A state-of-the-art guide to the sterilization of thermoplastic polymers and resin materials used in the additive manufacturing of medical devices

Bibliographic Details
Title: A state-of-the-art guide to the sterilization of thermoplastic polymers and resin materials used in the additive manufacturing of medical devices
Authors: Roland Told, Zoltan Ujfalusi, Attila Pentek, Monika Kerenyi, Krisztina Banfai, Andras Vizi, Peter Szabo, Szilvia Melegh, Judit Bovari-Biri, Judit E. Pongracz, Peter Maroti
Source: Materials & Design, Vol 223, Iss , Pp 111119- (2022)
Publisher Information: Elsevier, 2022.
Publication Year: 2022
Collection: LCC:Materials of engineering and construction. Mechanics of materials
Subject Terms: Sterilization, Medical device, Mechanical test, Structural analysis, Polymer, Cytotoxicity, Materials of engineering and construction. Mechanics of materials, TA401-492
More Details: Continuous development of additive manufacturing technologies has reached new areas, including medical research and healthcare applications, where precision, highly accurate reproducibility, disinfection, or even sterility of the end product is essential. The study aims to critically evaluate the effect of different sterilization and disinfection methods for most commonly used additive manufacturing technologies and materials in medical device development: PLA (polylactic acid), PETG (polyethylene terephthalate glycol), ABS (acrylonitrile butadiene styrene), and HIPS (high impact polystyrene) for material extrusion technology (FFF; fused filament fabrication), polyamide (PA2200) for powder bed fusion technology (SLS; selective laser sintering), MED610™ for PolyJet™ material jetting, and standard Formlabs™ white resin (V4) for SLA (stereolithography) technology. The materials were tested before and after different sterilization and disinfection protocols, including treatment with 70% ethanol, chlorine solution, H2O2 plasma sterilization, autoclave and dry heat sterilization, applying 10 and 20 cycles in all cases. Bacteriostatic/fungistatic and sterility tests were performed using Escherichia coli, Enterococcus faecalis, and Candida albicans as reference strains. Cytotoxicity was evaluated using A549 cells. The samples showed significant structural or aesthetic alterations detected by various mechanical tests, scanning electron microscopy, or differential scanning calorimetry (DSC-TGA). No significant cytotoxic effect was revealed during the experiment. Our results can serve as a guide for the selection of effective sterilization and disinfection methods for the most common materials used in 3D printing in medical and healthcare applications.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 0264-1275
Relation: http://www.sciencedirect.com/science/article/pii/S0264127522007419; https://doaj.org/toc/0264-1275
DOI: 10.1016/j.matdes.2022.111119
Access URL: https://doaj.org/article/883fb3183b4a4cfd9cfc44976a4713b7
Accession Number: edsdoj.883fb3183b4a4cfd9cfc44976a4713b7
Database: Directory of Open Access Journals
More Details
ISSN:02641275
DOI:10.1016/j.matdes.2022.111119
Published in:Materials & Design
Language:English