Pharmaceutical Manufacturing Facility – Control System Replacement

The Challenge

A large mid-western pharmaceutical company planned to replace their entire batch control system for one of its manufacturing areas.  This control system included 8 Programmable Logic Controllers and a supervisory batch management system.  Because of ongoing production demands for the facility, the new control system needed to be installed and qualified with very minimal (near-zero) impact on production schedules.

The Solution

Performance Validation provided a dedicated team with a Project Leader experienced with managing qualification projects and interfacing effectively with diverse project teams.  Te ensure success the project execution plan required the following practices to be put into place.

  • Performance Validation 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 Project Leader interfaced effectively with the multi-faceted team including client automation, engineering, operations and maintenance personnel, as well as other contracting firms responsible for installation and integration of the new control system.  Coordination between all of these groups was vital to ensuring the most efficient use of the small amounts of available line time on the production system required for installation, calibration and testing.
  • Performance Validation worked with the client and project team to develop a plan to maximize the amount of commissioning and qualification that could be conducted in an offline test environment (demonstrated to be equivalent to the online environment), while minimizing the amount of testing that needed to be conducted in the production environment.
  • With the new control system initially installed in parallel with the old control system, a crossover procedure was developed and qualified to enable switching back and forth between the control systems during commissioning and qualification.  This allowed testing of the new controls system to be conducted on off-shifts, and then the old control system could be switched back to for operations.

The Results

  • The control system was successfully replaced and qualified with very minimal interruptions to the production schedule.  This was achieved through very careful planning, excellent teamwork and communication between the project team and operations, and the flexibility and dedication of team members willing to work long hours, nights, weekends and holidays in order to meet the needs of the customer.
  • The new control system was demonstrated, through well-planned engineering studies and qualification, to perform equivalently to the former control system.  This resulted in significant savings in cost and schedule by eliminating the need to perform product validation studies for existing products made with the new control system.

The Benefits

The completed project accomplished the following for the manufacturing facility

  • Provided a contemporary controls platform to support operation.
  • Improved reliability and maintainability of the control system and eased support burdens, thereby reducing cost.
  • Eliminated obsolete control system equipment and software that was no longer supported by suppliers.

For additional information, contact:

John Underwood, Division Manager, Michigan
Performance Validation, LLC.
5168 Sprinkle Road
Portage, MI 49002
(269) 373-9112 x2752
(269) 217-0353 Mobile