案例研究:预装注射器塞技术与蒸发过氧化终端杀菌过程的兼容性测试
Juha Mattila1, Michael Kienzle2, Arja Ruley3
1STERIS Life Sciences; and juha_mattila@steris.com.
PDA journal of pharmaceutical science and technology
|August 23, 2024
概括
斯特里斯和W.L.L. 戈尔 (GORE) 测试了一种用于预填注射器的新型无活塞. GORE IMPROJECT的水栓兼容蒸发过氧化 (VHP) 灭菌,确保眼科应用的容器完整性.
科学领域:
- 药品包装 药品包装 药品包装
- 灭菌技术 灭菌技术
- 眼科药物输送是眼科药物输送.
背景情况:
- 越来越多的行业趋势是蒸发过氧化 (VHP) 灭菌作为氧化乙烯 (EO) 的替代品.
- VHP灭菌需要深度真空脉冲,这对预装注射器容器的完整性构成了挑战.
- 在眼科应用中,传统的化注射器可能会导致可见微粒和炎症等问题.
研究的目的:
- 为了测试和报告0.5毫升的GORE IMPROJECT活塞与VHP终端杀菌的兼容性.
- 评估用于眼科应用的无注射器溶液.
- 为应对与传统预填注射器系统相关的挑战.
主要方法:
- 在STERIS和W.L.之间的案例研究合作. 戈尔 (GORE) 是一个古老的语言.
- 测试GORE IMPROJECT与深真空VHP终端杀菌的兼容性.
- 评估主要容器的完整性,堵塞的脱气/入气,以及视觉检查.
主要成果:
- 戈尔项目设计和材料与深真空VHP终端杀菌的成功兼容.
- 主要容器关闭系统的完整性得到证明.
- 没有观察到关于塞口脱气或入口的不良影响.
结论:
- GORE IMPROJECT 活塞是用于眼科预填注射器的可行的无溶液.
- 活塞符合眼科应用的严格容器封闭和终端灭菌要求.
- 成功的VHP杀菌兼容性支持其在敏感的制药应用中使用.
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