Theon Lifesciences upholds its legacy of precision and sterility with a fully automated Eye Drop Filling Line powered by Romaco (Italy). Designed for minimal human intervention, this high-performance system ensures aseptic filling and sealing of ophthalmic vials ranging from 2 to 10 mL. Every process, from vial handling to final sealing, is streamlined under stringent cleanroom conditions to maintain consistency, quality, and sterility.
By integrating state-of-the-art machinery with cGMP, EUGMP, USFDA, TGA Australia, and WHO guidelines, Theon Lifesciences delivers ophthalmic formulations that meet the highest global regulatory standards. With automation that minimizes contamination risk and ensures volume accuracy, we provide a robust solution for large-scale manufacturing of sterile eye drops that are safe, stable, and compliant.
Compatible with droppers, aluminum caps, or plastic screw caps.
Equipped with 4 (or 4+4) volumetric rotary piston pumps for accuracy and consistency.
Maintains ±1% tolerance for 2, 5, and 10 mL vials.
Features motorized infeed, star-wheel filling/closing, and synchronous belt conveyance.
Integrated online sampling and rejection system for continuous quality control.
Capable of filling up to 6000 vials per hour.
Equipped with oRABS and extended LAF systems for aseptic operations.
Fully compliant with 21 CFR Part 11, ensuring audit trail, electronic records, and secure user management.
Manufacturing sterile ophthalmic drops requires a combination of technical precision, aseptic control, and regulatory compliance. At Theon Lifesciences, every stage of the process is automated, monitored, and validated to ensure the utmost purity and product integrity.
Active pharmaceutical ingredients (APIs) are dissolved in sterile Water for Injection (WFI) along with suitable stabilizers and buffers to form the base solution. The formulation undergoes sterile filtration using 0.22-micron filters to remove particulates and microorganisms, ensuring clarity and sterility.
At Theon Lifesciences, innovation meets integrity. Our Eye Drop Line combines cutting-edge automation, rigorous quality systems, and global manufacturing excellence to deliver sterile ophthalmic solutions that inspire confidence and ensure patient safety. From formulation to final packaging, every vial reflects our vision, to advance eye care with precision, purity, and trust.