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.
An early prototype was developed in conjunction with Tharsus Group, a collaborative manufacturing specialist. The technology will enable medical equipment manufacturers to sterilise medical devices at the point of production.
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).
