Cleaning and Sterilization Validation of Reusable Medical Devices

We provide testing, cleaning and sterilization services for a wide range of medical devices. All products are inoculated using appropriate test soils and biological indicators. Following cleaning, advanced analytical techniques are employed to ensure the cleanliness of the device. We provide validation for both manual and automatic cleaning methods and design validation procedures specifically to meet the requirements of each device.

Our chemical and microbiological testing facilities coupled with our long-standing experience working with medical devices make us the ideal partner for such validations. We work in accordance with the following standards and guidance documents, AAMI TIR30:2011, AAMI TIR12:2010, ISO 17665-1, ISO 11138-1, ASTM E1766-15 among others so you can be confident that our experts can assist you with your regulatory submissions. We can perform such validations on the finished product or work with you throughout the development phase to assist device design and material selection.

Webinar Recordings:

» Perspectives on Extractables - Pharmaceutical Products and Medical Devices
» Update on USP Tests for Elemental Impurities - Are you ready?
» Cleaning Validation of Reusable Medical Devices

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Resources

  • White paper

    Single Use Systems in the Pharmaceutical Industry – Advantages and Considerations

    pdf 113 KB

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