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Sterilization Validation – Hydrogen Peroxide

Applicable Standards & Guidance (Project Dependent)

  • ISO 22441
  • ISO 10993-1
  • ISO 10993-17
  • AAMI TIR12

Vaporized hydrogen peroxide (VHP) is a sterilization modality that continues to gain popularity in the medical product industry.  The publication of ISO 22441:2022 and its recognition by the United States Food and Drug Administration (US FDA), coupled with the FDA’s reclassification of VHP sterilization as an Established Category A process in 2024, has fueled interest in VHP sterilization processes among medical product manufacturers for both healthcare and industrial settings.

Nelson Labs offers comprehensive services to meet your VHP sterilization needs, including, but not limited to, the following:

  •  Test method and regulatory strategy development for healthcare and industrial settings with our Expert Advisory Services (EAS) group,
  • Validation and supporting test protocol development,
  • Validation of VHP sterilization instructions for use (IFU) to be provided to end users in healthcare facilities,
  • Validation services for VHP sterilization processes to be performed in industrial settings, e.g., contract VHP sterilization processes,
  • Laboratory testing to support VHP sterilization validation activities, and
  • Technical and regulatory support during the submission process for market clearance.

In addition to testing that directly relates to VHP sterilization processes, we can also provide testing that supports your process, including biocompatibility testing, bioburden testing, cleaning validations for reusable devices, packaging validation and testing services, routine BI sterility testing, residual testing, and Expert Advisory Services. Learn about all of our testing services.

Study Outline

While the study outline for your project can differ depending on the product specifics, sterilization equipment, process parameters, product packaging, processing setting (e.g., healthcare setting, contract sterilization setting), and other factors, a general process validation typically includes the following:

  • Cycle development testing:  This testing is performed prior to the start of validation, and could include process challenge device (PCD) development, biocompatibility testing, bioburden characterization, relative resistance testing, cycle design (parameter selection), and other testing.
  • Validation of the sterility assurance level (SAL):  The validation of a VHP sterilization process includes microbiological testing, through our sterilization partner, with fractional cycles to demonstrate the ability of the process to deliver the selected SAL to the product.  The SAL can be validated using the overkill approach (required for items to be processed in healthcare facilities) or a bioburden-based approach such as the combined BI/bioburden approach.
  • Sterilant residue testing:  The validation of the sterilization process includes sterilant residue testing through the routine sterilization process to demonstrate the ability of the process to remove sterilant residues from the product and its packaging.  Hydrogen peroxide residues in/on the product are quantified
  • Hydrogen Peroxide Residuals Risk Assessment: Safety limits are required for each device per ISO 22441:2022 section 5.4.5. A residuals risk assessment will be provided as part of this validation process which will identify the safe residual limits specifically for the subject device. The risk assessment will consider the specific contact type and duration of the device as well as the intended patient population.
  • Other supporting testing:  This testing could include testing such as packaging validation testing, sterilization exposures for product functionality testing, material compatibility screening, and product functionality testing.

Testing/Project Location

  • Salt Lake City, UT, USA

Learn more about our locations and their certifications.

Contact Us

If you have additional questions about Radiation Sterilization Validation testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.