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Cleaning validation is a required regulatory compliance step in medical device manufacturing and reprocessing. This white paper covers the fundamentals — process controls, residue identification, detection and sampling methods, recovery studies, acceptance criteria (including Total Organic Carbon), and final reporting — and explains how cleaner-manufacturer support can simplify and accelerate the validated or verified state.
Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money when establishing either cleaning validation or cleaning verification processes. This white paper outlines the basics of cleaning validation and how the cleaner manufacturer can help simplify and speed up the process, as well as support ongoing maintenance of the validated or verified state. Contents What Is Cleaning Validation? Definitions Production and Process Controls Inspection, Measuring, and Test Equipment Process Validation Validating the Use of…
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