Novel Ozone Based Sterilizer for Medical Device and Life Sciences

“目前的赠款将允许Anacail有限公司通过建立一个原理证明机器来验证产品概念，该机器可以对一次性使用的医疗设备进行灭菌，并同时在制造时将其包装在密封的初级包装中。市场对这种设备的需求是所有医疗和医疗保健设备无菌的共同要求。传统的技术，如辐射或环氧乙烷，要么对材料造成损害，要么会在设备上留下有毒残留物。现代医疗和保健设备在先进材料和表面处理以及电子和光学集成方面的日益复杂，加剧了这些缺点。此外，使用危险或有毒化学品会带来重大的健康和环境风险，因为这些材料必须以安全和负责任的方式储存和处理。Anacail开发了一种基于臭氧的技术，一种天然存在的氧的同素异形体，一旦灭菌完成，它就会衰变回天然氧。这使得该技术对环境无害，并且处理起来相对安全，因为没有用于储存、运输或处置的有毒化学物质。臭氧已经被FDA等监管机构认可为灭菌剂（www.fda.gov/downloads/MedicalDevices/.../由于两个关键缺点，臭氧没有被更广泛地用作灭菌剂：当用作传统的基于腔室的灭菌器时，与替代品相比，其作用相对较慢，并且其历史上使用纯氧作为原料气体，Anacail最近获得了一项非危险气体成分的专利，该成分仅含有21%的氧气，但可以提供高浓度的臭氧。这消除了易燃性问题，从而允许Anacail将这种气体注入袋子中，然后密封。袋内物品经过消毒，然后袋内的臭氧分解为氧气，不留任何残留物。这项技术对社会的好处是减少医疗获得性感染的发生率，在减少使用危险化学品或放射源方面提供更高的安全性，并减少与使用、储存和处置危险化学品相关的环境影响。该技术可适用于医疗保健和医院环境中的应用，从而开辟第二市场并直接解决医疗保健获得性感染。"

"The current grant will allow Anacail Ltd to validate a product concept by building a proof of principle machine which can sterilize single use medical devices, and simultaneously pack them in a sealed primary pack, at point of manufacture.The market need for such a device is the common requirement across all medical and healthcare devices for sterility. Traditional techniques such as radiation or ethylene oxide are either damaging to materials, or can leave toxic residues on devices. The increasing sophistication of modern medical and healthcare devices in terms of advanced materials and surface treatments and the integration of electronics and optics, exacerbates these drawbacks.Furthermore, the use of hazardous or toxic chemical presents a significant health and environmental risk as these materials must be stored and disposed of in a safe and responsible manner.Anacail has developed a technology which is based on ozone, a naturally occurring allotrope of oxygen, which, once the sterilization is complete, decays back into native oxygen. This renders the technology environmentally benign and relatively safe to handle as there are no toxic chemicals for storage transport or disposal.Ozone is already recognised as a sterilant by regulatory authorities such as the FDA (https://www.fda.gov/downloads/MedicalDevices/.../ucm109897.pdf) which can remove significant hurdles to its adoption.Ozone has not been more widely adopted as a sterilant because of two key drawbacks: When used as a conventional chamber based steriliser, its is relatively slow acting compared with alternatives, and it historically uses pure oxygen as a feedstock gas, which creates significant flammability issues.Anacail has recently patented a non hazardous gas composition which only contains 21% oxygen, yet can provide high ozone concentrations. This removes the flammability issues which in turn allows Anacail to inject this gas into a bag, which is then sealed. The bag contents are sterilized, and then the ozone in the bag decays back to oxygen, leaving no residues.The benefit to society for this technology is to reduce the incidence of healthcare acquired infections, provide increased safety in terms of reduced use of hazardous chemicals or radioactive sources, and reduce environmental impact associated with use, storage and disposal of hazardous chemicals.Once developed, the technology can be adapted for application in healthcare and hospital environments, opening up a second market and directly addressing healthcare acquired infections."