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Cleaning Validation Report: Paracetamol 500mg Tablets
Report
Cleaning Validation Report: Paracetamol 500mg Tablets
Batch Details
• Product Name: Paracetamol 500mg Tablets
• Batch Size: 500,000 tablets
• Manufacturing Site: Dublin, Ireland
• Equipment Involved: Tablet press, coating machine, blister packaging unit
Cleaning Validation Parameters:
1.Residual API (Paracetamol):
Acceptance Criteria: ≤ 10 ppm
Test Method: HPLC Analysis
2.Microbial Contamination:
Acceptance Criteria: ≤ 100 CFU per swab
Test Method: Swab Testing
3.Detergent Residue:
Acceptance Criteria: ≤ 1 ppm
Test Method: TOC Analysis
4.Visual Inspection:
Acceptance Criteria: No visible residue
Test Method: Manual Check
Analysis & Conclusion
All cleaning validation runs met the acceptance criteria, confirming that equipment cleaning is effective. This ensures compliance with HPRA and EMA regulatory standards.
Cleaning validation ensures that pharmaceutical equipment is free from residues that could affect product quality. This project details a cleaning validation process for Paracetamol tablets in an Irish manufacturing site.