Clinical Trials Manufacturing – Conversion of a Manual to Automated Process

The Challenge

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.

The Solution

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 expertise during the commissioning and qualification activities to ensure all necessary documentation was created and all required testing was captured. When faced with the task of qualifying automated vision system measurements and automated inspection processes, Performance Validation was able to implement new, robust test procedures and test reports which captured the accuracy and precision of the vision systems in easy-to-read reports.
  • Performance Validation resources were able to draft the Standard Operating Procedures and Quality Inspection In-Process Testing Procedures to meet the CMO’s needs for process control and product release.
  • Lastly, Performance Validation provided resources to oversee and complete the Performance Qualification phase, which encompassed equipment testing, operator training, new electronic batch record creation, new quality inspection processes, and new procedure approval.

The Benefits

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:

Brad Henry
Vice President and Indiana Division Director
Performance Validation

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