Clean Room validation
Hey everyone,

i hope i'm in the right forum, if not please forgive me.

we are currently in the process of designing and constructing a class 7 clean room.
I am looking for reading material on validation of clean rooms, performing IQ,DQ,OQ,PQ etc.
anyone knows a good source, or might have some pointers?

Many thanks
Omri
1 Replies
Start with ISO 14644

At a high level, Environmental Qualification for clean rooms in a GMP facility consist of the following:
  • In-situ Studies to assess disinfectant procedures following construction
  • Environmental Risk Assessment, Site Selection, and Disinfection Rational
  • Environmental Qualification Execution and Final Report
  • Facility Certification Validation Protocol and Final Report
  • Post EQ Environmental Monitoring Program Development
  • Development of Routine Environmental Monitoring Program (SOP)

As always, your terminology and exact document clustering may differ.