Best Practices for Designing a Die Cut Lid With Your Supplier

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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: 

1

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. 

2

Design your tray with a raised flange:

Whenever possible, designing your tray with a raised flange is highly recommended because the raised flange is a formed feature that provides more consistency in material thickness than a flat flange. The characteristics of a raised flange can also help protect the seal from outside forces. Regardless of tray flange style, the lid should be designed with an overhang to prevent the potential of sealing the edge of the lid to the tray A raised flange can help build overhang into the design more cleanly and effortlessly.
3

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:   

       A diagram of a tab

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4

Know details of the sterilization modality:

Along with tray design, sterilization has a major impact on material and adhesive coating decisions. Will the die cut lid need to be breathable? Is the adhesive coating or sealant layer compatible with the modality? Sharing this information with your lid supplier upstream can help mitigate risks that may arise later in the validation process. 
5

Ensure proper identification of both sides of the lid:

It is essential that it is clear to the production staff which side of the die cut lid contains the adhesive coatingIf a poka- yoke isn’t already built into the tray design or sealing equipment, applying print to the top side of the die cut lid or using a blue-tinted adhesive coating can help aid in visual identification to prevent issues during the sealing process
6

Communicate your production expectations with your supplier:

Share your specifications for first article inspection or ongoing quality assurance requirements, as well as clean room needs, early in the design process. This may impact which production lines or sites your supplier will need to use to manufacture a die cut lid that meets your specifications. 
7

Work in tandem with your suppliers:

Your tray supplier, die cut lid supplier, and tray sealer supplier should all be engaged early in the development process, alongside one another. A design decision made with one of these suppliers might impact the other two. Maintaining open communication across these partners can help you optimize your finished design and process, mitigating risks to timing and cost. 

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.

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