ISO14644-3(2019版)与ISO14644-1(2015版)-有问有答-蒲公英 - 制药技术的传播者 GMP理论的实践者
23 June 2025 admin
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众所周知iso是国际的标准,所以国内大部分的药企还是非常重视这一新版的标准。 和前一版本(第一版ISO14644-3:2005)相比 , 修订后的测试方法包括:压差测试、气流测试、气流方向和流型、自净时间测试、温度测试、湿度测试、已安装过滤器泄漏测试、隔离检漏、静电和电离子器检测、粒子沉降 ...
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