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EXCLUDING BACTERIAL SPORES FROM ASEPTIC COMPOUNDING

机译:从无菌化合物中排除细菌菌落

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摘要

Cherwell Laboratories' triple-wrapped TSB is a faster and more effective way to prevent spore contamination resulting in misleading false results in compounder validation. This prevents unnecessary retraining of fully competent operators, which interrupts workflow and reduces the efficiency of the pharmacy laboratory. It ensures that the media fill simulation procedure is an accurate interpretation of operator competency. This study highlighted the risk of resilient spores contaminating the compounding process. However, the risk to the sterility assurance of the media fill process was deemed to be greater than the risk to the sterility assurance of routine compounding.
机译:Cherwell Laboratories的三层包装TSB是一种更快,更有效的方法,可防止孢子污染,从而在配混机验证中误导错误结果。这样可以防止对完全称职的操作员进行不必要的再培训,从而中断工作流程并降低药房实验室的效率。它确保了介质填充模拟过程是对操作员能力的准确解释。这项研究强调了弹性孢子污染复合过程的风险。但是,认为介质填充过程的无菌保证风险要大于常规混料的无菌保证风险。

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