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Sterilization of products contaminated with Pyronema domesticum

Carol M Lampe1, Joyce M Hansen, Therese M Rymer

  • 1Baxter Healthcare, USA. carol_lampe@jmhai.com

Biomedical Instrumentation & Technology
|January 1, 2010
PubMed

Insights

Pyronema domesticum, a mold found in Chinese cotton, showed low resistance to moist heat and radiation sterilization. However, this organism demonstrated high resistance to ethylene oxide (EO) processing, impacting product sterility.

Area of Science:

  • Microbiology
  • Sterilization Science
  • Medical Device Manufacturing

Background:

  • Product recalls in 1993-1994 were linked to non-sterile Chinese cotton products sterilized with ethylene oxide (EO).
  • The primary contaminant identified was Pyronema domesticum, a mold with specific reproductive requirements.

Purpose of the Study:

  • To investigate the sterilization resistance of Pyronema domesticum found in China-sourced cotton.
  • To understand the implications of P. domesticum contamination on ethylene oxide sterilization efficacy.

Main Methods:

  • Sterilization resistance studies were conducted on cotton naturally contaminated with P. domesticum.
  • Resistance to moist heat, radiation, and ethylene oxide (EO) processing was evaluated.

Main Results:

  • Pyronema domesticum exhibited low resistance to moist heat sterilization (121°C).
  • Radiation resistance was comparable to the bioburden-based model (Population C).
  • The organism showed significant resistance to ethylene oxide (EO) sterilization processing.

Conclusions:

  • Pyronema domesticum poses a sterilization challenge, particularly for ethylene oxide processes.
  • Understanding the resistance profile of P. domesticum is crucial for ensuring the sterility of medical products.

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