MeDFila® – Making Medical Application Possible
Additive Manufacturing (AM) has received enormous attention for decades, the application in clinical practice, however, remains stagnant. This is mainly contributed by the lack of integration between material science, machinery and medical regulation. In light of that, MeDFila® was launched to eliminating the obstacles.
MeDFila® is a registered trademark of a series of biodegradable polymeric filaments (some blended with ceramics in various ratio) designed for medical application via FDM system. Three different grades, i.e. Research grade, Medical grade for research and GMP grade, of MeDFila® are offered to specifically fulfill various demands and requirements, such as early stage prototyping, animal study, and manufacture of medical devices or implants.
With the release of MeDFila® , medical applications become possible for additive manufacturing. A fully traceable documentation is exclusively provided for medical devices manufacturers to facilitating clinical approval as well as systemic quality control. The sky is no longer a limit for your outstanding and innovative research and development.
MeDFila® is an ideal material for medical implant manufacturing, base on features below:
- Medical-grade filament ready for medical implant printing
- Adjustable bio-degradation time
- Produced in GMP-like environment
- Gamma sterilizable
- Standard diameters for FDM system (1.75mm & 3.00mm)
In addition, with ABT’s proprietary desktop FDM printing system, users could print medical implant directly for clinical use.
All medical-grade filaments are produced under Good Manufacturing Practices guidance. Medical grade filaments are fabricated in the clean room with well-controlled humidity, temperature, and particles. Certificate of Analysis (COA) will be provided within each lot of medical-grade filament.
Check our online store for more information:
The manufacturing process of MeDFila®
Features of different grades of MeDFila®
We provide three different grades of MeDFila® filaments for various intended use including R&D, Medical (R&D) and Medical (GMP) grade. Clients should select the appropriate grade depend on their specific application. Should you have any uncertainty, please Contact Us to discuss for more detail.
|R&D||for research purpose||1. For research only|
|Medical (R&D)||for medical related research purposes||1. CoA
2. Ready for animal study
3. Not for human use
|Medical (GMP)||for device design||1. CoA
3. ISO 7 clean room
4. Controlled temperature
5. Controlled humidity
6. Particle control
7. Please call for quote and availability. (Manufacturing on Demand)
Packaging and Logistic
Packaging, storage, and environmental consistency during logistics are vitally important for bio-degradable filament to avoid unpleasant degradation especially for medical-grade materials. At ABT, we consider every detail for our products to ensure the consistency of quality till the product be delivered to our customers. The packaging process was performed in a clean room to maintain the quality of MeDFila®, filaments are heat-sealed in Tyvek bag and further heat-sealed in aluminum foil bags as an outer bags.
All GMP grade MeDFila® will be delivered by a professional logistics company* within the precise temperature control and certified packaging to ensure superior quality.(*Depends on client’s demand)
Should you have any enquiries, please Contact Us for more detail.