The Challenge

Based on inefficiencies in operation and maintenance costs, a large Midwestern Animal Health manufacturing company decided to move its Quality Control, Technical Services, and Cell Culture laboratory (QC Lab) operations from the existing facility — an administrative building retrofitted to be used as a QC Lab many years ago — to a new state of the art QC Lab facility.

As the facility would remain in operation throughout construction, a fully functional QC lab was necessary during the construction and transition from the existing QC Lab to the new QC Lab.

The Solution

The project scope included a new stand-alone building with HVAC, water, and gas utilities, as well as transfer and replacement of lab equipment including fume hoods, autoclaves, biosafety cabinets, incubators, refrigerators, freezers, and glass washers.

The general contractor, MEP contractor, and the end users for the project were not experienced with the company’s capital project delivery process, specifically the associated quality and documentation requirements. Performance Validation (PV), being very familiar with the governing specifications and expectations of Facility Delivery Team, was able to provide the necessary oversight to ensure project success.

PV was responsible for development and execution of commissioning and qualification documentation for the entire project, including building and utility systems and lab equipment.  PV was integral to the project from the initial design phase, working with users in development of requirements, qualifying the design with the design firm, receiving materials through the general contractor, providing oversight of construction documentation and system startup, and verifying installation and operational requirements of the completed systems and equipment.

A phased relocation strategy was used to allow each lab group to perform a coordinate move thus minimizing impact to site operations and manufacturing.

The Results

The customer was very pleased with C&Q protocol development, execution, and management by PV.

The lab systems and equipment were commissioned/qualified and turned over on schedule with no negative impact to manufacturing operations.

The Benefits

The project accomplished the following for the animal health manufacturing facility:

  • Moved entire site QC lab operations (cell culture, technical services, and QC) to a new building that was actually designed to be a lab and with utility, space, and layout considerations for all of the different users’ requirements.
  • Provided QC lab space that consistently meets required temperature, humidity, and pressure requirements for the different lab operations.
  • Replaced old/aging biosafety cabinets, fume hoods, autoclaves, and incubators with new and improved equipment.

Have a question about Performance Validation? Please schedule a call with one of our subject matter experts.

Brad Henry
Vice President, Indiana Division Director
Performance Validation

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