Overview of Services

    • Routine Product Release Testing: sterility, LAL, bioburden, cytotoxicity
    • Sterilization Packaging Systems
    • Cleaning and Sterilization Validation of Reusable Devices
    • Packaging Solutions
    • Validation of Gamma and E-beam Irradiation Sterilization Processes
    • Validation Services: Process, Equipment, Method, Software, Cleaning, Laboratory
    • Bacterial and Fungal Disinfectant Efficacy Studies
    • Environmental Monitoring: viable, non-viable, bioburden
    • Microbial Suspensions and Growth Promotion Organisms
    • Custom R&D Projects: product performance evaluations, microbiology, product/process development,
    • Biological Indicator Testing (EO, Steam, custom): Performance verification, D-value, z-value, survivor/kill, custom production
    • Training and Seminars
    • Regulatory Assistance: 510(k) and PMA preparations, 483 preparations, 483 and warning letter responses
    • Compliance Auditing: QRS, Laboratory, cGMP, and Computer Systems

To learn more about our capabilities, please download our company brochure.

Ready to submit your sample for testing?  Please download our Sample Submission Form and return to the LexaMed sales team.