Closed system production of serum eye drops using dockable saline

Area of Science:

• Pharmaceutical Manufacturing
• Ophthalmology
• Biotechnology

Background:

• Manufacturing serum eye drops in a fully closed system was previously challenging.
• Existing methods required clean suites, increasing costs and reducing efficiency.
• Growing demand for serum eye drops necessitated improved production methods.

Purpose of the Study:

• To implement and evaluate a fully closed manufacturing process for serum eye drops.
• To address bacterial contamination risks in serum eye drop production.
• To improve production efficiency and patient safety.

Main Methods:

• Utilized a dockable format for sterile saline with custom tubing for sterile connections.
• Implemented a fully closed manufacturing workflow at New Zealand Blood Service.
• Manufactured serum eye drops in a general laboratory environment, bypassing clean suite requirements.

Main Results:

• Achieved a 45% reduction in average production time.
• Manufactured over 30,000 serum eye drop vials without any bacterial contamination.
• Demonstrated robust sterile connections and successful implementation of the closed system.

Conclusions:

• The dockable saline system transforms serum eye drop manufacturing into a fully closed process.
• This innovation enhances patient safety and significantly cuts manufacturing time and costs.
• The new workflow is practical, effective, and portable, moving away from restrictive clean suite processes.