Prefilled Ophthalmic syringes - New Possibilities in Terminal Sterilization.

Autor: Zeiss B; Gerresheimer, Bünde, Germany; bernd.zeiss@gerresheimer.com., Offermann E; Sterigenics, Oak Brook, IL; and., Gillet A; Sterigenics, Oak Brook, IL; and., Haghedooren E; Sterigenics, Oak Brook, IL; and., Bischof M; Frueh Verpackungstechnik AG, Fehraltorf, Switzerland.
Jazyk: angličtina
Zdroj: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2024 Aug 23; Vol. 78 (4), pp. 532-533. Date of Electronic Publication: 2024 Aug 23.
DOI: 10.5731/pdajpst.2024.012968
Abstrakt: In a joint study carried out by Gerresheimer, Sterigenics and Früh, it could be shown that also NO 2 is well suited to terminally sterilize prefilled ophthalmic syringes. In detail 5 topics were addressed: (1) Compare EtO vs. NO 2 penetration into the filled syringe; (2) Analyze gas ingress though 4 different plunger stoppers including silicone oil free and standard rubber plungers; (3) Scrutinize gas ingress through 2 different cap designs based on different elastomer properties; (4) Investigate gas permeation through COP plastic barrels compared to glass; (5) Check if the Tyvek®-layer has an influence on either sterilization.Depending on the needs a suitable sterilization method, packaging and syringe type can be suggested to customers.
(© PDA, Inc. 2024.)
Databáze: MEDLINE
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