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European Biopharmaceutical Review

Supporting Closed Operations with Flexible Single-Use Solutions

Single-use solutions (SUS) designed for continuous processing reflect a paradigm shift in biopharmaceutical facility design. Utilised in almost all new products in early clinical trials so far, SUS are progressively applied in GMP environments as well. The combination of SUS and continuous bioprocessing is changing the industry’s conception of itself – having a significant impact on facility design by offering a smaller equipment footprint and substantially lowering cleaning requirements. The implementation of a continuous process monitoring, in turn, guarantees to keep process stability and raise overall efficiency. Critical points in upstream and downstream processes are, therefore, equipped with flow sensors to fulfil regulatory goals of the process analytical technology (PAT) framework.

PAT has been defined as a mechanism to design, analyse, and control biotechnical and pharmaceutical manufacturing processes through the measurement of critical process parameters. Constant flow monitoring can fundamentally support its overall targets to:
• Reduce production cycling time
• Prevent rejection of batches
• Enable real-time release
• Increase automation and control
• Improve energy and material use
• Facilitate continuous processing
As continuous processing is closely linked to the presence of moving fluids through the system and operates different volume and flow rates fed by peristaltic pumps, noninvasive flow sensors can reliably assume the requirements of PAT. Within upstream and downstream processes, clampon flow sensors are successfully integrated at various critical points.

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Special thanks to everyone who contributed to the creation of this article, especially SONOTEC's Melanie Schimdt (Business Unit Director Non-Invasive Fluid Monitoring) and Daniel Thieme (Marketing Manager Non-Invasive Fluid Monitoring).
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