Round, Stainless Steel, Load Cells 50 L, Round, Stainless Steel, Jacketed 50 L, Round, Stainless Steel, Jacketed, Load Cells 50 L, Cubical, Stainless Steel 50 L, Cubical, Stainless Steel, Load Cells 50 L, Cubical, Stainless Steel, Jacketed 50 L, Cubical, Stainless Steel, Jacketed, Load Cells 100 L, Round, MDPE 100 L, Round, Stainless Steel 100 L, Round, Stainless Steel, Load Cells 100 L, Round, Stainless Steel, Jacketed 100 L, Round, Stainless Steel, Jacketed, Load Cells 100 L, Cubic , Stainless Steel 100 L, Cubic , Stainless Steel, Load Cells 100 L, Cubical, Stainless Steel, Jacketed 100 L, Cubical, Stainless Steel, Jacketed, Load Cells 200 L, Round, Dual Port, MDPE 200 L, Round, Stainless Steel 200 L, Round, Stainless Steel, Load Cells 200 L, Round, Stainless Steel, Jacketed 200 L, Round,Stainless Steel, Jacketed, Load Cells 200 L, Cubical, Stainless Steel 200 L, Cubical, Stainless Steel, Load Cells 200 L, Cubical, Stainless Steel, Jacketed 200 L, Cubical, Stainless Steel, Jacketed, Load Cells www.pall.com 3 Tanks for Use with LevMixer System Part Number Description LEV350PR LEV350NR LEV350NR420SLC LEV350JR LEV350JR420SLC LEV400NC LEV400NC420SLC LEV400JC LEV400JC420SLC LEV500PR LEV500NR LEV500NR420SLC LEV500JR LEV500JR420SLC LEV650NC LEV650NC420SLC LEV650JC LEV650JC420SLC LEV1000NR LEV1000NR420SLC LEV1000JR LEV1000JR420SLC LEV1000NC LEV1000NC420SLC LEV1000JC LEV1000JC420SLC LEV2000NR LEV2000NR420SLC LEV2000JR LEV2000JR420SLC LEV2000NC420SLC LEV2000JC420SLC 350 L, Round, Dual Port, MDPE 350 L, Round, Stainless Steel 350 L, Round, Stainless Steel Load Cells 350 L, Round, Stainless Steel, Jacketed 350 L, Round, Stainless Steel, Jacketed, Load Cells 400 L, Cubical, Stainless Steel 400 L, Cubical, Stainless Steel, Load Cells 400 L, Cubical, Stainless Steel, Jacketed 400 L, Cubical, Stainless Steel, Jacketed, Load Cells 500 L, Round, Dual Port, MDPE 500 L, Round, Stainless Steel 500 L, Round, Stainless Steel, Load Cells 500 L, Round, Stainless Steel, Jacketed 500 L, Round, Stainless Steel, Jacketed, Load Cells 650 L, Cubical, Stainless Steel 650 L, Cubical, Stainless Steel, Load Cells 650 L, Cubical, Stainless Steel, Jacketed 650 L, Cubical, Stainless Steel, Jacketed, Load Cells 1000 L, Round, Stainless Steel 1000 L, Round, Stainless Steel, Load Cells 1000 L, Round, Stainless Steel, Jacketed 1000 L, Round, Stainless Steel, Jacketed, Load Cells 1000 L, Cubical, Stainless Steel 1000 L, Cubical, Stainless Steel, Load Cells 1000 L, Cubical, Stainless Steel, Jacketed 1000 L, Cubical, Stainless Steel, Jacketed, Load Cells 2000 L, Round, Stainless Steel 2000 L, Round, Stainless Steel, Load Cells 2000 L, Round, Stainless Steel, Jacketed 2000 L, Round, Stainless Steel, Jacketed, Load Cells 2000 L, Cubical, Stainless Steel, Load Cells 2000 L, Cubical, Stainless Steel, Jacketed, Load Cells Dollies for Use with LevMixer System Part Number Description LM-DBMC034 LM-DBMC036 LevMixer System, Round Tubing Type A Part Number* Description Tubing Type B Part Number** 705114 730440 730307 705116 705117 705118 705119 730218 – 705121 730221 30 L, 2 in. Powder Port, Allegro TK8 Film, Side EZ Drain, Sterile 50 L, 2 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 100 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 200 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 350 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 425 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 500 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 1000 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 1900 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 2000 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 730493 730442 730443 730444 730445 730446 730359 730448 730449 LevMixer System, Cubical Tubing Type A Part Number* Description Tubing Type B Part Number** 730182 730467 730183 730184 730185 730186 730187 50 L, 2 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 100 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 200 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 400 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 650 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 1000 L, 4 in. Powder Port, Allegro TK8 Film, EZ Drain, Sterile 730468 730469 730470 730471 730472 *Tubing Type A: Standard Systems with Altimex tubing **Tubing Type B: Standard Systems with Saint Gobain tubing LevMixer dolly, 316 stainless steel, dual impeller port, full handle LevMixer dolly, 316 stainless steel, dual impeller port, partial handle Visit us on the Web at www.pall.com/biopharm E-mail us at allegro@pall.com Corporate Headquarters Port Washington, NY, USA +1.800.717.7255 toll free (USA) +1.516.484.5400 phone biopharm@pall.com e-mail European Headquarters Fribourg, Switzerland +41 (0)26 350 53 00 phone LifeSciences.EU@pall.com e-mail Asia-Pacific Headquarters Singapore +65 6389 6500 phone sgcustomerservice@pall.com e-mail International Offices Pall Corporation has offices and plants throughout the world in: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, New Zealand, Norway, Philippines, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam. Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit www.pall.com/contact. The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly. © 2015, Pall Corporation. Pall , and Allegro are trademarks of Pall Corporation. ® indicates a trademark registered in the USA and TM indicates a common law trademark. Filtration. Separation. Solution. is a service mark of Pall Corporation. 8/15, PDF, GN15.6343 USD2952a1