Writing cleaning instructions for reprocessed medical devices can pose unique challenges during IFU development, but it is critical to get it right the first time. In a recent article for MedTech Intelligence, WuXi AppTec Principal Scientist Dan Fowler dives into developing IFU cleaning instructions for the worst-case scenario. Fowler walks through how to determine the master product for validating product families, identify proper test soils and stay ahead of risks.
While the cleaning validation testing stage is sometimes seen as a box to check on the path to final submission, validating against the worst-case scenario can reveal more value than a manufacturer initially anticipated. Check out “Designing the Worst-Case Test to Get the Best-Case Results” in MedTech Intelligence for advice on understanding the worst-case scenario when writing your next IFU and ensuring a smoother evaluation of your device’s reprocessing method.
Still hungry for more on this topic? Learn more in our blog on developing cleaning instructions with validation and feasibility in mind.
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Established in December 2000, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,100 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated”.
For more information, please visit: http://medicaldevice.wuxiapptec.com/
