Automation platform:
Smart control of biopharmaceutical plants

Our novel, user-friendly automation platform is GAMP5-compliant and includes all the software modules needed for recipe control and process control logic. It allows users to simultaneously increase process development flexibility while maintaining the GMP-compliant features required for manufacturing operations.

  • Our solution includes all the software modules needed for recipe control and process control logic “out-of-the-box”.
  • For bioreactor applications, the control software is based on a validated library of standard components that are compliant with both GAMP5 and 21CFR11. Compliance to these standards markedly reduces the time and effort required for qualification activities. 
  • Bilfinger uses the Siemens TIA Portal in accordance with IEC 61131-3, thereby ensuring that the equipment can be operated with a high level of stability and reliability.
  • The software platform’s expandability features allow easy changes or additions to hardware and process control. External process control interfaces are supported as well, meaning existing equipment control systems from other manufacturers can be seamlessly integrated.

 

Batch System

  • ISA-88-compliant batch system (recipe control system)
  • The batch system segregates the equipment from the process-control system and allows the process units to be operated and transitioned into new configurations, synchronizing data both in parallel and sequentially as required.

Supervisory Control and Data Acquisition (SCADA)

  • The SCADA system utilized for supervisory control, analysis and data acquisition was built from the ground up specifically for biopharmaceutical workflows.
  • The user interface (HMI) has been thoughtfully designed with input from a panel of usability experts to assure the best possible user experience. Tight integration between SCADA functions and the control interface makes operation of equipment simple and intuitive.
  • All critical process parameters can be visualized in a number of ways, including a freely configurable dashboard view. This virtual control panel allows the system to be monitored at a glance.
  • The configurable trend display enables users to analyze process variables for active batches or saved historical data sets. Critical process parameters can be easily bundled and stored as individual trend profiles. 

 

Interface with QUBICON

The basic automation package also serves as an ideal interface with QUBICON®, Bilfinger’s platform-independent “Quality by Control” software. This powerful tool bundles data from process equipment and sensors and makes them available in real-time for process comparisons and computation, thereby allowing any potential problems to be identified and averted at an early stage. QUBICON® supports the creation of software sensors and to track individual critical process parameters (CPPs). CPPs can be used for advanced control strategies, which serve to maintain the ideal critical quality attributes (CQAs).

 

Intelligent bioprocess technology of tomorrow

Bilfinger’s new process automation platform and optional QUBICON® software have strategically expanded the spectrum of products and services offered by Bilfinger Industrietechnik Salzburg. They are the foundation for the integrated, intelligent bioprocess technology of tomorrow.

 

Integrated tools

A fully automated workflow covers all the steps required to determine the kLa value, such as the “stripping out” of oxygen with the aid of nitrogen, the calibration of the process parameters, the measurement of the saturation curve and the calculation of the kLa value. The kLa value represents the volumetric mass-transfer coefficient and is a key indicator used to track the transition of compounds from the gaseous phase into the fluid phase within a given reaction system.

It is possible to sterilize the bioreactor using the F0 method. The “F” value measures the aggregate sterilization effect achieved during the process cycle, including the heat-up, sterilization and cool-down phases. The end result is a gentle sterilization method that reduces the impact on the materials being sterilized while extending the lifespan of gaskets and sensors.


 

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