Sterilisation of Polymer Healthcare Products

Chapter 6: Ethylene Oxide Sterilisation - Ubiquitous for Most Non Liquid Heat Sensitive Materials

Overview

EO is useful for sterilising heat and radiation sensitive materials, polymers and plastics [1, 2, 3]. It is still one of the predominant methods of sterilisation used in the healthcare industry and second to steam sterilisation in hospitals, and equivalent to radiation in the medical device industry. EO sterilisation acquired this position with the advent and popularity of using heat sensitive polymeric materials for medical devices and special surgical instruments and supplies such as sutures.

Originally EO was used for the decontamination of spaces, but it has become the predominant means of sterilising heat sensitive polymer materials in healthcare products.

Some effects of EO sterilisation on materials in healthcare products are:

  • Compatible with most polymeric materials

  • Some materials are sensitive to the humidity of the EO process. For example, certain hydrophilic coatings

  • Some materials can be more compatible with other methods under certain moulding, configuration, and load conditions

  • Certain extremely temperature sensitive materials are not compatible at its higher temperatures (e.g., > 60 C)

  • Residues may be toxic - often requiring long degassing times

  • Penetration is limited through thick gas diffusion barriers, and some mated surfaces.

EO sterilisation is a gaseous method. It is an ideal gaseous sterilant because of its characteristically high diffusivity and permeability. It is a ring ether compound, with relatively no charge. One of its disadvantages is toxic residuals, (e.g., ethylene oxide, ethylene chlorohydrin, and the less toxic ethylene glycol). Other significant characteristics of this chemical are its low...

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