Validation of cleaning processes has long played a critical role in pharmaceutical manufacturing. FDA requires that firms provide written documentation detailing the cleaning processes used for various pieces of equipment as well as how the cleaning processes are validated. Validation requires the development of a cleaning verification method with the typical detection limits of either 10 ppm or biological activity levels of 1/1000 of the normal therapeutic dose. Two methods of sampling the surface of equipment after cleaning are direct-surface and rinse sampling. The advantages of the direct-surface method are that it can reach hard-to-clean areas and it allows insoluble residues to be sampled. However, rinse sampling can evaluate a larger surface area as well as areas that are not accessible with a swab.
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