High Intensity X-Ray Generator to Eliminate High Activity Sources used for Sterilization

Three different modalities of radiation sterilization currently exist: gamma-ray sterilization, electron beam sterilization, and x-ray sterilization. One of the most common ways to sterilize goods is with gamma producing radioactive sources, most commonly Co-60 and Cs-137. Long-term possession of these sources is undesirable due to security concerns, Nuclear Regulatory Commission oversight, and rising replacement, storage, and disposal costs. In addition, gamma sterilization typically requires relatively long exposure times to achieve the doses necessary for effective sterilization. Lastly, these sources present a homeland security risk as they may be used to build a Radiological Dispersal Device i.e., a Dirty Bomb. We propose to develop a radiation sterilization system which uses a superconducting linear accelerator (linac) to provide high radiation doses and thus eliminate the industrys reliance on disadvantageous Co-60 and Cs-137 sources. Electron linacs offer many advantages over radioactive sources. First, they can produce high energy bremsstrahlung x-rays by striking a metal converter on demand and can easily be turned on and off. Second, linacs can produce radiation of varying intensity, photon energy, and power. Third, a bremsstrahlung photon cone is focused, compared to the isotropic radiation emitted by sources and thus is more efficient. Finally, linacs produce little radioactive waste, and they are a low security risk because they cannot be used in any way to build a dirty bomb. These positive factors make linacs a compelling option when choosing among radiation sterilization methods. Niowave has been developing superconducting linacs for nearly a decade. Recent advances in superconducting accelerator technology have reduced the capital and operational costs to the point where they are now competitive with conventional (normal conducting) linacs. Niowave has started construction on a new sterilization facility that will become operational in 2015. The sterilization system using a superconducting linac will be compliant with the ISO 11137 scope within the ISO 13485 standard and Niowave will seek certification from the accredited certification body, BSI. By having a certified system, Niowave will then be a reliable contract sterilization facility capable of sterilizing FDA approved medical devices, pharmaceuticals, and tissue implants. This project will result in an operational sterilization facility by the end of Phase II that can replace high activity source sterilization. The resulting design of this superconducting accelerator based sterilization system will be marketed as a turnkey system in Phase III.