As a partner in your manufacturing process Mi3 understands the need for validated sterilisation protocols to deliver trusted single use sterile medical devices to the market.

The choice of sterilisation technology used on a complex medical device must take into account the device design, materials, product packaging and final packaging to ensure terminal sterilisation.

Mi3’s Sterilisation Processes

Our team of experts can help you identify the most appropriate medical device sterilisation method for your product, and our depth of knowledge can fast-track your route to selection of your sterilisation validation pathway.

We can offer customised solutions to ensure sterilisation of medical instruments and equipment and we also have a number of live validations which provide us with significant data to assist this process.

Our sterilisation processes include:

- Gamma Irradiation [R]
- Ethylene Oxide [EO]

Gamma Irradiation

Suitable for a wide range of polymers commonly used in medical devices, this is an attractive method for the sterilisation of many types of medical equipment.

The process results in little or no rise in temperature and leaves no residue.

Gamma sterilisation of medical products also requires no quarantine period post processing, enabling products to be shipped directly to the customer or end user following completion of the process.

Gamma sterilisation does have some limitations due to its oxidation effects.

Ethylene Oxide (EO)

Considered as the most common industrial sterilisation techniques with a broad application for medical devices and medical equipment.

This is an effective method to sterilise at low temperatures and is generally compatible with a wide range of materials, resins and polymers. Sterilisation at low temperatures ensures the integrity of both the product and its packaging.  

Resource Centre

Mi3 News

Regulatory Update - IVDR Implementation Amendment

EU Commission’s proposed amendment to transition period of the In Vitro Diagnostic Devices Regulation (IVDR) calls for a progressive roll out.

Read more
Mi3 News

Student Placement Blog

In July 2021, Mi3 took on four students from different universities to participate in “A Year in Industry”. Over the course of the year, the students will post multiple blog entries here, to showcase their experiences, highlighting some of the key activities they are involved in.

Read more
Mi3 News

Amendment of MDR (EU) 2017/745|OJ L241/7 on 8th July 2021

On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017/745 was published in the Official Journal of the European Union with some changes and corrections, including, misprints, typos and translation errors.

Read more

Speak to our experts about our Sterilisation Services