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非无菌原料药生产中物料过滤器的验证

Validation of the filter in non-sterile API production
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摘要 在对法规研究的基础上,参考除菌过滤器的验证,以具体的例子进行具体分析。结论:普通物料过滤器的验证应该得到制药企业的重视。 Based on regulatory research,refer to the validation of the sterilization filter,use a concrete example to analyze.RESULTS:Validation of ordinary filter should get the attention of pharmaceutical companies.
作者 王莉
出处 《机电信息》 2012年第23期30-34,共5页
关键词 过滤器 完整性测试 化学相容性 溶出物实验 性能 验证 filter integrity test chemical compatibility dissolved matter test performance validation
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