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Steriline's solution for cell and gene therapy meets GMP requirements in accordance with Annex 1
Compact filling machine combines robots, magnetic levitation technology, and double-walled insulation system
Wednesday, 28. May 2025
| Redaktion
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A look inside Steriline's new filling machine, which combines robots, magnetic levitation technology, and a double-walled insulation system
A look inside Steriline's new filling machine, which combines robots, magnetic levitation technology, and a double-walled insulation system, Photo: Steriline

Steriline will unveil its new RVFCM11-S filling machine at this year's Pharmintech in Milan at the end of May 2025. The system is specifically designed for pharmaceutical companies involved in cell and gene therapy. It meets the current regulatory requirements of Annex 1 of the EU GMP guidelines. The RVFCM11-S combines robot technology, magnetic levitation technology, and a double-walled insulation system. With a footprint of only 2.25 x 1.65 meters, it is one of the most compact solutions in its class. The machine was developed for the primary packaging of liquids in bottles, syringes, or nested cartridges at a rate of up to 15 units per minute.

Technology combination for loss-free processes

At the heart of the new filling solution is the interaction of two Stäubli Stericlean robots, a magnetic levitation system and a peristaltic pump. This configuration enables contact-free and precise processing of the primary containers. The integration of a weight control system supports accurate dosing and minimizes deviations in the filling process. With the development of the RVFCM11-S, Steriline is consistently pursuing its zero-loss philosophy. The machine allows defective containers to be reprocessed by refilling, resealing, and controlled reintroduction into the process. The fast decontamination cycle with vaporized hydrogen peroxide also enables efficient batch changes.

Filling machine with a focus on safety and regulatory compliance

The double-walled insulation system reduces the risk of microbial contamination and supports compliance with GMP requirements in accordance with Annex 1. All process steps take place in a closed environment, monitored by a camera-based system to control the sealing process.“This machine confirms the innovative and flexible approach of Steriline solutions,” says Federico Fumagalli, Chief Sales Officer of Steriline. “Combining robotic technology with dual-wall isolation systems and magnetic levitation technology is the natural consequence of our zero-loss philosophy, which aims to further reduce waste.”

Aseptic filling machine and packaging solutions for safe production of sterile pharmaceuticals

With its trade fair appearance, the manufacturer of aseptic packaging solutions is underlining its claim to contribute to the safe and economical production of sterile pharmaceuticals through technological innovations and modular systems. “I am very pleased that Steriline is present at Pharmintech with its own stand,” emphasizes Ilaria Fumagalli, CEO of Steriline. “We consider this trade show to be very important for our positioning and growth in the marketplace.” You will find Steriline at Pharmintech 2025 in Milan in Hall 2, Stand B17.

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