Related Experiment Video
Updated: Nov 1, 2025

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Published on: August 11, 2017
Application of Processing Guidance: Case Study of Cleaning Validations on Flexible Endoscopes
Abstract:
In 2015, the Food and Drug Administration (FDA) updated its guidance on test methods for cleaning validations for reusable medical devices. The changes include the condition and contamination of devices, test samples and controls, cleaning process performed during validation, extraction methods, and endpoints. This article reviews the FDA's changes to cleaning validations. Examples are presented using flexible endoscopes in order to provide a practical guide to performing cleaning validations.
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