LexaMed is ISO 13485 Certified, holds State of Ohio and federal drug licenses and DEA registrations, and maintains FDA registered laboratories for both medical devices and pharmaceuticals testing. LexaMed offers a full complement of microbiology and chemistry services in our corporate laboratories located in Toledo, Ohio.
LexaMed has extensive knowledge and experience in all aspects of Ethylene Oxide (EO) Sterilization. LexaMed associates 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. They also currently serve as active participants on the Microbiological Methods, Aseptic Process, Microbiological Methods, Ethylene Oxide Sterilization Hospital Practices, Radiation, Industrial Steam, Sterility Assurance Levels, Cleaning of Medical Instruments and Packaging AAMI technical working groups.
The 3M™ Steri-Vac™ Sterilization System is a 100% EO system that is effective for the safe low temperature sterilization of moisture-sensitive medical devices. The GSX Series sterilizers; Models GS5X and GS8X are for use in life science, medical device, contract sterilization, R&D laboratory applications, and other research and industrial applications for terminal sterilization. They can automatically aerate the processed load in the sterilization chamber after EO gas sterilization.
LexaMed currently has two validated 3M™ Steri-Vac™ 5XL Sterilizers (5 ft3 capacity) and one validated Model GS8X sterilizer (8 Ft3 capacity) in-house. LexaMed also has an additional 3M aeration unit to assist with any aeration or residual studies.
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
- BI and CI testing. PCD development
- Product Sterility Assurance Program
- Product aeration characterization
- EO Residuals
- Quality Systems support