Radiation Sterilization of Medical Devices – today drapes, gowns, surgical gloves, scalpels and prosthetic implants are among the medical devices routinely sterilised by radiation sterilisation.

In the 1950’s the replacement of re-usable devices by single-use devices was made possible by the availability of affordable polymers. As these new materials could not withstand the high temperatures of traditional heat sterilization, it was necessary to use a ‘cold’ processes. Gamma irradiation using a Cobalt-60 source provided the required penetration and characteristics and became a leading sterilisation modality. Today electron beam and X-ray technologies offer alternatives but to date these technologies are not widely used to sterilise medical devices.

Today advanced Drug-Device combination products can offer significant advantages over conventional but independently used drugs and devices. The advantages include efficiency performance and convenience but combining materials and biologics can create challenges especially in sterilising the drug device product.

The economic and social importance of the sterilisation of healthcare products globally can be seen from the following infographic.

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