Process and Design Control Improvements to Prevent Tray Seal Defects in Medical Device Packaging

Abstract

Tray seal variability in sterile medical device packaging can affect package consistency and reduce the effectiveness of inspection controls. This project evaluated abnormal seal width and Tyvek marking observed in thermoformed trays at a medical device manufacturing facility. A DMAIC-based approach was used, including record review, process mapping, dimensional assessment, and cause-and-effect analysis. The investigation identified three main contributors: supplier-generated flange variation during tray trimming, equipment setup associated with abnormal Tyvek marks, and unclear inspection criteria for seal width and mark interpretation. Supplier investigation found flange widths as low as 0.25 in., below the minimum acceptable width of 0.28 in. Corrective actions included revision of design and inspection requirements, supplier die-cutting improvements, and implementation of a Go/No-Go inspection. These actions strengthen packaging controls and support reliability.