一个全面的基于科学的方法,容器封闭的完整性亲肠道产品:教训从疫苗需要深冷储存使用常规的瓶子系统的经验教训
Michael Edey1, Josine Wilmer2, Derek Duncan2
1Pfizer Inc., 1 Lexia Place, Mulgrave, Vic 3170, Australia(1).
概括
确保无菌注射剂的容器封闭完整性 (CCI) 需要一个整体的战略,而不仅仅是CCI测试. 这涉及风险评估,坚固的包装设计,以及对腹腔注射瓶产品的工艺控制.
科学领域:
- 制药科学 制药科学
- 包装工程 包装工程
- 质量控制 质量控制 质量控制
背景情况:
- 确定性分析方法为亲肠道包装提供了对容器封闭完整性 (CCI) 的高级见解.
- 确保无菌注射产品的CCI需要一个全面的战略,不仅仅是测试.
研究的目的:
- 描述一种以科学为基础的,整体的方法,以确保亲肠道包装中的容器封闭完整性 (CCI).
- 详细说明这种方法对需要深冷储存的疫苗的实施.
主要方法:
- 对容器关闭完整性的风险识别.
- 强大的初级包装组件设计和密封/组装工艺的合格.
- 实施适当的过程控制.
主要成果:
- 为深冷储存疫苗实施了一项整体战略,证明了其适用于亲肠注射小瓶产品.
- 该研究强调了初级包装设计和过程控制之间的关键相互作用,以实现CCI.
结论:
- 以科学为基础的整体方法对于保证亲肠道包装中容器封闭的完整性至关重要.
- 该战略包括风险评估,组件设计,工艺合格和控制.
- 这些发现可以将其推广到门注射瓶产品上,强调设计和流程在CCI保证中的联合作用.
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