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发表于 2017-12-19 07:27:26
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PDA TR48
1.0 Introduction 引言
Moist Heat Sterilization is a process that uses moist heat as the lethal agent to render liquid and porous/hard goods items tree of viable microorganisms. There are two main types of processes used in moist heat sterilization: saturated steam sterilization and air overpressure sterilization. Saturated steam sterilization is used primarily for porous, hard goods loads, while air overpressure is used for liquid loads.
湿热灭菌是一种采用湿热作为灭菌手段来杀灭液体和多孔/坚硬物品中活微生物的工艺。湿热灭 菌采用两种主要的工艺:饱和蒸汽以及空气超压(用空气加压条件下)灭菌。饱和蒸汽灭菌主要 用于多孔/坚硬物品的灭菌,而空气超压灭菌则用于液体产品。
Sterilizers are used to sterilize many types of articles, including:
灭菌柜可以用来给很多类型的物品灭菌,包括:
Porous/hard goods, e.g., equipment, tools, laboratory glassware, product components, packaging, or devices
孔/坚硬物品,如设备、工器具、实验室玻璃器皿、产品组件、包装材料或器具
Product components that are not part of a porous or liquid load, e.g., vials and syringes
不属于多孔或液体装载的产品部件,如小瓶和针筒
Cleaning materials and product intermediates
清洁材料和产品中间体
Product in final container (terminal sterilization)
在最终容器中的产品(最终灭菌产品) Heat labile media 热稳定性差的培养基
Biological solutions and products, equipment, tools
生物溶液及产品、设备、工器具
Air over-pressure applications are used to minimize destruction or distortion of plastic containers or syringes containing liquids.
空气超压的湿热灭菌用于减少装有液体的针筒或塑料容器的损坏或变形。
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