Project objective: installation of new preparation area to support vial and syringe filling lines.
New equipment: unidirectional air flows, two small parts washers, two autoclaves, clean steam generator
New utilities: clean steam. Extended utilities: nitrogen, purified water, water for injection, compressed air, black steam
New clean rooms: C grade (ISO 8 in operation)
Project budget: 7.5 M
Provided services: project management and execution (qualification), update of requirement specifications, issuing, execution and completion of qualification: qualification master plan, risk analyses (FMEA), DQ, IOQ, IT, OT, FT, QES, Smoke Studies, support at execution and completion of FAT/SAT reports.
Project status: successfully completed, line in production