5
Downstream
thirty seven
Systems approach
The systems approach behind the UniFlux design was a
natural step for membrane separations for two primary
reasons. First, membrane separations often work in tandem
with chromatography, where systems approaches and process
automation have long been employed. A systems view of
membrane separations allows both tighter control of overall
processes and less of what might be termed "process
hysteresis", where some steps flow freely because they are
automated, while others are slowed and complicated by
manual processes. Second, in all but early research and
development phases, most bioprocessing has increasingly
adopted well-known protocols and operating procedures,
which have become (or are becoming) progressively more
receptive to automation. The closer a product is to market
release, the less desirable is the adoption of non-systemic or
ad-hoc solutions. Adopting a systems approach early in
product development thus greatly reduces validation
requirements.
In addition to significant ease of use, an automated systems
approach to membrane filtration offers reduction in operator
error and greater consistency and reproducibility. UniFlux
networking capabilities permit the monitor and control of
the entire downstream process, and provides a single control
platform for all scales of operation.
Consistency and repeatability
All UniFlux systems are designed for consistent setup.
Automated UniFlux systems with UNICORN offer many
options for programming, monitoring, and reporting
methods that help ensure consistent, repeatable operation
from batch to batch. System parameters scale up from pilot
to production, allowing processes validated at low volumes
to move quickly to validation at process volumes.
Full function
UniFlux is a full-function membrane separations system
family designed for integration into bioprocesses, either
standalone, or processes that utilize Amersham Biosciences'
chromatography systems. UNICORN capability brings new
automation possibilities to filtration steps that formerly had
to be controlled independent of other subprocesses. Flexible
configurations permit cassette or hollow-fiber cartridge
operation for a variety of protocols and procedures.
Latest release UNICORN v5.0
UNICORNTM control software - the key component in all
our system designs - is now available in a new major
release, UNICORN v5.0. in this latest version more
functionality has been added for connectivity, performance,
and regulatory compliance, and usability has been improved.
UNICORN offers a user-friendly interface combined with
sophisticated functionality, providing a powerful control
solution for both chromatographic and membrane
separations.
The major developments in UNICORN 5.0 are outlined
below:
Connectivity
UNICORN v5.0 includes extended support for OPC, with
new functions added to Data Access. The OPC interface is
Compliance tested for the OPC Data Access 2.05A
specification, and for the Alarms & Events 1.1 specification.
The Security and Historical Data Access supports versions
1.0 and 1.1 respectively.
Communication robustness
The new controller CU 950 now includes an optional
operating mode for increased fault tolerance in the
communication between the CU and the controlling
computer. If the communication between the CU and
computer is interrupted, the communication is buffered in
the CU until communication is re-established.
Regulatory
The certified support provided for validation and regulatory
compliance, such as for CFR 21 part 11, has been improved.
Examples include enhanced backup and restore functions,
new items logged in the audit trail, increased data integrity,
and automated log-off when inactive.
Usability
Developments here include the possibility to hide functions
not available for a particular user profile.
Application knowledge
We continue to invest our knowledge into product
development. For UNICORN v 5.0 this translates into an
improved method wizard function that generates more
specific and efficient methods for the column used.
UNICORN is an advanced control software that we
continually develop for better functionality and usability to
meet the challenges at the lab-bench and in the production
hall.
