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Principles and Practices of Manufacturing Sterile Medical Devices

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Sterile Medical Devices

Marriott Courtyard, 7-11 Talavera Road, North Ryde
Sydney, Australia

ams Laboratories is proud to be supporting this event organized by the ISPE (Australasian Division).

ISPE have brought together a group of some of the leading suppliers to the medical device industry in Australia to discuss the requirements and approaches that are used to meet the end goal a Sterile Medical Device.

What factors are involved in determining the sterility assurance of a medical device? How is sterility assurance controlled and what do we need to do to demonstrate compliance with the stated assurance levels?

Sterile medical devices are regulated through adherence to a number of ISO standards defining how the device should be packaged, how it should be sterilised and how it should be verified as sterile.

For terminal sterilisation techniques such as Gamma Irradiation and Ethylene Oxide treatments the process is often outsourced, however it is still important that the manufacturer and supplier of the product has an understanding of what is needed to demonstrate sterility assurance.

To find out more about this event and how you can register, please click here to see the event flyer.