Sterile barrier systems
One supplier for everything but the device.
A sterile barrier system is the minimum package that minimizes the risk of microorganisms getting in and lets the device be presented aseptically at the point of use (ISO 11607-1). Your tray comes from your thermoformer; we supply the lid that seals to it and the cards and film parts that go inside it, or the pouch or bag that replaces it. It is rarely one part. We cut the lids, cards and film components in our ISO Class 8 cleanroom and supply the rollstock, pouches and bags that go with them.
Anatomy
How the parts fit together
Select a part to see what it does, whether we cut it or supply it, and where to find 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.
Common builds
Four ways the pieces combine
Rigid tray + coated lid + mounting card
Your thermoformed tray (PETG, PVC, HDPE, HIPS or PP) holds the device. A heat-seal coated Tyvek® 1073B lid seals to the flange and peels back cleanly. An HDPE mounting card keeps the device from moving. We cut the lid and the card; the seal is validated on your tray and sealer, or your customer's.
- Coated Tyvek® die-cut lidsCut in our cleanroom
- HDPE mounting and insert cardsCut in our cleanroom
- Coated Tyvek® rollstockSupplied by CleanCut
Chevron pouch + insert card
A Tyvek®, paper or foil chevron pouch forms the barrier and gives a controlled peel for aseptic presentation. An HDPE insert card holds the device flat and helps protect the pouch from sharp edges. We cut the card and supply the pouch.
- Tyvek® chevron pouchesSupplied by CleanCut
- Paper chevron pouchesSupplied by CleanCut
- Foil chevron pouchesSupplied by CleanCut
- HDPE mounting and insert cardsCut in our cleanroom
Header bag + film components
For bulky devices and kits, a 100 µm (4 mil) LDPE header bag lets sterilant in through its porous header strip. HDPE/LDPE film components add liners and protective layers inside. We supply the bag and cut the film parts.
- Header bagsSupplied by CleanCut
- HDPE/LDPE film die-cut componentsCut in our cleanroom
- HDPE/LDPE film rollstockSupplied by CleanCut
Your own line + our rollstock
If you form, fill and seal in-house, we supply coated Tyvek®, medical papers, cold-seal paper and HDPE/LDPE film on cores, and cut the die-cut parts that go alongside.
- Coated Tyvek® rollstockSupplied by CleanCut
- Medical-grade sterilization paperSupplied by CleanCut
- Coated medical-grade paperSupplied by CleanCut
- Latex-free cold-seal paperSupplied by CleanCut
- HDPE/LDPE film rollstockSupplied by CleanCut
Why one supplier
Fewer suppliers, fewer hand-offs
One PO, one contact
Lids, cards, rollstock, pouches and bags on one order, with one person to call: Michael Wollberg, Head of Sales, at +1 902-841-0746 or sales@cleancuthealthcare.com.Parts checked together
Send the tray spec, the device and the pouch together, even before the specs are final. We check how the lid and card fit before we cut, so fit questions get caught early.Clear about who makes what
Every product is marked cut in our cleanroom or supplied by CleanCut. We confirm each manufacturer's certification (standard, registrar and expiry) in writing as part of your supplier qualification. Each lot ships with our certificate of conformance, which records the manufacturer's lot number.
The finished sterile barrier system is validated to ISO 11607-1 and -2 by the device maker, or by the contract manufacturer that seals it for them, on their own equipment and cycle. We supply the components and the documents that support it.
Start a project
Send the whole package. We'll quote every part.
Share the tray, device and sterilization method, or send your packaging bill of materials with part numbers and revisions. We'll quote each line and come back with a plan and samples.