Biopharmaceutical manufacturers are facing the challenge of faster process changeover in order to stay competitive in the future.
To address this, we have developed an automation platform that manages multiple process steps with a modular design. Smart modular package units reduce integration efforts by implementing pre-tested and pre-qualified sequences. Additionally, the modular integration solution eliminates four major tasks, significantly reducing the overall time required for vendor skid integration by 50-75%.
The Sartorius automation platform will be included in the next-generation FlexAct® system that offers configurable industrial software, hardware and consumable solutions for 6-unit operations in one single system.
Fast process changeover will be a necessity to stay competitive in manufacturing of biopharmaceuticals. We therefore developed an automation platform that manages diverse process steps by a modular design.
Based on the chosen hardware (e.g. holders, tanks, pumps) and wetware (e.g. tubings, filters) the system activates the control modules needed and the automated process sequences including the user guidance. The resulting configuration is stored and can be qualified if needed to allow easy process adaptation.
In the past, a big engineering effort was required to integrate vendor skids in manufacturing Supervisory Data Acquisition and Control Systems (SCADA) and Distributed Control Systems (DCS), such as Emerson Delta-V, Siemens PCS7 and Rockwell’s Allen Bradley.
Remote IO integration (Entry Point Level 3) was the common root for integration. Our Smart Modular Package Unit that comes with pre-tested and pre-qualified sequences expands the possibilities of recipe integration (Entry Point 1 & 2) and reduces integration effort. It comes equipped with a set of different interfaces, such as ProfiNet, ModBus TCP/IP, OPC UA and classic OPC, to serve the different integration scenarios, which can be advantageous in Greenfield to Brownfield installations.
Our modular integration solution allows four major tasks to be eliminated, substantially reducing the overall time required for vendor skid integration by 50-75%.
The smart modular package unit is focused on the local control of an instrument or one process step. It has to be integrated into the higher elements in an automation pyramid such as SCADA and DCS system, which are focused on plant-wide control.
The smart package unit delivers benefits through reduced integration efforts, integration of pre-tested and pre-qualified sequences. Furthermore, human errors are minimized by adaptive user-guidance.
We provide the FlexAct® single-use automation platform skid to facilitate multi-product production, while decreasing the risk of cross-contamination. The design space has been application release tested for six industry-relevant separation unit operations.
Each FlexAct® is preloaded to perform any of these six unit operations at various scales. In order to achieve product consistency, the modular software recipe is loaded and guides the operator through all steps of the arrangement of peripherals, wetware installation and process automation. With a touch of a button, the next recipe can be started and the corresponding unit operation or configuration variant begins. The modular structure over all three platform elements (hardware, software and wetware) adds speed and flexibility to your processes.
Addressing Cost, Speed, and Flexibility Challenges in Biologics Manufacturing
By Burkhard Joksch (Product Manager Bioprocess Automation) and Stuart Tindal (Product Manager FlexAct® Platform)
In the rapidly changing healthcare landscape, biopharmaceutical companies are continually looking for strategies to reduce their costs while increasing speed and flexibility. In this article, our experts dive into details about the evolution of automation for single-use technology towards modular packaging units. The case studies clarify how these units can be used in real life cGMP processes and how smart modular packaging units can deliver manufacturing and industry benefits for biomanufacturing – now and in the future.
This webcast features: Burkhard Joksch (Product Manager Bioprocess Automation and Stuart Tindal (Product Manager FlexAct® Platform)
Multi-product facilities need modular package units to realize fast change-over while guaranteeing high product quality and process performance. The FlexAct® platform is a smart modular package unit that can run pre-qualified and pre-tested recipes. Moreover, users can rapidly integrate Sartorius Stedim Biotech’s or third-party manufacturers’ single-use technology in bioprocess operations to achieve faster installations and reduced downtime.
Single-use automation solutions
Get an idea of the complete FlexAct®-flexibility:
Large scale filtration system for single-use
Depth filters for demanding clarification applications
Based on body feed filtration specially designed filters for challenging harvesting applications
Reliable retention under all circumstances