Sterile Barrier Packs — ISO 11607 Packaging | MedicoPax by InnovaPax
Packaging type · Sterile barrier packs

Sterile until the
moment of useISO 11607 sterile barrier systems — thermoformed trays and blisters with peelable lidding, matched to your sterilization method and validated under one roof in Denmark.

See our validation service
Standard
ISO 11607
Sterilization
EO · Gamma · Steam
Formats
Tray · Blister · Lid
Traceability
Label per box
Made in Denmark
Sterile barrier packs

The pack is part of the device

A sterile barrier system is the last line between sterilization and the patient: it must let the sterilant in, keep microorganisms out, survive transport and storage, and peel open cleanly at the point of use.

Under the MedicoPax brand we design the tray or blister, cut the tooling, form and seal under clean conditions, and validate the barrier to ISO 11607 — one documented chain from material batch to labelled box.

From cleanroom to point of use

A barrier that holds through sterilization, transport and storage — and peels open in one clean motion

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Formats

Sterile barrier formats we produce

All thermoformed and sealed on our own tooling under clean conditions — the format follows the device and how it's presented in the OR.

Tray with peelable lid

Rigid thermoformed tray closed with porous, peelable lidding — the classic device pack.

Device blister

Compact formed blister shaped to a single-use device, peel-open at the flange.

Double sterile barrier

Pack-in-pack systems for aseptic presentation into the sterile field.

Inner trays & kit organisers

Compartment trays that organise instruments and components inside the barrier.

Dust covers

Protective outer trays that shield the sterile barrier through logistics.

For medical devices →

See the full Medical Device industry page for applications and compliance.

Compliance & validation

Validated, not just made

A sterile barrier is a regulated component of the device. Our materials, process and documentation are built to prove it holds.

ISO 11607-1

Requirements for materials, sterile barrier systems and packaging systems — the design baseline.

ISO 11607-2

Validation of forming, sealing and assembly processes — IQ, OQ and PQ on the packaging line.

Seal integrity testing

Seal strength and integrity verified and documented as part of validation.

Sterilization compatibility

Porous lidding for EO; materials matched to gamma or steam — confirmed for your process.

Clean processing

Materials handled and packs produced under controlled, clean conditions, wrapped in bundles.

Full traceability →

Every box and bundle labelled and logged — any batch traceable end to end.

Materials

Barrier materials, in stock

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

All materials →
How we help

One partner, from design to validated barrier

Every stage under one roof means fewer hand-offs, faster iterations and a sterile barrier that's documented from the first sample.

FAQ

Sterile barrier questions, answered

What is a sterile barrier system?+
The minimum package that prevents microorganisms from entering and allows the product to be presented sterile at the point of use — typically a thermoformed tray or blister closed with a porous, peelable lid. ISO 11607 defines the requirements.
Which sterilization methods are your packs compatible with?+
The pack is designed around your method: porous lidding for EO sterilization, and material choices matched to gamma or steam. Compatibility is confirmed as part of validation.
How is the sterile barrier validated?+
Per ISO 11607: seal-strength and integrity testing, ageing and performance documentation matched to your device and process — delivered as a documented validation package.
Are the packs produced under clean conditions?+
Yes. Materials are handled and packs produced under controlled, clean conditions, wrapped in bundles and labelled per box — see traceability.
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