Cleaning Validation Limits Calculator
Calculate the maximum allowable carry-over by HBEL, dose and 10 ppm criteria, then the surface, swab and rinse limits, and check your swab results.
- EMA HBEL approach
- Swab and rinse limits
- Recovery-corrected
- No sign-up
Four steps, or fewer
- Enter the HBEL (PDE) of the previous product, and optionally its lowest therapeutic dose.
- Enter the maximum daily dose and minimum batch size of the next product.
- Enter the shared surface area, swab area, rinse volume and swab recovery.
- Paste swab results to check them against the limit.
Not sure what to enter? Press Load example to see the calculator with realistic data. Your inputs are saved in this browser, so they are still there when you come back.
How carry-over limits are calculated
MACO(dose) = TDD_A,min × MBS_B / (SF × TDD_B)
MACO(10 ppm) = 10 mg/kg × MBS_B
Surface limit = MACO / shared surface area
Swab limit = surface limit × swab area Rinse limit = MACO / rinse volume
A is the product being cleaned, B the next product made in the same equipment, MBS the minimum batch size and TDD the total daily dose. The calculator uses the lowest of the available criteria.
Since the EMA guideline on health-based exposure limits (2014), carry-over limits for shared facilities should be based on a toxicologically derived HBEL (PDE). Dose and 10 ppm criteria remain useful as additional, often stricter, limits. Equipment must also be visually clean; residues are often visible from about 4 µg/cm².
References
- EMA Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- EU GMP Annex 15: Qualification and validation
- PIC/S PI 006 and PI 046 aide-memoire on HBEL assessment
These calculators are decision support for orientation and training. They are not validated GMP software, and results must be checked against your approved method, SOP and the current pharmacopoeia or guideline before use in GMP records. Your data is processed in your browser and is not sent to Molgenium.