Services

Testing services support unique expertise in sterilization

Highly developed competencies in validation testing support TSO3's ability to innovate in hardware design.

TSO3 offers product development and a wide range of services to medical device manufacturers and other interested parties, including the following:

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Hydrogen Peroxide (H2O2) and Ozone (O3) Sterilization Validation

  • Sterility testing (direct and indirect inoculation of medical devices)
  • In-use testing
  • Custom biological indicator preparation and validation
  • D-Value determination
  • H2O2 and O3 residual analysis
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Compatibility Testing Services (CTS)

  • Define and conduct repeat sterilization cycle studies
  • Material compatibility testing
  • Sterility testing (direct and indirect inoculation of medical devices)
  • Medical devices/material evolution standardized characterization
  • Spectroscopic (FTIR) and microscopic (SEM) surface analysis
  • H2O2 and O3 residual analysis
  • STERIZONE® VP4 Compatibility Matrix
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Medical Devices Cleaning Method Development

  • Bioburden determination (pre and post cleaning)
  • Standardized cleaning method development
  • Fluorescence microscopy
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Medical Packaging Compatibility Verification with H2O2/O3 Processes

  • Sterilant penetration study (direct and indirect inoculation of medical devices)
  • Shelf life determination

ISO Certification

Studies are conducted in accordance with international standards (ISO 14937, ISO 11737, ISO 14161, ISO 11607 and ISO 10993) for demonstrated safety of reprocessing reusable medical devices and packaging materials.

Adjustable Protocols

Test protocols may be adjusted to follow specific guidelines and recommendations of the Canadian Standards Association (CSA), the Association for the Advancement of Medical Instrumentation (AAMI), the US Food and Drug Administration (FDA) and the European Committee for Standardization (EN).

For information and pricing packages, contact us at customerservice@tso3.com or 1-866-715-0003.