data file

Control systems

UNICORN control system

Fast, confident control Room 1

• from laboratory to production

ÄKTAexplorer 100 A

Fast, easy method programming in ÄKTAFPLC™

research and development ÄKTApurifier 10 XT

Local PC
• column library Remote PC ÄKTAexplorer 10 XT

• scouting schemes
• method templates Room 2

Buffer preparation unit

Simple, secure control for production
Ultrafiltration unit
• direct start
Server BioProcess System 1
• option for Standard Operating Procedures PC Network
• WATCH functions Share data Local PC BioProcess System 2

Real-time overview of the system Fig. 1. UNICORN control system – a complete control,
and separation evaluation and reporting system.

• access to control through run data and flow scheme

• display of actual run status and current flow path

Automatic, customized report generation Introduction

• extensive data evaluation and reporting options
Control and network overview of systems
with complete data security
• control ÄKTA™design or BioProcess™ systems and other
liquid handling units
• designed for Windows NT™ operating system
• complete, unalterable result files
• OPC™ specified driver
UNICORN™ is a control system for real-time control of
chromatography systems, from laboratory bench, through
development, to full scale production. UNICORN is used
world-wide in over a thousand laboratories and controls
hundreds of production scale process systems.
This control system provides the flexibility needed for
research and method or process development together with
the stringent requirements for commercial manufacture of
biopharmaceutical products.

Using UNICORN control ensures quick, simple control and

Reduced time and costs for preparation scale-up throughout all stages of a project. The same user
of submissions to authorities interface and methods used to optimize a purification in
research or process development are applied at production
• regulatory support
scale.
• comprehensive validation support
• optional IQ/OQ services

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Control systems

UNICORN is designed primarily for control of ÄKTAdesign

and BioProcess systems supplied by Amersham Pharmacia A mAU 280nm Conductivity (mS/cm)
Biotech. UNICORN can be adapted to control other liquid
handling process units and to connect to other control
400
systems or Plant Management systems. This versatility Conductivity 150
makes UNICORN a reliable, long term investment for every
company.
300
Comprehensive documentation is supplied to support
regulatory requirements for GLP and GMP.
100

Fast, confident control – from laboratory 200

to production
UNICORN has one common control platform and one
Fab
common user interface for operations from µg to kg scale. 100
50
This allows fast, trouble-free and predictable scale up of
optimized methods (Figure 2). The operator interface and
documentation remain consistent from one stage to the next,
reducing investment and the need for personnel training as 0
well as supporting validation requirements. 0
0.0 10.0 Time (min)

Fast, easy method programming for

research and development B AU 280 nm Conductivity
(mS/cm)
Method programmes use time, volume or column volume b)
base. 2.00

Columns can be selected from a column library and details

of run parameters for the column (such as column volume 100
and pressure limits) are transferred automatically into a
method template. New columns can be added to the library
and run in the same secure way.
1.00
Scouting schemes allow automatic variation of parameters 50
over a number of runs (Figure 3). This eliminates the need
to program a large number of individual methods, thus
speeding up development and optimization.

Pre-programmed method templates are supplied with

0
ÄKTAdesign systems for all liquid chromatography 0 500 1000 1500 2000 2500
techniques to save time and allow fast system start-up Volume (ml)
(Figure 3).

New method templates are created easily and conventional
method programming can be used to fine tune the method.
Complete manual programming control of systems is also an
option.
Fig. 2. A Media screening (HiTrap™ HIC Test Kit, 1 ml
columns) during purification development of a recombinant
antigen binding fragment. B Scale up (200 ml column) of the
optimized purification of the recombinant antigen binding
fragment. Purification can now be transferred to a BioProcess
system.

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 Control systems

User-defined start protocols prompt the operator to answer

specific questions before the start of a run. Protocols could
include the input of parameters that vary between runs, for
example, volumetric flow rate, feed volume or signal warning
▲ levels.

A more extensive Start Protocol (Figure 5A and B) can be

▲ Up to 99 created as part of a standard operating procedure (SOP).
programmable runs

User selected
scouting parameters

▲
Scouting schemes. User defined questions

Select technique

Select template
▲

▲
Fig. 5A. User defined Start Protocols to follow Standard
Select column Operating Procedures.
▲
▲ Run

Pre-programmed method templates.

