Cleaning Validation HBEL and PDE Limits Checklist

HBEL Derivation

Establish the health-based limit basis.

• Is a health-based exposure limit (HBEL/PDE) established for each product using the ADE/PDE derivation approach? *
• Is the HBEL derived and endorsed by a suitably qualified toxicologist or expert? *
• Are point of departure, uncertainty (adjustment) factors, and route considerations documented? *
• Are highly hazardous compounds identified for potential dedicated or segregated facilities? *

MACO and Limit Calculation

• Is the maximum allowable carryover (MACO) calculated from the HBEL, batch size, and maximum daily dose of the next product? *
• Are HBEL-based limits compared against legacy criteria (e.g., 10 ppm, 1/1000 dose) with the most stringent scientifically justified limit applied? *
• Is the limit expressed as a residue per surface area with defined swab and rinse acceptance? *
• Record the calculated MACO surface limit (mcg/cm2) for the worst-case product pair.

Analytical and Sampling Controls

• Is the analytical method sensitive enough to detect residues at or below the HBEL-based acceptance limit? *
• Are swab recovery and sampling locations validated for hardest-to-clean, worst-case surfaces? *

Lifecycle and Governance

• Are HBEL values reviewed periodically and updated when new toxicological data emerge? *
• Is the cleaning validation program reassessed under change control for new products or shared equipment? *