When a manufacturing firm produces a product designated for use in the medical field, the company must supply one element regardless of part design: assurance. Through the use of in-line product testing and final package testing, a manufacturer can document the steps taken to assure the end user that the product has been examined and has passed the standard testing procedures designated by organizations such as the Food and Drug
Administration (FDA), International Standards Organization (ISO), and American Society for Testing and Materials (ASTM). A quality control department, therefore, must be aware of different testing methodologies in order to gain this control and assurance over the production and packaging processes.

This report examines different product and package testing procedures, focusing on the pressure decay leak and mass flow tests for product integrity and seal strength, and pressure decay leak testing for package integrity.

By implementing pressure decay leak testing, mass flow testing, and seal strength testing to a quality control system, a manufacturer of medical devices will gain control over their manufacturing process, and therefore gain quality assurance in the field.

Read our report on testing medical device and package integrity