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PDA J Pharm Sci Technol ; 78(4): 532-533, 2024 Aug 23.
Article in English | MEDLINE | ID: mdl-39179391

ABSTRACT

In a joint study carried out by Gerresheimer, Sterigenics and Früh, it could be shown that also NO2 is well suited to terminally sterilize prefilled ophthalmic syringes. In detail 5 topics were addressed: (1) Compare EtO vs. NO2 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.


Subject(s)
Drug Packaging , Sterilization , Syringes , Sterilization/methods , Drug Packaging/standards , Drug Packaging/methods , Administration, Ophthalmic , Equipment Design , Ophthalmic Solutions/administration & dosage , Glass
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