Adhesive bonding processes are often used within the medical device industry for manufacturing various medical devices and instrumentation. The process includes the device, an adhesive, and any ancillary equipment required to support the process (fixtures, heat sources, timers, etc.). The bond strength is often crucial to assuring proper functionality and patient safety. This study will serve as an example of using DOE in process validation.

This study is not intended to be a model for all adhesive bonding processes, as each application will vary by requirements and additional sources of variation. However, it should serve as an example to guide similar efforts through the process validation procedure.