乙烯氧化物灭菌的参数过程控制:数据驱动的释放
Biomedical instrumentation & technology
|May 12, 2025
概括
乙烯氧化物 (EO) 灭菌中的参数释放可以使用统计过程控制来改进. 通过压力增量计算EO/水度为气体分析仪探针提供了可行的替代方案,提高了可靠性并减少了杀菌剂的使用.
科学领域:
- 医疗器械灭菌 医疗器械灭菌
- 工业微生物学 工业微生物学
- 工艺工程是过程工程.
背景情况:
- 乙烯氧化物 (EO) 灭菌依赖于生物指标或参数释放 (PR) 根据ISO 11135:2014.
- 当前的PR方法面临的挑战是气体分析仪探针用于测量EO度和湿度.
- 根据ISO 11135:2014标准,基于EO度和湿度等控制参数来限制PR.
研究的目的:
- 评估统计过程控制以检测EO灭菌中的偏差.
- 证明使用可靠的工艺数据用于PR.
- 探索测量关键参数的替代方法.
主要方法:
- 来自100个常规EO灭菌周期的工艺数据的分析.
- 室内相对湿度 (RH),温度和EO度的趋势.
- 过程中获得的数据与气体分析仪探头测量的比较.
主要成果:
- 统计过程控制有效预测过程故障.
- 通过压力增量计算EO/水度被证明是气体分析仪探针的可行替代方案.
- 关键参数的变化减少,可以减少灭菌剂的使用.
结论:
- 统计过程控制提高了EO灭菌监测的可靠性.
- 流程衍生数据,特别是通过压力增量,可以支持PR.
- 优化参数控制导致更高效和潜在的更安全的灭菌过程.
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