Articles
The Basics Of Cleaning And Cleaning Validation
November 25, 2009
•Feature Article: The Basics Of Cleaning And Cleaning Validation
By Jean-Michel Cardot and E. Beyssac
During the past three years, cleaning or cleaningvalidation problems ranked in the top four of the 483s and warning letters issued by the FDA (1, 2), reflecting the agency's emphasis on cleaning. The main points mentioned are a lack of documented procedures, inadequate training of workers, and insufficient validation of analytical and/or cleaning methods.
Manufacturers are concerned about the definition of clean. A clean product, surface, apparatus, fluid, or gas is one "with an acceptable and predefined level of contamination" (3). Contamination is defined as "the presence of contaminant," and contaminant means "a solid, liquid, biological or gaseous matter, a microorganism, or any combination of these likely to alter in any way the health or safety of workers, patients, product, or process." A contaminant is not always a dangerous substance, which is defined as "any substance which, by reason of its characteristics, constitutes a danger to the health, safety or physical well-being of a worker."
Reprinted with permission from BioProcess International
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