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Cleaning Validation Glossary

Worst-Case Products

Most challenging scenarios

Worst-case product or worst-case soil is defined in PDA TR29 Points to Consider for Cleaning Validation as, "A soil or product that is most difficult from production equipment based on knowledge generated from laboratory studies, scientific properties and/or production experience." For cleaning validation when determining a worst-case product, solubility in cleaning agent, product toxicity, product potentcy, and data from laboratory cleanability studies should be considered and discussed in an approved report.

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