基于测试及CFD条件下GMP制药厂房送风量研究

Air Flow Rate of GMP Plant Based on Test and CFD Technology

新版GMP标准关于制药厂房洁净提出了不同以往的要求,但却没有提供量化数据,主要体现在无法合理确定送风量,导致工程应用上的莫衷一是,没有统一的标准。本文根据工程现场测试及调试结果,反推出合理的送风量,并通过CFD仿真验证了该送风量的可靠性。

The new version of the GMP standard on clean made different previous requirements, but it did not provide quantitative data. In practice, it mainly reflected in the inability to reasonably determine the air supply, resulting in no consensus of opinions on projects. According to a large number of engineering field testing and debugging results, a reasonable amount of air supply was derived, and its reliability was verified through the CFD simulation.