a Department of Biochemical and Chemical Engineering , TU Dortmund University , Dortmund , Germany.
Pharm Dev Technol. 2018 Dec;23(10):1136-1145. doi: 10.1080/10837450.2018.1492618. Epub 2018 Jul 23.
Fused deposition modeling (FDM) is a promising 3D printing technique for the fabrication of personalized drug dosage forms and patient-specific implants. However, there are no market products produced by FDM available at this time. One of the reasons is the lack of a consistent and harmonized approval procedure. In this study, three FDM printers have been characterised with respect to printing parameters relevant for pharmaceutical and medical applications, namely the positioning, hot-end temperature, material residence time, printing velocity and volumetric material flow. The printers are the Ultimaker 2 (UM2), the PRotos v3 (PR3) as well as an in-house developed printer (IDP). The positioning results showed discrepancies between the printers, which are mainly based on different types of drive systems. Due to comparable utilised hot-ends and nozzle geometries, the results for the temperature and residence time distribution measurements were quite similar. The IDP has a high positioning accuracy but is limited with respect to printing velocity, while the achievable material volume flows were different for all printers. The presented characterisation method aims to contribute to the development of a harmonized equipment qualification framework for FDM printers, which could lead to an acceleration and facilitation of an approval procedure for 3D printed products.
熔融沉积成型（FDM）是一种很有前途的 3D 打印技术，可用于制造个性化药物剂型和患者专用植入物。然而，目前还没有市场上可用的 FDM 生产的产品。其中一个原因是缺乏一致和协调的审批程序。在这项研究中，对三种 FDM 打印机进行了特性描述，这些打印机与制药和医疗应用相关的打印参数有关，即定位、热端温度、材料停留时间、打印速度和体积材料流量。这三种打印机分别是 Ultimaker 2（UM2）、PRotos v3（PR3）以及内部开发的打印机（IDP）。定位结果显示，打印机之间存在差异，这主要是基于不同类型的驱动系统。由于使用了类似的热端和喷嘴几何形状，因此温度和停留时间分布测量的结果非常相似。IDP 的定位精度很高，但打印速度受到限制，而所有打印机的材料体积流量都不同。所提出的特性描述方法旨在为 FDM 打印机的设备资格认证框架的开发做出贡献，这可能会加速和简化 3D 打印产品的审批程序。
