The Challenge

An Animal Health Facility in Georgia desired to increase the production capacity of an API in order to meet anticipated customer demand. This product is an innovator in helping to meet the future demand for affordable food. Rather than simply adding duplicate capacity, the facility desired to achieve the capacity increase through process optimization, a sustainability option.

The Solution

The Animal Health Facility reviewed the manufacturing process and identified several process bottlenecks that prevented maximum throughput. The process optimizations included modification of existing systems, or in some cases replacement of existing systems, to allow for the maximum utilization of processing equipment with a subsequent increase in yield.

Performance Validation was retained as a commissioning, qualification, and validation contractor to implement the planning, development, and execution of the desired modifications. The Performance Validation team was responsible for:

Validation Project Management

  • PV Project Management included tracking each document with regard to budget, schedule, and status.

Validation Project Planning

  • Performance Validation worked with the client and project team to define the project scope, establish user requirements, and determine engineering documentation requirements.
  • The PV team developed a validation strategy that supported the site project team’s scheduling efforts by developing validation documentation that aligned with construction efforts and that provided an interim report option to minimize impact to production.
  • The PV lead was actively involved in project status meetings, monitoring the schedule, and providing direction to the team on courses of action to take when issues arose.


  • The PV team showed great flexibility by aligning to a 24 hours a day, 7 days a week schedule to match construction efforts. This aided in expediting the execution and closeout schedule for systems. PV also procured additional staffing needed to support the 24 hour a day schedule to ensure sufficient staffing needs.
  • The PV team took an innovative approach to expedite turnover of systems from construction. System walk-downs and documentation reviews were initiated prior to system completion allowing issues to be identified early on in the process, which in-turn allowed for a smoother and more efficient turnover of systems.
  • The PV team members worked closely with both the client and the equipment vendors to troubleshoot and resolve all issues. Equipment and automation issues impacting qualification were identified and a strategy was provided to complete qualification with open punch list items that Engineering and Quality Assurance were able to agree upon to enable the equipment to be available for the facility to perform product testing.
  • The PV team developed communication tools to keep the project team aware of system status across the shifts and to communicate outstanding issues to help align support resources.
  • The PV team worked effectively with many departments throughout the project, including Design, Automation, Operations, Maintenance, Engineering, and Project Management. Communication and coordination with these various departments by members of the PV team was key to efficiently solving problems and reaching project goals.

The Results

The process equipment upgrades and modifications made to the facility were successfully completed, exceeding the client’s expectations.

To support the capacity expansion project the PV team generated, executed, and delivered more than 200 separate documents across more than 20 systems.  These documents included but were not limited to User Requirements, Design Qualification, Installation Verification, System Startup, Functional Testing, and Operational Qualification.

The client was particularly pleased that the team members were available around the clock in order to complete commissioning and qualification and get production back up and running as quickly as possible. Keys to the success of this project included good planning, great teamwork, and exceptional communication between the PV team and the client.

The Benefits

On successful completion of the capacity expansion project, the manufacturing process was streamlined and optimized which achieved the desired goal of providing a sustainability solution to achieve capacity expansion without duplicate capacity.

For additional information please schedule a call with one of our subject matter experts. 

John Underwood
Vice President, Michigan Division Director

Performance Validation

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