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Low Energy X Ray Sterilizer – bringing OEM medical device sterilization in house and streamlining production

Periodic Reporting for period 1 - LEXR Sterilizer (Low Energy X Ray Sterilizer – bringing OEM medical device sterilization in house and streamlining production)

Período documentado: 2017-02-01 hasta 2017-05-31

The sterilization of medical devices (such as for example: implants, artificial joints, syringes, blood bags, etc.) is currently provided as a service by third-parties. For medical device OEMs this means that, to sterilize their products they lose valuable time and indirect costs to this final, critical part of the manufacturing process. Medical device sterilization is currently not properly documented and controlled, often causing broad product recalls should a single product be found to be non-sterile. This uncertainty causes loses in profits and imposes additional costs and time due by the need to repeat the sterilization process (and can diminish the good name of the OEMs when publicised by the media). Approaches to sterilization currently present on the market generate excess CO2 across the supply chain, from the process itself to product transportation. In addition, the current Gamma irradiation process employs use of Cobalt-60, which is a harmful synthetic radioactive isotope which has been proven to cause cancer after prolonged exposure.
LEXR Sterilizer will deliver high efficiency ionizing radiation in an affordable manner to enable safe on-site, in-house & on-demand sterilization of medical devices, reducing by 40% time & indirect costs to this final, critical part of a company’s manufacturing process. Our technology sterilizes medical devices individually and document each item to provide 100% traceability of medical devices and their sterility, which is a level of information that cannot be provided by existing batch-based sterilization methods. This will reduce the potential for broad product recalls should a single product be found to be non-sterile. LEXR Sterilizer eliminates the need for transportation of devices to sterilisation service providers’ site in the supply chain, which reduces the emission of CO2. Additionally, it produces no other harmful chemicals during sterilization, making LEXR the most environmentally friendly and hazard free solution.
LEXR responds to several challenges related to the standards in sterilisation, safety standards, as well as waste and pollution reduction. LEXR Sterilizer project satisfies the European requirements contained in the Directive 93/42/CEE, ensuring the quality of sterilization calling off all the phases that now are necessary to achieve the SAL and at the same time providing a better certification for single and individual medical device sterilization. The technology also meets the Council Directive of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionizing radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom. (OJ L-13 of 17/01/2014 page 1), bringing the entire process within the machine, reducing the risk of a contact. On the environmental aspects, LEXR Sterilizer contributes to the realisation of the objective of European Directive n° 2008/1/CE, which objective is to achieve an integrated pollution prevention and control. As LEXR Sterilization eliminates the need of transportation of medical devices to be sterilized by a third party, the CO2 emission is reduced by the equivalent of the reduced transportation need. Moreover, LEXR Sterilizer meets the EU Packaging and Packaging Waste Directive that direct packagers to develop materials that can be reused and also expect packagers to recycle materials.
During the Phase 1 feasibility assessment, we have completed a full analysis of the technical and business potential of the LEXR Sterilizer system. Throughout the project, we have expanded our knowledge of the market for sterilization of medical devices and the benefits our technology can deliver with a particular focus on the European and US markets, and a potential entry in Asia. In the meantime we have expanded our network of potential stakeholders, including partners, suppliers, and subcontractors, as well as first customers.
The Phase 1 feasibility study was instrumental in deriving important product and commercialisation developments needed for the market launch of LEXR Sterilizer. The findings have confirmed the next key feature developments of the device based on the customers’ needs investigation. With promising growth projections and considering the overall results of the Phase 1 assessment, we have concluded that it will be worthy to follow-up with the implementation of the development and commercialisation plan.
The project is fully aligned with our strategy to validate and maximise LEXR’s potential for the commercially favourable uses.