Clean Rooms and HVAC Systems - Online Training Recording

This course outlines the principles of planning, qualification and operation of cleanrooms & barrier systems and their associated HVAC systems in the GMP environment. Both the protection concepts and the premises for aseptic and non-sterile manufacturing will be addressed.

Knowing the regulatory requirements on rooms and HVAC systems is an absolute prerequisite for all further steps like design, qualification and operation of clean rooms.

It is therefore essential to be aware of all restrictions and relations between material and personnel flows before starting with the building of clean rooms for pharmaceutical manufacturing. This is the starting point for the zone concepts and the required airlocks.

The clean room itself consists of floor, wall and ceiling systems suitable for the intended use.  Now, which systems are suitable for which clean zones or processes? How can an isolator be integrated in the concept?

The classification and qualification of the rooms have to be done after the construction. The formal requirements on qualification are the same for clean rooms dedicated to the manufacture of both sterile and non-sterile dosage forms. Only the contents to be examined and fulfilled are different.

Qualification – which serves the verification of the correct functioning of the production rooms – merges into the routine monitoring. Moreover, the systems in place for requalification, change control, deviation and maintenance ensure the GMP status to be kept.