Clean Room Innovation: BRAV3 device manufacturing in silicone (LSR)

Thanks to the technological capacity and competitiveness in plastic and liquid silicone manufacturing for the medical sector, OSF has been able to work for the BRAV3 Project, due to its close collaboration with one of the consortium partners, Leartiker.

This European project led by the Clínica Universitaria de Navarra, “BRAV∃: Computational biomechanics and bioengineering 3D printing to develop a personalized regenerative biological ventricular assist device to provide lasting functional support to damaged hearts” is funded within the Horizon 2020 call of the European Commission.

OSF: Collaborating on Medical Device Innovation

The overall concept is the development of a durable and functional support for damaged hearts by means of a customized advanced biological ventricular assist device. 

After suffering a myocardial infarction, the heart is no longer able to function properly. 

In these cases, the patient is implanted with a device called a “ventricular assist device” which is an implantable mechanical pump that helps pump blood from the ventricle to the rest of the heart. 

The BRAV∃ project proposes to use tissue engineering for the development of an implantable patch in the regenerative zone which will help to fulfill the function of the heart. 

This project, led by the University of Navarra (UNAV) involves the participation of 14 partners including European universities, technological institutes, etc.

Leartiker, within the framework of the project, is responsible for the development of the bioreactor in which the cardiac tissue will be matured.

Leartiker has identified the need to complement its experience in the manufacture of medical devices by injection in a clean room, as well as in the design and development of the necessary tools for this process.

These devices are part of a bioreactor for the maturation of cardiac tissue, which requires the services of a company specialized in this type of project.

To address this need, OSF brings its experience and capabilities in the manufacture of media and components of the device, ensuring an efficient and high quality development.

The set of parts that is part of the device for maturing cardiac tissue, is composed of a body and a lid.

Biocompatible silicone. Optical silicone.

The material required for this application is biocompatible silicone. In addition, for the lid, it is necessary to use optical silicone that guarantees adequate transparency and performance properties.

Its processing has been challenging, as liquid silicone injection is delicate and requires a high level of skill and experience to be performed safely and effectively.

In our ISO 7 rated Clean Room we have specialized equipment and ovens, fully adapted to medical standards.

We have made several improvements to the mold to meet the specific needs and requirements of our customers, ensuring quality and precision in every device we manufacture.

Silicone post-curing in Clean Room

In addition, silicone parts are post-cured, handled and conditioned in the Clean Room to guarantee conditions and avoid contamination during transportation and storage.

ISO 13485 manufacturing for the medical sector

With our manufacturing expertise and rigorous quality standards in accordance with ISO 13485, we are committed to delivering high-performance products that contribute to the advancement of the medical industry.