Manufacturing and quality

Cleaning validation and exposure limits

Annex 15 links residue carryover limits to a toxicological evaluation and documented rationale. A generic calculator cannot establish a substance-specific PDE.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: Shared facilities; consider substance exceptions, exposure route and microbial contamination risks.

View my progress Practise in the lab

Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

Document the HBEL/PDE source and its applicability.
Justify the product, equipment and worst-case selection.
Review recovery, analytical sensitivity and calculation units.
Assess hold times, cleaning-agent residues and microbial risks.

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Cleaning validation and exposure limits

Prepare your evidence before a decision

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