Qualifying

The suitability of plant and processes is demonstrated through qualification. Qualification refers to the systematic and documented demonstration that plant, equipment, processes or procedures are suitable for their intended purpose and reliably meet the defined requirements. Qualification is carried out on the basis of established test criteria and traceable documentation.

In process engineering, qualification encompasses the verification of design, function, performance and reproducibility. In this process, technical parameters, operating conditions and interfaces are evaluated.

Particularly in regulated industries, such as pharmaceutical, food and chemical production, qualification is a prerequisite for safe, controlled and validated operation. It forms the basis for validation, quality assurance and the approval of manufacturing processes.

A practical example is the qualification of a powder mixer in galenics: here, it is demonstrated that the mixing process ensures a homogeneous distribution of the active ingredients without compromising their chemical stability. Suitability is verified through standardised mixing quality tests and the evaluation of the resulting mixing quality curve.