Manufacturing

Transforming silicone in a controlled environment in order to produce the safest and most efficient medical devices

We rely on an experienced production team

Based on a huge expertise, we transform elastomers of silicone, gels of silicone in order to obtain the best of this perfect biocompatible material and certified FDA.

Production team

Our team develops innovative silicone transformation processes to ensure the best quality and a high level of safety for our class III medical devices.

With the support of the industrialization team, they use machines developed by SYMATESE AESTHETICS and optimise the products to take into account their rheology, chemistry and mechanical behaviour regarding our different types of silicone.

All the processes of production are validated and done in a control environment (more than 1000 m² of clean rooms ISO 7 & 8) validated and dedicated to medical devices class III

Sterilisation process

Our Silicone Gel-Filled Breast Implants are terminally sterilised on our manufacturing site by dry heat according to the standard ISO 20857. This validated process ensures a sterility assurance level (SAL ) of 10^-6 even inside of the implant. Moreover there is no risk of residual product with this type of sterilisation.

Packaging process

Our Silicone Gel-filled Breast Implants are packaged in a double sterilised barrier, conform ISO 11607-1 and the process is fully validated according ISO 11607-2

Focused on safety and performances of our medical devices

Production teams are dedicated 100% to the best practices. They are trained and qualified in order to ensure a very high level of safety for our medical devices to meet physicians and patients expectations