In medical and pharmaceutical projects, cleanroom thermoformed trays is only acceptable when the paperwork is right. This article maps the standards, test methods and documents you should ask for.
The notes below come from day to day production and export work with overseas buyers.
This category covers a family of products rather than a single item. In practice a buyer defines cleanroom thermoformed trays by three things: the base resin, the format or dimension, and the performance or certification level it has to meet. Typical options in this category include gauge 0.40 to 1.50 mm; laser marked identification; low particle and low outgassing grades. Materials most often specified are Polypropylene, Polyethylene Terephthalate, Polyethylene Terephthalate Glycol, Polystyrene, and the choice between them changes stiffness, temperature resistance, chemical behaviour and price.
In the medical and pharmaceutical sector the decision is usually driven by validated sealing and sterilisation compatibility, with traceability as a secondary requirement. Typical end uses include IV and catheter kits, device trays, surgical kit trays.
The table below summarises the values that usually decide the material choice.
| Material | Density | Tensile strength | Service temperature |
|---|---|---|---|
| Polyethylene Terephthalate | 1.35-1.40 g/cm³ | 50-70 MPa | -40°C to 70°C |
| Polypropylene | 0.90-0.91 g/cm³ | 25-40 MPa | -10°C to 100°C |
| Polystyrene | 1.04-1.06 g/cm³ | 30-50 MPa | -20°C to 70°C |
Polyethylene Terephthalate Glycol is frequently the default selection here: PETG forms at lower temperatures and holds detail well, which is why it dominates medical trays.
Paperwork matters as much as the part itself in regulated markets.
Ask the supplier to state the standard number, the test method and the result on the certificate. A test report without a standard reference is difficult to defend during an audit.
Beyond the base resin, most suppliers offer UV stabilised, food contact, flame retardant, anti-static and recycled content versions of the same product. Ask which additive package is included, because it is often the difference between a part that lasts three years and one that lasts ten.
The route below is the one most factories use for this type of part.
Secondary operations such as printing, welding, machining and assembly are often cheaper to do in the same factory, and they reduce the risk of mismatch between components.
Work through these points in order and most specification mistakes disappear.
Send this list to your supplier with the drawing and you will receive comparable quotations from every factory you contact.
A new tool typically takes 25 to 45 days depending on cavity count and complexity, followed by T1 samples within one week. Existing tools can usually start production within 10 to 15 days of order confirmation.
Standard packing is export cartons on fumigation-free pallets, with custom labelling, barcode and retail packing available. We also handle consolidated containers and door to door delivery.
Yes. {mat1} is one of our regular materials for this item, and we can supply virgin, modified and certified grades with full traceability. Material certificates and test reports are issued per batch.
We can provide ISO 9001 quality system documentation, material certificates, RoHS and REACH statements, and where applicable food contact, flame retardancy or drinking water approvals. Tell us your target market and we will match the document set.
Colour is controlled with a masterbatch reference approved by the customer, and every production lot is checked against the approved sample under standard lighting before shipment.
Our team supplies cleanroom thermoformed trays to medical and pharmaceutical customers worldwide, with samples, material certificates and full inspection reports available before mass production.
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