Cleaning validation
Cleaning validation
Presented by Marc Fini 21 May, 2013
What is cleaning validation?
Cleaning validation is documented evidence that the cleaning process can effectively and reproducibility clean equipment to a predefined acceptable level.
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What does CLEAN mean?
Oxford Dictionary definition: ? To be free from dirt, marks, or unwanted
matter
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Types of cleaning
Clean in Place (CIP)
? Skid ? WFI System ? Recirculation
Clean out of place
? Equipment washer
? Loading patterns
Manual Cleaning ? Brushes
? Procedural ? Operator
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Cleaning agents
Solvent: ? A substance, usually a liquid, capable of dissolving another substance Water (WFI, RO, Municipal Supply)
Ethanol or other organic solvents
Detergent solutions
Acidic or Caustic Solutions
Placebos
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Cleaning agents
Solute: ? A substance dissolved in another substance, usually the component of a solution present in the lesser amount.
API Excipients Cleaning Agents Degradation Products Solvents Intermediates
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Cleaning modes of action
Physical
? High Pressure Spray ? High Velocity Flow ? Scrubbing ? Vacuuming
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Cleaning modes of action
Chemical
? Solubility ? Emulsification ? Wetting ? Chelation ? Dispersion ? Hydrolysis ? Oxidation
"Like dissolves Like"
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