Medical Device Tray Materials: APET, RPET and PVC/APET Laminates Compared

Why tray material is a validation decision

A device tray has to hold the device through handling, transport and sterilisation without losing its geometry. In most programmes the tray sits inside a sterile barrier system, so the thermoformed material influences seal integrity, peel behaviour and the evidence package assembled for regulatory submission. Changing resin after validation usually means new forming trials, new seal parameters and sometimes repeat stability work — which is why the material is worth fixing early.

The three options we produce

[APET rigid film](/products/apet-rigid-film) is amorphous PET. It offers high clarity, good stiffness at moderate gauge and a wide thermoforming window, and it is available in medical grades with batch documentation. It is the default starting point for shallow trays, device kits and presentation packs where the product should be visible.

[RPET rigid film](/products/rpet-rigid-film) is PET containing post-consumer recycled content. Clarity is slightly lower than virgin APET at the same gauge, and the recycled content has to be declared and supported by certificates rather than assumed. It fits programmes with an explicit recycled-content target where the tray is not the primary clarity element.

[PVC/APET laminated rigid sheet](/products/pvc-apet-laminated-sheet) pairs PET surface appearance with PVC forming behaviour. It is used where deep pockets, existing PVC tooling or an already qualified PVC process make a switch to mono-PET unattractive.

How the three compare

Checks worth running before tooling

1. Forming trial at production gauge. Confirm draw depth, corner thinning and dimensional stability on the actual film gauge, not on a sample sheet. 2. Sterilisation compatibility. Ask for dose-specific data for gamma and e-beam, and confirm colour and mechanical behaviour after sterilisation for your dose range. 3. Seal and peel with the chosen lid. Tray material and lidding are a system. Seal strength and peel cleanliness should be validated together. 4. Extractables and leachables. Scope depends on contact duration and device type, but the material supplier should be able to supply the underlying statements. 5. Recycled content evidence. For RPET, request certificates and chain-of-custody documentation, and confirm the grade is consistent batch to batch. 6. Traceability. Lot, gauge, width and core should be recorded on the label and the certificate of analysis.

Documentation buyers usually request

• Material datasheet with gauge and tolerance range
• Compliance statements covering USP <661> and EP 3.1/3.2 where applicable
• Sterilisation compatibility statement
• Batch certificate of analysis
• Heavy-metal and restricted-substance declarations
• For RPET, recycled-content certificates

Comparing on one platform

APET, RPET and PVC/APET laminated sheet are produced on the same ISO 15378 certified platform, so the comparison is about the device and the process rather than about which plant supplies the material. Send the tray drawing, device weight, sterilisation method and target market through our contact form, and our engineers will return a material recommendation with the documentation package your qualification file needs. Background on how trays are specified by market is in industries we serve.