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首页> 外文期刊>Journal of validation technology >Validation Requirements for Gaseous Sterilization Using Ethylene Oxide
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Validation Requirements for Gaseous Sterilization Using Ethylene Oxide

机译:使用环氧乙烷进行气体灭菌的验证要求

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Gaseous sterilization is long-established but it is increasingly being reassessed and adopted due to the growth in the markets for medical devices and for single-use sterile disposable technologies for pharmaceuticals. Gaseous sterilization is not an exact term and there are different types of gaseous sterilization (and a further distinction between gases and vapors). The first division is with the agents and here sterilizing gases include: formaldehyde, ethylene oxide, propylene oxide, ozone, and chlorine dioxide (1). A second division is with vapors, such as peracetic acid and hydrogen peroxide. In drawing out the gasvapor distinction, a gas is a substance that has a single defined thermodynamic state at room temperature; in contrast, a vapor is a substance that is a mixture of two phases at room temperature, namely gaseous and liquid phase (2).
机译:气体灭菌技术已经建立了很长的历史,但是由于医疗器械和一次性使用的一次性无菌灭菌技术市场的增长,气体灭菌技术正在被重新评估和采用。气体灭菌不是一个确切的术语,并且有不同类型的气体灭菌(以及气体和蒸汽之间的进一步区别)。第一类是试剂,此处的灭菌气体包括:甲醛,环氧乙烷,环氧丙烷,臭氧和二氧化氯(1)。第二部分是蒸气,例如过氧乙酸和过氧化氢。在得出气体蒸气的区别时,气体是一种在室温下具有单一定义的热力学状态的物质。相反,蒸气是在室温下为两相的混合物的物质,即气相和液相(2)。

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