Lilly B103 Project Summary

Objective

Commissioning Agents was contracted to develop the overall commissioning and qualification strategy for the retrofit of Lilly’s repurposed facility.

Services

CAI authored the C&Q Master Plan, the overarching change control strategy and all system change controls that the project inherited from the existing facility. CAI facilitated all Design Reviews, authored all component-level classification and system commissioning and qualification master plans.

Equipment Used

We supported FAT execution for the new vial filling line, lyophilizer loading/unloading system, and syringe filling and inspection equipment. We then transitioned to onsite commissioning protocol/test case development and execution, IQ/OQ development and execution for all equipment, HVAC and supporting clean and indirect utility systems.

CAI provided project information management services managing project equipment data, documentation and drawings. CAI also was responsible for maintenance package development and entering the new systems into the computerized maintenance management system.

Project Success:

The Commissioning Agents team drove issues to prompt closure as the client target product needs for the facility changed over the life of the project. We will drive this same level of communication throughout your project.

 

Time Frame

3 Years

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