Closed system production of serum eye drops using dockable saline

• Published in: Vox sanguinis Vol. 118; no. 9; pp. 790 - 793
• Main Authors: Kirwan, Susy, Kwan, Patrick S. L., So, Ronald, Tuinukuafe, Alice
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-09-2023; S. Karger AG
• Subjects: bacterial contamination; closed system; Contamination; dockable saline; Manufacturing; Manufacturing industry; ocular surface disease; patient safety; serum eye drops; Workflow; dockable saline; ocular surface disease; bacterial contamination; patient safety; serum eye drops; closed system
• ISSN: 0042-9007; 1423-0410; 1423-0410
• DOI: 10.1111/vox.13494

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.