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Medical Device Sterlisation Services

Isotron employs the following sterilisation technologies:

Gamma sterilisation (Cobalt 60)

A wide variety of healthcare products from implants to pharmaceuticals employ gamma for its sterilising capability. In the context of sterilisation it is generally accepted that these species induce breaks in the DNA double helix, preventing replication and hence sterilisation.

Electron beam sterilisation (beta ray)

As well as being a highly established method used for initiating change at a molecular level in polymers, electron beam irradiation has also established itself as an effective sterilisation process for medical devices, dressings and pharmaceuticals.

Ethylene Oxide sterilisation

Ethylene oxide (EtO) is a gas that is widely used for sterilisation in the healthcare industry. During the sterilisation phase, products are exposed to the EtO gas which kills the organisms by reacting with its cellular constituents.

Microbiology laboratories for medical device testing

In addition to its technologies, Isotron operations are fully supported by microbiology laboratories. With its markets primarily in medical devices and related industries, these Isotron facilities are able to provide a range of regulatory complaint tests such as microbiological validations and determination of contamination levels.

Regulatory compliance in medical device sterilisation

In order to satisfy your customers’ requirements you need to work with a partner that can offer and deliver a reliable and comprehensive service. Isotron prides itself on its continued commitment to technical excellence by investment in its employees and active participation in ISO CEN committee working groups to ensure compliance to all the applicable regulatory standards is guaranteed.

Quality and regulatory affairs consultancy

Isotron has entered in to collaboration with High Edge Consultancy to provide additional support to our customer base. This collaboration creates invaluable links between Isotron and High Edge Consulting, which will benefit both companies’ clients. By working together, manufacturers of medical devices can now have expert advice on both sterilisation technologies and on compliance to the relevant directives and standards.

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