This article is based on an original publication by Texwipe.
What Is Cleaning Validation
Since the US Food and Drug Administration (USDA) released its Guide to Inspections - Validation of Cleaning Process in 1993, cleaning validation procedures in critical environments have been placed under careful scrutiny. At the heart of this concern is the possibility of cross-contamination.
Particularly in a pharmaceutical manufacturing environment, any sort of cross-contamination can present a safety risk to patients. Extraneous residues can threaten the strength, chemical identity and integrity of a substance formula. Thus it is essential for the production environment to be cleaned consistently, employing validated cleaning protocols to ensure the appropriate level of sterilization.