The sterilization of medical devices, such as implants, artificial joints, syringes and blood bags, as well as food packaging, and even wine corks, is a service currently provided by third-parties, adding time and cost to this critical part of the manufacturing process. In developing countries, hygiene is a serious problem in hospitals where sterilization of medical devices is difficult to obtain. Many new medical devices can only be sterilized through chemical gas processes, resulting in harmful gases remaining in the packaging. Medical device sterilization is currently not properly documented and controlled, often causing broad product recalls which adds further delay and expense. Current approaches, from the process itself to product transportation, generates excess CO2 across the supply chain. In addition, the current Gamma irradiation process uses Cobalt-60.
EnXray has developed the LEXR Sterilizer, an innovative sterilization machine that delivers high efficiency ionizing radiation using low energy X Rays in an affordable manner, enabling safe on-site, on-demand sterilization of medical devices. LEXR provides sterilization at the Sterility Assurance Level (SAL) of most common materials and also new materials used in medical devices, enabling the invention and growth of new medical devices and greater customisation of medical devices to end user requirements. Individual sterilization and documentation of medical devices provides 100% traceability, which reduces the potential for broad product recalls should a single product be found to be non-sterile.
The LEXR Sterilizer is much smaller than existing systems, with a footprint of around 1.5m x 2.5m. This allows it to be incorporated easily in-house into most manufacturing environments, removing the need to outsource sterilization. This reduces time and indirect costs by 40%, as well as CO2 emissions generated by sterilization-related transportation, and produces no other harmful chemicals during sterilization.