This presentation deals with Sterile Filling and Closing under cGMP aspects.
In particular Mr Hans Thomas will talk about machine design according the current cGMP guideline concerning parenteral products carrying out the FDA requirements and the safety regulations valid in the EU and he will touch reliable solutions able to handle almost every kind of pharmaceutical container available on the market, from semi-automatic to fully automatic systems, for every output required by the customer.
In relation with these topics Mr Thomas will speak about the complete production of Bausch + Stroebel comprises the individual steps: washing, sterilizing, depyrogenation, filling, closing, conveying, buffering and loading in trays.
Besides he will speak about production on line and stand-alone machines. He will also touch Qualification performance (IQ/OQ) of Bausch + Stroebel.