Artikel ; Online: Closed system production of serum eye drops using dockable saline.
2023 Band 118, Heft 9, Seite(n) 790–793
Abstract: 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 ... ...
Abstract | 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. |
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Mesh-Begriff(e) | Humans ; Ophthalmic Solutions ; Serum ; Drug Contamination/prevention & control ; New Zealand |
Chemische Substanzen | Ophthalmic Solutions |
Sprache | Englisch |
Erscheinungsdatum | 2023-07-10 |
Erscheinungsland | England |
Dokumenttyp | Journal Article |
ZDB-ID | 80313-3 |
ISSN | 1423-0410 ; 0042-9007 |
ISSN (online) | 1423-0410 |
ISSN | 0042-9007 |
DOI | 10.1111/vox.13494 |
Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
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