A facility handled sterile blending and packing powder from a tilting filter dryer under sterile conditions. They were transferring the discharge of the tilting dryer by screw feeder and transferring into an agitated mixer. Discharging the mixer by a screw feeder into a packing system. They were encountering sterility loss through mechanical seals and docking of the dryer to the screw feeder and difficulties to clean and sterilize the system in place. A solution was a full automatice system including a transfer system, batchmixer and sampling device.
An operation required manual filling of IBCs by using a flexible isolator installed on an upper floor with large amounts of excipients (lactose and micro cellulose)> 100 kg and only a small amount of APls of a few kilos. Operation was strenuous due to the large quantity of excipients to be handled in the isolator which lead to the damage of the flexible isolator and containment breach. Several equipment and process changes allowed them to see an increase of plant productivity.