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原帖见下,感谢HelloWorld的分享
https://www.ouryao.com/forum.php ... &page=1#pid12278804
翻译了下,没有校对,希望对大家有帮助
Steam sterilization is widely usedacross the healthcare industry, and among the most documented and standardized.Despite its broad application, there is considerable confusion regarding thedifferent process control consideration and sterilizer designs necessary forits successful use. The methods and equipment used for porous (equipment,components and tools) loads are established to address air removal and steampenetration as these are critical to process efficacy. Sterilizing processesand equipment for non-porous loads (sealed aqueous containers) seek to minimizevariations across the load, and minimize the potential for under orover-processing of portions of the load. These distinctions are not alwaysevident in publications. United StatesPharmacopieal content brought attention to these differences in Sterilizationby Direct Contact <1229.1> and Moist Heat Sterilization of AqueousLiquids <1229.2>. This publication provides expanded content beyondthat found in USP in a side-by-side comparison of the process considerationsand equipment design details. It also reviews sterilization practices inlaboratory, formulation and biowaste sterilization applications which oftenrequire the simultaneous sterilization of porous and non-porous items. 蒸汽灭菌在医疗保健行业被广泛使用,最具文档化和标准化。尽管它有广泛的应用,但对于成功使用它所必须的不同的过程控制考虑和灭菌器设计,还存在相当大的混淆。多孔负载(设备、组件和工具)所使用的方法和设备是为了解决空气去除和蒸汽穿透问题,因为这些对工艺效率至关重要。非多孔负载(密封的液体容器)的灭菌过程和设备力求减少负载的变化,并尽量减少部分负载处理不足或过度的可能性。这些区别在一些发表的文章中并不总是很明确阐述。美国药典的内容引起了人们对直接接触灭菌<1229.1>和水溶液的湿热灭菌<1229.2>的关注。本文提供扩展的内容在USP所述的基础上,对灭菌过程和设备设计细节进行逐项比较。它还回顾了在实验室的灭菌实践,制剂产品和生物废物灭菌应用,这些往往需要同时灭菌的多孔和非多孔物品。
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