Medical packaging die-cutting, fast and small-batch friendly.

What we do

• 01

  Cut in our cleanroom

  Precision die-cutting

  We die-cut coated Tyvek® lids, uncoated Tyvek® sheets, HDPE mounting and insert cards, and HDPE/LDPE film components to your spec, or to your customer's. Send the geometry you need, including rounded corners, cut-outs, slots, slits and tab shapes, and we'll tell you how we'd cut it. If something in your spec will cause trouble on the die or on your line, we'll tell you before we cut.

  As a guide, we hold ±0.010 in (±0.25 mm) on outlines and ±0.015 in (±0.38 mm) on hole and slot positions, depending on material and part size. We hold the dimensions and tolerances on the spec you send; if one is tighter than we can hold, we say so on the quote, before we cut.

  Tooling: every part we cut, prototype or production, is cut on a steel-rule die. A new die adds about one week to the first order, and it belongs to you once paid.

  • Coated Tyvek® lids
  • HDPE cards
• 02

  Cut in our cleanroom

  Built to an existing spec

  Contract manufacturers and device makers often need a part that is already validated. Send the approved spec, its revision and the material callout. We cut to it as written, and we don't substitute materials or change the process without your written approval.

  We quote to your part number and revision, and can put them on your labels and certificates. Each customer's specs, dies and parts are kept separate.

  • Quality and change control
  • Send a spec
• 03

  Cut in our cleanroom

  Cleanroom converting

  Every part we cut is converted in our ISO Class 8 cleanroom in Kensington, Prince Edward Island, under our ISO 9001 quality management system.

  Components go inside your sterile barrier system, next to the device. Converting them in a controlled environment reduces particulate on the parts before they reach your package.

  • Quality and cleanroom
• 04

  Cut in our cleanroom

  Quick-turn prototyping

  Prototype samples cut from production material, typically in weeks, not months, once the spec is approved and the die is made, so you can test fit, seal and presentation before you commit to a design.

  Prototypes are cut on a steel-rule die, and the die is quoted with your first order. The same die then cuts your validation and production parts. If a revision changes the outline, the die changes with it, and we quote that on the same terms. Each round is labeled with the spec revision it was cut to.

  • Request prototype samples
• 05

  Cut in our cleanroom

  No spec yet? Start here.

  Send what you have: a sketch with key dimensions, a photo, a 3D model, a sample tray or pouch, or a sample of the device. Tell us how you plan to seal and sterilize, if you know. We'll come back with a suggested lid outline or card layout, the material we'd start from, and what we need to cut samples.

  We draw the die-line for you to approve, free for parts we quote.

  What we'll tell you

  • Whether the part will cut cleanly in the material you've picked
  • Where a tab, slot or corner is likely to tear or catch
  • Whether the lid covers the flange with room for a peel tab
  • Which material and thickness to sample first
  • What to put on the spec for the next round

  • Send what you have
• 06

  Sample kit for early design work

  A free kit of swatches and parts to handle before you draw anything: coated and uncoated Tyvek®, HDPE card in 10, 20 and 35 mil, PE film, medical paper, and sample Tyvek®, paper and foil chevron pouches and a header bag. It ships in five business days.

  We don't hold stock items: every part is cut or supplied to order, to your size and construction.

  • Request a sample kit
• 07

  Cut in our cleanroom

  Printing on lids

  Coated Tyvek® lids are available printed or unprinted, in up to two colors by flexographic printing, with registration within ±1/16 in (±1.5 mm). Send your artwork or tell us what the print needs to show, and we'll quote it with the lid.

• 08

  Cut in our cleanroom

  Tabbing

  Add a peel tab to a lid so users can find the edge and start the peel easily, even with gloved hands.

• 09

  Cut in our cleanroom

  Rollstock on cores

  HDPE card material is available as finished die-cut cards, or on rolls, wound on plastic cores, as plain HDPE web up to 20 mil thick for automated lines that cut their own cards.

  • HDPE cards
• 10

  Cut in our cleanroom

  Custom shapes up to 30 × 30 in

  Uncoated Tyvek® sheets in custom shapes with rounded corners, up to 30 × 30 in (762 × 762 mm). No minimum order, and production typically ships in 2–3 weeks.

  • Uncoated Tyvek® sheets
• 11

  Cut in our cleanroom

  Small batch to production volumes

  No minimum order quantities on the parts we cut. Order ten prototypes for a feasibility build, a few hundred for validation, then production volumes. A new production outline needs a cutting die, which we quote once, separately from the part price, typically US$250–900 depending on size and complexity.

  Mix part numbers on one order with no per-line minimum, and set up a blanket order with scheduled or kanban releases for repeat parts.

• 12

  Supplied by CleanCut

  Sourcing and supply

  We supply rollstock, chevron pouches and header bags from manufacturers in North America and Europe that we approve under our ISO 9001 supplier controls, consolidated on one PO with one point of contact: Michael Wollberg, Head of Sales, at sales@cleancuthealthcare.com. If your spec names a material, we quote that material, and once your part is set up we don't switch its source or construction without telling you first.

  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. Country-of-origin details are available for customs and regulatory files.

  • Rollstock
  • Pouches and bags