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并检查滤膜完整性测试的程序。
Because they are antibiotics, low bioburden of these formulations would be expected at the time of batching.
因为它们是抗生素,所以在定量的时候处方里有较低的微生物污染水平。
In some cases, manufacturers have performed bioburden testing on bulk solutions after prefiltration and prior to final filtration.
在一些案例中,生产厂商,在原液进行预滤后,在进行最终过滤前取样进行微生物污染水平测试。
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、原料药的起始物料、中间体或原料药中的微生物的水平和种类(例如,致病的或不致病的)。
Bioburden assessment and sterility issues are also addressed, and a summary table describes adventitious agents, recommended tests, and stages at which to perform testing.
生物负载评价和无菌问题也提到了;并且有汇总表描述了偶然试剂,建议的检测和在何阶段进行检测。
Bioburden assessment and sterility issues are also addressed, and a summary table describes adventitious agents, recommended tests, and stages at which to perform testing.
生物负载评价和无菌问题也提到了;并且有汇总表描述了偶然试剂,建议的检测和在何阶段进行检测。
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