Pharmaceutical Facility Remodel – Commissioning & Qualification

A large mid-western pharmaceutical company planned to remodel an existing facility to accommodate the production of a finished pharmaceutical product.  Constraints existed on both schedule and budget, as the new equipment and manufacturing suites were needed for new product lines.

The Solution

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

Performance Validation worked with the client and project team to assist in defining the scope, determining user requirements, and determining engineering documentation (commissioning) requirements.

  • The PV Project Leader assisted the site project team in aligning documents to meet client expectations with minimal impact to cost and schedule.
  • 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.
  • Project Leader developed an Excel spreadsheet to facilitate communications to the project stakeholders that communicated overall health of the project and state of documents to keep the project team aware of Commissioning, Qualification and CSV needs throughout the project.
  • 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.
  • The PV team created, executed (including Temperature Mapping), managed, and delivered more than 200 discrete documents across multiple systems which was necessary to turn over the facility in the production-ready state.
  • The PV team took a proactive role in identifying automation issues and other equipment issues which impacted qualification and the desired operation of the production equipment.  PV team was able to provide a plan to complete the qualification with open action items that everyone including Quality Assurance was able to agree upon to enable the equipment to be available for new product /clinical testing.
  • The PV team interfaced effectively with the multi-faceted stakeholders including client project management, automation, engineering, operations and maintenance personnel, equipment vendors, 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.

The Results

The remodel of the facility was successfully completed on time, budget and exceeded the customer’s quality expectations.  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 completed project accomplished the following for the manufacturing facility:

  • Provided a single product containment facility with current industry-standard qualification documents for the modified utilities and all new product process train equipment:
    • Utilities consisted of Purified Water, Wastewater, Compressed Air, House Vacuum, and three (3) Air Handler units.
    • Modified Facility consisted of new Tumble Bin washing / drying and storage rooms as well as new Tumble Blending manufacturing suite.
    • The new non-computerized equipment consisted of a Bin Containment System, 9 new Tumble Bins, and a Floor Scale.
    • The new computerized equipment consisted of a new Tumble Bin Blender with Intensification Bar and a new Tumble Bin NIR.

For more information contact:

Brad Henry
Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave
Suite 100
Indianapolis, Indiana
(317) 248-8848
(317) 727-8495 Mobile