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Cleaning & Sterilization Validation

Whether it's single-use or reusable, your vascular device needs to be clean and sterile for use.  Our cleaning and sterilization validation service ensures your processes and reagents are suitable to effectively clean your devices.

Single Use Devices

We can:

  • Implement a new cleaning procedure to gain regulatory approval
  • Ensure continual cleanliness of your manufacturing and cleaning processes
  • Identify the presence and source of contaminants
  • Develop effective cleaning protocols for products
  • Determine why residue limits are being exceeded, and set appropriate limits
  • Verify and validate that a process change has not negatively affected cleanliness
  • Perform residue analysis of detergents and manufacturing lubricants.

Reusable Devices

We offer:

  • Process design and development for the reprocessing of a medical device
  • Validation of the effectiveness of a reprocessing method (cleaning, disinfection and sterilization)
  • Validation of the compatibility of a device with the method
  • Sourcing and identification of appropriate soils and detergents.

Vascular Device Manufacturing Equipment

Validation of your cleaning method ensures that your processes are safe and that they consistently achieve the required levels of cleanliness, removing the requirement to verify cleanliness each time cleaning is performed.

Regulatory Submission Support

Some examples of what we do:

  • Develop and write the testing protocol for regulatory submissions
  • Compare dossiers from one regulatory submission against the requirements of another
  • Validate hydroxyapatite coatings against FDA guidance
  • Evaluate porous metallic surfaces
  • Simulate wear testing of hips and knees
  • Establish and validate cleaning processes
  • Characterize new materials for biocompatibility and benchmarking
  • Provide full mechanical testing including fatigue
  • Establish substantial equivalence
  • Validate FEA models, by testing to failure or using our new 3D-strain service.

VALIDATA

VALIDATA quantifies residual contamination using advanced surface analysis techniques, to detect what has not been removed by your cleaning processes.  This is then compared to what is expected to be there and, by the application of a proprietary combinatorial algorithm, expresses the result as a single “Cleanliness Index” parameter in the form of a “% clean” figure.

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Resources

  • White Paper

    Cleaning and Sterilization Validation of Reusable Medical Devices
    pdf (333 KB)

  • White Paper

    Medical Devices - Cleanliness Validation
    pdf (812 KB)