Background and objectives: A fully closed system solution to manufacture serum eye drops using diluted serum has remained elusive, necessitating production steps to mitigate bacterial contamination risks in a clean suite environment, hampering production efficiency amid growing demand. We describe our recent implementation of a fully closed manufacturing process at New Zealand Blood Service.
Materials and methods: A dockable format for sterile saline manufactured to custom specifications configured with a 15-cm tubing to enable sterile connections was sourced from a local pharmaceutical manufacturer.
Results: From a total of 30,168 eye drop vials manufactured since implementation, the average production time was reduced by up to 45% performed in the general laboratory environment, attributed to eliminating processes performed in a clean suite. No bacterial contamination was observed, demonstrating robust sterile connections.
Conclusion: Dockable saline takes serum eye drops manufactured from a functionally closed system to a fully closed system, thereby enhancing patient safety, significantly reducing manufacturing time and cost and transforming production from a highly restrictive process into a portable workflow that is simple, practical and effective.
Keywords: bacterial contamination; closed system; dockable saline; ocular surface disease; patient safety; serum eye drops.
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