There are two standard formats for medical packaging, pouches and thermoformed trays. Thermoformed trays offer product protection and orientation, workflow organization (if a procedural kit), and ease and grace of opening. Pouches provide a sterile barrier, but do not provide the same structural protection to medical products, nor do they offer a controlled opening experience, when compared with thermoformed trays.
If you are investigating thermoformed tray packaging for your medical product or device, below are things that you should know.
Pricing & material type, material thickness:
Dordan can provide budgetary pricing based on the anticipated layout of the medical device in the tray. All we need to quote is an estimated tray size, material, thickness, and quantity. Medical grade PETG, blue tint or clear, is the standard for medical tray packaging. It is ETO/gamma compatible; die cuts clean (reduces potency of "tags" left on thermoformed trays after being stripped from the plastic web after forming); forms well as it has more "give" then PET; and, is optimum for being heat sealed to Tyvek or other lidding substrates. The recommended minimum material thickness for medical tray packaging is 0.030" to allow for a strong seal to lidstock. Anything thinner poses challenges to the heat sealer, as slight variability in the seal flange thickness, inherent in the thermoforming process, impacts the consistency of seal. At .030" thick, the worst case scenario for seal flange thickness is typically sufficient for a good seal. If the medical product is heavy, large, or deep, thicker material may be appropriate. Most procedural/surgical kits are .040" medical PETG, because the thermoformed kit is incorporated into the procedural workflow, and therefore requires a more robust composition.
Dordan can quote the minimum order quantity, which is based on the size of the tray/how much material is consumed per tray. Typical MOQs range from 1-5K trays. Dordan offers production in our standard facility and our ISO Class 8 cleanroom. The cost of standard facility production tooling is less than our cleanroom tooling, because our cleanroom thermoformer requires more components, like automatic stackers and strippers.
Dordan's cleanroom for manufacturing medical packaging
Timeline for development:
Timeline for medical tray design and production can take anywhere from 8-14 weeks, depending on the complexity of the part and the engineering backlog. It typically takes 3-4 weeks to develop the prototype; then, another 5-6 weeks to produce the tooling. We offer various tiers of part/process validation of the production parts, based on our customer requirements. We'll conduct a risk-based assessment and determine the critical dimensions in a pre-production meeting with engineering, production, and quality management. After we produce our first articles, we’ll provide a final part drawing that will reflect the part size with real-time production tolerances. You can then use this drawing for incoming material inspections.
Dordan QC Manager and technician
Prototype and production tooling:
Included in the cost of tooling is prototyping. Prototypes are hand-formed on an aluminum prototype tool, typically out of PVC. PVC is the best representation of how PETG will form in production, and is easier to form on our sample press. If it is required that the prototypes be formed in the production material, then we can accommodate. Once the prototype is approved, the tool paths for the prototype tool are replicated across the production tool, which consists of multiple cavities. The rest of the production tooling is cut, built, and assembled (assist plugs, stainless steel die, etc.).
Dordan CNC-machined aluminum prototype tool
Heat sealing to Tyvek or other lidding:
Sealing Tyvek or other lidding to PETG thermoformed trays is a standard sterile barrier for medical packaging. The seal flange, which is slightly inboard from the outside die cut, extends up from the tray cavity, providing a raised perimeter that the lidding adheres to. It is typical to have a peel tab, or several, around the perimeter of the tray. It is important to understand the preference of the end user when determining how the lidding should be designed to be removed from the tray.
Once the thermoformed trays have been produced, it is recommended that they be supplied to the heat sealer for the development of the heat seal tooling. Typically, the company that is selling the sealing equipment should develop the heat seal tooling. Heat seal tooling typically has a silicone or other substrate gasket that mates with the underside of the tray raised seal flange when the tray is placed into the tooling. The lidding is then placed within the locators (pins or other) on the tooling and the machine indexes/shuttles forward, compressing and heating the tray seal flange with the lidding, activating the adhesive.
Dordan siblings and company principals, Aric and Chandler Slavin
Dordan Manufacturing is a third-generation, family-owned and operated custom thermoform designer and manufacturer, based in Woodstock, IL. Please consider contacting Dordan at firstname.lastname@example.org or (815) 334-0087 for assistance with your medical packaging project.