不同级别洁净区压差控制

wangyue07

除了中国GMP指南，到底有哪个国外法规提到了不同级别洁净区压差指导值为12.5？

狱霸

差不多的问题   https://www.ouryao.com/forum.php ... hlight=%D1%B9%B2%EE

狱霸

不好意思没看到这条也是你提的

wangyue07

狱霸 发表于 2023-7-18 15:52
差不多的问题   https://www.ouryao.com/forum.php?mod=viewthread&tid=726377&highlight=%D1%B9%B2%EE

那个也是我提的，但是本人仍然存疑。领导说国外都用的12.5Pa. 我想知道从何而来？

准圣级药老

FDA给的建议值，中国现在很多设计院也会用这个值作为初始设计值。

hhww14

FDA指导值，

wangyue07

制药初学者 发表于 2023-7-18 16:07
FDA给的建议值，中国现在很多设计院也会用这个值作为初始设计值。

请问具体是在哪里给出的建议

wangyue07

hhww14 发表于 2023-7-18 16:21
FDA指导值，

请问这个指导值的出处是FDA的什么文件吗？

Doitasyoulike

Guidance for Industry
Sterile Drug Products
Produced by Aseptic Processing — Current Good Manufacturing Practice
September 2004
Pharmaceutical CGMPs

IV.        BUILDINGS AND FACILITIES

C.         Clean Area Separation

In some cases, the aseptic processing room and adjacent cleanrooms have the same classification.  Maintaining a pressure differential (with doors closed) between the aseptic processing room and these adjacent rooms can provide beneficial separation.  In any facility designed with an unclassified room adjacent to the aseptic processing room, a substantial overpressure (e.g., at least 12.5 Pa) from the aseptic processing room should be maintained at all times to prevent contamination.  If this pressure differential drops below the minimum limit, it is important that the environmental quality of the aseptic processing room be restored and confirmed.

wangyue07

Doitasyoulike 发表于 2023-7-18 17:03
Guidance for Industry
Sterile Drug Products
Produced by Aseptic Processing — Current Good Manu ...

这个意思不是说无菌处理室与未分级的房间的压差的指导值是12.5吗，反而上一段提出了一个不同级别洁净区的压差要求10-15Pa
For example, a positive pressure differential of at least 10-15 Pascals (Pa)6 should be maintained
between adjacent rooms of differing classification (with doors closed).

狱霸

Doitasyoulike 发表于 2023-7-18 17:03
Guidance for Industry
Sterile Drug Products
Produced by Aseptic Processing — Current Good Manu ...

好像是这个 CDE翻译的

Rob_Edwin

学习了，谢谢

好吧那就这样吧

记得是欧盟甚至要求15pa

wangyue07

好吧那就这样吧 发表于 2023-7-19 13:15
记得是欧盟甚至要求15pa

EU GMP附录1 4.14 不同级别的相邻房间应该维持至少10Pa（指导值）的压差

是为山河故人

FDA无菌生产指南吧

wangyue07

是为山河故人 发表于 2023-7-25 14:20
FDA无菌生产指南吧

FDA无菌工艺生产IV.C.
For example, a positive pressure differential of at least 10-15 Pascals (Pa)6 should be maintained
between adjacent rooms of differing classification (with doors closed).
In any facility designed with an unclassified room adjacent to the aseptic processing room, a substantial
overpressure (e.g., at least 12.5 Pa) from the aseptic processing room should be maintained at all
times to prevent contamination.
这两段的意思不是不同级别洁净区压差10-15，无菌操作室与非洁净区12.5吗？