Process Validation

A customer in the medical device industry required process validation for an extremely complex device that had to be manufactured using an intricate mold design. The part was created with overall dimensions of 1.1″ x 0.3″ and featured tolerances as tight as + .0025″.

Problem
We had to employ extremely precise process capability statistics in order to satisfy our customer’s requirements. As industry experts in validation services for the medical industry, our team was challenged to analyze the customer’s production specifications.

Solution
For the manufacturing run, we employed our state-of-the-art injection molding system, robot-assisted part removal process, and latest Mini-tab statistical software package. Using our 130-ton injection molding press, we manufactured the part using polycarbonate plastic. All of our work conformed to ISO 13485 and was conducted entirely in our Class 8 clean room. The finalized part featured a high polish material finish. Employing stringent quality control procedures, we utilized our in-process testing capabilities to conduct high volume measurement inspections, defect analysis, and physical testing. We performed a series of IQ/OQ/PQ verification and validation checks to ensure that the part met all requirements for quality control. We also developed an intensive statistical analysis algorithm and as a result, achieved Ppk standards that were greater than 1.67 for the overall variation of measurements taken.

Results
This work not only required many in-house production and validation capabilities, but also extensive coordination between our process engineer, statistician, and technical writer. Our customer was pleased with every aspect of our work, our communication, and our ability to analyze the data. We went above and beyond their needs and continue to work with them on additional projects. To learn more about our process validation capabilities, please contact us.