LexaMed sterilization validation consultants offer customized solutions designed for your specific requirements. We will work with you to understand your product, objectives and regulatory commitments. We have extensive knowledge and experience in Ethylene Oxide (EO), Radiation and Steam (Moist Heat) Sterilization and can assist you in navigating the complexities of the sterilization validation process to help ensure the sterility of your product while meeting regulatory expectations.
Our expert consultants serve on AAMI Sterilization Standards Committees for Industrial Ethylene Oxide Sterilization, Radiation Sterilization and Steam Sterilization which position us to have current knowledge of global regulations, including FDA, ISO, and industry-specific guidelines. We will design a comprehensive validation protocol compliant with current regulatory expectations and guide you through the process from choosing the appropriate biological indicators, sterilization cycle development, determining cycle parameters, interpretation of sterilization and testing data through final report generation.
In addition to our consulting services, we offer the microbiology and chemistry testing associated with the validation studies in our ISO 17025 accredited laboratories. We also are equipped with a 3M™ Steri-Vac™ R&D EO sterilizer that can be used in cycle development studies. Whether you require a sterilization validation for the release of product from a single batch for clinical trial product, or a full validation study our sterilization consultants are here to help.