Page 8 - Cleaning and sanitation in GMP
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GMP Training – Cleaning and Sanitation in GMP Areas by www.gmpsop.com
What is cleaning?
Cleaning is the removal of visible and microscopic contamination by dirt,
extraneous mailer, or product residues by mechanical or physical means.
Cleaning is usually followed first by visual inspection, and then by laboratory
testing to verify that the cleaning continues to be effective.
Effective cleaning usually requires the use of cleaning agents such as detergents
and solvents, which are used under specified conditions of pH, temperature, time
and solvent concentration.
A concern with cleaning is whether or not the cleaning agent itself will have a
negative effect on the life of the equipment or on the quality of the product.
What is sanitation?
Sanitation is the reduction of microbiological contamination. It is usually
achieved by the use of chemicals. However, it can also be achieved by hearing
and even vigorous mechanical action, such as scrubbing.
(Note: Cleaning may result in a partial reduction of the microbial load.)
If sanitizing chemicals are used, it may be necessary to remove the sanitizers'
residues by further cleaning. It is therefore very important to use the specified
amount of sanitizing agent.
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