Novel Ozone Based Sterilizer for Medical Device and Life Sciences

"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."