STERILIZATION & VALIDATION

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  • Hospital reusable Instrument Sterilization (performed to the 2011 FDA draft guidance)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

3M STERI-VAC STERILIZER:AERATOR 8XL

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.