STERILIZATION & VALIDATION
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Ethylene Oxide (EtO) Sterilization
Small-batch, quick-turn in-house sterilization
Life Science Outsourcing is uniquely positioned to support R&D, custom product, and lean manufacturing EtO cycles in-house, 3M Steri-Vac™ sterilizers ~8 cubic feet, validated chambers. We also provide in-house BI testing.
EtO 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- Hospital reusable Instrument Sterilization (performed to the 2011 FDA draft guidance)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
EtO Sterilization in support of Package Integrity & Product testing
- Destructive Testing
- Packaging Evaluation
- Pouch Qualification
3M™ Steri-Vac™ Sterilizer/Aerator GS8X
Chamber Volume: ~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 Batch EtO Sterilization
Life Science Outsourcing also provides large scale EtO Sterilization processing in association with our partners, utilizing a broad inventory of chamber sizes.
All processing is performed in accordance with ISO 11135.
