LevMixer® System

Ideal for buffer preparation and product contact mixingFeatures and Benefitsu Superconductive levitation technology.

No shaft, seals or bearings inside the single-use mixer system: No mechanical shear.

u High level of flexibility. Use one drive unit for multiple tank sizes to mix from 6 L to 1000 L.

u Proven mixing technology capable to suspend powders and other solids without clogging or shearing.

Applicationsu Product homogenization

u Suspension/re-suspension

u Final formulation

u Media, buffer preparation

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OverviewThe 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 hardware has been engineered for use with Pall single-use systems (SUS) 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 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 1The levitating impeller rotates inside a sterile single-use mixing system

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. It is animal derived component free (ADCF) and complies fully with USP Class VI requirements.

Figure 2Mobile and flexible, the LevMixer system allows efficient mixing in a wide range of volumes

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Principle of OperationThe 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 3The magnet-superconductor interaction results in a very stable magnetic coupling

Figure 4LevMixer universal drive unit

Technical SpecificationsTechnical Specifications – Drive UnitParameter Details

Power Single phase 100 V–230 V AC, 50/60 HzInput wattage < 350 WattsFootprint 40 cm x 112 cm (16 in. x 44 in.)Height 92 cm to top of control box (36 in.)Material of construction 304 L stainless steel, at least 35 μin. RaUser interface Touchscreen PLCControl box IP rating IP 65

Technical Specifications – Single-Use SystemParameter Details

Number of impeller blades 4Impeller diameter 161 mm (6.35 in.)Impeller and ports material High density polyethylene (HDPE) of construction Maximum RPM 210Biocontainer film(1) TK8 (ULDPE contact layer)Temperature 4 – 60 °CShelf life 2 yearsIn process controls Leak test (100%); Visual control (100%);

Seal strength – ASTM-F88 (per batch); Cleanliness - USP<788> (monitoring); Bioburden – ISO 11737 (monitoring)

(1)All components of TK8 film are animal derived component free (ADCF)

Technical Specifications – Standard TanksParameter Details

Material of construction AISI type 304 stainless steelInternal (SUS contact) Glass bead blasted Ra ≤ 1.2 μm (47 μin) surface finish External surface finish Glass bead blasted Ra ≤ 0.89 μm (35 μin)Weld specifications In accordance with EN ISO 15607 Specification and qualification of welding

procedures for metallic materials - General rules

Welding quality standards In accordance with EN ISO 5817 Welding: Fusion-welded joints in steel, nickel,

titanium and their alloys (beam welding excluded). Quality levels for imperfections

Weld treatment Ground smoothJacketed tanks operating Maximum 6.2 bar (90.0 psig) at -5 °C to range +90 °C Load cell accuracy 0.3% of the nominal volume

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Quality Standards and Validation

The LevMixer single-use mixer biocontainers are 100% leak tested at manufacture.

All mixer biocontainers are manufactured in a controlled environment (Class 10,000) certified to IS09001.

The materials of construction of the LevMixer mixer biocontainers meet:

u Biological reactivity – In Vitro

– USP<87> Biological Reactivity Tests In Vitro, Cytotoxicity

– ISO 10993, Part 5: Cytotoxicity of Medical Devices

u Biological reactivity – In Vivo

– USP<88> Biological Reactivity Test In Vivo for Class VI - 70 °C Plastics

– ISO 10993, Part 6: Implantation Test

– ISO 10993, Part 10: Intracutaneous Reactivity Test

– ISO 10993, Part 11: Systemic Injection Test

u USP<661> Physico-chemical Testing for Plastics

u EP 3.2.2.1 Tests on Plastic Containers for Aqueous Solutions for Parenteral Infusion

Ordering InformationDrive Unit for Use with LevMixer SystemPart Number Description

