One of the things we’re most looking forward to at the BIOMEDevice San Jose 2012 conference this year (Dec. 4-5) is the opportunity to exchange ideas with medical device manufacturers about the sterilization of combination devices. A combination device is a product comprised of two or more regulated components (drug/biologic/device) – the full text of the FDA Office of Combination Products 21 CFR 3.2(e) definition appears here. As these innovative new products are being developed, sterilization has presented some challenges along the way.
For example, in a non-combination device, such as a cartridge that delivers a drug, the cartridge would typically be sterilized through radiation, with the drug itself sterilized aseptically. In a combination device, such as a drug-eluting stent (DES), the drug is integrated into the device itself (in this example, into a stent platform’s polymer coating). Radiation will sterilize the DES, but what effect will that have on the efficacy of the medication?
Given this concern and other complexities, sterilization procedures for these progressive new technologies are still being developed on a trial-and-error basis. Even large corporations have yet to develop a consistently effective combination sterilization methodology. NUTEK offers a variety of solutions to assist in delivering safe, sterilized combination devices. Our reliable electron beam (e-beam) irradiation processing can determine the effect of irradiation at various dose levels. It can target a specific area of your device, so that you can examine the effects of a precise dose on that area. We can even provide a 3D map of the dose received throughout the product or package during the irradiation process.
In the above example, if the dose of radiation required to sterilize a DES (or other combination device) is found to reduce the effectiveness of the device’s drug by 20%, the device can be manufactured to contain precisely the amount of additional medication required to counteract this effect. We look forward to discussing this and other ideas with you at the show. Contact us to arrange a meeting in advance, or stop by Booth #1107. (Reminder: we are “NUTEK,” with a K!)