Ethylene Oxide ProcessingSustainable EO® Sterilization

Ethylene oxide (EO) is a universally accepted sterilization technology that has delivered safe, sterile healthcare products for patient care since the 1960s. However, with the use of ethylene oxide as a sterilant, human safety and environmental challenges must be considered.

As part of our commitment to providing innovative and sustainable solutions, STERIS AST has developed the Sustainable EO sterilization services program. Our Sustainable EO services provide Customers with strategies to reduce the EO sterilant used in the sterilization process to achieve the prescribed Sterility Assurance Level.

The program includes innovative approaches to EO sterilization, such as cycle design, validation strategy, and process challenge device design, all focused on the reduction of EO residuals on healthcare products.

Optimized sterilant input may provide several benefits, including:

  • Lower product residuals to meet current and future patient safety requirements
  • Improved occupational safety
  • Improved supply chain efficiencies due to reduced aeration (off-gassing) of ethylene oxide gas

Our EO TechTeam® experts support manufacturers of healthcare products with validating the Sustainable EO sterilization cycles for their unique products. Upon completion of the validation, a final report is provided that includes the Sustainable EO Services Scorecard.

The scorecard, which can also be provided as a benchmark for existing sterilization cycles, highlights the achieved sustainability rating by showing the EO concentration (mg/l) used in each cycle.

 

Sustainable EO Scorecard

Go here to learn how the Ethylene Oxide Master File Pilot Program may help Customers modify existing EO process through the STERIS Sustainable EO® sterilization program, without the need to submit a PMA supplement to the FDA for approval.

Interested in learning how Sustainable EO sterilization services can be applied to your product?

Contact STERIS AST using the form on this page or by calling:
Americas: 877-783-7479
EMEAA: +44 (0) 8456 88 99 70

Contact our team of experts to find out more about our Global Contract Sterilization, Testing and Validation Services.