3
Downstream
thirty seven
UniFluxTM systems provide a highly
flexible means for incorporating
membrane separations into an overall
downstream process. The systems are
available in a manual, data-logging
version, or an automated version
using UNICORNTM control, newly
expanded to encompass membrane
separations as well as
chromatography. UniFlux works in
concert with other Amersham
Biosciences components to provide
consistent, repeatable, and
validatable results.
UniFlux membrane systems with
UNICORN control
O
ur expansion into membrane separations technologies
has led to the development of a new family of
bioprocessing systems controlled by UNICORNTM
UniFluxTM systems. These systems incorporate crossflow
membrane separations and high performance hardware in a
single, easily set-up system. UniFlux systems may be
configured for either hollow-fiber or cassette membranes.
Automated configurations of UniFlux use a membrane
separations-specific version of UNICORN control system
that provides FDA 21 CFR Part 11 compliant software. For
those who prefer manual control, there are also data-logging
UniFlux systems which utilize UNICORN for monitoring and
logging process parameters during operation. This allows the
operator to manually set and adjust pump speed and back
pressure on the retentate line for transmembrane and
differential pressure control, as well as flux regulation. UniFlux
is available in three sizes (30, 120 and 400 lpm) capable of
processing batches from 50 to 10 000 liters of material.
Manufactured to GMP
UniFlux was developed with input from biopharmaceutical
manufacturers and key research facilities to meet the
industry's needs. Both the data-logging and the automated
UniFlux systems are based on portable skid-mounted,
integrated hardware. UniFlux systems are also designed to fit
through conventional doorways. At the heart of the system
are either cassette holders or hollow-fiber cartridge manifolds
designed for easy access. A rotary lobe pump, sanitary
diaphragm valves, zero dead leg piping, USP Class VI
compliant gaskets, and overpressure and anti-dry running
protection are included. All systems are manufactured to
cGMP requirements. A Windows® based PC provides
interactive monitoring of feed and permeate flow; feed,
retentate and permeate pressure; retentate pressure; pH on
the permeate; and conductivity on the permeate. Calculated
values such as transmembrane pressure, differential pressure,
flux, and shear rate are also monitored and controlled.
Rapid changeover
Sanitary design assures cGMP compliance and facilitates
validation, while low working and hold-up volumes provide
higher concentration factors and more recovered product
than with other designs. UniFlux is based on standard parts,
enabling rapid field change between cartridge and cassette
configurations if needed. All product contact is with 316L
stainless steel (surface finish Ra < 0.8 mm), glass, quartz, and
