药厂车间的新风及循环风的设计是保证车间产品质量的关键，也是顺利通过GMP认证的基本要求。因此，在设计时也要充分考虑风险。德斯特给大家分享下最新的制药车间全新风和循环系统设计案例，仅供大家参考。

Manufacturers may select to have full fresh air systems or recirculate treated air supplied to production areas (In a full fresh air system, no air is recirculated. In recirculation systems, a defined percentage of the air is recirculated.). In both cases, the air supplied to the production areas should be appropriately treated to ensure that the environmental conditions specified are met and that the risks for contamination and cross-contamination are controlled.

生产企业可以选择有全新风系统或再循环处理过的空气供应到生产区（在全新风系统中，没有空气再循环）。在循环系统中，一定百分比的空气被再循环。在这两种情况下，应适当处理供应到生产区的空气，以确保满足规定的环境条件，并控制污染和交叉污染的风险。

Manufacturers using recirculation systems should determine the percentage of fresh air to be supplied to the relevant manufacturing areas, as required by national and international standards. This volume of air should be verified during qualification.

使用循环系统的企业应根据国家和国际标准的要求，确定供应到相关制造区域的新鲜空气的百分比。这个空气量应该在确认期间进行验证。

In both scenarios, appropriate levels of filtration should be applied to prevent contamination and cross-contamination. Manufacturers should ensure that when HEPA filters are used that these are appropriately installed, not damaged and thus suitable for the intended use.

在这两种情况下，应采用适当的过滤水平来防止污染和交叉污染。企业应确保在使用高效能过滤器时，这些过滤器得到了适当的安装，没有损坏，因此适合于预期的用途。