PT  - JOURNAL ARTICLE
AU  - Zeiss, Bernd
AU  - Offermann, Eric
AU  - Gillet, Annick
AU  - Haghedooren, Erik
AU  - Bischof, Markus
TI  - Prefilled Ophthalmic syringes - New Possibilities in Terminal Sterilization
AID  - 10.5731/pdajpst.2024.012968
DP  - 2024 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 532--533
VI  - 78
IP  - 4
4099  - http://journal.pda.org/content/78/4/532.short
4100  - http://journal.pda.org/content/78/4/532.full
SO  - PDA J Pharm Sci Technol2024 Jul 01; 78
AB  - 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.