Highpower Validation Testing & Lab Services
HIGHPOWER Validation Testing & Lab Services Inc. is a leading validation and testing laboratory specializing in medical device validation services, including cleaning, packaging, sterilization, and material compatibility testing. With extensive regulatory experience and a commitment to safety and quality, HIGHPOWER supports medical device manufacturers throughout design, validation, and regulatory approval processes. The company operates a state-of-the-art facility with advanced sterilization and validation equipment, serving a global customer base and ensuring compliance with industry standards such as ISO 17025.
Industries
Nr. of Employees
small (1-50)
Highpower Validation Testing & Lab Services
125 Highpower Road, Rochester, NY 14623 USA
Services
Laboratory execution of manual and mechanical cleaning validation studies, including worst-case soiling, programmable washer-disinfector cycles, sonic irrigation, and residue quantification.
Validation of sterilization processes across steam and low-temperature modalities using biological indicators, half-cycle (overkill) methods, thermal profiling, and residual moisture testing to demonstrate sterility assurance levels.
Testing and validation of sterile barrier systems and packaging processes including shelf-life (real-time and accelerated), whole-package integrity (aerosol/dye), bacterial filtration efficiency, and physical performance tests.
Validation and performance testing of sterilization equipment and reprocessing devices to confirm cycle parameters, vacuum/pressure profiles, and repeatable sterilant contact for intended device loads.
Repeat-cycle exposure testing for materials and device assemblies to evaluate corrosion, degradation, and functional performance after multiple cleaning and sterilization cycles.
Standard biocompatibility assessments (e.g., cytotoxicity, sensitization, intracutaneous reactivity) to evaluate biological responses to device materials.
Laboratory execution of manual and mechanical cleaning validation studies, including worst-case soiling, programmable washer-disinfector cycles, sonic irrigation, and residue quantification.
Validation of sterilization processes across steam and low-temperature modalities using biological indicators, half-cycle (overkill) methods, thermal profiling, and residual moisture testing to demonstrate sterility assurance levels.
Testing and validation of sterile barrier systems and packaging processes including shelf-life (real-time and accelerated), whole-package integrity (aerosol/dye), bacterial filtration efficiency, and physical performance tests.
Validation and performance testing of sterilization equipment and reprocessing devices to confirm cycle parameters, vacuum/pressure profiles, and repeatable sterilant contact for intended device loads.
Repeat-cycle exposure testing for materials and device assemblies to evaluate corrosion, degradation, and functional performance after multiple cleaning and sterilization cycles.
Standard biocompatibility assessments (e.g., cytotoxicity, sensitization, intracutaneous reactivity) to evaluate biological responses to device materials.
Expertise Areas
- Medical device cleaning validation
- Sterilization process validation (steam, ethylene oxide, hydrogen peroxide, gas plasma)
- Packaging system validation and sterile barrier testing
- Material compatibility and repeat-cycle durability testing
Key Technologies
- High-performance liquid chromatography (HPLC)
- Gas chromatography (GC)
- Spectrophotometry
- Total organic carbon (TOC) analysis
News & Updates
HIGHPOWER Labs hosted 30 visitors from the Delta Chapter of the Medical Device Reprocessing Association of Ontario, offering presentations and lab tours on validation of reusable medical devices.
HIGHPOWER Labs added a state-of-the-art Getinge steam sterilizer to support validation of sterilization efficacy for FDA 510k clearance.
An overview of methods used to validate the sterilization of medical devices, including biological indicators and validation protocols.
Discussion of common issues faced during steam sterilization validation and how to address them.
Insights into cleaning procedures for reusable medical devices and validation strategies.
HIGHPOWER is accredited under ISO 17025, ensuring high standards in testing and calibration services.
HIGHPOWER Labs hosted 30 visitors from the Delta Chapter of the Medical Device Reprocessing Association of Ontario, offering presentations and lab tours on validation of reusable medical devices.
HIGHPOWER Labs added a state-of-the-art Getinge steam sterilizer to support validation of sterilization efficacy for FDA 510k clearance.
An overview of methods used to validate the sterilization of medical devices, including biological indicators and validation protocols.
Discussion of common issues faced during steam sterilization validation and how to address them.
Insights into cleaning procedures for reusable medical devices and validation strategies.
HIGHPOWER is accredited under ISO 17025, ensuring high standards in testing and calibration services.