Biomedical Engineering Reference
In-Depth Information
the Flexel
®
Bags for LevMixer
®
and a clamp holder to facilitate powder trans-
fer. The hinged door allows easy installation of the bag system, whereas the
front bottom gate facilitates easy tubing installation and access. Windows on
lateral and rear sides enable the user to visually control the mixing process.
The cubical shape improves the mixing efficiency and offers scalability from
50 to 1,000 L.
Pall's Allegro™ 3D single-use mixers are impellor-based systems for large-
volume applications including vaccine and drug formulation, and mixing
viscous fluids. Available as 200 L systems for working volumes from 50 to
200 L, Allegro 3D mixers are also ideal for a wide range of liquid-liquid and
solid-liquid mixing applications such as compounding, formulation, buffer
and media preparation, and pH/conductivity adjustment. Front-loading of
the disposable mixer assembly eases setup. Mixing data is available for a
wide range of industry standard applications, demonstrating fast and com-
plete mixing even for preparations requiring high concentrations and large
additions of solids.
Summary
There are tremendous advantages to the use of single-use, presterilized
dosing systems for commercial filling operations. Increased processing effi-
ciency through the elimination of preparative steps such as CIP and SIP,
reduction of validation efforts including elimination of cleaning validation,
containment of toxic products, and matching existing single-use upstream
processes are all compelling arguments for these systems for product filling
operations. However, significant technical achievements must be realized
before a system can be scaled for high-speed filling operations.
