Qualification and validation of a fully automated filling plant for disinfectants

Rühl AG as a contract manufacturer of disinfectants for healthcare applications manufactures products for renowned companies, among others in the medical device industry, at its headquarters in Friedrichsdorf im Taunus. Rühl is DIN ISO 13485 certified and required the qualification and validation of a new, fully automated multi-product filing plant for disinfectants in accordance with customer requirements and standards. Here Rühl was assisted by gempex, the GMP service provider based in Mannheim.

The GMP experts placed special emphasis on processes relevant to quality, such as the qualification and validation of the screw-top device, scale and also the camera since the new filling plant features fully automated optical label checking. Two to ten-litre canisters are filled with a made-to-order disinfectant, sealed with a screw top and labelled.

The GMP consultants from gempex encountered tricky requirements in the risk analysis that took a close look at the factors critical to quality. These included the interplay of the various plant elements and the identification of points critical to quality.

Attend the real life presentation at LOUNGES to learn what other hurdles had to be overcome and especially how. Dr Markus Rugen (Rühl AG) and Dr Ralf Aubeck (gempex) will be jointly reporting on the project from their respective perspectives and providing practical tips. You also get the opportunity to review concrete documents and talk to the two speakers personally at exhibition stand D1.2 after their presentation.