May 3 2012
Xcellerex, Inc., a provider of turnkey biomanufacturing solutions, has
launched its XDUO™ Quad™ single-use
mixing system supporting single-use biomanufacturing in upstream and
downstream mixing applications and unit operations.
The XDUO mixer represents the next-generation advancement in automated
single-use solutions for the mixing of buffer, media, product, and other
process fluids. An evolution of the original XDM™ system, the XDUO mixer
enables unparalleled performance by adding new features and onboard
instrumentation to support the application needs of the GMP
manufacturing environment.
The XDUO
mixer integrates with existing biomanufacturing production lines as
well as with the Xcellerex
FlexFactory®, a modular biomanufacturing platform that
leverages single-use technology and advanced process automation. The
FlexFactory flexible platform enables biomanufacturers to accelerate
their deployment of new manufacturing capacity while lowering risk,
decreasing time to market, and reducing capital costs. The approach
enables the deployment of new production facilities in 9 to 18 months
(versus 3 to 5 years for current technology) at a total cost less than
50% that of conventional plants.
The XDUO single-use mixing system is the first mixer available with all
instrumentation and automation features integrated as a stand-alone
single-use mixing platform. The instrument panel includes a Siemens
S7 1200 PLC, analog I/O cards, a 4-port switch, and a 4-inch monochrome
HMI display. The instrument panel can be equipped with pH and
conductivity transmitters, weight measurement, temperature monitoring,
temperature control, and onboard pumps to support automated titration
applications such as pH adjustment and viral inactivation. The XDUO
system is also capable of both local and remote operation, data
trending, and capture for batch record requirements in GMP manufacturing
suites in data historian platforms, so it's ideal for supporting
downstream unit operations in a single-use platform.
The single-use nature of the system eliminates time-consuming and costly
clean-in-place (CIP), steam-in-place (SIP), and cleaning validation. The
results are more efficient processing and rapid batch turnover.
The XDUO mixing system is easy to install and operate. As each unit is
equipped with its own onboard instrumentation, the operator can commence
unit operations and mixing processes instantaneously upon startup —
without any need for time-consuming charging of superconducting magnets
or complicated mating of drive systems to storage tanks. The systems are
available in 50-, 100-, 200-, 500-, and 1,000-liter volumes and in
stainless steel and jacketed stainless steel tanks.
The XDUO mixing system is immediately available. In addition to
integrating with the Xcellerex FlexFactory, the XDUO mixer is also
available for use with existing biomanufacturing production lines.