PMID: 9178738Jul 1, 1997Paper

Autosterilization of biodegradable implants by injection molding process

Journal of Biomedical Materials Research
C KönigJ Blaser

Abstract

Sterilization of degradable implants by standard procedures may damage the parts due to the labile chemical nature of the polymers. This study examined whether the injection molding process used for the production of polymeric parts may itself sterilize the implant due to high temperature, pressure, and shear forces applied. Poly-D,L-lactic acid (PDLLA) and poly-L-lactic acid (PLLA) granules were contaminated with thermoresistant spores of Bacillus stearothermophilus (>10(5) spores/g). Sterile and contaminated granules of both polymers were injection molded and tested for sterility. All 27 samples produced with sterile PDLLA and processed at 120 degrees C and all 18 samples produced with sterile PLLA at 200 degrees C remained sterile after injection molding and handling. However, in five out of 28 PDLLA samples and in one out of 26 PLLA samples produced with contaminated material, spores had survived the process. In conclusion, the injection molding process could not reliably sterilize parts produced with polylactic acid granules that were heavily contaminated with thermoresistant organisms. However, the number of viable spores was significantly reduced by more than 99.99%. Thus, the injection molding process might allow the au...Continue Reading

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Citations

Sep 1, 1999·Proceedings of the National Academy of Sciences of the United States of America·A K DillowR Langer
Sep 2, 1999·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·A Rothen-WeinholdR Gurny
Dec 31, 2011·Journal of Biomaterials Applications·Odd V HöglundAnne-Sofie Lagerstedt
Nov 5, 2003·Biotechnology and Bioengineering·S Spilimbergo, A Bertucco
May 9, 2006·Journal of Biomedical Materials Research. Part B, Applied Biomaterials·Björn Atthoff, Jöns Hilborn
Feb 6, 2003·Biotechnology and Bioengineering·Sara SpilimbergoNeil R Foster

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