Steriline to Show New Robotic Vial Filling and Capping Machine at CPHI Milan 2024

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Among the design features of the machine is software-based tracking that is meant to ensure that products that are temperature-sensitive do not exceed their time limit in the solution.

Steriline, based in Lake Como, Italy, will display RVFCM11-S, its new, robotic vial filling and capping machine, in the company’s home country at CPHI Milan from Oct. 8–10, 2024, Steriline announced in a press release on Sept. 2, 2024 (1).

Designed specifically for primary packaging of cell and gene therapies, RVFCM11-S measures 2.25 m by 1.65 m, contains nested vials in four different sizes, and can be configured to fill pre-filled syringes and cartridges, according to Steriline (1). The machine uses two robots for handling of primary containers with no glass-to-glass contact, and an integrated, double-wall isolator that minimizes contamination risk.

“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, in the press release. “The entire supply chain can now benefit from a solution that ensures minimal loss, a high degree of sterility assurance, and compliance with [European Union good manufacturing practice] Annex 1 requirements.”

Vials are removed discretely by RVFCM11-S’s use of magnetic levitation, to move each vial to a robot arm. The vials then proceed to the filling station, with a check-weigh system integrated into the design to ensure precise filling (1). A second robot arm handles capping, and places vials back into their nests.

Overall, the machine has a production capacity of 15 nested vials, syringes, or cartridges per minute, according to Steriline (1). Additional software-based tracking features are deployed to ensure that temperature-sensitive materials do not exceed their time limit in the solution, therefore preserving pharmacological efficacy.

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Steriline said in the press release that the RVFCM11-S would attract both pharmaceutical professionals, and other companies, that want to enhance their production efficiency while keeping in line with the stringent standards of the industry.

“Steriline remains committed to developing innovative pharmaceutical packaging solutions,” Federico Fumagalli, Steriline commercial director, said in the press release. “Our aim is to advance the industry by providing more efficient systems that optimize the production process for the greater good.”

Previous Steriline showcases at CPHI have included its RVFCM2, designed to integrate robotics and isolators with a zero-loss philosophy, at the 2023 conference in Barcelona (2). And in 2022 in Frankfurt, Steriline displayed the VCFM100, a vial filling and capping machine under double-wall isolator that had been developed for the purpose of increasing production capacity for a contract development and manufacturing organization that at the time was supplying COVID-19 vaccines throughout the world (3).

The RVFCM11-S will be on display during CPHI Milan at the Steriline stand, located in room A42, Hall 18, according to the press release (1).

References

1. Steriline. Steriline Unveils New Robotic Vial Filling Machine at CPHI Milan 2024. Press Release. Sept. 2, 2024.
2. Steriline. Robotic Vial Filling and Capping Machine (RVFCM2) Under Isolator. PharmTech.com, Oct. 9, 2023.
3. Steriline. CPHI Frankfurt 2022: Steriline Leverages on Compactness and Versatility. Press Release. Nov. 1, 2022.