Therapies are becoming more personalized: New freedom in the manufacturing of infusion bags

In the production of medical infusion bags, there is no room for compromise. Every seam, every detail determines safety, quality – and ultimately the well-being of patients. At the same time, today’s pharmaceutical industry demands something that pushes many production lines to their limits: ever-smaller batch sizes, frequent format changes, and seamless traceability.

Thimonnier has developed an adaptive solution for the production of flexible medical bags in collaboration with B&R. This enables the world’s leading French manufacturer of filling machines for flexible bags to meet the growing demands of the market and optimally support the unique dynamics of personalized therapies.

Personalized therapies demand maximum flexibility: production lines must process different pouch sizes and formats by the minute. Traditional machines require time-consuming changeovers that waste valuable cleanroom time. Thimonnier faced the challenge of designing a new system that would allow format changes in minutes instead of hours. At the same time, it needed to reduce material waste, ensure end to end traceability, and integrate seamlessly into a GMP compliant* environment.

“Our top priority is to develop machines that are not only fast, flexible, and efficient but that grow with the increasing needs of our customers,” says Eric Duhoo, CEO of Thimonnier. “With B&R’s adaptive automation solutions, we can guarantee exactly that.”

True format freedom is achieved through the individual shuttle control of B&R ACOPOStrak. Each shuttle on the track system moves independently, and bag sizes can be changed without mechanical adjustments. This saves cleanroom time and makes even small batches economically viable. Smart image processing via the integrated B&R Vision System identifies the shuttles precisely and reliably. This allows operators to maintain a constant overview – intuitively, clearly, and browser‑based.

Compliance isn’t just a requirement in the pharmaceutical industry – it’s a decisive factor for patient safety. mapp Audit and mapp UserX meet the requirements of CFR21 Part 11**. A powerful B&R industrial PC tracks every shuttle in real time, ensuring full transparency and safe processes. The user interface developed with mapp View provides intuitive web visualization, and OPC UA compatibility ensures complete data integration.

Already in the concept phase of the bag‑manufacturing machine, B&R provided a digital twin of the system. This made it possible to determine the optimal ACOPOStrak configuration and shuttle speeds before working with actual hardware. The digital twin makes it possible to detect and eliminate risks such as misconfigurations early and to simulate processes realistically. As a result, the final machine assembly is significantly faster and smoother.

With the new machine, Thimonnier now has a system that delivers exactly what modern pharmaceutical manufacturers need:

• Fast product changeovers without burdening the cleanroom
• Higher machine availability
• Reduced material usage
• Seamless traceability
• Greater safety – for operators and patients

Thanks to the modularity of B&R technology and Thimonnier’s forward looking approach, the machine is ready for future developments in personalized medicine.

This project shows what can be achieved when mechanical engineering, automation, and pharmaceutical expertise don’t work sequentially – but together.

“Together with B&R, we have achieved a breakthrough in the pharmaceutical industry with this machine. This truly innovative solution is something only Thimonnier can offer,” says Eric Duhoo. The production of infusion bags is now as flexible as the therapies that make them possible.

* GMP-compliant = meets the legal quality and purity standards for the safe manufacture of pharmaceuticals.

** CFR 21 Part 11 = FDA regulation for secure, traceable, and tamper-resistant electronic data and signatures.