Medical Device Link .

STERIS Isomedix and iiA, Whippany, New Jersey, USA Pharmaceutical, biotech and medical device manufacturers, and radiation processing experts came together on 6 December 2006 in La Jolla, San Diego, California, USA, at a Workshop sponsored by the international irradiation Association (iiA). The objective was to explore scientific advances, future technical challenges and practical aspects of the radiation sterilisation of advanced combination drug-device products. Combination products are comprised of more than one type of regulated article or component (device, drug or biologic) and typically have more than one identifiable mode of action or therapeutic benefit. Manufactured under highly controlled conditions and in small quantities for just-in-time delivery, these products are likely to have an extremely low bioburden. Many require stringent temperature control and have extremely tight dose tolerance requirements. In the case of tissue allografts there is no such thing as a standard size, shape or material, and the small quantities and possible presence of viruses add complexity. These issues pose unique challenges for any sterilisation method. Regulators, when comparing aseptic processing with terminal sterilisation, are saying that wherever possible terminal sterilisation is preferred. This is because it lowers the chance of error and the risk of a contaminated product causing infection or transmitting a disease to the patient. During the Workshop it became apparent that the successful irradiation and regulatory approval of these high