RT Journal Article
SR Electronic
T1 Prefilled Ophthalmic syringes - New Possibilities in Terminal Sterilization
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 532
OP 533
DO 10.5731/pdajpst.2024.012968
VO 78
IS 4
A1 Zeiss, Bernd
A1 Offermann, Eric
A1 Gillet, Annick
A1 Haghedooren, Erik
A1 Bischof, Markus
YR 2024
UL http://journal.pda.org/content/78/4/532.abstract
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.