BioProcess Product Guide - GE Healthcare Life Sciences

Real-time control
Up to four systems can be connected to one UNICORN
workstation where individual controllers handle the realtime
control of each system. Data evaluation or methods
programming can be done while the systems are running.
The control unit CU 950 (Ethernet and USB) provides a high
degree of security for control and data. The unit secures
started runs even if the local PC and communication is
disrupted. CU 950 Advanced also contains an internal
memory that collects data in case of communication
failure.
Extensive data evaluation
All monitor data are stored in a Result File for storage and
evaluation. Extensive data processing routines include
curve smoothing, differentiation, normalization, baseline
calculation, peak integration and height equivalent to a
theoretical plate (HETP) calculations.
Start protocols are user-defined questions that must be
answered before a run can be started. Questions can
vary between simple operator prompts to those requiring
mandatory answers and authorized approval.
Notebooks permit additional text to be included in the
process documentation. Separate files are generated for
method notes, start notes, run notes, and evaluation notes.
These notes can be entered at the designated time and
cannot be altered after the run is complete.
All programmed and manual events occurring during the
run, including alarms and warnings, are documented in the
logbook and cannot be altered.
Security
UNICORN provides a system for password authorization
and access control. Operators log in by name and
password. The user profile includes an access level that
defines system functions available to each operator.
Scalability
Using UNICORN for method or process development on
ÄKTA systems simplifies scale-up to BioProcess system.
Personnel retraining is minimized and continuity exists in
batch documentation and report generation.
6
UNICORN Method Development
Evaluation procedures can be
retrieved from a programmed
method to process data and
generate reports as part of
an automated procedure.
Batch documentation
Along with the chromatographic results of each run, the
Result File also includes the programmed method, start
protocols, notebooks and the logbook. These files are
protected and cannot be manipulated. Processed data
generated from an evaluation procedure are stored in the
Result File, but separate from the original data.
Lab Scale Pilot Scale Manufacturing
Scale
up/down
Scale
up/down
UNICORN methods can be transferred between systems at different scales.
Validation support
UNICORN is fully compliant with 21 CFR Part 11 and is
extensively documented for validation purposes.
A Validation Support File is available describing our
software development model including routines and test
models.
Chromatography systems
Installation and Operational Qualification documentation
packages consisting of preprinted forms and test methods
are also available (see p 224).
www.gelifesciences.com/bioprocess 147