Quality & compliance
We are a supplier and exporter, not a converter. Production runs in partner facilities that hold the certifications — and our job is to make sure the evidence reaches your QA department intact, attached to the right lot number.
What we are, and what we are not
Buyers get burned by suppliers who imply they own a factory. So here is the straight version, before you ask.
- We do not own the extrusion lines. We work with a small, fixed set of partner manufacturers in Jiangsu and Zhejiang, each audited by us and holding ISO 9001 or ISO 13485 certification.
- We own the specification and the relationship. Your drawing, resin choice and acceptance criteria are documented by us, and we are accountable for what arrives.
- We do not claim certificates we don't hold. Where a certificate is held by a partner site, we say so and provide the certificate with the site name visible.
- We do not certify your transport packaging. If you need UN3373 Category B certification, that is a validation on the complete package — we supply the components and the data, you hold the certification.
- We do not do clinical or regulatory submissions. We support your technical file with material and process documentation. The submission stays yours.
If any of that is a problem for your procurement process, tell us early. It is better to find out at enquiry stage than after a purchase order.
The frameworks we work inside
Each item below is either a certification held by a partner manufacturing site or a standard we test and document against.
ISO 13485:2016
Medical device QMS at partner manufacturing sites. Certificate provided with the site name visible.
ISO 9001:2015
General quality management covering order handling, traceability and document control.
USP <661>
Physico-chemical testing of plastic materials and components intended for pharmaceutical contact.
USP <87> / <88> — Class VI
Biological reactivity and implantation testing, the highest USP plastic classification.
EU 10/2011
Plastic materials and articles intended to come into contact with food — declaration of compliance and migration data.
FDA 21 CFR 177
Indirect food additives — olefin polymers. Statements issued against the specific resin grade.
ISO 11137 — irradiation
Sterilisation of health care products by radiation. Dose mapping and dosimeter records per lot.
ISO 14644 — cleanrooms
Classification of air cleanliness. Forming and bagging under Class 8 (ISO 8) as standard; Class 7 available.
ISPM 15 / P650
Heat-treated export pallets, and P650 performance requirements for Category B transport components.
Where the checks happen
Incoming material, in-process, and release. Nothing ships on a verbal assurance.
Incoming material
Resin grade verified against the specification and the certificate. Lot number recorded and linked forward to every unit produced from that batch.
In process
Film gauge, seal parameters and weld integrity monitored during the run. Deviations stop the line rather than being sorted out afterwards.
Release testing
Dimensional check, seal strength, visual inspection and leak testing as applicable to the product. Results recorded per lot on the CoA.
Post-sterilisation
Dosimetry records, dose range confirmation, and sterile barrier integrity check on the packaged unit before it is released for export.
One lot number, all the way back to the resin
Every carton carries a lot number. That number resolves to the production run, the resin batch it came from, the sterilisation cycle it went through, and the documents issued for it. If there is ever a question about a shipment, the answer should take minutes, not weeks.
- Lot number printed on the primary unit, the inner bag and the export carton
- Forward and backward traceability from resin batch to shipped carton
- Retained samples kept for the agreed retention period
- Complaint and deviation records linked to the lot, with a written response
- Recall procedure with customer notification inside 24 hours of a confirmed issue
What ships with the goods
Standard with every order unless marked optional. Ask for anything else at quotation stage.
| Document | Content | When issued |
|---|---|---|
| Commercial invoice | Values, HS codes, Incoterm, country of origin | With shipment |
| Packing list | Carton count, dimensions, gross and net weight, lot numbers | With shipment |
| Certificate of Origin | Issued by CCPIT or the local chamber, as required by destination | With shipment |
| Certificate of Analysis | Test results against the agreed specification, per lot | With shipment |
| Sterility / irradiation certificate | Dose range, dosimetry reference, SAL basis | Per sterilisation lot |
| Material declaration | Resin grade, supplier, additives, food-contact status | Per order |
| Safety data sheet (MSDS) | For any item where the destination requires it | On request |
| Third-party inspection report | SGS / BV / TÜV pre-shipment inspection | Optional, at your cost |
| Fumigation / heat-treatment certificate | ISPM 15 compliance for timber pallets | When palletised |
Need a specific document before you can approve us?
Send the list your QA department wants. We will tell you which we can issue, which the partner site issues, and which we simply do not have.