Bernd Zeiss, Eric Offermann, Annick Gillet, Erik Haghedooren, Markus Bischof
{"title":"预灌封眼科注射器--终端灭菌的新可能性。","authors":"Bernd Zeiss, Eric Offermann, Annick Gillet, Erik Haghedooren, Markus Bischof","doi":"10.5731/pdajpst.2024.012968","DOIUrl":null,"url":null,"abstract":"<p><p>In a joint study carried out by Gerresheimer, Sterigenics and Früh, it could be shown that also NO<sub>2</sub> is well suited to terminally sterilize prefilled ophthalmic syringes. In detail 5 topics were addressed: (1) Compare EtO vs. NO<sub>2</sub> 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.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 4","pages":"532-533"},"PeriodicalIF":0.0000,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Prefilled Ophthalmic syringes - New Possibilities in Terminal Sterilization.\",\"authors\":\"Bernd Zeiss, Eric Offermann, Annick Gillet, Erik Haghedooren, Markus Bischof\",\"doi\":\"10.5731/pdajpst.2024.012968\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>In a joint study carried out by Gerresheimer, Sterigenics and Früh, it could be shown that also NO<sub>2</sub> is well suited to terminally sterilize prefilled ophthalmic syringes. In detail 5 topics were addressed: (1) Compare EtO vs. NO<sub>2</sub> 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.</p>\",\"PeriodicalId\":19986,\"journal\":{\"name\":\"PDA Journal of Pharmaceutical Science and Technology\",\"volume\":\"78 4\",\"pages\":\"532-533\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-08-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"PDA Journal of Pharmaceutical Science and Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5731/pdajpst.2024.012968\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"PDA Journal of Pharmaceutical Science and Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5731/pdajpst.2024.012968","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
Prefilled Ophthalmic syringes - New Possibilities in Terminal Sterilization.
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.