在表面灭菌中测量蒸汽成分的标准方法的定量评估
Francesco Tessarolo1,2, Michela Masè3
1Department of Industrial Engineering, University of Trento, via delle Regole, 101, Trento, 38123, Italy. francesco.tessarolo@unitn.it.
Scientific reports
|December 1, 2025
概括
在蒸汽灭菌中测量非可冷凝气体 (NCG) 的标准方法由于未指定的参数而不可靠. 优化测试程序对于准确的蒸汽成分评估和杀菌器验证至关重要.
科学领域:
- 医疗器械 医疗器械
- 消毒技术 消毒技术 消毒技术
- 质量控制 质量控制
背景情况:
- 蒸汽成分,特别是非可冷凝气体 (NCG) 的部分,对于有效的蒸汽杀菌至关重要.
- 标准EN 285:2015+A1:2021提供了测量NCG分数 (NCG%) 的方法,但缺乏工艺参数和环境条件的详细规格.
研究的目的:
- 量化未指定的参数对NCG%测量的影响.
- 在蒸汽杀菌试验中确定影响NCG%变量的因素.
- 为更可靠的蒸汽杀菌试验程序提出改进建议.
主要方法:
- 具有不同配置和负载的灭菌周期是在中型蒸汽灭菌器中进行的.
- 非可冷凝气体和蒸汽冷凝液体积在30秒间隔间进行测量.
- 在不同的时间点和凝结体量计算NCG%值,并对环境条件影响进行理论估计.
主要成果:
- NCG%值和测试结果受到工艺配置文件,负载量和凝结物收集时间/体积的显著影响.
- 环境条件 (温度和压力) 显示对NCG%测量产生不可忽视的影响.
- 在NCG测量的变化损害了杀菌器资格和蒸汽组成估计的标准方法的可靠性.
结论:
- 标准方法中缺乏详细规范导致NCG%的测量变化,影响消毒器的资格.
- 建议在生产过程中实时对蒸汽成分进行定量监测.
- 改进的测试程序是必要的,以提高蒸汽杀菌的有效性和质量保证.
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