Cleaning Validation

List of Practicals

1. Preparation of a cleaning validation protocol for a tablet machine
2. Calculation of MACO (Maximum Allowable Carry Over)
3. Swab sampling technique demonstration using stainless steel surface
4. Rinse sampling technique for equipment residue detection
5. Visual inspection for equipment cleanliness (case photos/videos)
6. Preparation of recovery study protocol using a known contaminant
7. Demonstration of Total Organic Carbon (TOC) analysis (video/simulation)
8. HPLC method development for residue analysis (demo dataset)
9. Interpretation of swab analysis results and comparison with acceptance limits
10. Validation of cleaning agents: detergent effectiveness and rinsibility
11. Determining dirty hold time and clean hold time experimentally (conceptual)
12. Designing a matrix approach for multi-product equipment
13. Simulated deviation report and CAPA for cleaning failure
14. Preparation of a final cleaning validation summary report