UNICORN™ - For fast and efficient control of protein purification
UNICORN protein purification software is used by more than 50,000 people in more than a thousand manufacturing installations worldwide. Our software is able to generate high-quality purification results due to its flexible and intuitive method concept supported by advanced tools for result assessment.
Control system description
UNICORN control system enables real-time control of ÄKTAdesign chromatography systems in basically any scale, from laboratory bench, through development, to full-scale production. The Method Wizard provides easy method generation, and extensive data evaluation can be done using automated Evaluation Procedures.
The UNICORN control system 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 of the control system. Within the limits of the specified hardware UNICORN offers complete, simple programming for the user. The operation sequence is fully programmed by the end-user.
UNICORN control system functions include:
- Real-time flow scheme
- Trend curve data
- Display of all monitor values
- Method Logbook for full documentation
- Method start protocol
- Note books for pre-run, run, and post-run notes
- Method handling with full flexibility
UNICORN Control System fully conforms to 21 CFR Part 11 guidelines
UNICORN™ is the control system for ÄKTA™ , BioProcess™ chromatography systems, and OligoProcess™ peptide synthesis system. It is currently in use in many biopharmaceutical production processes approved by the FDA.
21 CFR Part 11
With the increased use and complexity of automated systems in biopharmaceutical manufacturing, the integrity of data has come into focus. The FDA has enforced its federal regulation for Electronic Signatures and Electronic Records - 21 CFR Part 11 - the rule to ensure security, accuracy and reliability of all electronic data used to meet GMP requirements.
Successful audit
UNICORN is regularly audited by an independent consultant with more than twenty years’ experience of inspections and audits of biopharmaceutical systems. Dr. Weinberg concluded that UNICORN conforms in all respects to all current and relevant FDA regulations including 21 CFR Part 11 for Electronic Records and Electronic Signatures, as well as with System Validation Standards and GAMP (US equivalent).
GAMP (Good Automated Manufacturing Practice) is a set of guidelines developed for suppliers and users of automated systems within the pharmaceutical manufacturing industry. These guidelines provide a framework for convergence with other existing standards and schemes, and will reduce the cost and time taken to achieve compliant systems.
Features
The new Electronic Signature System utilizes a dual password confirmatory and documenting locking scheme that is appropriate, compliant and applicable to the above mentioned guidelines.
The automatic audit trail system comprises complete documentation of the runs, such as raw data, method used, calibration, logbook etc., presented as a result file. There is also an Audit Trail Function for tracking data changes, user actions and fraud control on both a global and a system level. These functions are also appropriate, compliant and applicable to above mentioned guidelines.
Full report
The certificate and complete audit report on UNICORN are available upon request from your nearest sales office.
Overall structure of UNICORN control system software
System strategies include all information needed by the system control, method editor, and hardware modules as well as customization of specified software definitions.
Strategies for standard ÄKTAdesign systems are supplied with each system. User defined strategies are built to order for BioProcess and other liquid handling modules using
a specific Configurator program.
GLP (Good Laboratory Practice) Support
• User access levels
• Built-in start-up diagnostics (ÄKTAdesign only)
• Log books:
- run/method
- audit trail
• Protection of raw data
• Master batch records
For further information please read the Data file
(pdf)
Software strategy
Download the desired Software strategy from below:
ÄKTAexplorer™
ÄKTAexplorer 10 and Frac-920 or Frac-900 (exe. file)
ÄKTAexplorer 10 and Frac-950 (exe. file)
ÄKTAexplorer 100 and Frac-920 or Frac-900 (exe. file)
ÄKTAexplorer 100 and Frac-950 (exe. file)
ÄKTAFPLC™
ÄKTAFPLC and Frac-920 or Frac-900 (exe. file)
ÄKTAFPLC and Frac-950 (exe. file)
ÄKTApurifier™
ÄKTApurifier 10 and Frac-920 or Frac-900 (exe. file)
ÄKTApurifier 10 and Frac-950 (exe. file)
ÄKTApurifier 100 and Frac-920 or Frac-900 (exe. file)
ÄKTApurifier UPC 10 and Frac-920 (exe. file)
ÄKTApurifier UPC 10 and Frac-950 (exe. file)
ÄKTApurifier UPC 100 and Frac-920 (exe. file)
Software change description
UNICORN Software Change Description summarizes the main differences between two UNICORN versions.
Download the desired Software Change Description by choosing the UNICORN version from below.
UNICORN 5.2 vs 5.11 (pdf)
UNICORN 5.11 (pdf)
UNICORN 5.01 vs 5.0 (pdf)
UNICORN 5.0 vs 4.12 (pdf)
UNICORN 4.12 vs 4.0 (including version 4.01 and 4.11) (pdf)
UNICORN 4.0 vs 3.1 (including versions 3.21AA, 3.21AB and 3.22) (pdf)
UNICORN 3.2 vs 3.1 (pdf)
UNICORN 3.1 vs 3.0 (pdf)
Information letter description
Minimize time spent on troubleshooting on programming by consulting UNICORN Information Letter. The information letters for the different software versions comprise the latest information about bugs and issues and how to solve them. Simply choose your UNICORN version and download the Information Letter.
UNICORN 6.0 (pdf)
UNICORN 5.20 (pdf)
UNICORN 5.10 (pdf)
UNICORN 5.01 AB (pdf)
UNICORN 5.01 AA (pdf)
UNICORN 5.01 AA vs 5.01 AB (pdf)
UNICORN 5.0 (pdf)
UNICORN 4.12 (pdf)
UNICORN 4.11 (pdf)
UNICORN 4.01 (pdf)
UNICORN 4.0 (pdf)
UNICORN 3.22 (pdf)
UNICORN 3.21 (pdf)
UNICORN 3.21 (Ettan LC) (pdf)
UNICORN 3.2 (pdf)
UNICORN 3.1 (pdf)
UNICORN 3.0 (pdf)
UNICORN 2.34 (pdf)
UNICORN 2.33 (pdf)
UNICORN 2.32 (pdf)
UNICORN 2.20 (pdf)
UNICORN 2.10 (pdf)
UNICORN 2.0 (pdf)
UNICORN 1.0 (pdf)
