DR JUSTIN DAVIES Manager, Irradiations Group, ANSTO Sydney
JAMES KYRIAKOPOULOS General Manager, Steritech
MALCOM HAMMOND Director, Manufacturing Quality and Licensing (MQL) & Assurance (AERP | Recalls | HGP) Registration Management, APVMA
The Gamma Irradiation process is widely used in our industry, whether for terminal sterilisation or bioburden reduction. However, this process is not fully understood, particularly from a regulatory perspective. In Australia, gamma treatment is monopolised. As the contract giver, there are responsibilities that we must share, notably, ensuring the product's safety, integrity, stability, and validation. We are fortunate to have speakers from the three major aspects, such as: (i) Steritech provides an industrial scale of gamma irradiation service for many industries world-wide; (ii) ANSTO with their unique gamma irradiation facilities that enable the delivery of high doses of radiation with more precision that is not achievable in industrial-scale and (iii) APVMA/TGA plays an important role in ensuring all gamma irradiation services meet their standards and regulation. In this seminar, Mr. James Kyriakopoulos from Steritech will discuss some fundamentals of gamma irradiation and its applications including sterilisation, decontamination of many types of product or components. Dr Justin Davies from ANSTO will share good practices in dose mapping, ie dosimetry systems, mapping methodology and how it is intended to provoke consideration of this effective sterilisation method in pharmaceutical and healthcare industry.
Dr Justin Davies is a radiation physicist and an expert in high-dose irradiation and dosimetry. He manages a range of gamma and x-ray irradiation facilities that provide low and high-dose irradiation and dosimetry capabilities for research and agriculture, healthcare, materials and space technology industries. He currently serves as the Manager of Irradiations Group at ANSTO Sydney. The Science & Validation of Radiation Processing: ANSTO operates cobalt-60 gamma irradiators providing the Australian community with irradiation services to a wide range of sectors including healthcare, agriculture, advanced materials and space science. ANSTO's unique gamma irradiation facilities enable the delivery of high doses of radiation with a high level of precision not achievable in industrial-scale irradiators. Precision irradiation is enabled by accurate dosimetry. Applications of gamma irradiation include food biosecurity, agriculture, polymer modification, vaccine development, space technology, validation of medical product sterilisation and sterilisation of medical products and devices, including donated human tissue. This talk will provide an overview of how irradiation works, how we measure it, its applications and our capabilities.
James Kyriakopoulos is a recognised thought leader in sterilisation services, with over 25 years of experience. A qualified industrial chemist, he has provided expert guidance on Australian Standards and the medical industry. James has played a key role in designing and constructing numerous sterilising facilities across Australia and internationally. He currently serves as the General Manager of Steritech. The Process of Gamma Irradiation at an Industrial Facility: Steritech operates 3 gamma irradiators, together with an E-beam and X-ray irradiators. These irradiation services are available to Australian Industry as well as the general public for when decontamination or sterilisation is required. Steritech also plays a key part in Australian Quarantine and Biosecurity Requirements. Steritech processes medical, healthcare, packaging, research, laboratory and bee industry products for a variety of customers. As one of the largest Contract Sterilisation providers in the world, Steritech provides a full-service including validation, advice and process certification. This talk will focus on how Irradiation works within an industrial setting and how a facility manages the various requirements and loads that are presented for processing.
The Lounge, Level 2Wests Ashfield Leagues Club115 Liverpool Rd, Ashfield NSW 2131
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melissa.bourke@biomerieux.com
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