Novel Ozone Based Sterilizer for Medical Device and Life Sciences

“目前的拨款将允许Anacail有限公司通过建立一个原理验证机器来验证产品概念，该机器可以对一次性医疗设备进行消毒，同时在制造时将它们包装在密封的主包装中。市场对这种设备的需求是所有医疗和保健设备对无菌的共同要求。辐射或环氧乙烷等传统技术要么对材料有害，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日益复杂，加剧了这些缺点。此外，使用危险或有毒化学品对健康和环境构成重大风险，因为这些材料必须以安全和负责任的方式储存和处置。Anacail开发了一种基于臭氧的技术，臭氧是一种天然存在的氧的同素异体，一旦杀菌完成，它就会衰变回天然氧。这使得这项技术对环境无害，处理起来相对安全，因为没有有毒化学品需要储存、运输或处置。臭氧已经被FDA （https://www.fda.gov/downloads/MedicalDevices/.../ucm109897.pdf）等监管机构认可为一种消毒剂，这可以消除其采用的重大障碍。臭氧并没有被广泛采用作为灭菌剂，因为有两个关键的缺点：当用作传统的基于室内的灭菌剂时，与替代品相比，它的作用相对缓慢，并且它历来使用纯氧作为原料气体，这产生了明显的可燃性问题。阿那卡伊最近申请了一种无害气体成分的专利，它只含有21%的氧气，但可以提供高浓度的臭氧。这就消除了可燃性问题，从而使Anacail能够将这种气体注入袋子中，然后将其密封。袋子里的东西被消毒，然后袋子里的臭氧衰变成氧气，不留任何残留物。这项技术对社会的好处是减少医疗保健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。一旦开发出来，该技术可以适用于医疗保健和医院环境，开辟第二个市场，直接解决医疗保健获得性感染问题。”

"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."