Capping of Vials

For aseptic processing of vials, should the capping be perfromed within a Grade A area, or is Grade B sufficient to perform this task. Our stoppering of vials is performed in the Grade A area.

Are there any guidleines on the environment in which capping should be performed?

here you will find more details, in my opinion, it (process)should be under class A, B class should be arround of machine (background).
See by your self, you will find more usefull info…


2008_02_12_gmp_annex1.pdf (123.1 KB)

Thanks Cubica,

Nice share.

Many thanks for your advice. This is very useful.

Be aware, that in annex 1 is not defined the surrounding of the capping machine. It is clear that capping has to be under class A, but without particulate monitoring.