Cleanroom die-cut components · Cut in Prince Edward Island, Canada
Sterile Barrier Packaging. Custom solutions.
Tyvek® lids, sheets, and HDPE cards die-cut in our ISO Class 8 cleanroom in Prince Edward Island, plus the rollstock, pouches, and bags to complete your sterile barrier system. Quick-turn prototypes. No minimum order on the parts we cut.
Sterile Barrier Packaging. Custom solutions.
- Years in plastics
- 30+
- Certified quality system
- ISO 9001
- ISO cleanroom
- Class 8
- On parts we cut
- No MOQ
- Lids · cards · rollstock · pouches
- One PO
Products
Everything but the device. From one supplier.
Five product families. We cut the lids, cards, film parts and sheets in our own cleanroom, and supply the rollstock, pouches and bags from qualified manufacturers.
Pouches and bags
4 products- Tyvek® chevron pouches
- Paper chevron pouches
- Foil chevron pouches
Supplied by CleanCut
Why CleanCut
Built for the way device and packaging teams actually work.
Fast turns.
Prototype parts in weeks, not months, once the drawing is approved and the die is made, then production in 2–3 weeks. Every new outline needs a cutting die, not a new mold, so parts change quickly when your design does.Small runs welcome.
No minimum order quantities on the parts we cut. Order what the build or validation run needs, not what a big converter's press schedule needs, and put several part numbers on one order with no per-line minimum.One supplier, one PO.
Die-cut lids and cards from our cleanroom, plus the rollstock, pouches and bags that go with them, on one PO with one point of contact: Michael Wollberg, Head of Sales, at sales@cleancuthealthcare.com.Talk to the makers.
A family-run team that answers the phone. The people who quote your part are the people who cut it.
Cleanroom made: our die-cut components are converted in an ISO Class 8 cleanroom to keep particulate low from the start.
Sterile barrier systems
See how the parts fit together.
Tray and lid with a mounting card. Chevron pouch with an insert card. Header bag for bulky kits. Select a part to see what it does and whether we cut it or supply it.
- 01Coated Tyvek® lidPeels cleanly from the tray.
- 02Your deviceWhat the whole system protects.
- 03HDPE mounting cardHolds and protects the device.
- 04Rigid trayYour thermoformed tray; our lid seals to it.
- 05Insert cardKeeps the device in place.
- 06Chevron pouchControlled peel for aseptic presentation.
- 07Header bagPorous header for sterilant exchange.
How it works
From drawing to delivered parts.
- 01
Send your drawing or CAD
A PDF, DXF, DWG, STEP or IGES file, your customer's drawing with its revision, or a sketch or sample part if you have no drawing yet. Add the material if you know it, and your tray or pouch.
- 02
Engineering review and quote
We check the geometry, material and critical tolerances, tell you about anything that will cut, tear or seal badly and what we'd change, and aim to quote within two business days of having what we need, for the parts we cut.
- 03
Prototype samples
Quick-turn samples cut from the production material.
- 04
Validate or verify
Seal, sterilize and test the parts on your own line and cycle. If the package is already validated, check the first parts against the approved spec with the first-article inspection report we send for every new part or revision.
- 05
Production and ship
Small runs or full volumes, shipped to Canada, the US and the EU.
Cleanroom and quality
Converted in an ISO Class 8 cleanroom, under ISO 9001.
Particles inside a sterile barrier system are a risk you can reduce at the source. We die-cut lids, cards, film parts and sheets in an ISO Class 8 cleanroom, classified to ISO 14644-1, under a certified ISO 9001 quality management system, so parts reach your line with less particulate to begin with.
ISO 9001ISO Class 8 cleanroom
How we control qualitySterilization
Sterilization compatibility at a glance.
A preview of the full chart: every product against EtO, gamma, e-beam and steam, with notes where the answer depends on grade or package design.
| Product | EtO | Gamma | E-beam | Steam |
|---|---|---|---|---|
| Die-cut lids | ||||
| Coated Tyvek® lids | Compatible | Compatible | Compatible | Not yet confirmed: ask us1 |
| Die-cut components and cards | ||||
| HDPE cards | Compatible2 | Compatible | Compatible | Not recommended3 |
| HDPE/LDPE film components | Compatible2 | Compatible | Compatible | Not recommended |
| Rollstock | ||||
| Coated Tyvek® rollstock | Compatible | Compatible | Compatible | Not yet confirmed: ask us1 |
| Medical paper | Compatible | Depends on grade or configuration4 | Not yet confirmed: ask us | Depends on grade or configuration5 |
| Pouches and bags | ||||
| Foil chevron pouches | Not recommended6 | Compatible | Compatible | Not recommended7 |
Legend
- Compatible
- Depends on grade or configuration
- Not recommended
- Not yet confirmed: ask us
- 1Restricted, lower-temperature cycles only (up to 127 °C).
- 2Inside a package with a porous side.
- 3HDPE softens at steam temperatures; generally not suited.
- 4Grades optimized for gamma are available.
- 5Steam grades are available.
- 6Only with a built-in porous vent, sealed off after sterilization. Ask us for a vented foil header bag.
- 7PE sealant layer; generally not suited to steam.
Compatibility depends on grade, coating, and your process. Validate in your own sterilization cycle.
Insights
Notes for device and packaging teams.
6 min read · Sep 27, 2026
Coated vs. uncoated Tyvek®: choosing the right lidding for rigid trays
What the heat-seal coating does, when uncoated Tyvek® is the right call, and how to pick 1073B or 2FS for your tray.
5 min read · Sep 27, 2026
What ISO Class 8 cleanroom manufacturing means for your packaging components
What ISO 14644-1 Class 8 limits, what it does not mean, and why it matters for die-cut components in a sterile barrier system.
5 min read · Sep 27, 2026
Prototype to production: how small-batch die-cutting shortens packaging development
Use quick-turn samples and small runs to test fit, seal and presentation early, then reach validation with fewer late design changes.
Start a project
Have a drawing, a spec or a sample part? Send it over.
Yours or your customer's, or a sketch if there's no drawing yet. We'll reply within one business day with questions, then a quote and a sample plan.