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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