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Project

New building for packaging of sterile dosage forms

Location

Switzerland

Description

Commissioning & Qualification Services

Building of secondary packaging of sterile forms.

The job was to manage all the Commissioning and Qualification efforts.

Telstar developed an integrated strategic approach where the different suppliers, the customer and the consultancy Telstar division worked together in order to successfully perform a cost-effective qualification, leveraging some testing activities and where the principles of risk management were applied throughout the project. This strategy was successfully audited by the competent authority.

Scope

  • Manufacturing Area: Assembly, Labeling, Inspection, Manual Packaging & Warehouse, 6 Packaging Lines.
  • Head Building: Wardrobes, Offices, Meeting, Training and Break Rooms.
  • Equipment: New Assembly and Packaging Pre-Filled Syringe (PFS) Lines, New Assembly Auto-Injector Line, Upgrade of Existing PFS Line, Relocation of existing Equipment.