Ethylene oxide sterilization: III--Influence of carrier nature in a biological monitor performance

J Pharm Sci Technol. 1994 May-Jun;48(3):155-8.

Abstract

The ethylene oxide sterilization process control should take into account several parameters, so that only the biological monitor can integrate in all of them, presenting a biological challenge similar to the product under sterilization conditions. The authors evaluated spore resistance on several different carriers: paper, aluminum foil and plastic. The influence was studied through the challenge of sub-lethal cycles, followed by the lethality study and the D-value calculation. There was a significant statistical difference in spore resistance between paper and plastic carriers.

MeSH terms

  • Bacillus subtilis / growth & development
  • Colony Count, Microbial
  • Environmental Monitoring / methods
  • Ethylene Oxide*
  • Linear Models
  • Materials Testing*
  • Paper
  • Plastics
  • Spores*
  • Sterilization / methods*
  • Sterilization / standards*

Substances

  • Plastics
  • Ethylene Oxide