Ethylene Oxide (EO) Sterilization

Ethylene Oxide (EO) Sterilization

Ethylene Oxide (EO) Sterilization is used for gas compatible devices of all types and configurations for both terminal sterilization as well as sterilization of reusable devices. LSO provides contract EO sterilization services for both purposes, as well as EO validation services. We break our EO service offering into two groups, Small Batch Processing, and Large Batch processing.

In-House Small Scale EO Sterilization

At LSO, we are uniquely positioned to support R&D, custom product, and lean manufacturing EO cycles in our two in-house, 3M Steri-Vac™ sterilizers ~8 cubic feet, validated chambers. We also provide in-house BI testing. These unique in-house capabilities enable us achieve faster turn-around times and provide services in a cost effective and efficient way.

LSO Provides the following EO Services:

  • R&D and Cycle Development
    • Fractional Cycle
    • Half Cycles
    • Full Cycle with EO Residual testing
    • 2X qualification
    • Selection of PCDs
  • Complete EO Validation Package
  • Routine EO Sterilization
  • Hospital reusable Instrument Sterilization
    • Performed to the 2011 FDA Draft Guidance
  • Expediting for urgent or immediate requirement projects.
  • Ability to deliver process documentation via fax or e-mail
  • EO Sterilization in support of Package Integrity & Product testing
    • Destructive Testing
    • Packaging Evaluation
    • Pouch Qualification

Equipment

  • Two EO Sterilizers - 3M™ STERI-VAC™ STERILIZER/AERATOR 8XL
  • LSO chambers provide "All in One" cycles: Preconditioning, Sterilization and Aeration are performed in-chamber
  • Chambers and processing equipment conform to all regulatory requirements; EPA, OSHA, SCAQMD, AAMI

3M™ STERI-VAC™ STERILIZER/AERATOR 8XL

Chamber Vol: ~8ft³
Chamber Size: 18" H x 20" W x 38" D
Standards Performed: ISO 11135 - 2007
Cycle Types and Temps: 37°C - 55°C (Typical 55°C)

Cycle Parameter Ranges

Exposure Time: 1 - 8 hours (Standard is 4 hours)
Applications: Medical Devices and Hospital Reusable Instruments

Large Scale EO Sterilization

LSO also provides large batch EO Sterilization processing in association with our partners, utilizing a broad inventory of chamber sizes.

All processing is performed in accordance with ISO 11135.


As part of any sterilization validation or production sterilization project, LSO offers:



This information was provided by Sterilization Validation Services, a Division of Life Science Outsourcing, Inc. For more information visit www.lso-inc.com/svs