Cut in-house
Coated Tyvek® lids, uncoated Tyvek® sheets, HDPE cards and HDPE/LDPE film components are converted in our ISO Class 8 cleanroom under our ISO 9001 quality management system. We control the process, and we answer for it directly.
Quality
ISO Class 8 cleanroom parts, clear paperwork.
An ISO 9001 certified quality system and an ISO Class 8 cleanroom for the components we cut, and one accountable point of contact for everything we supply.
ISO 9001ISO Class 8 cleanroom
ISO 9001
What ISO 9001 means for you
ISO 9001 is the international standard for quality management systems. Our certification means the way we quote, cut, inspect, pack and ship is written down, followed, audited and improved.
For you, that shows up as parts made the same way every run, and a documented process for handling anything that goes wrong, from the first report to the corrective action.
Change control
We don't change your part without telling you.
Once you have approved a part, we don't change its material, grade, material source, cutting die, process, packing or production site without written notice at least 90 days before the change. Where a change affects your validated specification, we wait for your written approval before we ship. We don't substitute materials on a part you have approved.
For supplied rollstock, pouches and bags, we pass on any change notice we receive from the manufacturer within five business days, and we can arrange a last-time buy of the current material. If you build for a device maker, that gives you time to tell your customer and decide whether anything needs retesting.
We can write this into a quality agreement.
ISO Class 8 cleanroom
What an ISO Class 8 cleanroom controls
ISO 14644-1 classifies cleanrooms by how many airborne particles they allow. Class 8 limits particles of 0.5 µm and larger to 3,520,000 per cubic meter of air. Filtered air, controlled materials and clean handling keep the room inside that limit.
It matters because our components sit inside your sterile barrier system, next to the device. Sterilization kills microorganisms; it does not remove particles. Particulate that gets onto a lid, card or film part during converting can end up on the device or in the sterile field. Converting in a controlled room keeps it to a minimum from the start.
Our room is classified ISO 14644-1 Class 8 in operation, is recertified every year by an independent certifier, and is monitored with monthly particle counts to ISO 14644-2. Ask us for the current certificate and recent monitoring results.
A cleanroom controls particles, not sterility. Our components are for sterile barrier systems; they are not supplied sterile.
Cleanroom questions
Our answers
The questions to ask any cleanroom converter, answered for our room. If you want the records behind them, ask us, on a call or during an on-site or remote audit.
| Question | Our answer |
|---|---|
| Which ISO 14644-1 class, and in which occupancy state? | ISO Class 8, classified in operation. |
| How often is the room monitored, and can I see recent results? | Particle counts are taken monthly to ISO 14644-2, and the room is recertified every year by an independent certifier. Recent results are available on request. |
| Which steps happen inside the room? | Cutting, counting, inspection, bagging and labeling. |
| How are finished parts packed before they leave the room? | Counted and double-bagged in the room, with a lot label on every bag. See Packed to go straight into your cleanroom. |
| How are dies and tools cleaned and stored between jobs? | Dies are cleaned with isopropyl alcohol before they enter the room, and stored bagged between jobs. |
| How are incoming materials unwrapped or cleaned at entry? | Outer packaging comes off in the anteroom, and rolls and sheets are wiped down before they enter the room. |
| How are lots identified and traced from material to shipment? | A lot number is assigned when material is received and carried on the job traveler through to your certificate of conformance. |
| What happens when a monitoring result is out of limits? | We stop, investigate, clean and retest under our ISO 9001 corrective action process, and tell affected customers if product could be affected. |
| How will you tell me before a material, process or site change? | In writing, at least 90 days ahead. See We don't change your part without telling you. |
Materials
100% virgin HDPE for our cards
Our HDPE mounting and insert cards are cut from 100% virgin HDPE, with no regrind or recycled content, and converted in our ISO Class 8 cleanroom to keep particulate low.
Packing
Packed to go straight into your cleanroom.
Parts are counted and bagged inside our cleanroom, so they stay clean after cutting. Each bag holds 100 parts as standard, or the count you ask for, and 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.
Two paths
Two paths, one standard of care.
Some parts we cut ourselves. Others we supply from qualified manufacturers. Every product page tells you which, and the way we describe it never blurs the line.
