Pharmaceutical Manufacturing Facility Remodel (Stability Suite)

The Challenge

A large mid-western pharmaceutical company planned to remodel an existing facility into a Stability Suite containing seven temperature/humidity controlled walk in chambers, and three reach-in stability chambers.  The facility remodel was under a compressed timeline based on completing the demolition, construction remodel, commissioning, qualification and validation of the remodeled facility in a 3 month period.

The main constraint was equipment availability.  As with any project, there were a lot of people in the area working on a variety of things.  PV’s was flexible enough that as soon as a chamber became available it was being temperature mapped allowing for the project to stay on schedule.

The Solution

Performance Validation provided a dedicated team with a Project Leader experienced with managing temperature mapping projects and interfacing effectively with diverse project teams.

Project Management-

  • The PV Project Leader was actively involved in weekly project status meetings, proactively monitored the schedule and provided direction to the team on courses of action to take when issues arose.
  • The PV team interfaced effectively with the multi-faceted stakeholders including client automation, engineering, operations and maintenance personnel, as well as other contracting firms responsible for the remodel.  Effective coordination between all entities was vital to ensuring the most efficient use of time to troubleshoot and resolve issues to minimize potential project delays.
  • PV Project Management included tracking each document in regards to budget, schedule and quality.  Performance Validation’s engineers worked closely with both the client and the equipment vendors to troubleshoot and resolve all issues.

Deliverables Approach-

  • The PV Project Leader assisted the site project team in aligning documents to meet corporate expectations with minimal impact to cost and schedule.
  • The PV team managed over 60 data loggers used in 128 locations throughout the 10 chambers.
  • The PV team also qualified the Environmental Monitoring System by creating the testing documents and executing and troubleshooting them.

Problem Resolution timeline.

  • The PV team took a proactive role in identifying automation issues which impacted qualification and the desired operation of the production equipment, allowing for less costly fixes and lowered impact to the schedule.
  • When a temperature mapping deviation was discovered, the PV team worked with the client to resolve the issue, develop the non-conformance, and execute the non-conformance. .

The Results

The remodel of the facility was successfully completed on time and on budget.  This was achieved through very careful planning, excellent teamwork and communication between the PV team and our customers, and the flexibility and dedication of team members willing to work long hours, nights and weekends, in order to meet the needs of the customer.

The Benefits

The remodel of an underused space at the client facility has provided additional stability capacity at a fraction of the cost of a comparable new constructed facility.

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