​​Ethylene Oxide sterilization Validation services

​​​​​​​​Sterilization and Quality System Consulting LLC

  • Ethylene Oxide Sterilization Validation to ISO 11135 requirements
  • Process Validation - Protocol development, analysis and final report ,
  • ​Process Development for product and packaging compatibility
  • Product Adoption, Product Families, Process category development
  • Process Optimization

  • ​Process Challenge Device Development

  • Materials Selection and Compatibility

  • Ethylene Oxide residual limits to ISO 10993-7 requirements 

  • Supplier / contractor audits 
  • Process troubleshooting, deviation and disposition assistance. 
  • ​Development of Ethylene Oxide equipment requirements, emission control equipment, purchase justification and project management

  • ​​​​Design Requirements

  • ​URS / FRS - User and Functional Requirements Specification.