Steriline has completed the delivery and installation of a fully integrated aseptic filling line at a manufacturing facility operated by Tubilux Pharma. The system is designed to process both plastic and glass vials, supporting applications ranging from eye drops to lyophilised formulations. The installation marks a strategic upgrade for Tubilux Pharma, which sought to modernise its production capabilities and address operational limitations in its existing setup.
Part of the Content Group, Tubilux Pharma brings over five decades of experience in ophthalmic manufacturing, with a focus on advanced technologies and research-driven production. The company required a hybrid solution capable of handling both liquid and freeze-dried products, prompting a supplier evaluation process that ultimately led to Steriline’s selection. According to Marco Ferri, PM at Tubilux, “On our existing lines, we experienced difficulties with the primary packaging loading stations, which did not fully meet cGMP requirements. On the new line these issues have been resolved with innovative loading stations that remove the need to open the o-RABS each time materials are introduced.”
The installed line integrates six core units washing machine, depyrogenation tunnel, unscrambling machine, filling machine, swing belt, and capping machine engineered to accommodate multiple container formats. Glass vials are processed through dedicated washing and sterilisation stages using WFI and CCA, followed by depyrogenation, while plastic containers are introduced via an automated unscrambling system. Downstream processes are unified, enabling continuous operations across both formats. The aseptic filling line also incorporates a freeze-drying interface that can function as a bypass conveyor when lyophilisation is not required, enhancing operational flexibility.
Steriline highlighted the system’s ability to manage diverse closure systems, including droppers, screw caps, and preservative-free multidose solutions, alongside traditional glass vial configurations. Filippo Parini, Sales Area Manager at Steriline, stated, “We are very satisfied with the results achieved. It’s truly gratifying to have addressed all of the customer’s needs through one flexible, multi-purpose platform capable of managing plastic bottles, glass vials and both liquid and lyophilised production all integrated into a single, smart line designed in full compliance with regulatory standards.”
The upgrade addresses prior capacity constraints and compatibility issues with freeze-drying equipment, with Tubilux indicating a near doubling of output following implementation. Andrea Piersigilli, Plant Director at Tubilux, said, “Our previous lyophilised product line had limited production capacity. With the new equipment, we are set to nearly double output, while gaining the flexibility to process both plastic and glass vials on a single line.” Building on this deployment, the company is evaluating further upgrades across additional aseptic lines.
