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

Guide

IVDR Classification Rules

Understand the device classification rules for in vitro diagnostic devices. Download your copy of the IVDR Classifications here...

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White Paper

Technologies Series No.1 - 3D Scanning

3D scanning is a technology that naturally comes one step before 3D printing and can be particularly useful in the design & development of medical devices, yet is does not receive as much attention. Learn more about the different types of 3D scanning technologies available...

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White Paper

Regulatory Series No.2 - Strategic Considerations for Drug-Device Combinations

The key to getting a new device to market compliantly is in the classification of the product. This is especially important when you have a drug-device combination.

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Speak to our experts about our Sterilisation Services