Fig. 3. Easy to use, time-saving features for research and

development.

Fig. 5B. Mandatory or authorized questions displayed before

Simple, secure control for production
Figure 4 shows the simplicity of starting a production run.
▲
the start of a run.
A method editor allows customization of any run.
An example of customization is the use of the WATCH
instruction, when a watch is set on a process event to

Run activate a response under a given condition. WATCH

instructions are applied to monitor signals, such as UV,
conductivity, pH, pressure and air, and are often essential for
process scale operators. A WATCH on a sample inlet air
sensor can control an automatic switch to buffer when
▲

sample application is complete, improving process

performance.

Select method Another example of customization uses an air sensor placed

before the column and connected to an ALARM to stop a
process immediately if air is detected, protecting the column
from damage.
Fig. 4. Simple, direct start for production runs.
For added security active processes can be locked for
unattended operation without risk of unauthorized
interference.
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Control systems

Real-time overview of the system and Automatic, customized report generation

separation Result files can be rapidly identified and selected using a
A dynamic display keeps users well informed and updated Quick View option (Figure 8).
about the real-time status of the current run.

Selected monitor signals are displayed numerically or as

curves as the separation progresses.The flow scheme shows
the actual flow path and critical valve positions (Figure 6).

User selected
monitor values

User selected
▲

real-time display
▲

Flow path and Fig. 8. Rapid identification of result files using QuickView.
valve positions

Extensive data evaluation is available, including HETP

Fig. 6. UNICORN control system shows the current status of a determination (Figure 9). To allow automatic data
run as an easy-to-follow visual display. processing, an evaluation procedure can be included within a
programmed method.

Interactive flow schemes and run data give direct access to

manual instructions for a specific component (Figure 7).

Fig. 7. Access to component instructions via interactive flow

scheme or run data.

Fig. 9. HETP determination in customized report format.

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Control systems
An optional UNICORN analysis module includes additional
quantification options, such as a unique molecular weight
estimation for proteins separated by gel filtration and
calculations using internal/external standards for reference.
Procedures and reports are easily customized to suit
individual needs. Reports can be generated in formats
suitable for presentation (Figure 9). Curves and tables can
be copied into other office programmes such as Word or
Powerpoint for presentation.
Systems control, network overview and
complete data security
UNICORN controls ÄKTAdesign and BioProcess systems
from Amersham Pharmacia Biotech, but may be adapted to
control other liquid handling process units and to connect
to other control systems or Plant Management systems.
UNICORN controls up to four systems from one PC,
simultaneously, independently or in a pre-programmed
sequence. UNICORN network support allows control and
monitoring of systems from any connected UNICORN
workstation, subject to access rights defined by the system
administrator. Figure 1 (front page) illustrates how
UNICORN control can be applied in a fully networked
system. UNICORN is specifically designed for a Windows
NT operating system.
▲ Local UNICORN PC
Define access level
Fig. 10. Defined user access levels for added security.
* Further details on the OPC Foundation can be found on
www.opceurope.org.
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System control and data access via a PC network are easy to
use, providing an overview of operations and security of
results. User levels from Administrator to Process Operator
can be defined and each user is password protected. All
functions are subject to user access set up by the user
company (Figure 10). Operators supervise and control any
system in the network in real time, from a remote or local
PC, switching smoothly between supervised systems during
runs.
All run data are stored in a single, unalterable Result File,
together with the method, start protocols and run log
(Figure 11). The system audit trail is stored separately. Data
includes records of manual interactions and all other events
occurring during the run. Results are saved automatically on
the local computer or on the server in networked
installations. Evaluation and generation of reports can be
made locally or at remote PCs. If network communication
fails during a run, the run will continue and the result will be
saved on the local PC.
Fig. 11. All run data in a single result file.
An “open connection interface” (Figure 12) gives the
possibility to communicate with any other Control and Data
Acquisition or Archiving system. For implementation of this
communication UNICORN includes a driver that has been
developed according to OPC specification 1.0A*. Amersham
Pharmacia Biotech can undertake customer ordered projects
to assist with the establishment of such communication
systems.
Remote or local UNICORN PC
User interface User interface
modules modules
Open Connection
Interface Module
Interface for Other systems
specific driver
System
Fig. 12. Open connection interface allows communication
with any other Control and Data Acquisition or Archiving
system.
Control systems

Reduces time and costs for preparation Documentation is available for review in a formal vendor
audit at Amersham Pharmacia Biotech. This includes
of submissions to authorities
requirement including requirement specification, system
specification, test protocol and report, source code listing
Complete documentation and protection and reviews of Standard Operating Procedures for the
software development model.

