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Cleaning Validation Glossary

Health-Based Limit

Limit established based on health risks to patients

The term "health-based" limit is used to reference that the acceptance daily exposure (ADE), permitted daily exposure (PDE), or acceptable intake (AI) had been used during the determinitation of the limit. The ADE, PDE, and AI are defined in other sections of this glossary however, they are all used to described a drug specific threshold that when exceeded will result in adverse health effects. In cleaning health-based limits are used to set limits for residue on equipment surfaces to prevent carryover residues from causing negative health effects in the dose of the next product

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