STERIS和W.L.GORE合作进行了一个案例研究,测试了新的预填充注射器柱塞设计与VHP终端灭菌的兼容性。VHP腔室条件需要深真空脉冲,这可能是对预填充注射器容器完整性的挑战。VHP灭菌的日益增长的行业趋势是由FDA对EO的替代灭菌方法的搜索和最近发布的VHP特定工艺标准推动的。本研究的目的是测试和报告新的0.5mLGOREIMPROJECT柱塞的兼容性,用于眼科应用的无硅胶注射器溶液,用VHP灭菌。已经报道了各种挑战,当使用传统的,硅化,用于玻璃体内注射的预填充注射器系统,如可见颗粒,炎症,硅胶漂浮物,和眼内压增加。GORE柱塞消除了硅油作为柱塞和筒上的润滑剂的需要,同时满足严格的容器封闭和眼科应用的终端灭菌要求。本案例研究展示了深度真空VHP终端灭菌工艺与GORE柱塞设计和材料成分的兼容性的成功结果。测试结果包括主容器完整性,塞子放气/进入,和视觉检查。VHP真空灭菌工艺原理,测试周期配置,并给出了其主要参数。
STERIS and W.L. GORE collaborated on a
case study testing the compatibility of a new prefilled syringe plunger design with VHP terminal sterilization. VHP chamber conditions require deep vacuum pulsing, which may represent challenges to prefilled syringe container integrity. The growing industry trend toward VHP sterilization is driven by the FDA search for alternative sterilization methods to EO and the recent publication of a VHP specific process standard. The purpose of the study is to test and report compatibility of the new 0.5 mL GORE IMPROJECT plunger, a silicone free syringe solution for ophthalmic application, with VHP sterilization. Various challenges have been reported when using conventional, siliconized, prefilled syringe systems for intravitreal injections such as subvisible particles, inflammation, silicone floaters, and intraocular pressure increases. The GORE plunger eliminates the need for silicone oil as a lubricant on the plunger and barrel, while meeting strict container closure and terminal sterilization requirements of ophthalmic applications. This
case study presents successful results of deep vacuum VHP terminal sterilization process compatibility with the GORE plunger design and material composition. Test results include primary container integrity, stopper off-gassing/ingress, and visual inspection. Principles of VHP vacuum sterilization process, test cycle configuration, and its main parameters are presented.