guidel!ne Medical Grade Features:
guidel!ne is a unique high strength PETG based 3D printing material with excellent high temperature printing capabilities. Users know that printing small features of some parts can be difficult due to thermal build-up. guidel!ne is much less susceptible to these thermal issues allowing for finer detail without distortion. guidel!ne is also released as a starting point for individuals and companies wishing to obtain eventual FDA/CE certification for a medical grade device knowing that the raw material itself is listed with the FDA and has already passed specific FDA testing. guidel!ne is sold as a raw material modified in form only into 3d printing line and most important, extruded in a manner that keeps contaminates out of the material during the cooling process, where contaminates and bacteria could be embedded in the soft extrusion. In addition, pH and ORP levels are monitored and adjusted to maintain acceptable levels.
Information provided to the user will be in sync with the FDA’s “Technical Considerations for Additive Manufactured Devices Draft Guidance for Industry and Food and Drug Administration Staff”. Section “C” “Material Controls”. While COA’s will be the responsibility of the end user, taulman3D will provide information to support such efforts.
guidel!ne meets the following:
ISO 11607-1: 2006
USP Class VI
DMF (Drug Master File) number 16525
Print temperature = 245C to 252C
When 3D Printed, guidel!ne has a tensile strength of 6,850PSI.
Elongation is 5.9 and a modulus of 281,469PSI.
Heat distortion temp is 70C.
Softening temperature is 100C
guidel!ne is a clear PETG based polymer that prints at 250C. guidel!ne is very easy to print needing only a small amount of retraction. A key feature of guidel!ne is that one can easily print small hollow tubes without the issue of heat build-up deforming the tube.
guidel!ne’s use as a Support Material:
Another feature of guidel!ne is that it’s higher print temperature allow it to be used as a support material for medical grade Nylon. guidel!ne used as a zero-gap support material works extremely well on Nylon with just enough adhesion to form mechanical support yet easy to remove from parts where mechanical removal is accessible.
To register your spool/s of guidel!ne, send an email to the address below and include your serial # in the subject line.
In the body, include any info you wish to provide as to your use of guidel!ne.
guidel!ne is sold as a raw material modified in form only into 3d printing line and most important, extruded in a manner that keeps contaminates out of the material during the cooling process, where contaminates and bacteria could be embedded in the soft extrusion.
In addition, pH and ORP levels are monitored and adjusted to maintain acceptable levels.