LevMixer® System product photo Primary L

LevMixer® System

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 to suspend 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 singleuse 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 impellerbased 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 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 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



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Description

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 to suspend 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 singleuse 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 impellerbased 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 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 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

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

Mixing of High Powder Loads using a LevMixer System

Dissolution of Sodium Hydroxide Pellets using a LevMixer System

High-Viscosity Mixing with 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

Scalability of the 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

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
 

 
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 TK8 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 Vivo

  • USP<87> Biological Reactivity Tests In Vitro, Cytotoxicity
  • ISO 10993, Part 5: Cytotoxicity of Medical Devices

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

USP<661> Physico-chemical Testing for Plastics

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

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 Tanks

 
Part 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, LM square cont stainless steel
LM 50JCN-B4N 50 L, LM square cont stainless steel, jacketed
LM 50NCMA-B4N 50 L, LM square cont stainless steel, with load cells
LM 50JCMA-B4N 50 L, LM square cont stainless steel, jacketed, with load cells
 
LM 100NCN-B4N 100 L, LM square cont stainless steel
LM 100JCN-B4N 100 L, LM square cont stainless steel, jacketed
LM 100NCMA-B4N 100 L, LM square cont stainless steel, with load cells
LM 100JCMA-B4N 100 L, LM square cont stainless steel, jacketed, with load cells
 
LM 200NCN-B4N 200 L, LM square cont stainless steel
LM 200JCN-B4N 200 L, LM square cont stainless steel, jacketed
LM 200NCMA-B4N 200 L, LM square cont stainless steel, with load cells
LM 200JCMA-B4N 200 L, LM square cont stainless steel, jacketed, with load cells
 
LM 400NCN-B4N 400 L, LM square cont stainless steel
LM 400JCN-B4N 400 L, LM square cont stainless steel, jacketed
LM 400NCMA-B4N 400 L, LM square cont stainless steel, with load cells
LM 400JCMA-B4N 400 L, LM square cont stainless steel, jacketed, with load cells
 
LM 650NCN-B4N 650 L, LM square cont stainless steel
LM 650JCN-B4N 650 L, LM square cont stainless steel, jacketed
LM 650NCMA-B4N 650 L, LM square cont stainless steel, with load cells
LM 650JCMA-B4N 650 L, LM square cont stainless steel, jacketed,
with load cells
 
LM 1000NCN-B4N 1000 L, LM square cont stainless steel
LM 1000JCN-B4N 1000 L, LM square cont stainless steel, jacketed
LM 1000NCMA-B4N 1000 L, LM square cont stainless steel, with load cells
LM 1000JCMA-B4N 1000 L, LM square cont stainless steel, 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
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
 

LevMixer Single-Use Mixing Biocontainers - Cubical

 
Part 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