Project objective: decomissioning of the old equipment, modification and requalification of rooms, installation of new syringe inspection line for the inspection and labelling of glass syringes. Line speed 200 -300 syringes/min
New equipment: denester, inspection machine, two renesters, syringe buffer, labeller, re-trayer
Extended utilities: compressed air
Modified clean rooms: E grade
Project budget: tbd
Provided services: project management and execution (qualification), update of requirement specifications, issuing, execution and completion of qualification plans, risk analyses (eFMEA), data integrity and electronic records assessments, DQ, IOQ, IT, OT, FT, ReQ, SPs, support by FAT and SAT execution.
Project status: ongoing