53050Validation of a sterile process in manufacturing of microneedlesClosedStudyInnovate UKInnoture Ltd, a Swansea-based medical device developer, and has patents in the production of unique microneedle-based, transdermal drug delivery technology. This takes the form of a flexible patch which can be adapted for the self-administration of a variety of medicines. The microneedles painlessly make small channels in the skin allowing rapid uptake of a drug. This is especially advantageous as most drugs are poorly absorbed by the skin or in some cases not at all. Production of the micro-devices can be complex. However, the Innoture method removes complexity, can be mass produced simply, and uses safe materials. The efficacy of the technology was successfully applied in a clinical investigation in 2018 and in 2 other trials regards its cosmetic products. We are now aiming to demonstrate that the unique production process can sterilise the devices when produced. This project provides the funding to establish a clean area, develop new processes and gain independent data proving that the process does affect how clean the product is when leaving the production line. Once complete we will have a unique position in the field of microneedle based micro-devices, strengthens our position and credibility in the industry. This significantly reduces the risk of technology adoption providing a strong negotiating platform when we seek to licence our technology to large pharmaceutical companies regards. In addition, the project will reduce the need for road based transport of product to and from service providers reducing carbon emissions and road traffic.