High-strength, medical-grade PETG-based polymer introduced for 3D printing
A high-strength PETG-based material that withstands high-temperature 3D printing has been introduced by taulman3D (St. Peters, MO) for medical device applications. The material, branded as guidel!ne, complies with the international biocompatibility standard ISO 10993 and is “released as a starting point for individuals and companies wishing to obtain eventual FDA approval or CE certification for a device,” writes the company.
Although the raw material is listed with FDA and has passed specific FDA testing, it should be noted that market clearance or approval is only conferred on the finished medical device.
Guidel!ne is sold as a raw material modified in form to be compatible with 3D printing, according to taulman3D, and is extruded in a manner such that contaminates cannot infiltrate the material during the cooling process. In addition, pH and oxidation-reduction potential (ORP) levels are monitored and adjusted to maintain acceptable levels.
Taulman3D will provide the user with information that is aligned with FDA’s “Technical Considerations for Additive Manufactured Devices Draft Guidance for Industry and Food and Drug Administration Staff, Section C, Material Controls.”
Guidel!ne is supplied in one-pound spools measuring 1.75 or 2.85 mm that include a QR code to ensure traceability. Each individually numbered spool is vacuum sealed and shipped in its own box, and users will be able to register their spools with taulman3D.
Under 3D printing conditions, guidel!ne has a tensile strength of 6,850 psi, 5.9 elongation and 281,469 psi modulus. The heat distortion temperature is 70°C, and softening temperature is 100°C. The clear PETG-based polymer prints at 250°C.
A key feature of guidel!ne is the capability of easily printing small, hollow tubes. Printing small features can be difficult because of thermal buildup that, in this application, would result in deformation of the tube. Guidel!ne is less susceptible to thermal issues, according to taulman3D, allowing for finer detail without distortion.
Moreover, the material’s high print temperature allows its use as a a zero-gap support material for medical-grade nylon. It provides sufficient adhesion for mechanical support yet is easy to remove from parts where mechanical removal is possible.
Source: www.plastictoday.com
