4
Downstream
thirty seven
FDA-compliant polymers and elastomers, including silicone.
Where possible, UniFlux components have been aligned with
Amersham Biosciences chromatography systems for spare
parts interchangeability.
Typical applications encompass all multi-step bioprocesses
that include both chromatography and membrane
separations, as well as standalone uses in monoclonal
antibody clarification and concentration; recombinant
protein concentration; vaccine concentration and
purification; plasma concentration and purification; and cell
harvesting and clarification.
UNICORN provides control and monitoring
UNICORN controls, monitors, and records all operations.
The software can be quickly set up to meet any end-state
threshold, e.g., concentration factor, volume of product, or
permeate conductivity. Method-based programming uses
membrane separations concepts and terminology while
sharing interface and operational features with UNICORN
for chromatography. Programming and monitor screens use
conventional process symbols (Figure 2). UNICORN can be
programmed to maintain constant trans-membrane pressure
(TMP) regardless of filter surface conditions, regulate feed
flow to maintain constant differential pressure across the
membrane, or regulate crossflow velocity to minimize process
flux and help ensure maximum efficiency of process.
Additional control features in UNICORN include user-
configurable membrane parameters in tandem with a
permeate flow meter, for process monitoring and
performance profiling. There is logic for level control of a
(customer-supplied) feed tank, enabling automatic
diafiltration/buffer exchange through UNICORN. Air flow
and pressure hold integrity tests can be performed
electronically, while the membranes are installed on the
system. Flux can be monitored for percentage decrease from
a reference point, and the system can be programmed to
react accordingly at any value. Concentration steps can be
programmed using volume setpoints or automated
concentration factor calculation. Real-time overview of
system operation provides process status throughout a run.
Finally, diafiltration steps can be programmed using volume
setpoints or the automatic diafiltration factor calculation.
Smart protocols can be created as part of a standard
operating procedure, and active processes can be locked for
unattended operation without risk of unauthorized changes.
In addition to process control, UNICORN can provide a
broad range of data evaluation and reporting functionality.
Functions satisfy 21 CFR Part 11 requirements for electronic
records and signatures.
1
PIT111
Bar
6
FT141
l/min
2
PIT112
Bar
7
RetenFLow
l/min
3
PIT113
Bar
8
FT142
l/min
4
TE161
°C
9
CIT101
mS/cm
5
FT143
ml/min
10
AIT121
pH
11
AIT131
OD
XV 064
%
%
BUFFER FEED
PUMP
PERMEATE
PUMP
9
2
1
6
5
7
4
10 3 11 8
XV 031
XV 032
PERMEATE RECYCLE
PERMEATE
RETENTATE
AIR INTEGRITY TEST ASSEMBLY
RETENTATE DRAIN
INST. AIR
FEED
FEED DRAIN
FILTER DRAIN
PERMEATE DRAIN
XV 062
%
XV 051
XV 052
XY 041
Bar
Pressure Set Point:
PY 353
T/P
XV 001
XV 061
XV 063
P 201
%
PCV 341
m
2
FILTER (S)
FL 231
F
Fig. 2. UNICORN screens use conventional process control
symbols to program or monitor processes.
TMP
Bar
Delta P
Bar
Flux
LMH
Shear
sec
-1
VolTank
1
VolRetent
1