Logbook
Logbook Installation Qualification and Operational Qualification
(IQ/OQ) services are available. For further information
please contact your local representative.
Method Method System Result
editor Evaluation
control
Control System Description
UNICORN control systems is based on a dedicated
controller and I/O interface with a computer based graphical
user interface. This graphical user interface is an integral part
Controlled user access Report of the control system.

ÄKTAdesign chromatography systems are supplied as

Main menu Validation Support
dedicated pre-assembled with UNICORN control. For all
other systems UNICORN is configured specifically for each
module.
GLP (Good Laboratory Practice) Support
• User access levels
• Built-in start-up diagnostics (ÄKTAdesign only) Within the limits of the specified hardware UNICORN offers
• Log books: complete, simple programming for the user. The operation
– run/method
– audit trail sequence is fully programmed by the end-user.
• Protection of raw data
• Master batch records UNICORN control system functions include:
• Real time flow scheme
Fig. 13. UNICORN fulfils stringent control and data handling
procedures.
• Trend data
• Display of all monitor values
• Method logbook for full documentation

Figure 13 shows examples of the many features supplied to

• Method start protocol

comply with the requirements of GLP and GMP. UNICORN

• Note books for pre-run, run and post-run notes

offers an extensive password protected security system with

• Method handling with full flexibility

flexible, end-user programmable access levels, together with

• Manual system interaction

batch operation and process documentation (programmed

• Control loop tuning

method, start protocols, notebooks and logbooks). Raw

• Report generation

data are protected and cannot be manipulated.

• Extensive result evaluation module
• Export of data
UNICORN controlled systems are supplied with a • Batch record storage on computer hard disk
Validation Support Package to support validation • Security system
requirements. Comprehensive documentation includes: • User administration
• introduction to UNICORN validation • System Audit trail
• recommendations for control system validation A UNICORN analysis module can be added to the
• Amersham Pharmacia Biotech standards and development evaluation module offering:
model
• details of UNICORN Control System including design and
• Quantification by internal or external standards

functionality
• Determination of molecular weight by gel filtration

• software quality assurance documentation for UNICORN 3.10

• Quantification of sample amount and sample concentration

• recommendations for validation of a UNICORN based

• Recovery calculations

chromatography system

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Control systems

Figure 14 shows the overall structure of UNICORN control

system software.

System strategies include all information needed by the Main Menu Method Editor System Control Evaluation

system control, method editor and hardware modules as well

as customization of specified software definitions. Strategies System Strategy
for standard ÄKTAdesign systems are supplied
automatically with each system. User defined strategies are
Customized strategy for BioProcess Systems
built to order for BioProcess and other liquid handling Built-in strategy for all and other liquid handling modules
ÄKTAdesign systems
modules using a specific Configurator programme.
Modular hardware

Fig. 14. UNICORN software structure.

Figure 15 shows the main components of UNICORN

control units when used within BioProcess or other custom
designed systems.

UNICORN PC
Control Control Control Control
unit unit unit unit

Electrical CAN/
cabinet Optomux Optomux

I/O I/O P-line

module module monitor

Chromatograph System Components

CAN/ = 1 PC: CAN/Optomux

Electrical Optomux interface with 1 or 2
cabinet Optomux networks
RS-485 with Optomux
standard protocol

I/O P-line
module monitor

Optomux standard analogue UV, pH, Conductivity

or digital boards
Up to 16 signals, in or out
(free mix) per module
Each signal can be different
/0–10 V, 4–20 mA etc)
(Pharmacia developed)
Pump and Valve control
boards
Direct communication
with Control Unit

Fig. 15. UNICORN software structure.