Supplied by CleanCut
Rollstock, chevron pouches and header bags are sourced from manufacturers in North America and Europe that hold ISO 9001 certification and that we approve and monitor under our ISO 9001 supplier controls. That is what “qualified manufacturers” means everywhere on this site. We confirm each manufacturer's certification (standard, registrar and expiry) in writing as part of your supplier qualification.
Once you order a part, we keep its source and material the same and pass on any manufacturer change notice to you in writing. Every lot is traceable to the manufacturer's lot, and CleanCut stays your single point of contact for quotes, orders, complaints and corrective actions: Michael Wollberg, Head of Sales, at sales@cleancuthealthcare.com.
Confidentiality
Your specs stay yours.
We sign NDAs before you send specs: we'll sign yours, or send our mutual NDA within one business day. Tick the NDA box on the quote form and leave the files out until it's in place.
Specs, dies and parts for each customer are kept separate, and only the people working on your order can see your files. If you build for a device maker, we don't contact your customer, and we don't put their name on anything you haven't asked us to.
Documentation
Documents for your supplier file
What ships with every lot, and what you can ask for. Requests usually go out within two business days.
- ISO 9001 certificateISO 9001:2015. Scope: die-cutting and converting of medical packaging components in a cleanroom, and supply of medical packaging materials. Ask us for a copy of the certificate.
- Certificate of conformanceWith every shipment of parts we cut, with a packing list, stating part number, spec revision, lot, quantity and ship date.
- Lot traceabilityEach lot is traced from the incoming material lot to your shipment: material lot, cutting date, die, inspection results and operator. Lot numbers are on every bag and carton label.
- First-article reportDimensions measured against your spec, for every new part or new revision, at no charge.
- Manufacturer certificationWe 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. If your validated specification needs the source of a supplied item, we disclose it to your quality team under NDA.
- Origin details for sourced itemsFor customs and regulatory files, on request.
Supplier qualification
Everything your supplier file needs.
- Qualification packOur ISO 9001 certificate, cleanroom classification, completed supplier questionnaire and change notification policy, sent within two business days.
- Supplier questionnaireWe complete yours within five business days.
- Quality agreementWe review and sign customer quality agreements, or can send ours.
- AuditsOn-site or remote audits are welcome with two weeks' notice, including audits your own customer asks for.
- Complaints and corrective actionWe acknowledge a complaint within one business day and send a corrective action report within 30 days, under our ISO 9001 system.
- InsuranceA certificate of product liability insurance is available on request.
Validation support
How we support your validation
The sterile barrier system is validated to ISO 11607-1 and -2 on the actual tray, sealer and sterilization cycle, by the device maker or by the contract manufacturer that seals for them. Our job is to make that easier: consistent components, quick-turn samples cut from production material, and documentation when you need it.
You validate; we support.
Under ISO 11607-1, the device maker shows that the materials and the sterile barrier system are suitable, including performance after sterilization, aging (ASTM F1980 accelerated aging, confirmed by real-time aging) and distribution (for example ASTM D4169 or ISTA). Under ISO 11607-2, the forming, sealing and assembly processes are validated, typically through installation, operational and performance qualification, with seal strength (ASTM F88) and seal integrity (for example ASTM F1929 or ASTM F2096) testing.
What we provide: samples cut from production material for your builds; validation-lot quantities with no minimum; a certificate of conformance and lot records for the parts you test; manufacturer data for supplied materials, on request; written notice before any change after you validate.
What we don't do: we don't validate your package or claim compliance on your behalf.
Production-material samples
Prototype parts are cut from the same material grade and thickness you'll order. Tell us which build feeds your validation and we'll cut those parts on the production die and process, so your test results reflect the production part.Consistent parts, no silent changes
The same spec, material and process for every run under ISO 9001, and written notice before anything changes.Documents on request
Certificates and supplier documents for your supplier file.Honest scope
We don't claim ISO 11607 or EN 868 compliance on anyone's behalf. The device maker, or its contract manufacturer, validates; we supply the same parts, from the same material, every run, with the documents that support it, and we tell you before anything changes.
Supplier qualification
Qualifying a new supplier? We'll send your file first.
Ask for our qualification pack: ISO 9001 certificate, cleanroom classification, a completed supplier questionnaire and our change notification policy. We'll also book an audit, or send samples for your first articles, and the same for your customer if you build for one.