Frequently asked questions.

Parts we cut in our cleanroom have no minimum order quantity:

• Order the number you need, from a prototype run to production volumes.
• Every new outline, prototype or production, needs a cutting die. We quote the die once, separately from the part price, and you own the die once it is paid for.

For supplied rollstock, pouches and bags, small orders are welcome too:

• Standard items have no minimum.
• Custom printed pouches and custom-width or printed rollstock may carry a manufacturer's minimum, which we show on the quote.

Use the quote form and send your spec or CAD file with:

• Material and dimensions
• Tray or pouch substrate
• Sterilization method
• Quantities and timeline

If you are not sure of a detail, leave it blank. If you build for a device maker, add their part number and revision, and tell us if the part is already validated.

We reply within one business day. Our target for most quotes, once we have the details we need from you, is:

• 2 business days for parts we cut
• 3–5 business days for supplied items

Each quote shows:

• The unit price at each quantity you ask for
• Any one-time die charge
• Lead time
• Currency and shipping terms
• How long the price is valid

Typical lead times by order type:

• Prototype parts we cut: weeks, not months, from spec approval, when the material is in stock.
• Production parts we cut: 2–3 weeks on an existing die.
• New outline: every new outline needs a die, which adds about 1 week.
• Standard supplied rollstock, pouches and bags: 3–4 weeks.
• Custom size or print on supplied items: 6–8 weeks.
• Validation builds: order at least 3–4 weeks ahead.

The exact time depends on the product, the quantity, and any custom size, print or new die. We confirm the lead time with your quote. If you have a hard date, tell us when you ask.

Yes. You can order lids, cards, sheets and film parts from our cleanroom alongside supplied rollstock, pouches and bags. They come on one purchase order and one invoice, with one person to call: Michael Wollberg, our Head of Sales, for quotes, orders and deliveries, at sales@cleancuthealthcare.com. One supplier covers everything in your sterile barrier system except the device.

Yes. We'll sign your NDA or send our mutual NDA before you share specs. Tick the NDA box on the quote form and leave the files out until it's in place. Each customer's specs, dies and parts are kept separate.

Your quote shows:

• The unit price at each quantity you ask for.
• Any one-time charge for a new cutting die, quoted separately so small runs stay affordable.
• The lead time.

The same die cuts your prototypes, validation lots and production parts, so you pay for it once per outline.

You own the die once it is paid for:

• We store it at no charge.
• We keep it for your orders only.
• We tell you before we retire it, and only consider retiring a die after three years without an order.

Yes. Tell us the quantities you want priced and we quote each one. Unit price falls with quantity mainly because set-up time and material waste are shared across more parts.

Currency and validity:

• CAD for Canadian customers.
• USD for US and international customers.
• EUR on request.
• Quotes are valid for 30 days.

Payment terms are quoted per order. Our terms and conditions of sale come with every quote and are available on request.

Yes. Place a blanket PO for a year's volume and call off releases, scheduled or kanban, as you need them. We can hold finished stock against a forecast.

Yes. We hold agreed finished stock for repeat parts against a forecast or blanket order. Consignment stock is available on request.

Ask about samples on the quote form. Tell us the product, your tray or pouch and your sterilization method, and we will come back with a sample plan.

Send purchase orders to orders@cleancuthealthcare.com.

• A mixed order of parts we cut and supplied items comes on one invoice.

Yes. Send the approved spec, its revision and the material callout.

• We cut to it as written.
• We can quote to your customer's part number and revision and put them on labels and certificates.
• If we can't hold a dimension or supply the exact material, we say so on the quote rather than offer a substitute.

Yes:

• You get advance written notice of any change that affects an approved part, which gives you time to tell your customer and decide whether anything needs retesting.
• We don't substitute materials on an approved part without your written approval.
• Where the change affects the validated specification, we wait for your written approval before we ship.
• We're glad to discuss a quality agreement.

Parts are counted and bagged inside our cleanroom, so they stay clean after cutting:

• Each bag holds 100 parts as standard, or your count.
• Each bag is sealed inside a second bag, so you can remove the outer bag at your airlock.
• Every inner bag and carton carries a label with our part number, your part number and revision, lot number, quantity and date.
• Each customer's parts are packed and labeled separately.

If your intake procedure needs a different count, bag or label, tell us on the quote.

Yes. Each customer's specs are kept in access-controlled folders, and dies and parts are labeled to the customer and stored separately. We don't contact your customer, and we don't put their name on anything you haven't asked us to.

Yes:

• We complete supplier questionnaires promptly.
• We host audits by arrangement, including audits your customer asks for.
• On-site and remote audits are both welcome.

Prototype parts we cut:

• Typically ship in weeks, not months, from spec approval, when the material is in stock.
• Every new outline needs a cutting die, which adds about 1 week and is quoted with your prototype order, so send the spec early.
• A revision that changes the outline needs a new die.

Timing depends on the part and the material. We confirm it with your quote. Put your target date on the quote form so we can plan around it.

A spec or CAD file is the best start. Add:

• The material and dimensions.
• The tray or pouch it goes with.
• Your sterilization method.
• Prototype and production quantities.
• Your timeline.

A photo, a sketch with key dimensions, or a sample tray or device part also works for a first conversation.

Yes. Send any of these:

• A sketch with key dimensions.
• A photo.
• A 3D model.
• A sample tray or part.

