According to EnXray its sterilisation product for the medical sector will improve efficiency as well as cutting costs allowing manufacturers to sterilise devices at the point of production.
EnXray, a UK medical technology start-up is commercialising its technology for sterilisation of medical devices and life science products with the aim of developing, producing and distributing equipment for in-house sterilisation.
Medical devices must meet stringent regulatory requirements, including ISO13485. This governs the manufacture of medical devices, including the requirements for medical devices to be designated sterile. Sterility is typically defined by demonstrating a 6 Log reduction in the bacterial load to achieve the required Sterility Assurance Level (SAL).
Currently, the majority of OEM medical device manufacturing sterilisation is performed on an outsourced, third-party basis, with approximately 53% of the market treated with ethylene oxide (ETO) gas sterilisation, and 43% using some form of ionising radiation (gamma, electron beam or high energy x-ray), and the remainder comprised of other methods, such as autoclaving, H2O2 gas, O3 and NO2 gas.
This can vary considerably in different regions. For example, the UK market is heavily reliant on ionising radiation. China predominantly uses ETO; however, a large number of gamma facilities are being built, which will increase radiation sterilisation in that region.
While the US is broadly in line with the global breakdown, this can vary regionally within the US, based in part on proximity to the third party service providers’ regional capabilities. Ionising radiation and ETO sterilisation are capital intensive systems and when transportation and logistics time is considered, sterilisation represents the largest single process step involved in getting the product manufactured and delivered to the point of care.
Edward Cappabianca, co-founder of EnXray, said: “Companies continuously seek process improvements and cost reductions, as well as competitive advantages in time to market. The last step of sterilisation is the only one outside of their control. Most manufacturers would prefer to manage sterilisation in house; however, the capital costs associated with current methods make it prohibitive, as well as additional health and safety requirements which would come with the existing methods.”
To overcome this challenge, EnXray is pioneering a new approach to sterilising medical devices using low energy x-ray (LEXR).
Cappabianca added: “With increasing regulatory pressures, combined with the need to identify cost-savings, terminal sterilisation is an area that will become more important in the future.
“With the advent of LEXR sterilisation, companies will be able to streamline their production processes, while lowering costs and improving time to market.”
The characteristics of LEXR make it suitable for individual ‘on site and on demand’ sterilisation of medical devices for OEMs. LEXR is not able to transmit very far however, the local absorption rate is very high, resulting in a high dose efficiency ratio.
The intention is to provide a ‘matched kGy dosage’ to that achieved by the existing method, to provide an alternative for sterilising rush orders or small batches more efficiently.
The modular nature of the equipment is expected to enable easy integration into most manufacturing environments, allowing for ‘distributed sterilisation’ that will increase efficiency and shorten time to market for many companies.
This technology has now been developed into a prototype device by the Tharsus Group, which was part of a development partnership agreement with EnXray.
Tharsus Group’s position as an early adopter of the original equipment design and manufacture (OEDM) outsourcing service model includes product design and development and contract manufacture. This will enable it to take the product from initial concept through to scaled production in the shortest possible time.
Brian Palmer, chief executive of Tharsus Group, said: “This is a ground-breaking innovation that will have a significant impact on the way medical equipment is manufactured.
“Tharsus will tackle the complexities that come with the realisation of EnXray’s latest innovation, mitigating risk and generating a commercially successful product based on the company’s intellectual property.
“Our knowledge-based approach to new product creation enables our engineers to realise EnXray’s insight into its market, which will deliver a scalable system that will be manufactured for the global medical industry.”
Cappabianca added: “Partnering with Tharsus is a significant element of the evolution of our expertise in medical sterilisation. Their specialism in the commercialisation of high value, electro-mechanical products will help us bring a new solution in the med-tech field that will meet the requirements of medical device OEMs.”