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QUBICON – Quality by Control

QUBICON® – Quality by Control
Software Solution for Advanced Process Monitoring and Control

Qubicon: Quality by Control software

Overview

Qubicon® is a software that enables advanced real-time monitoring and control of processes in a flexible way. Qubicon® offers data-alignment, processing, management and reporting as well as the use of user-defined control strategies, the implementation of software-sensors and a flexible way to combine equipment, sensors and actors. On-line and off-line data integration allows real-time visualization and analysis as well as quick and straightforward comparison of different live-processes or live and historical ones (golden-batch).

The web-based software runs on a server infrastructure on-premise and can be accessed via clients. The complete user interface is in English language. A flexible database, representing the heart of Qubicon®, enables easy integration of new equipment and measuring devices (e.g. PAT-sensors).

Qubicon® has been designed with the industry’s priorities in mind. It makes advanced planning, execution and analysis of processes intuitive. The modular architecture of Qubicon® allows custom-tailored implementation of functionalities needed in the user‘s workflow.

Qubicon® ultimately enables the implementation of the "Quality by Control" concept to bioprocesses.

Quality cannot be tested into products;
it should be built-in or should be by design.

US Food and Drug Administration (FDA)

Qubicon Features

Flexible hardware setup

The heart of Qubicon® is a database, storing and managing data from different sources. Process equipment is connected to the Qubicon® server via Ethernet and provides the signals via the communication standard OPC-UA, either directly or via the communication bridge PAT-Box. Qubicon® supports the integration of up to 100 process entities, delivering data at varying time intervals.

Flexible hardware setup
A flexible hardware setup of Bilfinger and third-party equipment

In addition, off-line measured values can be imported either manually or via an import function. The thus acquired additional data is then correctly time-aligned within Qubicon®, enabling the export of complete datasets. Accordingly, the data can be directly used for statistical analyses or model development in the user's standard environment without prior manual processing.

Advanced monitoring and control

Developed process models or soft-sensors can be integrated into Qubicon® using the Python scripting language or model runtime files. Calculations can be performed on historical as well as ongoing batches in real-time.

Qubicon model calculation

Mathematical models can be further used to control the process (e.g. feed-on-demand). A Wizard guides the user through a straightforward process planning module, including the intuitive mapping of scripting-variables to process sensors.

Qubicon two chart view

The Charts module visualizes multiple data sets, such as on-line, off-line historical- or live values, as well as calculated data within one chart using up to five different y-axes. A navigator below each chart allows for easy orientation and quick navigation through the whole process in zoom mode. In addition, various view modes facilitate and speed up the visualization and inspection of all data.

Further functionalities

All actions within Qubicon® are tracked and linked to the operator through identification and authentication upon login. User access rights can be defined by the system administrator by assignment to pre-defined user groups.

The Status module gives a quick overview of the whole system environment including all equipment connected to Qubicon and their actual status information.

The multi-client access allows several users to operate on the software simultaneously without interrupting each other.

Qubicon® is constantly being improved and additional new functionalities are currently in the planning process, such as an improved workflow for design of experiment (DoE) execution as well as the integrated control of continuous manufacturing setups.

Background

The state-of-the-art for process control and quality assurance in biopharmaceutical manufacturing is based on a static Quality by Testing approach. The production process is fixed and tightly specified to guarantee a constant and defined product quality, which is verified by intensive testing. Exceeding the specification ranges of such processes results in rejection of batches and consequently leads to increased consumption of raw material and energy. In 2002 the US Food and Drug Administration started the Process Analytical Technology (PAT) initiative, aiming to guide the industry towards more dynamic manufacturing processes. PAT is focusing on the identification of Critical Process Parameters affecting the product’s Critical Quality Attributes and subsequently their real-time monitoring and control.

However, these quality attributes are usually not directly measurable. The proposed strategy to be followed is to employ complex on-line analyzer systems (f.i. 2D fluorescence spectroscopy or Raman spectroscopy) in combination with mathematical techniques to build up correlations between nonspecific signals and process variables for real-time estimation of process performance and product quality.

Schematic illustration of Quality by Design benefits

Schematic illustration of the variable inputs of a bioprocess as well as the link between critical process parameters and quality attributes.

The main hurdle of this approach is the implementation of advanced sensor systems, delivering hundreds or thousands of values at each measurement, to the Process Control System. This includes data storage, pre-processing and data alignment in a GMP conform manner.

 

Qubicon is a registered trademark in the EU and other countries.

Qubicon® Key Features


GENERAL

Client-Server architecture
Unlimited access points
Platform independent
 

DATA SOURCES

On-line data from up to 100 process units or additional analyzers
Directly via OPC-UA or via PAT-Box
Off-line data
Manual entry of single values
Import of complete data sets
Metadata
 

DATA MANAGEMENT 

Powerful server
Comprehensive database
Libraries as main access to recurring data
Flexible combination of equipment
 

DATA PROCESSING

Straightforward calculations (real-time and retrospective)
Soft sensors, KPIs, setpoints, alerts
Deviations from other batches
Advanced process control (APC)
 

REAL-TIME MONITORING

Wide range of visualization options
Golden-batch comparison
Unlimited charts
Up to five y-axes in one chart
 

EXPORT/REPORT

Flexible configuration
Multiple batches
Audit trail

Get in contact

If you are interested in our PAT/APC solution or you would like to become a beta tester, please contact us:

Research Partner

University of Natural Resources and Life Sciences 
Vienna
Department of Biotechnology
Research Group Striedner