What is cleaning validation?

Question

Accepted Answer

Cleaning validation is the process of ensuring that cleaning procedures effectively remove residues from equipment used in manufacturing processes.

Cleaning validation is essential in industries such as pharmaceuticals, food and beverage, and medical devices to prevent cross-contamination and ensure product quality.
It involves establishing documented evidence that cleaning procedures consistently and effectively remove residues to predetermined levels of cleanliness.
Validation typically includes developing a cleaning validation plan, conducting cleaning studies, setting acceptance criteria, and documenting results.
Analytical techniques such as swab sampling, rinse sampling, and visual inspection are commonly used to assess cleanliness.
Examples of cleaning validation parameters include residue limits, cleaning methods, cleaning agents, and equipment surfaces to be cleaned.

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