Low-temperature sterilization · Ozone

Validated low-temperature sterilization for the products no one else will take.

For heat- and radiation-sensitive products at pilot and small-batch scale. Ozone-based, low temperature, residue-free, with the ISO 14937 qualification owned by Damgaard Solutions. Ethylene-oxide-free.

Temperature
Low temp, ~30 to 35 C
Residue
Oxygen and water
Standard
ISO 14937
Scale
Pilot and small batch
Gloved hands holding a clear biologic vial in a pharmaceutical cleanroom
Why now

Why ozone sterilization, and why now.

Ethylene oxide is being squeezed out of Europe, and manufacturers of heat- and radiation-sensitive product are running out of options. Low-temperature ozone is the route that remains.

EtO under EU withdrawal
Ethylene oxide is classified as a CMR carcinogen, and the European Commission intends to withdraw its approval as a biocidal substance.
Radiation disqualifies biologics
Gamma, X-ray and e-beam cause free-radical damage, so they are not an option for many biologics and advanced therapies.
10 to 14 days of aeration
EtO loads need long toxic-residue aeration. Ozone reverts to oxygen and water, with no aeration hold.
The method

What ozone sterilization is, and what it is not.

A low-temperature gas process that leaves no toxic residue, validated to the standard written for novel sterilization methods.

The honest part. Ozone has material-compatibility limits, not every polymer or material qualifies, and it is an emerging contract method rather than a decades-old one. That is exactly why every engagement starts with a feasibility assessment before anything is committed.
Abstract ozone molecule motif in steel and navy tones
Low temperature
Runs at roughly 30 to 35 C, gentle enough for heat-sensitive product.
Residue-free
Ozone reverts to oxygen and water in situ. No toxic residue, no long aeration step.
Validated to ISO 14937
The standard for defining, validating and controlling a sterilization process. We own that qualification for your product.
Who it is for

The products that cannot take heat or radiation.

If it cannot go through an autoclave, an ethylene oxide cycle, or a radiation dose, it is a candidate for low-temperature ozone.

Advanced therapies (cell and gene)Drug-device combination productsSingle-use systems and componentsSmall biotech and pilot-scale CDMOsViral vectors and biologics
What we do

We lead with the validation, not the chamber.

One feasibility assessment, one owned ISO 14937 qualification, one pilot-scale service. No method touches your product until it is proven for your product.

Validation engineer reviewing a protocol beside a cleanroom window
01

Feasibility

We confirm ozone compatibility for your product, materials and packaging before you commit, and define the cycle.

02

Validation

We build and own the ISO 14937 qualification, with audit-ready documentation that survives inspection.

03

Service

Pilot-scale contract sterilization, scoped to your batch and quoted per project.

Questions we hear

Common questions.

Does ozone leave residues?

No. Ozone reverts to oxygen and water, with no toxic residue and no long aeration hold.

What temperature does it run at?

Low temperature, roughly 30 to 35 C, suitable for heat-sensitive product.

Which standard do you validate to?

ISO 14937, the standard for defining and validating a sterilization process. We own that qualification for your product.

Is every material compatible?

No. Ozone has material-compatibility limits, so every engagement starts with a feasibility assessment.

Is this an ethylene oxide alternative?

Yes. It is a low-temperature, EtO-free route for products that cannot take ethylene oxide, heat or radiation.

What scale do you serve?

Pilot and small batch, not commercial truckload volumes. Every engagement is scoped and quoted per project.

Tell us what you need. We reply in two business days.

Every quote is a written proposal with a named engineer. Start with a feasibility assessment for your product, and we will tell you honestly whether ozone is the right route.

This is some text inside of a div block.
This is some text inside of a div block.
This is some text inside of a div block.
This is some text inside of a div block.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.