ISO 9001:2015
Certified quality management system covering extrusion, coating, lamination and converting — audited annually by an accredited certification body.
Quality & Compliance
Compliance-forward manufacturing: certified systems, per-lot verification and documentation your regulatory team can file.
Certifications & Standards
Verified against the frameworks that matter
FDA 21 CFR
Resin grades compliant with 21 CFR 177.1500 (nylon), 177.1520 (polyolefins) and 177.1630 (PET) for food-contact and pharma packaging use.
EU Regulation 10/2011
Formulations screened against the EU positive list with migration testing to Annex III simulants — documentation available per product.
USP <788> / EP
Particulate testing by light obscuration per lot for cleanroom and medical-grade products; container closure integrity support.
REACH & RoHS
Full SVHC declaration for all raw materials; no restricted substances above 0.1% w/w in any finished structure.
ISO 11607 (support)
Sterile-barrier constructions designed to ISO 11607-1/-2 requirements, with customer validation support for seal strength, dye penetration and accelerated aging.
Quality Control
Every lot, verified before it ships
01
Incoming Resin
Supplier COA verification, FTIR identity confirmation and silicone/amide screen on every resin lot before release to production.
02
In-Process
Continuous gauge monitoring, inline defect detection and hourly COF and seal-strength checks during converting.
03
Final Release
OTR/WVTR permeation verification, USP <788> particulates and visual inspection against master samples before lot release.
04
Documentation
Lot-specific COA, extractables summary and traceability record issued with every shipment — retained for five years.
Traceability
Resin batch to packed carton in one step
| Stage | Data captured | Retention |
|---|---|---|
| Resin receipt | Supplier, batch no., COA, FTIR identity, additive screen | 5 years |
| Extrusion | Line, operator, parameter log, gauge profile | 5 years |
| Coating / lamination | Coating weight, adhesive batch, cure verification | 5 years |
| Converting | Machine, date, QC results, packing operator | 5 years |
| Shipment | Customer, PO, carton serials, COA reference | 5 years |
Frequently Asked
Compliance questions, answered
Are your products truly silicon-free?
Yes. All structures in our SF range are manufactured without silicone oils, slip additives or erucamide/amide lubricants. Resin handling uses dedicated hoppers and lines to prevent cross-contamination, and each lot COA includes an extractables screen confirming the absence of silicone compounds.
Which regulations do your materials comply with?
Our materials are formulated to meet FDA 21 CFR food-contact requirements, EU Regulation 10/2011 on plastic materials in contact with food, and China's GB 4806 series. Product-specific migration and extractables data is available under NDA, and we support customer regulatory filings with documentation packs.
Do you provide extractables and leachables data?
Yes. Every lot ships with a Certificate of Analysis summarizing the extractables screen (GC-MS/ICP-MS). Full migration studies, USP <788> particulate results and simulant testing per EU 10/2011 Annex III are available for qualified projects.
Can your packaging be sterilized?
Selected constructions — including our SF-MDP pouches and SF-ALX80 lidding film — are compatible with ethylene oxide (ISO 11135), gamma irradiation up to 50 kGy (ISO 11137) and e-beam processing. Sterilization stability reports are available on request.
What is your minimum order quantity?
MOQ varies by structure: stock cleanroom PE bags from 5,000 pieces; custom laminates and rollstock from 500 kg. Digital print enables economical short runs for validation and pilot batches.
How does lot traceability work?
Every roll and carton carries a lot number linking resin batch, extrusion run, converting date, QC results and packing operator. Traceability records are retained for a minimum of five years and are retrievable within 24 hours for customer audits or recalls.
Need a certificate or migration dossier?
Send us the product code and destination market — we will provide the compliance documentation your filing requires.