LT- DBTL300 LevMixer 3 universal drive unit

Tanks for Use with LevMixer SystemPart Number Description

LEV30PR 30 L, round, MDPE LEV50PR 50 L, round, MDPE LEV50NC 50 L, cubical, stainless steel LEV50NC420SLC 50 L, cubical, stainless steel, load cells LEV50JC 50 L, cubical, stainless steel, jacketed LEV50JC420SLC 50 L, cubical, stainless steel, jacketed, load cellsLEV100PR 100 L, round, MDPE LEV100NC 100 L, cubical, stainless steel LEV100NC420SLC 100 L, cubical, stainless steel, load cells LEV100JC 100 L, cubical, stainless steel, jacketed LEV100JC420SLC 100 L, cubical, stainless steel, jacketed, load cellsLEV200PR 200 L, round, dual port, MDPE LEV200NC 200 L, cubical, stainless steel LEV200NC420SLC 200 L, cubical, stainless steel, load cells LEV200JC 200 L, cubical, stainless steel, jacketed LEV200JC420SLC 200 L, cubical, stainless steel, jacketed, load cells

Tanks for Use with LevMixer SystemPart Number Description

LEV350PR 350 L, round, dual port, MDPE LEV400NC 400 L, cubical, stainless steel LEV400NC420SLC 400 L, cubical, stainless steel, load cells LEV400JC 400 L, cubical, stainless steel, jacketed LEV400JC420SLC 400 L, cubical, stainless steel, jacketed, load cellsLEV500PR 500 L, round, dual port, MDPE LEV650NC 650 L, cubical, stainless steel LEV650NC420SLC 650 L, cubical, stainless steel, load cells LEV650JC 650 L, cubical, stainless steel, jacketed LEV650JC420SLC 650 L, cubical, stainless steel, jacketed, load cellsLEV1000NC 1000 L, cubical, stainless steel LEV1000NC420SLC 1000 L, cubical, stainless steel, load cellsLEV1000JC 1000 L, cubical, stainless steel, jacketed LEV1000JC420SLC 1000 L, cubical, stainless steel, jacketed, load cells

Dollies for Use with LevMixer SystemPart Number Description

LM-DBMC034 LevMixer dolly, 316 stainless steel, dual impeller port, full handle

LM-DBMC036 LevMixer dolly, 316 stainless steel, dual impeller port, partial handle

LevMixer Single-Use Mixer Biocontainers - RoundPart Number Description

730440 30 L, 2 in. powder port, Allegro TK8 film, side EZ drain, sterile

730493 50 L, 2 in. powder port, Allegro TK8 film, EZ drain, sterile 730442 100 L, 4 in. powder port, Allegro TK8 film, EZ drain,

sterile 730443 200 L, 4 in. powder port, Allegro TK8 film, EZ drain, sterile 730444 350 L, 4 in. powder port, Allegro TK8 film, EZ drain, sterile 730445 425 L, 4 in. powder port, Allegro TK8 film, EZ drain, sterile 730446 500 L, 4 in. powder port, Allegro TK8 film, EZ drain, sterile 730359 1000 L, 4 in. powder port, Allegro TK8 film, EZ drain, sterile

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LevMixer Single-Use Mixing Biocontainers - CubicalPart Number Description

730467 50 L, 2 in. powder port, Allegro TK8 film, EZ drain, sterile 730468 100 L, 4 in. powder port, Allegro TK8 film, EZ drain, sterile 730469 200 L, 4 in. powder port, Allegro TK8 film, EZ drain,

sterile 730470 400 L, 4 in. powder port, Allegro TK8 film, EZ drain, sterile 730471 650 L, 4 in. powder port, Allegro TK8 film, EZ drain, sterile 730472 1000 L, 4 in. powder port, Allegro TK8 film, EZ drain, sterile

Visit us on the Web at www.pall.com/allegroE-mail us at allegro@pall.com

© 2016, Pall Corporation. Pall, , Allegro and LevMixer are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. TM indicates a common law trademark. Filtration.Separation.Solution. is a service mark of Pall Corporation.

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Corporate HeadquartersPort Washington, NY, USA+1.800.717.7255 toll free (USA)+1.516.484.5400 phonebiopharm@pall.com e-mail

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International OfficesPall 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.