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首页> 外文期刊>RGUHS Journal of Pharmaceutical Sciences >Evaluation and Failure Risk of Microbiological Air Quality in Production Area of Pharmaceutical Plant
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Evaluation and Failure Risk of Microbiological Air Quality in Production Area of Pharmaceutical Plant

机译:制药厂生产区微生物空气质量的评估及失败风险

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Purpose: Microbiological environmental monitoring of air quality is a key tool to determine the appropriateness of manufacturing area in clean rooms for microbiologically safe medicinal products production. Since aerial microbial distributions are highly dynamic and show significant variability from time to time depending on several influential variables, a monitoring system was adopted in order to establish control on trends, major sources of risks and defects. Methodology: The present work covered both active and passive air samples during course of two years of study in liquid oral and semisolid products manufacturing class C area. Trend of results showed progressively rising microbial count in air using commonly available statistical software package. Findings: Airlocks and corridor regions were significant contributors to failure risk of active air samples by a factor of 2.65. Performance capability of the process (Ppk) of the manufacturing rooms with and without passage ways was 1.23 and 1.11, respectively. Significant, positive but moderate correlation existed between both active and passive air samples. The average relative microbial recovery ratio of active/passive samples was 1.50. The probability of microbiological failure from passive air samples was approximately 84.54 times that of active air samples. Application value: Both air monitoring techniques provided indispensable different prospective view of clean area quality.
机译:目的:空气质量的微生物环境监测是确定洁净室中生产区域是否适合微生物安全的药品生产的关键工具。由于空气中的微生物分布是高度动态的,并且根据几个影响变量不时显示出很大的变化,因此采用了一个监视系统来建立对趋势,主要风险和缺陷来源的控制。方法:在为期两年的液体口服和半固体产品制造C级地区研究期间,本研究涵盖了主动和被动空气样本。结果趋势显示,使用常用的统计软件包,空气中的微生物数量逐渐增加。调查结果:气闸和走廊区域是造成活动空气样本故障风险的重要因素,为2.65倍。具有和不具有通道的制造室的过程性能(Ppk)分别为1.23和1.11。主动和被动空气样本之间都存在显着的正相关关系。主动/被动样品的平均相对微生物回收率为1.50。来自被动空气样品的微生物失效的概率约为主动空气样品的微生物失效的84.54倍。应用价值:两种空气监测技术都提供了清洁区域质量必不可少的不同视角。

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