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Cleaning Validation Glossary

Cleaning agent

Chemical agent or solution used for cleaning

Cleaning agent is defined in PDA Technical Report 29, Points to Consider for Cleaning Validation as "The solution or solvent used in the washing step of a cleaning process. Examples of cleaning agents are water, organic solvent, commodity chemical diluted in water, and formulated detergent diluted in water". The selection of the cleaning agents used in a cleaning process depends on the properties of the product that was last produced on the equipment surfaces and the compatability with the material of construction for those equipments, this information should be captured in clenability studies. Cleaning agents mechanisms include solubility, emulsification, wetting, chelation, dispersion, hydrolysis, and oxidation. Following a cleaning process, depending on the manufacturing process and type of cleaning performed, it may be necessary to ensure a safe level of cleaning agent residues remain.

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