The Challenge

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.

The Solution

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:

Planning

• A detailed qualification schedule was developed for 24 / 7 validation support to ensure that all projects could be implemented within the allotted qualification window.
• A dedicated project team was identified to provide consistent support throughout the implementation window.

Execution

• An additional staff member was brought in to support existing site staff members preventing a potential lack of resources and allowing other projects that were occurring in parallel to the shutdown to proceed without delay.
• The PV Project Leader provided continual support throughout the qualification activities to direct PV staff members and supporting personnel from other vendors.
• The PV Project Leader provided an updated schedule based on daily progress to key project participants so that everyone involved was aware of the expected activities.
• The PV project team provided a scheduling solution and flexible support when it was identified that additional changes were required after the initial implementation and testing were completed.

Summary

• Performance Validation developed all of the required risk assessments, qualification protocols and summary reports.
• Performance Validation provided staff members that were experience and effective when communicating between departments.
• Performance Validation provided the required staff to ensure that the primary pin feedback project in addition to the parallel projects that were being implemented on the equipment stayed on schedule and allowed the shutdown to complete successfully.

The Results

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 Benefits

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.

For more information please contact:

John Underwood
Michigan Division Director
5168 Sprinkle Road
Portage, MI 49002
Office – (269) 393-9112 X 2752
Cell – (269) 217-0353