Cleanroom qualification is the process of documenting the conformity of a cleanroom (clean area) to a specified cleanliness class. INEX conducts all stages of the qualification of cleanrooms, laminar flow cabinets, biological protection cabinets, sampling areas and other clean rooms, including:

DQ (Design qualification);

IQ (Installation qualification);

OQ (Operation qualification);

PQ (Performance qualification).

In accordance with GMP requirements, cleanrooms must be equipped with HVAC - Heating Ventilation and Air Conditioning Systems. This is to provide protection for critical manufacturing operations and to prevent product quality risks. Air in clean rooms directly affects the quality of the manufactured products, HVAC systems and all clean rooms are critical systems and therefore must be qualified.

HVAC systems and clean rooms are also referred to as continuous operation systems, which usually require regular monitoring of critical functions and parameters for such systems, as well as re-qualification on a periodic basis.