Ideal for buffer preparation and product contact mixing
Features and Benefits
- Superconductive levitation technology. No shaft, seals, or bearings inside the single-use mixer system: No mechanical shear.
- High level of flexibility. Use one drive unit for multiple tank sizes to mix from 6 L to 1000 L.
- Proven mixing technology capable of suspending powders and other solids without clogging or shearing.
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 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 a 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 a 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 jacketed mixer either on-site or remotely from a different location.
Figure 1The levitating impeller rotates inside a sterile single-use mixing system
Additionally, the jacketed 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™ 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
Instrument Services and Service Contracts
Learn about our Instrument Services for LevMixer® Systems.
Learn about our Systems Service Contracts for LevMixer® Systems.
Our factory certified service engineers are experts in Pall equipment and are trained on the latest instrument and systems technology, product improvements, software and accessories.
Our field service engineers are located worldwide to ensure fast, efficient service response and provide constant coverage.
Learn more about our Worldwide Support.
Technical Specifications - Drive Unit
|Power||Single phase 100V–230V AC, 50/60 Hz|
|Input Wattage||<350 watts|
|Footprint||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. Ra|
|User interface||Touchscreen PLC|
|Control box IP rating||IP 65|
Technical Specifications – Single-Use System
|Number of impeller blades||4|
|Impeller diameter||161 mm (6.35 in.)|
|Impeller and ports material of construction||High density polyethylene (HDPE)|
|Biocontainer film(1)||TK8 (ULDPE contact layer)|
|Temperature||4 – 60 °C|
|Shelf life||2 years|
|In 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 Allegro film are animal derived component free (ADCF)
Technical Specifications - Standard Tanks
|Material of construction||AISI type 304 stainless steel|
|Internal (SUS contact) surface finishr||Glass bead blasted Ra ≤ 1.2 μm (47 μin)|
|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 -
|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 smooth|
|Jacketed tanks operating range||Maximum 6.2 bar (90.0 psig) at -5 °C to +90 °C|
|Load cell accuracy||0.3% of the nominal volume|
Quality Standards and Validation
The LevMixer single-use mixer biocontainers are 100% leak tested at manufacture.
All the mixer biocontainers are manufactured in a controlled environment(Class 10,000) certified to IS09001.
The materials of construction of the LevMixer mixer biocontainers meet:Biological reactivity - In Vitro
- USP<87> Biological Reactivity Tests In Vitro, Cytotoxicity
- ISO 10993, Part 5: Cytotoxicity of Medical Devices
- 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
USP<661> Physico-chemical Testing for Plastics
EP 184.108.40.206 Tests on Plastic Containers for Aqueous Solutions for Parenteral Infusion
- Product homogenization
- Final formulation
- Media, buffer preparation
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.
Drive Unit for Use with LevMixer System
|LT- DBTL300||LevMixer 3 universal drive unit|
Tanks for Use with LevMixer SystemPlastic Tanks
|LEV30PR||30 L round medium density polyethylene (MDPE) mixing container|
|LEV50PR||50 L round MDPE mixing container|
|LEV100PR||100 L round MDPE mixing container|
|LEV200PR||200 L round MDPE mixing container|
|LEV350PR||350 L round MDPE mixing container|
|LEV500PR||500 L round MDPE mixing container|
Stainless Steel Tanks
|LM 50NCN-B4N||50 L square stainless steel tank|
|LM 50JCN-B4N||50 L square stainless steel tank, jacketed|
|LM 50NCMA-B4N||50 L square stainless steel tank, with load cells|
|LM 50JCMA-B4N||50 L square stainless steel tank, jacketed, with load cells|
Stainless Steel Tanks
|LM 100NCN-B4N||100 L square stainless steel tank|
|LM 100JCN-B4N||100 L square stainless steel tank, jacketed|
|LM 100NCMA-B4N||100 L square stainless steel tank, with load cells|
|LM 100JCMA-B4N||100 L square stainless steel tank, jacketed, with load cells|
|LM 200NCN-B4N||200 L square stainless steel tank|
|LM 200JCN-B4N||200 L square stainless steel tank, jacketed|
|LM 200NCMA-B4N||200 L square stainless steel tank, with load cells|
|LM 200JCMA-B4N||200 L square stainless steel tank, jacketed, with load cells|
|LM 400NCN-B4N||400 L square stainless steel tank|
|LM 400JCN-B4N||400 L square stainless steel tank, jacketed|
|LM 400NCMA-B4N||400 L square stainless steel tank, with load cells|
|LM 400JCMA-B4N||400 L square stainless steel tank, jacketed, with load cells|
|LM 650NCN-B4N||650 L square stainless steel tank|
|LM 650JCN-B4N||650 L square stainless steel tank, jacketed|
|LM 650NCMA-B4N||650 L square stainless steel tank, with load cells|
|LM 650JCMA-B4N||650 L square stainless steel tank, jacketed,
with load cells
|LM 1000NCN-B4N||1000 L square stainless steel tank|
|LM 1000JCN-B4N||1000 L square stainless steel tank, jacketed|
|LM 1000NCMA-B4N||1000 L square stainless steel tank, with load cells|
|LM 1000JCMA-B4N||1000 L square stainless steel tank, jacketed, with load cells|
Dollies for Use with LevMixer System
|LM-DBMC037||Dolly full handle, compatible with probe support
|LM-DBMC038||Dolly partial handle, compatible with probe support
LevMixer Single-Use Mixer Biocontainers - Round
|6403-1157B||30 L round, 2 in. powder port, Allegro film|
|6403-1156X||50 L round, 4 in. powder port, Allegro film|
|6403-1121K||100 L round, 4 in. powder port, Allegro film|
|7403-0998Q||200 L round, 4 in. powder port, Allegro film|
|6403-1121J||350 L round, 4 in. powder port, Allegro film|
|7403-0998S||500 L round, 4 in. powder port, Allegro film|
|6403-1247R||1000 L round, 4 in. powder port, Allegro film|
LevMixer Single-Use Mixing Biocontainers - Cubical
|6403-1221T||50 L cubical, 4 in. powder port, Allegro film|
|6403-1158K||100 L cubical, 4 in. powder port, Allegro film|
|6403-1156V||200 L cubical, 4 in. powder port, Allegro film|
|7403-1086Z||400 L cubical, 4 in. powder port, Allegro film|
|7403-1105E||650 L cubical, 4 in. powder port, Allegro film|
|6403-1157G||1000 L cubical, 4 in. powder port, Allegro film|