Steriline, a leading Italian manufacturer of highly specialized production equipment for the pharmaceutical industry, will be showcasing its latest innovation at CPHI Milan (October 8-10). The new Robotic Vial Filling & Capping Machine (RVFCM11-S) will be displayed at the Steriline stand at CPHI (A42, Hall 18). This cutting-edge machine is poised to attract pharmaceutical professionals and companies eager to enhance production efficiency and maintain compliance with stringent industry standards.

RVFCM11-S: Enhancing Sterility and Efficiency

The RVFCM11-S is an advanced robotic solution specifically designed for the primary packaging of cell and gene therapies. With an exceptionally compact footprint of 2.25m by 1.65m, the machine operates with nested 2R, 6R, 8R and 10R vials and can also be configured to fill Pre-filled Syringes (PFS) and cartridges.  Equipped with a single filling head connected to an aseptic peristaltic pump, a single stoppering head, and a single capping head, the RVFCM11-S utilizes two Stäubli Stericlean Robots for the discrete handling of primary containers with zero glass-to-glass contact. The machine features a double-wall isolator that minimizes the risk of contamination and is integrated in the structure of the machine.

The process begins with a manual de-bagger and a de-lidder station, followed by the loading of empty vial trays into the filling zone via a conveyor belt. The vials are then removed discretely by the use of magnetic levitation, presenting each vial to the robot arm. They then proceed to the filling station, where an integrated check-weigh system (aligned with Steriline’s zero-loss philosophy) ensures precise filling. Once filled, the vials are moved to the capping station.

In a seamless movement, the second robot arm handles capping and places the vials back into the nest. The capping process is monitored and controlled by machine vision, ensuring each filled vial is accurately sealed.

Production Capacity and Storage Compliance

The RVFCM11-S boasts a production capacity of 15 nested vials, syringes or cartridges per minute. Additionally, its design includes software-based tracking features to ensure that temperature-sensitive products do not exceed the time limit in the solution, preserving their pharmacological efficacy.

Meeting the Needs of Cell and Gene Therapies

“Our new RVFCM11-S addresses the specific challenges associated with the production of cell and gene therapies, where sustainability is often determined by product loss,” said James Rorke, Vice President of Operations at Steriline North America. “The entire supply chain can now benefit from a solution that ensures minimal loss, a high degree of sterility assurance, and compliance with Annex 1 requirements.”

Federico Fumagalli, Commercial Director at Steriline, added, “Steriline remains committed to developing innovative pharmaceutical packaging solutions. Our aim is to advance the industry by providing more efficient systems that optimise the production process for the greater good.”