Closed system production of serum eye drops using dockable saline

Abstract

AbstractBackground and ObjectivesA 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 MethodsA 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.ResultsFrom 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.ConclusionDockable 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.