A large mid-western pharmaceutical company planned to add feedback to the primary pins on its suite of eight freeze dryers already in use. Significant constraints existed on the schedule because a facility shutdown was required to integrate feedback of the primary pins into the programming and multiple other projects were being implemented in parallel on the equipment. In addition it was determined that several of the upgrades needed to be removed after the initial installation and testing so that Operations was not negatively impacted by the feedback reliability after the scheduled installation and testing window had passed.
Performance Validation provided a dedicated team and Project Leader with experience managing qualification projects and interfacing effectively with multiple project sub-teams. The following activities and mitigations were implemented to maximize project success:
Performance Validation coordinated with multiple stakeholders during the planning execution and closeout phases of the project. The freeze dryer primary pin feedback qualification was successfully completed within the allotted schedule and budget. The successful qualification was achieved through detailed planning, dedicated team members and flexibility to meet the customer needs.
The completed project reduced the risk of not knowing if the primary pins were engaged before starting cycles thus reducing the risk that the facility and product could be compromised from an improperly closed main chamber door.
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Michigan Division Director
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