Bioburden Testing 生物负荷检测 Conducted on each batch of pre-sterilized (non sterile) drug product 每批产品应在灭菌前检测微生物负载 Quantity and resis...
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InIn-Process Bioburden Testing Results 生产过程生物负荷测试结果
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 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。
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。
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