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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.
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 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 1
The 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 2
Mobile 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.
Specifications
Technical Specifications - Drive Unit
Parameter | Details |
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
Parameter | Details |
Number of impeller blades | 4 |
Impeller diameter | 161 mm (6.35 in.) |
Impeller and ports material of construction | High density polyethylene (HDPE) |
Maximum RPM | 210 |
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
Parameter | Details |
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 - 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 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 3.2.2.1 Tests on Plastic Containers for Aqueous Solutions for Parenteral Infusion
Applications
- Product homogenization
- Suspension/re-suspension
- Final formulation
- Media, buffer preparation
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
Figure 4
LevMixer universal drive unit.
Application Notes
Dilution of 25% Salt Solution at the 200 L Scale using a LevMixer System
Dilution of 25% Salt Solution at the 500 L Scale using a LevMixer System
Dilution of 25% Salt Solution at the 2000 L Scale using a LevMixer System
Dilution of an Acid Solution at the 1000 L Scale using a LevMixer System
Dissolution of Sodium Bicarbonate Powder using a LevMixer System
Dissolution of Sodium Hydroxide Pellets using a LevMixer System
Evaluation of Visible and Sub-Visible Particle Generation in Pall Mixing Technologies
High-Viscosity Mixing with a LevMixer System
Liquid-Liquid Mixing Without Vortex Formation In the 50 L Allegro™ Mixer, the 100 L and 400 L LevMixer® System and the 1500 L Magnetic Mixer
Mixing of High Powder Loads using a LevMixer System
Preparing 160 L of a 150 mM Salt Solution using a LevMixer System
Preparing 400 L of a 128 mM Salt Solution using a LevMixer System
Type
Use
Related Documents
Regulatory/Quality Documentation
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
Plastic TanksPart Number | Description |
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
Part Number | Description |
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
Part Number | Description |
LM-DBMC037 | Dolly full handle, compatible with probe support LT-SVSP471 |
LM-DBMC038 | Dolly partial handle, compatible with probe support LT-SVSP471 |
LevMixer Single-Use Mixer Biocontainers - Round
Part Number | Description |
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
Part Number | Description |
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 |
Product Summary
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