Steriline has recently delivered and installed a complete filling line for plastic and glass vials, suitable for both eye drops and lyophilised products, at one of Tubilux’s manufacturing sites.
Steriline
Tubilux Pharma is an Italian company with a strong international outlook and more than 50 years of experience in the Ophthalmic industry. As part of the Content Group, an all-Italian company specialised in contract development, manufacturing and filling of pharmaceuticals, medical devices, and cosmetics in multidose bottles, single dose vials and tubes, Tubilux Pharma stands out for its outstanding scientific expertise, the use of state-of-the-art technologies, and a constant drive for innovation and research that permeates every aspect of its business. Tubilux Pharma is specialised in designing, developing and producing ophthalmic drugs and services to national and international standards, offering customers a wide range of top-quality products and full-service support activities.
Tubilux Pharma’s challenge
Tubilux Pharma faced the strategic challenge of introducing a new filling line for plastic and glass vials, suitable for both eye drops and lyophilised products. After an initial scouting phase involving three suppliers, the company ultimately selected Steriline as its preferred partner.
To achieve state-of-the-art ophthalmic processing and further strengthen its market positioning, the company has chosen to invest in a hybrid production line capable of handling both freeze-dried and liquid products, thereby maximising production flexibility.
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 solution
The new filling line offers maximum flexibility for the processing of both liquid and lyophilised products. Designed to handle a wide range of container types, it processes glass vials closed with rubber stoppers and aluminium caps, as well as plastic bottles equipped with various closure systems, including droppers, screw caps and multidose preservative-free droppers.
The line comprises six main units:
- Washing machine
- Depyrogenation tunnel
- Unscrambling machine
- Filling machine
- Swing belt
- Capping machine
With two dedicated inlet points, one for glass vials (via the washing machine and depyrogenation tunnel) and one for plastic bottles (via the unscrambling station), the system ensures smooth, continuous operation. All subsequent processing stages are common to both formats, providing first-rate operational flexibility and efficiency.
The washing machine uses WFI (Water for Injection) and CCA (Clean Compressed Air) to thoroughly clean and dry the glass vials before transferring them to the depyrogenation tunnel, where a precise thermal cycle ensures complete depyrogenation and sterilisation.
In the Class A aseptic area, the filling machine accurately fills the vials and inserts the half-stoppers. The vials are then automatically transferred to the freeze dryer’s loading and unloading system, which also functions as a bypass conveyor when lyophilisation is not required.
After the filling stage, the vials are closed, labelled and packed in a non-classified area, ready for downstream operations. For plastic bottles, the workflow is streamlined: containers are automatically sorted by the unscrambling unit, conveyed to the filling machine, then filled and closed using the selected closure system. This modular and flexible configuration ensures optimal performance, short changeover times, and adaptability to a wide range of pharmaceutical and biotech production needs.
Filippo Parini, sales area manager at Steriline: “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.”
Benefits for Tubilux Pharma
Tubilux Pharma reported that its previous filling equipment had insufficient production capacity and was no longer compatible with the new freeze-drying equipment. The new line installed by Steriline represents an innovation inf ophthalmic aseptic filling, offering significant advantages in terms of improving operational efficiency and production capacity.
The selected line also offers exceptional flexibility, allowing the processing of different types of containers through a streamlined format-change procedure. In particular, it can handle traditional plastic vials paired with various closure systems—such as droppers, screw caps or sealing solutions for multi-dose, preservative-free formulations—as well as glass vials with lyo stoppers.
Building on the successful installation of this line, Tubilux Pharma is now considering revamping three further aseptic filling lines for eye drops currently operating in its facilities.