Connect 2 Cleanrooms support Preclinical and Clinical trials for ArterioSorb™

Connect 2 Cleanrooms latest bespoke modular cleanroom installation supports the development of  next-generation bioresorbable cardiovascular scaffold (stent), ArterioSorb™.

ArterioSorb™ is an innovative medical implant product currently being developed by UK medical device SME, Arterius Ltd, to assist in the treatment of coronary artery disease which affected 110 million people and resulted in 8.9 million deaths in 2015.

As the first of its kind in the UK, the bioresorbable cardiovascular scaffold is to be implanted within coronary arteries in order to open blocked vessels, bio-degrading within two years when the healing is complete and no longer needed.  The ArterioSorb™ development was supported by a consortium of experts comprising a clinical advisory team; computational design group at Southampton University; polymer process engineering at Bradford University and first- class pre-clinical and clinical institutions.

After recently completing their initial pre-clinical trials, Leeds based Arterius Ltd quickly established the need for a cleanroom to facilitate the next stage of their project and start clinical trials by the end of 2018.  As a medical industry requirement, Connect 2 Cleanrooms designed, manufactured and installed a Modular Hardwall panel system at their premises to improve the quality, purity and consistency of their end product. 

With an overall footprint of 20.72m², the install included a small external change area which allows operators to gown up in a controlled environment.  The main cleanroom area is 4m x 4.4m, ISO Class 8 and controlled by the ECO System with a built in alarm function, providing Arterius with a sustainable approach for their cleanroom.  The design incorporates a mixture of hinged doors and sliding doors aiding the flow of material and personnel in and out of the cleanroom and the Arterius logos to the outer panels add personalisation to the room.

The flexibility and ease of the quotation process made the decision to go with Connect 2 Cleanrooms an easy one, stated Dr Naveed Ahmed, Development Scientist at Arterius ‘Our decision to use Connect 2 Cleanrooms as the supplier of our cleanroom was down to the rapid response to communications and quote requests, as well as the short lead time.  They listened to our needs and made recommendations to best match our requirements.’

‘The installation of the cleanroom has impacted our business greatly, it’s an asset we are proud to have which will rapidly progress the development of our products to the next stage.  It will allow us to manufacture medical device products to the necessary standards of quality.’ Naveed continued.