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首页> 外文期刊>European journal of parenteral & pharmaceutical sciences: the official journal of the ESPC >Facility-based case study: A comparison of the recovery of naturally occurring species of bacteria and fungi on semi-solid media when incubated under standard and dual temperature conditions and its impact on microbial environmental monitoring approach
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Facility-based case study: A comparison of the recovery of naturally occurring species of bacteria and fungi on semi-solid media when incubated under standard and dual temperature conditions and its impact on microbial environmental monitoring approach

机译:基于设施的案例研究:比较在标准和双重温度条件下孵育时半固体培养基上自然存在的细菌和真菌物种的回收率及其对微生物环境监测方法的影响

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This study compared the recovery of naturally occurring micro-organisms on tryptone soya agar (TSA) and Sahouraud dextrose agar (SDA), when incubated under three different temperature conditions. The micro-organisms were sourced directly from a factory environment. The incubation conditions employed were 20-25°C, 30-35°C and a combination of each, termed dual temperature incubation, for a period of 5 days. The results demonstrated that TSA was the most effective medium for the primary isolation of both bacterial and fungal/yeast micro-organisms. Bacteria were recovered best at 30-35°C with human commensals providing the largest numbers, while fungi and yeasts showed best recovery at 20-25°C. The use of dual temperature incubation at 20-25°C for 3 days followed by 2 days at 30-35°C gave reduced recovery for both types of micro-organisms. The authors recommend that similar studies should be considered for all manufacturing facilities in order to determine the optimal incubation temperature regime for the recovery of local, naturally occurring species of bacteria and fungi which may present a threat to aseptic manufacturing areas. This process should be undertaken as part of an overall risk assessment for the establishment and maintenance of a viable environmental monitoring programme and may also be relevant to the incubation conditions employed in process simulation studies.
机译:这项研究比较了在三种不同温度条件下孵育时,胰蛋白so大豆琼脂(TSA)和Sahouraud葡萄糖琼脂(SDA)上天然存在的微生物的回收率。微生物直接来自工厂环境。所采用的孵育条件是20-25°C,30-35°C以及每种条件的组合,称为双重温度孵育,持续5天。结果表明,TSA是用于细菌和真菌/酵母菌的初步分离的最有效培养基。在30-35°C时,细菌的回收率最高,其中人类共刺激物的回收率最高,而真菌和酵母菌在20-25°C时回收率最高。使用两种温度在20-25°C下孵育3天,然后在30-35°C下进行2天孵育,两种微生物的回收率均降低。作者建议对所有生产设施都应考虑类似的研究,以便确定最佳的孵化温度范围,以恢复可能对无菌生产区构成威胁的本地天然存在的细菌和真菌。该过程应作为建立和维护可行的环境监控程序的整体风险评估的一部分,并且也可能与过程模拟研究中使用的孵化条件有关。

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