Using Notebook Studies to Help Ensure a Successful Reusable Device Cleaning Validation

Kenny, Patrick
March 2013
Medical Design Technology;Spring Supplement2013, Vol. 17, p12
Trade Publication
In this article, the author discusses the areas of the guidance document of the U.S. Food and Drug Administration that are causing difficulties in cleaning validations of medical devices and also certifies how pre-validation laboratory work can help save time and money. The validation approach with the guidance document aims at proving the removal of physical soil to prevent buildup from repeated reprocessing.


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