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Medical Device Cleaning & Sterilization Validation

Trust us to be your independent validation team for your cleaning and sterilization methods.  With over 25 years’ experience delivering cleaning validation services it’s no wonder the top names in the orthopaedic and wider medical devices arena choose our experts to support their cleaning and sterilization method validation processes.

AAOS 2019

Whether you are looking to validate existing or in-house methods, or are looking to outsource the development of your cleaning and sterilization methods, Lucideon can help.  Using a tried and tested partner who understands not just FDA/CE requirements, but the needs of the manufacturer and their end user, ensures a smooth and robust solution to your cleaning validation process.  We work from GMP laboratories and operate to ISO standards, so you can be sure of a professional and reliable service.

Craig Donald is the head of our GMP chemistry team and oversees the majority of our cleaning validation projects.  You can read his bio by clicking below.

  • Craig Donald

    Craig Donald

    Organic Chemistry; Drug Discovery; Sterilization & Cleaning Validation; Project Management

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Reprocessing Validation – Medical Devices

Reprocessing of ‘single use’ medical devices and instruments has become more common place to help reduce costs, but it also increases the chances of cross contamination and pathogen infection.  Reprocessing methods have therefore become a focus for regulatory bodies, including the FDA.  We can help to develop and validate your Instructions For Use (IFU) to industry accepted levels.

Repeat processing can, overtime, lead to mechanical weaknesses and failures or a slow build-up of contamination that is not safely removed by your cleaning and sterilization processes.  Cyclic simulation using the IFU defined for your devices gives you confidence that your products are mechanically sound, as well as achieving acceptable levels of cleanliness, time and again through their approved lifecycle.

Worst Case Scenario Testing

Our method development capabilities are where our cleaning validation services really stand out, developing scenarios that test your devices and instruments to the worst case, and validating that your cleaning processes still leave them clean and safe to use.  We develop your methods, specific to your device, taking into account the hard to reach, high risk areas (hinges, crevices, knurled handles etc.) and the most stubborn contaminants that your device will come into contact with.

Test Soils

Test soils can be bought off the shelf, but are they right for your product?  As part of our evaluation for your cleaning validation assays, we will ensure that the test soil used is the most appropriate to simulate the soils that your devices will encounter.  This helps to make up our worst case testing scenario to ensure your IFUs are fit to effectively remove the most troublesome contaminants.

Whether you require routine testing, quality control or regulatory submission support, we have a depth and breadth of experience to provide the quality consultancy you need to help you get your products to the market faster.

We provide validation of single use device cleaning and sterilization processes (for devices delivered in a sterile state) as well as validation of reusable device cleaning, reprocessing and sterilization.

Learn more about our medical devices cleaning validation offerings for:

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Resources

  • White Paper

    Medical Devices - Cleanliness Validation
    pdf (793 KB)

  • White Paper

    Cleaning and Sterilization Validation of Reusable Medical Devices
    pdf (329 KB)

  • White Paper

    Single Use Systems in the Pharmaceutical Industry - Advantages and Considerations
    pdf (115 KB)