TPE 90A Fabrial-R

Convena is a company that bases its philosophy on bringing solutions together for companies. Since its foundation in 1994, Convena has become the largest independent trader of fluoropolymers in Europe. Convena is responsible for the distribution of materials in different formats such as powder, pellets or filaments.

The materials distributed by Convena are made using raw materials of the highest quality, and all products are subject to strict controls in order to offer high performance solutions.

Convena, an expert in fluoropolymers, has filaments with an optimised composition for optimal results in FDM 3D printing. It has a portfolio of materials including filaments such as TPE Fabrial-R, a TPE filament suitable for medical applications, as it has been tested for skin irritation and sensitisation according to ISO 10993-10.

Flexibility and elasticity

Fabrial-R filament is composed of TPE. TPE (Thermoplastic Elastomer) is also known as thermoplastic rubber. This material has thermoplastic and elastomeric properties, which means that it has elasticity and flexibility and can be processed when heated. It is this latter quality that allows the material to be produced in filament format for FDM 3D printing.

Unlike TPU (thermoplastic polyurethane) filaments, TPE has a smooth finish, which is pleasant to the touch and non-sticky, helping to achieve a high-quality finish on 3D printed parts.

In FDM 3D printing, the hardness of materials is usually indicated by the Shore A or Shore D scales, which perfectly cover the hardness ranges of thermoplastics for AM. In this case, Fabrial-R TPE filament has a hardness of 90A, a medium hardness within the usual range for flexible filaments.

Image 1: Parts 3D printed with Fabrial-R. Source: Convena.

Applications in the medical sector

In general, TPE filaments can be used to manufacture parts of interest for a wide range of sectors, particularly in the construction industry (expansion joints or window insulation) or in the automotive industry (sleeves, dust caps, spring washers or anti-vibration parts).

This is due to some of its intrinsic properties:

• Good resistance to oils/solvents.
• Good UV resistance.
• Abrasion resistance.

However, Fabrial-R TPE filament has a composition that differentiates it from other standard TPE filaments and has enabled it to be approved for skin contact according to ISO 10993-10. ISO 10993 is a biological evaluation of medical devices that validates to varying degrees whether materials or products are suitable for the medical environment. Part 10 of this ISO focuses on tests for testing in relation to skin sensitisation.

In addition, Fabrial-R has also passed the tests required for ISO 10993-5 certification for in vitro cytotoxicity. This test determines whether or not a material or product can cause toxic effects on living cells.

Thanks to these certifications, Fabrial-R TPE filament is a versatile material, suitable for applications within the medical sector such as customised orthotic solutions, support material to stabilise fractures, customised shoe insoles or for the manufacture of tools or devices for the healthcare environment.