University of Iowa

New Sterile Fill Line

UIP has completed qualification of a new Flexicon FP50 Aseptic Filling and Stoppering Machine for use in the Clean Room that serves our Hull 48 square foot lyophilizer in the Sterile Products department.  The FP50 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 and stoppered with 13 mm or 20 mm stoppers.  The filling and stoppering operations 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.