iiA Papers
Sterilisation of drug-device combination products presents unique challenges and demands some new thinking. Issues such as dose setting and controlling free radicals for these ultraclean, high-cost products are discussed together with the future advancements required for their efficient terminal sterilisation.
This article " Radiation Sterilisation of Advanced Drug-Device Combination Products" was first published in Medical Device Technology, vol. 18, no. 2, March - April 2007. Visit www.devicelink.com/mdt
Maritin S. Favero, PHD published "Sterility Assurance: Concepts for Patient Safety"Â is a must read paper on this subject.
As the global population ages, there will be rapid growth in the demand for sterile healthcare products.
Existing irradiation methods will be refined and new applications found for irradiation technology.
Sterilization companies will continue to develop versatile, flexible, technology-neutral global operations
The Future of Radiation Processing article was published in Medical Device Development 2006 Vol. 1 published by SPG Media Ltd, London.
In the mid-1950s, the rising demand for sterile single-use medical devices paved the way for the expansion of radiation processing and specifically gamma sterilization using cobalt-60. Over the ensuing decades, the industry has not only grown in size, but also in its diversity and sophistication. Gamma irradiation is a very widespread application of nuclear technology for peaceful purposes, and positively impacts the lives of millions of people on a daily basis.
The International Irradiation Association (iia) shall always support regulatory initiatives that protect any vulnerable radioactive source from malicious use. We believe these regulations need to be logical, balanced, harmonized and implemented in a manner that truly acts in the best interest of a global society. To obtain the best regulations and standards we advocate a collaborative approach that includes industry participation as related to the different radioactive source types and use. The iiA does not support an approach that treats all radioactive sources the same, nor ignores 50 years of experience and benefits of radiation processing.