预填眼科注射器 - - 终端杀菌的新可能性
Bernd Zeiss1, Eric Offermann2, Annick Gillet2
1Gerresheimer, Bünde, Germany; bernd.zeiss@gerresheimer.com.
PDA journal of pharmaceutical science and technology
|August 23, 2024
概括
二氧化 (NO2) 是有效的预填眼药注射器的终端灭菌. 这项研究比较了NO2和乙烯氧化物 (EtO) 灭菌,分析了气体通过注射器组件和材料的透.
科学领域:
- 药品的包装和杀菌方法
- 医疗器械制造业 医疗器械制造业
- 医疗保健中的材料科学
背景情况:
- 预填眼科注射器需要可靠的终端杀菌方法.
- 乙烯氧化物 (EtO) 是一种常见的灭菌剂,但正在探索替代品.
- 二氧化 (NO2) 在杀菌过程中具有潜在的优势.
研究的目的:
- 评估二氧化 (NO2) 作为预装眼科注射器的终端杀菌方法.
- 为了比较NO2和EtO的透和进入填充注射器的情况.
- 评估各种注射器组件和包装对气体灭菌功效的影响.
主要方法:
- 对二氧化 (NO2) 和乙烯氧化物 (EtO) 气体透的比较分析.
- 通过不同塞 (无油和标准) 进入气体的调查.
- 通过各种盖设计和循环烯酸聚合物 (COP) 对玻璃桶的气体进入的评估.
- 评估Tyvek®层对绝育的影响.
主要成果:
- 二氧化 (NO2) 已证明适用于预填眼药注射器的终端灭菌.
- 气体的入气量根据塞类型,盖帽设计和桶材质 (COP与玻璃) 有显著差异.
- 还检查了Tyvek®层对绝育效率的影响.
结论:
- 二氧化 (NO2) 是预填眼药注射器终端灭菌的可行替代品.
- 选择注射器组件 (堵塞器,盖子) 和桶材质是有效气体灭菌的关键因素.
- 根据这些发现,可以推优化的灭菌方法,包装和注射器类型.
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