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- Performed to the 2011 FDA Draft Guidance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
- 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 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.