Definition
Documented evidence that provides a high degree of assurance that a cleaning procedure will consistently remove chemical and microbiological residues to predetermined levels of acceptability.
When cleaning validation performed
- Initial qualification of process /equipment.
- Critical change in a cleaning procedure.
- Critical change in formulation.
- Significant change in formulation.
- Change in a cleaning process.
- Change in cleaning agent.
Worst-case product
Worst case product is selected based on risk level marking. This risk matrix is predominantly focused on permitted daily exposure value with the highest scale than other risk factor.
Calculation of maximum allowable carry over Limit (MACO)
Four approaches followed for calculation of MACO
- Dose based criteria
- Toxicity based criteria (LD50)
- PDE/ADE base criteria
- 10 ppm Criteria
1. Dose based Criteria
Not more than 1/1000 of minimum daily therapeutic dose of the previous product in the maximum daily dose of the next product
MACO Calculation for Swab:
2. Toxicity based criteria (LD50)
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MACO Calculation for Swab
MACO Calculation for Rinse
3. ADE/PDE Based criteria
MACO Calculation for Swab
MACO Calculation for Rinse
4. 10 ppm Based criteria
Not more than 10ppm of active pharmaceutical ingredient of previous product is permitted in next product.
MACO = 10 ppm x Minimum Batch Size of Product ‘B’ in kg.
MACO Calculation for Swab
MACO Calculation for Rinse
Tags
Validation
