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熔融沉积成型3D打印后聚乳酸的灭菌:固有无菌性评估及高压蒸汽灭菌的不可行性

Sterilization of PLA after Fused Filament Fabrication 3D Printing: Evaluation on Inherent Sterility and the Impossibility of Autoclavation.

作者信息

Neijhoft Jonas, Henrich Dirk, Kammerer Andreas, Janko Maren, Frank Johannes, Marzi Ingo

机构信息

Department of Trauma, Hand and Reconstructive Surgery, Goethe University Frankfurt, University Hospital, 60326 Frankfurt, Germany.

出版信息

Polymers (Basel). 2023 Jan 10;15(2):369. doi: 10.3390/polym15020369.

Abstract

Three-dimensional printing, especially fused filament fabrication (FFF), offers great possibilities in (bio-)medical applications, but a major downside is the difficulty in sterilizing the produced parts. This study evaluates the questions of whether autoclaving is a possible solution for FFF-printed parts and if the printer itself could be seen as an inherent sterilization method. In a first step, an investigation was performed on the deformation of cylindrically shaped test parts after running them through the autoclaving process. Furthermore, the inherent sterility possibilities of the printing process itself were evaluated using culture medium sterility tests. It could be shown that, depending on the needed accuracy, parts down to a diameter of 5-10 mm can still be sterilized using autoclaving, while finer parts suffer from major deformations. For these, inherent sterilization of the printer itself is an option. During the printing process, over a certain contact time, heat at a higher level than that used in autoclaving is applied to the printed parts. The contact time, depending on the printing parameters, is calculated using the established formula. The results show that for stronger parts, autoclaving offers a cheap and good option for sterilization after FFF-printing. However, the inherent sterility possibilities of the printer itself can be considered, especially when printing with small layer heights for finer parts.

摘要

三维打印,尤其是熔融长丝制造(FFF),在(生物)医学应用中提供了巨大的可能性,但一个主要缺点是对所生产部件进行灭菌存在困难。本研究评估了高压灭菌是否是FFF打印部件的一种可行解决方案,以及打印机本身是否可被视为一种固有的灭菌方法。第一步,对圆柱形测试部件进行高压灭菌处理后,对其变形情况进行了调查。此外,使用培养基无菌测试评估了打印过程本身固有的无菌可能性。结果表明,根据所需精度,直径小至5 - 10毫米的部件仍可通过高压灭菌进行灭菌,而更精细的部件会出现严重变形。对于这些部件,打印机本身的固有灭菌是一种选择。在打印过程中,在一定的接触时间内,施加到打印部件上的热量高于高压灭菌所使用的热量。根据打印参数,接触时间使用既定公式计算。结果表明,对于强度较高的部件,高压灭菌为FFF打印后灭菌提供了一种廉价且良好的选择。然而,打印机本身固有的无菌可能性也可加以考虑,特别是在以小层高打印更精细部件时。

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