We will:

• Suggest a lid outline or card layout and the material to start with.
• Tell you what we need to cut samples.
• Draw the die-line for you to approve, free for parts we quote.

Yes, for parts we cut in-house:

• We cut prototypes and production parts in the same ISO Class 8 cleanroom, from the same material grade and thickness.
• Validation lots are cut on the production die and process, so the parts you validate are the parts you order later.
• Once your design is released, we don't change the material, grade, material source, die or process without advance written notice to you.
• Small batches and production volumes are both welcome.

Tyvek® 1073B is the heaviest and strongest medical grade. It gives strength and puncture resistance for heavy or sharp devices such as orthopedic implants and surgical kits.

2FS is lighter and costs less. It is a cost-effective choice for lighter devices and high-speed form-fill-seal lines.

No:

• HDPE cards are rigid, 10–35 mil (0.25–0.89 mm) thick, and hold and protect a device inside a pouch or tray.
• HDPE/LDPE film is flexible, 28–60 µm (≈1.1–2.4 mil) thick, and is used for liners, protective layers and interleaves.

A heat-seal coating bonds to a tray or film when heat and pressure are applied. The coated Tyvek® lids we cut, and the coated rollstock and medical paper we supply, all use heat-seal coatings.

A cold-seal coating is cohesive. It seals to itself under pressure, with no heat. The cold-seal paper we supply is not made with natural rubber latex.

Our Tyvek® lids, sheets, rollstock and pouches, HDPE cards and header bags are compatible with EtO, gamma and e-beam. Steam for these is not yet confirmed, so ask us. Medical paper comes in steam grades.

Compatibility depends on grade, coating, and your process. Validate in your own sterilization cycle. The compatibility chart shows every product.

No. Our components are for sterile barrier systems. The device maker, or its contract manufacturer, assembles, seals and sterilizes the finished package and validates it to ISO 11607-1 and ISO 11607-2. We cut our in-house parts in our ISO Class 8 cleanroom and pack them in sealed double bags inside the room to keep particulate low all the way to your line.

EtO is a gas. It has to reach the device and then leave the package. Foil blocks gas, and polyethylene film is not porous, so the package needs a porous path: a built-in porous header or breather patch on a foil package, or a Tyvek® or paper side on a package that holds film parts. Gamma and e-beam pass through sealed packages, so they do not need one.

ISO 9001 is a standard for quality management systems. We are certified to ISO 9001:2015.

• Our certificate covers die-cutting and converting of medical packaging components in a cleanroom, and supply of medical packaging materials.
• It means we run documented, audited processes for that work, including how we handle problems and corrective action.
• It applies to CleanCut. It is not a product certification.
• Ask us for a copy of the certificate.

ISO 14644-1 classifies cleanrooms by airborne particle count. Class 8 allows no more than 3,520,000 particles of 0.5 µm or larger per cubic meter of air.

Our room:

• Is classified in operation.
• Is recertified every year by an independent certifier.
• Is monitored monthly to ISO 14644-2.

We cut our in-house parts in this controlled environment. Components inside a sterile barrier system sit next to the device, so keeping them clean matters.

For supplied rollstock, pouches and bags:

• Manufacturer certificates are available on request.
• Each lot ships with our certificate of conformance, which records the manufacturer's lot number.
• Origin details for customs and regulatory needs are available on request.

For parts we cut in-house:

• Every shipment includes a packing list and a certificate of conformance stating part number, spec revision, lot, quantity and ship date.
• Every bag and carton carries a lot number traceable to the incoming material lot.
• We notify you in writing in advance of any change to material, source, die or process on an approved part.
• Available on request: a first-article report and a completed supplier questionnaire. We're glad to discuss a quality agreement.
• Ask us for a copy of our ISO 9001 certificate.

Yes:

• We give advance written notice before any change to material, grade, material source, cutting die, process or packing on a part you have approved, and wait for your approval where the change affects your validated specification.
• We don't substitute materials on a part you have approved without your written approval.
• For supplied items we pass on the manufacturer's change notices.
• We can arrange a last-time buy of the current material.

No. There is no product certification to ISO 11607. The device maker, or its contract manufacturer, meets ISO 11607-1 and ISO 11607-2 by validating the complete sterile barrier system and its forming, sealing and assembly processes. ISO 11607-1 also sets requirements for materials, and material manufacturers often publish statements against them; for the materials we cut or supply, we can pass on what the manufacturer provides. We support that work with consistent components and the documents you ask for. We do not claim compliance on anyone's behalf.

We ship to customers in Canada, the United States and the European Union. Our cleanroom is in Kensington, Prince Edward Island. If you need delivery somewhere else, ask us and we will see what we can do.

We ship from Kensington, Prince Edward Island.

• Currency: quotes are in CAD for Canadian customers or USD for US and international customers.
• Shipping terms: quotes state the Incoterms, usually FCA Kensington, or DAP your dock on request.
• US deliveries: we prepare the export paperwork and work with your customs broker or ours. Parts that qualify as originating goods under CUSMA (USMCA) ship with a certification of origin so you can claim duty-free entry.
• EU deliveries: we ship DAP. You act as importer of record and pay import VAT and duty, and we supply the commercial invoice and origin documents.

Tell us your delivery address and any carrier or broker you prefer.

For supplied items, the quote states the country of origin of each item, and origin details for customs and regulatory needs are available on request.