HIGHPOWER Validation Testing & Lab Services has been validating reusable medical devices for over 25 years. With an experienced staff, a new facility (opened 2012) and an outstanding reputation for customer service, we provide a wide range of validation testing services and sterilization consulting to medical device manufacturers around the world. With the exception of Ozone, we offer every FDA cleared sterilization process under one roof and serve on numerous AAMI working groups related to medical device reprocessing. Let HIGHPOWER assist you with all your validation and regulatory compliance needs.

  • Steam (Gravity, Pre-vacuum, SFPP)
  • Dry Heat (Convection, Rapid Heat)
  • Chemical Vapor
  • STERIS SYSTEM 1®, V-Pro, V-Pro Plus
  • STERRAD® (100 GMP, 100S, 100NX, NX)
  • 100% EO Gas
  • Cold Sterilization
  • Mechanical (STERIS, Hamo and Medisafe)
  • Manual
  1. Population Assay (Population Verification)
    • Geo. stearothermophilus
    • B. atrophaeus
    • B. pumilus
  2. Cycle Development/Validation
    • Steam (Gravity, Pre-vacuum, SFPP)
    • Dry Heat (Convection, Rapid Heat)
    • Chemical Vapor (ChemiClave)
    • Hydrogen Peroxide (STERRAD®, V-Pro Processes)
    • 100% EO Gas
  3. Validation Studies
    • Sterilizers
    • Mechanical Cleaners
    • Medical or Dental Instruments
    • Sterilization Containers, Trays or Cassettes
    • Reusable or Single-Use Packaging Materials
    • Instrument Sets
  4. Bioburden
  5. Bacteriostasis
  6. Biocompatibility (Cytotoxicity)
  7. D-Value Determination
  8. Biological Indicator Survival/Kill
  9. Device Degradation (Repeat Sterilization Cycle Testing)
  10. Materials Compatibility
  11. Product Sterility Testing
  12. Burst Testing
  13. Shelf-life Testing (Real time & Accelerated)
  14. Package Integrity Testing (Aerosol Challenge) • ISO 11607
  15. Research & Development
  16. Sterilization Consulting Services
  17. Chemical Indicator Testing • ISO 11140
  18. Cleaning Validation for AAMI TIR 12
  19. Residual Testing (EO Gas & H2O2)
  20. Protein/TOC/Hemoglobin Analysis

SYSTEM 1 and V-Pro are a trademark of STERIS Corporation. STERRAD is a trademark of Advanced Sterilization Products, a division of JJMI.

For more information, please e-mail Don Tumminelli at dtumminelli@highpowervtls.com or Gary Socola at gsocola@highpowervtls.com or call us toll free at 1-888-722-1529.