Evaluating Disposable Mixing Systems - Drug manufacturers should follow a risk-assessment methodology when selecting a single-use mixing system for product development. - BioPharm International

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Evaluating Disposable Mixing Systems
Drug manufacturers should follow a risk-assessment methodology when selecting a single-use mixing system for product development.


BioPharm International
Volume 22, Issue 2

ATMI Life Sciences

ATMI offers the broadest range of mixing systems with a total of five different mixing technologies in their portfolio.

The Newmix PAD drive overhead impeller mixer with the paddle enclosed in a film sleeve is suitable for a comprehensive range of applications covering all powder-to-liquid and liquid–liquid applications available in a range from 5–1,000 L.

The LevTech Levmixer (a technology that ATMI recently acquired from LevTech) is a levitating radial impeller with two impeller sizes (4.95" and 6.35"). Standard bag sizes are available from 30–1,000 L, with the 2,000 L volume available as a custom item. Jacketed tanks are available and special bags can be customized with the Newsafe powder transfer system.

The LevTech Magnetic Mixer system is a versatile mixing universal drive machine suitable for most powder-to-liquid and liquid–liquid applications. It is available in 30–1,000 L volumes. Magnetic coupling and agitation generates more particulates than the levitating technology. These particulates are within largely acceptable limits and are not an issue provided there is a subsequent sterilizing filtration step.

The Wandmixer is suitable for small-scale mixing applications in the range of 5–200 L.

The jet drive is suitable for totally contained liquid–liquid mixing applications in 50 and 200 L volumes.

Newsafe contained powder transfer bags for media and buffer preparation applications are available in capacities from 5–100 L with triclamp port sizes available from 1–8 inches. These powder-transfer bags are available in antistatic format.

Millipore

The Millipore Mobius Mix is currently available in 100, 200, and 500 L sizes. A 1,000-L system is expected to be in the market later this year. The system includes a magnetically driven impeller with magnetic levitation technology. The system has no mechanical shaft and bearings. It doesn't have particulate generation and no recalibration is required.

Sartorius Stedim Biotech

The Levmix system uses the LevTech levitated impeller licensed from ATMI (see description above) and Sartorius Stedim Biotech's Flexel 3D bag. Sartorius Stedim offers the system in both drum and cubical Palletank format. The system is available from 50–650 L for Palletank and 50–1,000 L in drum format. Heating and cooling options are available.

Flexel 3D Aseptic Mixing system uses a double recirculation loop system and peristaltic pumps for completely contained liquid–liquid mixing applications from 200–1,000 L.

Xcellerex

The Xcellerex XDM Quad Mixing system is equipped with a disposable bottom-mounted impeller. The engagement between motor and disposable impeller is by magnetic coupling, and agitation is driven through stainless-steel bearings in the impeller. The bags have an integrated three-inch triclamp port for powder addition. The system is available in 100–1,000 L sizes adapted to a square configuration container taking advantage of the natural baffling effect of this shape. Standard features also include probe sheath assemblies, floor scale or load cells, and heating and cooling options.

Thermo Scientific

The Hyclone Single-Use Mixer is currently available in 200, 500, and 1,000 L volumes. According to Jon Reid, Hyclone's EU Bioprocess market manager, Hyclone is expanding the volume range from 50 to 2,000 L and adding a docking station option, which will be available in April 2009. The Single-Use Mixer is based on the same concept as the Thermo Scientific Hyclone Single-Use bioreactor (SUB) with a single-use bioprocess container, an integrated overhead impeller, and reusable hardware. The system is available with or without a heating or cooling jacket, and has cutout sections to facilitate bag positioning and monitoring probe capability. The same hardware also can be used with open top liners for media and buffer preparation. The system sports a powder port for contained powder transfer up to 25 k in one shot into a closed bag system.


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