Sterile & assembly support
Getting the device to the patient sterile: the barrier that has to survive the process, the sterilisation route it can take, and the validation that proves it.
When sterile support is the right step
For devices that reach the patient sterile. Plan it while the design is still open: the sterilisation method limits the materials, and the packaging is part of the device.
Choose and validate the method
Ethylene oxide or gamma, chosen to suit the materials and the device, then validated. We coordinate the sterilisation.
Sterile barrier packaging
Packaging that keeps the device sterile until use, validated for sealing, transport and shelf life.
Labels for the sterile field
Labels that state the sterilisation method and the expiry date, applied to each pack.
What you bring, and what you get back
You bring
- A materials list, with grades
- Drawings and the bill of materials
- The intended use, and how the device is presented in use
- The shelf life you need
- Any sterilisation or packaging data you already have
You get back
- A recommended sterilisation method, with the reasoning
- Coordination of ethylene oxide or gamma sterilisation
- A sterile barrier packaging design
- Validation records for sterilisation and packaging
- Labels with sterilisation and expiry information
The sterilisation method is a design choice
Gamma radiation can weaken or discolour some polymers. Ethylene oxide must reach every surface and then be removed, which calls for packaging the gas can pass through. So the method is chosen while the materials are still open. The packaging is part of the device too: ISO 11607 treats the sterile barrier system as something to validate for sealing, transport and shelf life.
How sterile support runs
Questions buyers ask
Should I choose ethylene oxide or gamma?
It depends on the materials, the geometry, the packaging and the volume. Gamma suits many single-use devices made of radiation-stable materials. Ethylene oxide suits materials that radiation would damage, but the gas residues must be removed afterwards.
When should the packaging be designed?
Alongside the device. ISO 11607 treats the sterile barrier system as part of the device, validated for sealing, transport and ageing. A shelf-life claim needs ageing data behind it.
Can I change the method later?
Yes, but it is a design change. Materials, packaging and validation may all need another look, and an approved device may need the regulator to be told.
Is this only for surgical devices?
No, it applies to any device supplied sterile. Surgical instruments and disposables are the common case. See surgical devices.
Sterility planned with the design
Materials, packaging and labels are decided by the team that designs the device: nine disciplines in one team, with labs and audited assembly lines in Navi Mumbai.
Devices we have worked on
We name the type of device, not the client. Client work stays confidential. See every device type.
Run under an ISO 13485:2016 quality system certified by TÜV SÜD, certificate 99 400 00046. What it covers.
Not quite you?
Standards this work is done against
- ISO 11135 / ISO 11137Sterilisation by ethylene oxide or radiation
- ISO 11607Packaging for terminally sterilised devices
- ISO 13485, 7.5.7Validation of sterilisation and sterile barrier systems
The list for a given device, and the edition of each, is set in its regulatory plan.
Where this sits
Also in Co-Manufacturing
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