Evaluating Surface Cleanliness Using a Risk-Based Approach
Surface cleanliness is crucial in ensuring that process residue, cleaning agent residue, and bioburden do not adversely affect the safety, quality, and potency of the drug manufactured.
2019-02-18
Paul Lopolito
Key Takeaways:
- A risk-based approach links rinse analysis and visual checks to surface cleanliness.
- The FDA’s validation model ensures structured cleaning process design and verification.
- Controlled studies define residue limits using light intensity, angle and variability.
- TOC and conductivity testing confirm surface cleanliness and cleaning effectiveness.
- Continuous monitoring reduces testing while ensuring compliance and product safety.