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Control systems

Computer and networking specifications Ordering information

Computer requirement Please contact your local sales office of Amersham
Pentium/233 MHz or later (minimum Pentium/90 MHz) Pharmacia Biotech
One system: 64 Mb RAM (minimum 32 Mb)
Two or more systems: 92 Mb RAM (minimum 64 Mb)
1 Gb available hard disk (150 Mb to run UNICORN), NTFS file Related Product Literature
system Description Code No.
Colour monitor, 1024 × 768 (minimum 800 × 600*) Validation support and service 18-1104-73
with 64k colours ÄKTAexplorer Systems 18-1124-09
1 ISA slot/connected system ÄKTApurifier 18-1119-48
Mouse ÄKTAFPLC 18-1128-41
CD-ROM drive ÄKTAbasic Systems 18-1128-19
1.44 Mb (3.5″) diskette drive

Operating system requirements

Windows NT Workstation 4.0 + Service Pack 4 or later

Network requirements
Supported network cards:
3COM Etherlink III
Compaq™ Netelligent 10/100 TX Embedded UTP Controller
Compaq Integrated NetFlex-3 Controller
AMD PCNET PCI Ethernet Adapter (Integrated)
Novell™ NetWare™ version 4.50.819 or later, alternatively
Windows NT Server 4.0
A valid network connection
* Available specification for industrially hardened screens.

to order:
Asia Pacific Tel: +852 2811 8693 Fax: +852 2811 5251 Australasia Tel: +61 2 9894 5152 Fax: +61 2 9899 7511 Austria Tel: 01 576 0616 20 Fax: 01 576 0616 27 Belgium Tel: 0800 73 888 Fax: 03 272 1637
Canada Tel: 1 800 463 5800 Fax: 1 800 567 1008 Central, East, South East Europe Tel: +43 1 982 3826 Fax: +43 1 985 8327 Denmark Tel: 45 16 2400 Fax: 45 16 2424 Finland Tel: 09 512 3940 Fax: 09 512 1710
France Tel: 0169 35 67 00 Fax: 0169 41 9677 Germany Tel: 0761 4903 401 Fax: 0761 4903 405 Italy Tel: 02 27322 1 Fax: 02 27302 212 Japan Tel: 81 3 5331 9336 Fax: 81 3 5331 9370 Latin America
Tel: +55 11 3667 5700 Fax: +55 11 3667 87 99 Middle East and Africa Tel: +30 (1) 96 00 687 Fax: +30 (1) 96 00 693 Netherlands Tel: 0165 580 410 Fax: 0165 580 401 Norway Tel: 2318 5800 Fax: 2318 6800
Portugal Tel: 01 417 7035 Fax: 01 417 3184 Russian Federation Tel: +7 (095) 232 0250,956 1137 Fax: +7 (095) 230 6377 South East Asia Tel: 60 3 724 2080 Fax: 60 3 724 2090 Spain Tel: 93 594 49 50
Fax: 93 594 49 55 Sweden Tel: 018 612 19 00 Fax: 018 612 19 10 Switzerland Tel: 01 802 81 50 Fax: 01 802 81 51 UK Tel: 0800 616 928 Fax: 0800 616 927 USA Tel: +1 800 526 3593 Fax: +1 800 329 3593

UNICORN, BioProcess, HiTrap, FPLC and ÄKTA are trademarks of Amersham Pharmacia Biotech Limited or its subsidiaries. Amersham is a trademark of Nycomed Amersham plc. Pharmacia and Drop Design
Produced by Wikströms, Sweden 991726, Nov., 1999

are trademarks of Pharmacia & Upjohn. Compaq is a trademark of Compaq Computer Corporation. Novell and Netware are trademarks of Novell Inc. OPC is a trademark of the OPC Foundation. Windows NT is
a trademark of Microsoft Corporation. Amersham Pharmacia Biotech AB Björkgatan 30, SE-751 84 Uppsala, Sweden. Amersham Pharmacia Biotech UK Limited Amersham Place, Little Chalfont, Buckinghamshire
HP7 9NA, England. Amersham Pharmacia Biotech Inc 800 Centennial Avenue, PO Box 1327, Piscataway, NJ 08855 USA. Amersham Pharmacia Biotech Europe GmbH Munzinger Strasse 9, D-79111 Freiburg,
Germany. All goods and services are sold subject to the terms and conditions of sale of the company within the Amersham Pharmacia Biotech group that supplies them. A copy of these terms and conditions
is available on request. © Amersham Pharmacia Biotech AB 1999 – All rights reserved.
Printed matter. Licence 341 051

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