Ophthalmic filling solution for eye drops
In ophthalmic manufacturing, maintaining sterility and accuracy in the filling process is crucial. High demand for sterile eye care products requires efficient solutions that can meet throughput demands while ensuring product quality.
Sterile and precise filling of eye drops
The Hull i-Dositecno Ophtha-Line™, offered by SP I-docitecno, is designed for the accurate and sterile filling of ophthalmic products, such as eye drops or eye solutions. It features an innovative, oversized mechanical unscrambler that sorts and feeds plastic containers up to 500 mL efficiently. Fully compliant with 21 CFR Part 11, the system includes integrated software and IQ/OQ validation packages to ensure regulatory adherence. Its servo-driven linear transport of containers and filling nozzles, along with flexible configuration options, allows the system to handle various container closures and doses ranging from 0.1 mL to 250 mL. Built to cGMP standards and compliant with GAMP5, this solution supports up to 12,000 units per hour, providing a high throughput while maintaining the necessary sterility and accuracy in the filling process.
Benefits
- High throughput of up to 12,000 units per hour
- Ensures ultimate sterility in various settings
- Flexible handling of different container types
- Servo-driven system for accurate, automated adjustments
- Meets rigorous regulatory standards and cGMP compliance