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Related Experiment Videos

Autosterilization of biodegradable implants by injection molding process

C König1, K Ruffieux, E Wintermantel

  • 1Department of Medicine, University Hospital Zurich, Switzerland.

Journal of Biomedical Materials Research
|July 1, 1997
PubMed
Summary

Injection molding cannot reliably sterilize heavily contaminated polylactic acid implants. However, this process significantly reduces bacterial spores, potentially offering autosterilization for lightly contaminated materials.

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Area of Science:

  • Biomaterials Science
  • Polymer Engineering
  • Sterilization Technologies

Background:

  • Standard sterilization methods can degrade labile polymers used in degradable implants.
  • Developing alternative sterilization techniques for biodegradable medical devices is crucial.

Purpose of the Study:

  • To investigate if the injection molding process itself can sterilize poly-D,L-lactic acid (PDLLA) and poly-L-lactic acid (PLLA) implants.
  • To assess the efficacy of injection molding in eliminating thermoresistant bacterial spores from polymer implants.

Main Methods:

  • Polymer granules (PDLLA and PLLA) were intentionally contaminated with Bacillus stearothermophilus spores.
  • Both sterile and contaminated granules were processed using injection molding at elevated temperatures (120°C for PDLLA, 200°C for PLLA).

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  • Molded parts were subsequently tested for microbial contamination to evaluate sterility.
  • Main Results:

    • All samples produced from sterile PDLLA and PLLA remained sterile post-injection molding.
    • In heavily contaminated samples, injection molding did not achieve complete sterilization, with some spores surviving.
    • A significant reduction of over 99.99% in viable bacterial spores was observed in contaminated samples.

    Conclusions:

    • The injection molding process is not a reliable standalone sterilization method for heavily contaminated polylactic acid implants.
    • Injection molding demonstrates potential for autosterilization of implants manufactured from raw materials with low levels of contamination.
    • The high temperature, pressure, and shear forces during injection molding significantly reduce microbial load.