With a device that will undergo reprocessing, there are critical steps an end user is responsible for to ensure the device is clean. These include cleaning, disinfection and sterilization. These are rigorous, time-consuming, and labor intensive processes. More importantly, the process must be validated and reproducible based on the device manufacturers’ instructions for use (IFU).
The validation and verification of the IFU falls to the device manufacturer. WuXi AppTec is a stronger partner in this process. As an independent, third party, we provide a new perspective and expert know how. We provide recommendations on how to approach a validation for cleaning, disinfection, and sterilization of a device.
Our approach is consistent with the latest regulatory guidance, including validation design to the worst-case conditions. Having worked with more than 1500 products, we leverage our experience from a vast, diversity of products to offer study design suggestions such as selection and placement of soil and relevant markers.
Our technical experts work with you on new and existing products, and we collaborate with you to review product families. We discuss product selection for the master product based on worst-case validation as well as consider your product design input. In addition, we also support third party reprocessors with their validation as well as ongoing release testing.
Contact us today to learn more about our approach and validation expertise. Email us at firstname.lastname@example.org or call 888-794-0077.