EO Sterilization Validations

LexaMed has extensive knowledge and experience in all aspects of Ethylene Oxide (EO) Sterilization.  LexaMed consultants have served as co-chairs of the AAMI Sterilization Standards Committee Working Groups for Industrial Ethylene Oxide Sterilization (ST/WG 01), Biological Indicators (ST/WG 04) and Hospital EO Sterilizers (STWG 62) and remain as current members. 

LexaMed can assist companies with all of the aspects of EO sterilization.   This included firms that currently have or are contemplating purchasing a 3M sterilizer, or companies that just want to utilize the unit’s capabilities for a specific project or requirement.   This support can include but is not limited to following services:

• Consulting and Technical services
• Determining most difficult to sterilize product/product location
• Product & Process Development
• Product and BI Comparative resistance studies
• Product Cycle Validation (PQ)
• Prototype or clinical sample sterilization
• Material Compatibility
• Cycle development
• Packaging
• BI and CI testing.  PCD development
• Product Sterility Assurance Program
• Product aeration characterization
• EO Residuals