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.
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