A Contract Manufacturing Organization (CMO) required a process improvement to increase the production capacity for prefilled syringe assembly and labeling operations. This parenteral assembly, labeling, and packaging process was currently being performed manually, but due to forecasted volume increases, an automated process was needed.
Performance Validation provided technical resources with direct experience with automated parenteral packaging processes who provided direct input during the equipment purchase, design, installation, and qualification phases.
Performance Validation provided a complete documentation package for the entire Design, Installation, Testing, and Maintain lifecycle phases of the equipment and manufacturing process. The automated process has completed system acceptance by the client and has been satisfactorily audited by the CMO’s customers. The documentation package met the customers quality requirements and expectations. The project met the CMO’s ultimate goal of increasing manufacturing volume to meet future anticipated production needs.
For more information about this project or how Performance Validation may assist you with the validation of automation process improvements please contact:
Vice President and Indiana Division Director
Performance Validation, LLC
5420 W Southern Ave
(317) 727-8495 Mobile