University of Iowa

New Sterile Fill Line

UIP completed the qualification and validation of a new Flexicon FPC50 Aseptic Filling, Stoppering and Crimping Machine in the Sterile Products department.  The FPC50 is designed to operate at speeds of up to 25 vials per minute, filling from 0.5 to 50 mL per vial with a filling accuracy of better than ± 1% (depending on the fill volume).  The entire fluid path of the peristaltic filling system is single use silastic tubing.  Self standing glass vials from 2 mL to 50 mL can be filled, utilizing 13 mm or 20 mm stoppers and flip-off crimp seals.  The filling, stoppering and crimp sealingoperations all take place within the ISO Class 5 (Class 100) areas in the Sterile Products Clean Rooms in accordance with both FDA and EU regulatory requirements.