Validation

Validation provides documented proof that a process or system fulfils the previously specified requirements in practical use. For this purpose, the equipment used (e.g. mixers, vacuum dryers, synthesis reactors, agglomerators) must be qualified in advance.

In practice, we speak of a process route when a substance flows through several devices in succession. Each individual apparatus carries out one or more physical or chemical treatments.

For example, active pharmaceutical ingredients or pesticides are synthesised in several stages.

Baby food, for example, is produced by mixing fresh milk with powdered nutrients. The resulting suspension is dried in a spray tower. The resulting powder is then agglomerated in the fluidised bed agglomerator. It is then cooled. Finally, trace elements, bacterial cultures and vitamins are added. In the online process, filling and packaging takes place directly under sterile conditions.

Many development steps are necessary from a chemical formula that works in the laboratory to the market-ready end product. Large-scale production facilities are the result of a great deal of experience and countless trials.

Every single piece of equipment and every single process step must be validated before the production line is started.