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首页> 外文期刊>Dhaka University Journal of Pharmaceutical Sciences >Control Chart in Microbiological Cleaning Efficacy of Pharmaceutical Facility
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Control Chart in Microbiological Cleaning Efficacy of Pharmaceutical Facility

机译:制药厂微生物清洗功效控制图

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Statistical process control and quality control charts have important applications in the field of microbiological quality control of clean area. Monitoring the environment and the surface samples using contact plates – is critical to verify microbiological cleaning efficacy of the surface and to understand the behavior of the operation. In the current study, RODAC? (Replicate Organism Detection and Counting) plates were used to sample surfaces in production rooms for semisolid and liquid products in a course of two years and overall performance was assessed using I-MR chart and data were subjected to analysis. The throughput yield (TPY) was 0.999993 and the overall process capability was acceptable (Ppk was 1.45). The used methodology in microbiological quality control is simple, fast and not expensive, which provides insight for the evaluation of the process efficiency and highlights the limiting factors and the drawbacks that affect the performance.Dhaka Univ. J. Pharm. Sci. 14(2): 133-138, 2015 (December)
机译:统计过程控制和质量控制图在清洁区域的微生物质量控制领域中具有重要的应用。使用接触板监测环境和表面样品–对于验证表面的微生物清洁功效和了解操作行为至关重要。在目前的研究中,RODAC? (生物检测和计数)板在两年的时间内用于生产室中半固体和液体产品的表面采样,并使用I-MR图评估整体性能,并对数据进行分析。吞吐率(TPY)为0.999993,总体处理能力可接受(Ppk为1.45)。微生物质量控制中使用的方法简单,快速且不昂贵,这为评估过程效率提供了见识,并突出了影响性能的限制因素和缺点。 J.药物科学14(2):133-138,2015(12月)

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