Medical Packaging
If you convert sterile-barrier pouches or lidding, the adhesive is only one variable in a validated package system. Here is what to verify before you qualify a laminating adhesive for ISO 11607 workflows.
Sterile-barrier packaging protects a medical device from contamination until the point of use. ISO 11607-1 and -2 define the requirements for the package system and the validation of its forming, sealing and sterilization processes — they are not adhesive certifications. A laminating adhesive must be validated as part of the actual pouch or lidding structure: the specific substrate combination, coating weight, dry/cure condition and sterilization method. This guide separates what an adhesive supplier can document from what the device manufacturer must validate.
These are the parameters converters routinely benchmark across laminating adhesives for medical paper and film lamination. Treat the "typical industry range" as a screening window, not a specification — your structure defines the real acceptance limits.
| Parameter | Typical range | Common test method |
|---|---|---|
| Solids content | 30–60 % | ASTM D2369; ISO 3251 |
| Viscosity @25 °C | 100–2,000 mPa·s | ASTM D2196; ISO 2555 |
| pH | 6.0–9.0 | ASTM E70; ISO 976 |
| Heat-seal initiation temperature | 80–140 °C | ASTM F2029 |
| Heat-seal strength | 2–10 N/15 mm | ASTM F88/F88M; ISO 11607-1 |
| Lamination peel strength | 2–8 N/25 mm | ASTM F904 |
| EO sterilization compatibility | ≥80 % retention (screening target) | ISO 11135; ISO 11607-1 |
| Sterile-barrier performance | Pass/Fail per validation design | ISO 11607-1/-2 |
| Extractables / chemical safety | Device- and risk-specific | ISO 10993-18 |
Our WJX-1011S (dialysis-paper lamination) and WJX-1012S (paper / coated-paper lamination) grades are built for these structures. Request the grade-specific TDS with measured values and test methods.
Sterilization resistance is a property of the finished laminate, not the adhesive alone. Compare the three routes before you specify:
| Route | Mechanism | What to verify on the laminate |
|---|---|---|
| Ethylene oxide (EO) | Gas diffusion; needs aeration | Seal/peel strength and barrier integrity after exposure + aeration; residual solvent/moisture |
| Gamma | Ionizing radiation | Adhesive yellowing, embrittlement and strength retention after dose |
| Electron beam (e-beam) | Ionizing radiation, shorter path | Same as gamma at the applied dose; verify for the actual layer thickness |
When a sterile laminate fails, the cause is rarely "the adhesive" in isolation. Map the symptom to the root cause:
| Failure | Root cause | Corrective |
|---|---|---|
| Low peel strength | Coat weight too low, poor wetting, surface-chemistry mismatch | Re-set coat weight; surface treatment; verify adhesive-substrate compatibility |
| Bubbles / pinholes | Residual moisture, trapped air, nip too hot | Improve drying; de-aerate; optimize nip |
| Blocking / roll sticking | Residual moisture, excessively tacky, hot rewind | More dry + cooling; lower rewind temperature/pressure |
| Curl / channel leaks | Uneven coating, wrinkles, under-developed bond | Web guiding, uniform coating, pressure control; verify integrity |
| Brittle after sterilization | Adhesive chemistry not matched to sterilization exposure | Validate against actual sterilization dose/cycle + aging |
ISO 11607-1 and -2 define requirements for the package system and the validation of forming, sealing and sterilization processes. They are not adhesive certifications. Validation must be run on the actual pouch or lidding structure: the specific substrate combination, coating weight, dry/cure condition and sterilization method. The adhesive supplier provides supporting data; the device manufacturer owns the final package validation.
EO compatibility is verified by exposing the finished laminate to a representative EO cycle (per ISO 11135) followed by aeration, then measuring seal strength, peel strength and sterile-barrier integrity against pre-sterilization baselines. Report the retention percentage and the test conditions, not just a pass/fail claim.
Common root causes are coating weight too low, poor wetting, substrate surface chemistry incompatibility, insufficient dry-through, and adhesive chemistry not matched to the sterilization exposure and accelerated aging. Each failure mode needs its own corrective.
At minimum: a TDS listing parameters with test methods, a 16-section SDS in the target language, an ISO 11607 validation report for the actual structure, an EO compatibility report, extractables/leachables data where device-contact applies, batch COA, and change-control records.
No. An adhesive is a material, not a medical device. The EU MDR (2017/745) places regulatory responsibility on the device manufacturer. Suppliers support conformity with data; they do not hold an "MDR certification" for the adhesive itself.
Send us your substrate combination, sterilization method and target volumes — we'll match a grade or propose a custom formulation and share the relevant validation data on request.
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