Ethylene Oxide Sterilization
A Commonly Used Sterilization Process
Ethylene Oxide (EO) is a low temperature gas that can penetrate thin films and breathable materials in order to sterilize effectively.
EO is an alkylating agent and alters the amino acids that make up a microorganism's proteins, DNA and RNA.
EO is most useful when a product cannot be exposed to heat, humidity, or radiation and thus is useful for a wide variety of medical devices that aren't enabled through other processes. For most types of thin films and breathable packaging EO will penetrate through and sterilize effectively.
Benefits
- Provides a low-temperature processing environment that is gentle on adhesives, bonding agents and materials of construction.
- Useful for long cannulated polymeric constructed devices
- Able to sterilize heat or moisture-sensitive products
- Least potential for product material degradation and widest material compatibility
Limitations
- Lengthy cycle, aeration and post-processing duration
- Materials with high absorption rates such as silicone may exhibit high levels of “residuals” that can pose cytotoxicity challenges.
- Potential for hazardous exposure to patients and staff
- Processing Environment risks include flammability and explosive potential