Prefilled Ophthalmic syringes - New Possibilities in Terminal Sterilization

PDA J Pharm Sci Technol. 2024 Aug 23;78(4):532-533. doi: 10.5731/pdajpst.2024.012968.

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.

MeSH terms

  • Administration, Ophthalmic
  • Drug Packaging* / methods
  • Drug Packaging* / standards
  • Equipment Design
  • Glass
  • Ophthalmic Solutions / administration & dosage
  • Sterilization* / methods
  • Syringes*

Substances

  • Ophthalmic Solutions