Project objective: Installation of new vial filling line with isolator technology, C grade clean rooms and new utilities for sterile filling of vials. Line speed 120 -300 vials/min.
New equipment: Vial Washing Machine, Depyrogenation Tunnel (incl. LAF in front of tunnel entrance), Filling Machine including stoppering (Rotary Piston Pumps, Peristaltic Pumps, Time Pressure dosing systems), Capper including lift & Grade A Air Supply, Tray Loading Unit, Isolator (A grade), Stopper Transfer System (Lift), Workstation, Glove Leak Tester, Transport Trolley Inside Isolator, Filter Integrity Tester
New utilities: WFI. Extended utilities: nitrogen, purified water, compressed air, clean steam
New clean rooms: C grade (ISO 8 in operation)
Project budget:
Provided services: project management and execution (qualification), update of requirement specifications, issuing, execution and completion of qualification: qualification master plan, qualification plans, risk analyses (FMEA), DQ, IOQ, IT, OT, FT, QES, Smoke Studies, FAT, SAT support, process validation support.
Project status: successfully completed, line in production