Project objective: Decommissioning and dismantling of grade A/B production facility with RABS technology and replacing it by two new vial filling lines with isolator technology: multipurpose modular filling and bulk filling line. Installation of new preparation area with UAF, C grade clean rooms and new utilities for sterile filling of vials. Line speed 140 vials/min.
New equipment: vial washing machine, depyrogenation tunnel (incl. UAF in front of tunnel entrance), isolator (A grade), filling machine including stoppering (rotary piston pumps, peristaltic pumps, time pressure dosing systems), laser printing, inspection and tray loading unit, multipurpose modular filling line, Biotrak viable and non-viable particle detector
Refurbished equipment: capper with grade A air supply, lyophilizer, lyo load/unload system
Extended utilities: water for injection, purified water, compressed air, clean steam, nitrogen
New clean rooms: C grade (ISO 8 in operation)
Project budget: 25 M
Provided services: project management and execution (qualification), update of requirement specifications, issuing, execution and completion of qualification: qualification master plan, qualification plans, risk analyses (eFMEA), data integrity and electronic records assessments, DQ, IOQ, IT, OT, FT, QES, ReQ, Smoke Studies, FAT, SAT support.
Project status: ongoing