致杀人的颂歌 - - 我们能做得更好吗?
Terra Kremer1, Donald C Singer2
1Johnson & Johnson.
PDA journal of pharmaceutical science and technology
|December 16, 2025
概括
单独的消毒剂不能在制造过程中确保微生物控制. 杀菌剂补充了持续性细菌子形成者的清洁和消毒,减少了污染风险.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 微生物学 微生物学
- 污染控制 污染控制
背景情况:
- 在制造过程中有效的污染控制依赖于一致性.
- 人们普遍认为,消毒剂单独控制微生物风险是一个错误的观念.
- 杀菌剂经常被误解为控制失败的独立解决方案.
研究的目的:
- 澄清运动杀虫剂在洁净室环境中的作用.
- 强调基于风险的污染控制方法的重要性.
- 促进在无菌制药制造中使用杀菌剂的最佳实践.
主要方法:
- 审查受控环境中的污染控制原则.
- 对运动杀虫剂在清洁和消毒方面的功能进行分析.
- 讨论对细菌子形成者的风险评估.
主要成果:
- 杀菌剂应该补充,而不是取代良好的清洁和广泛的消毒.
- 有效的污染控制需要虫杀虫剂,物质控制和养实践的组合.
- 了解细菌子形成者是管理风险的关键.
结论:
- 基于风险的方法来管理细菌子形成者是必不可少的.
- 杀菌剂是一种有价值的工具,当与其他控制措施一起适当使用时.
- 一致的污染控制实践减少了无菌制造中的微生物风险.
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