Sterile barrier systems comprised of a rigid thermoformed tray and die cut lid are very common in medical packaging, especially when packaging heavier devices, implants, and surgical kits (among many others). To ensure this type of system provides optimal performance (maintains the sterile barrier to the point of use and properly allows for aseptic presentation) while meeting project budget and timeline, there are several best practices that can and should be implemented as it relates to die cut lid design. Below are die cut lid design considerations that will be critical to the success of the sterile barrier system:
Be prepared to provide a tray drawing:
A thermoformed tray with finalized dimensions and material is an essential input to choose the correct die cut lid size and compatible adhesive coating.
Design your tray with a raised flange:
Be intentional when specifying your peel open features:
to prevent lid tearing, it is best practice to avoid sharp angles or placing a peel tab along the edge of a seal flange, as shown below. The location and design of the peel tab should promote the distribution of peel forces more evenly:
Know details of the sterilization modality:
Ensure proper identification of both sides of the lid:
Communicate your production expectations with your supplier:
Work in tandem with your suppliers:
That last tip is particularly important… while this article is from the perspective of a die cut lid supplier, there are many other considerations that impact the success of the thermoformed tray and lid sterile barrier system including the design requirements for the tray itself, equipment, tooling, etc. Thinking about these various components as a holistic system and communicating with suppliers and stakeholders in parallel as early as possible will ultimately result in a more streamlined development process with minimal surprises and straightforward troubleshooting.
