无菌测试用隔离器的去污和验证。,Biomedical Instrumentation &
用过氧化氢去污是一种广泛用于减少微生物污染的技术。该技术的典型应用是无菌测试隔离器的去污。本文介绍了如何对无菌测试隔离器进行消毒和验证过程，产妇护理13825404095以证明已经达到了微生物目标，并且排除了由于过氧化氢残留导致的假阴性风险。过氧化氢会不利地影响某些材料，从而抑制微生物的生长。包装完整性验证（其重点是去污剂渗透到不同产品容器中以及通过不同材料渗透的风险）是主要主题之一。几个案例研究可让读者了解最关键的项目，正确选择材料，并验证流程本身。在初级包装容器内部和水溶液内部的几种材料的表面进行过氧化氢测量是本文的一部分。验证去污周期以及验证手术程序是良好实验室规范方法的关键要素。
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Decontamination and Validation of Isolators for Sterility Testing.
Decontamination with hydrogen peroxide is a technology widely used to reduce microbial contamination. A typical application of this technology is in the decontamination of sterility test isolators. This article describes how to decontaminate sterility test isolators and validate the process in order to demonstrate that the microbiological target has been achieved and that the risk of false negatives due to residuals of hydrogen peroxide is excluded. Hydrogen peroxide can adversely affect some materials, resulting in inhibition of microbial growth. A package integrity verification, focused on the risk of penetration of decontaminating agent into different product containers and through different materials, is one of the main topics. Several case studies let readers understand the most critical items, choose their materials correctly, and validate the process itself. Hydrogen peroxide measurements on the surface of several materials, inside the primary packaging container, and inside aqueous solutions are part of this article. Validation of the decontamination cycle as well as validation of the operative procedure are key elements for a good laboratory practices approach.