Medical Device Packaging — Sterile Barrier Trays & Blisters | MedicoPax by InnovaPax
MedicoPax · Medical Device

Sterile-ready,
validated, traceableThermoformed sterile barrier trays, device blisters and instrument trays — designed to ISO 11607, matched to your sterilization method, and validated and traceable from first sample to production.

See ISO 11607 validation
Standard
ISO 11607
Sterilization
EO · Steam · Gamma
Core materials
PETG · Tyvek
Traceability
Batch + label
Made in Denmark
Medical Device

Packaging that protects the sterile barrier

Medical device packaging has one non-negotiable job: keep the device sterile from the cleanroom to the point of use — through sterilization, transport, storage and opening — and prove it with documented validation.

We bring the whole chain in-house — medical-grade forming films and lidding in stock, tooling we cut ourselves, and forming, sealing and cutting on one machine — so your sterile barrier system is designed, validated to ISO 11607 and traceable end to end.

From cleanroom to point of use

One partner for the sterile barrier, the tooling and the validated production line

See how we help ↓
Applications

Devices we help package

Thermoformed sterile barrier trays and device blisters — matched to the device, the sterilization method and the validation your market demands.

Sterile barrier trays

Thermoformed trays and lidding forming a validated sterile barrier system.

Device blisters & clamshells

Clear single-use device packs that present, protect and peel open cleanly.

Instrument & procedure trays

Deep-draw compartment trays that hold and organise instruments and kits.

Diagnostics & IVD

Trays and packs for test kits, cartridges and moisture-sensitive assays.

Implant & high-value devices

Protective, tamper-evident packs that safeguard sensitive, high-value devices.

Kits & procedure packs

Organising trays that hold multi-component kits in a defined, presented layout.

Materials

Medical-grade materials, in stock

Forming films and lidding, all documented for medical use. Tap through for parameters, datasheets and stocked formats.

All materials →
Regulatory & compliance

Built for the sterile barrier

Medical device packaging is validated, not just made. Our materials, tooling and process are built to prove the sterile barrier holds — and to give you the documentation your technical file needs.

ISO 11607-1 & -2

Sterile barrier packaging — materials and design (Part 1) and validated processes (Part 2).

EU MDR 2017/745

Documentation to support the packaging section of your MDR technical file.

ISO 13485 aligned

Materials and processes documented to medical-device quality practices.

Sterilization compatibility

EO, steam, gamma and e-beam — material selected to survive the method.

Batch traceability →

Every box and bundle labelled and logged, so any lot can be traced end to end.

Clean processing

Materials handled and packed under controlled, clean conditions.

How we help

One partner, from design to validated line

Every stage under one roof means fewer hand-offs, faster iterations and a sterile barrier system that's right the first time it runs.

FAQ

Medical packaging questions, answered

Is your packaging suitable for sterile medical devices?+
Yes. We produce sterile barrier systems — trays plus lidding — designed to ISO 11607, using medical-grade forming films and porous lidding such as medical paper and Tyvek, compatible with common sterilization methods.
Which sterilization methods do you support?+
Ethylene oxide (EO), steam, gamma and e-beam. We select the forming film and lidding so the sterile barrier survives the chosen method and the product's shelf life — see the materials hub.
Do you validate the sterile barrier?+
Yes. We validate to ISO 11607 Part 2, using ASTM methods such as F88 (seal strength), F1140/F2054 (burst) and F1929 (dye penetration), plus accelerated ageing and transport testing. See validation.
Are you ISO 13485 and MDR compliant?+
Our materials and processes are documented to medical-device standards and aligned to ISO 13485 practices, with documentation to support EU MDR 2017/745 technical files. Declarations are available on request.
Can I get samples before committing to tooling?+
Yes. We prototype with 3D-printed tooling so you can test fit, presentation and line behaviour before investing in production aluminium tools. Packaging design covers this stage.
Let's talk packaging

Tell us about your device

Send us the device, sterilization method and volume and we'll come back with a recommendation and a quote.

Contact us