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 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

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

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