Validation

“Validation is the systematic and documented demonstration that a process, device or procedure is fit for its intended purpose.” It demonstrates that, under defined conditions, a process consistently produces products of a specified quality. Validation is particularly important in regulated industries such as the pharmaceutical, food, chemical and battery sectors.

In process engineering, validation typically involves the qualification of equipment, the establishment of process parameters and the verification of product quality. A distinction is often made between design qualification, installation qualification, operational qualification and performance qualification. The results are documented in validation reports.

In mixing, drying and reaction processes, for example, the mixing quality, moisture content, temperature profiles and reproducibility are examined. Validated processes enhance product safety, process stability and regulatory acceptance.