• Determine if the firm knows the bioburden and examine their procedures for integrity testing filters.

    确定公司是否知道生物负载检查滤膜完整性测试程序

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  • Because they are antibiotics, low bioburden of these formulations would be expected at the time of batching.

    因为它们抗生素,所以定量时候处方较低微生物污染水平

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  • In some cases, manufacturers have performed bioburden testing on bulk solutions after prefiltration and prior to final filtration.

    一些案例中生产厂商,在原液进行预滤,在进行最终过滤取样进行微生物污染水平测试

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  • Bioburden The level and type (e. g. objectionable or not) of micro-organisms that can be present in raw materials, API starting materials, intermediates or APIs.

    生物负载可能存在于原料原料药起始物料中间体原料药中的微生物水平种类(例如,致病致病的)。

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  • Bioburden assessment and sterility issues are also addressed, and a summary table describes adventitious agents, recommended tests, and stages at which to perform testing.

    生物负载评价无菌问题提到了并且汇总表描述了偶然试剂建议检测何阶段进行检测

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  • Bioburden assessment and sterility issues are also addressed, and a summary table describes adventitious agents, recommended tests, and stages at which to perform testing.

    生物负载评价无菌问题提到了并且汇总表描述了偶然试剂建议检测何阶段进行检测

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