Facility qualification


One equipment is replaced in the Pharma area by breaking the wall and re-construct the wall and a dynamic pass box is newly installed in the wall for material movement.

In the above case clean room facility re-qualification is required ? or only area qaulification is enough!

you have added new equipment in facility, so clean room facility re qualification required.

1 Like

Dear Mr. Manoj,
So room to be qualified followed by dynamic pass box qualification right?!!
what will be the impact in media fill and other adjacent sterile areas?