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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.
STERIS experts, E. Rivera and P. Lopolito, have written "Evaluating Surface Cleanliness Using a Risk-Based Approach" BioPharm International 30 (11) 2017. This article talks about rinse sample analysis or visual inspection that can be correlated to surface cleanliness to replace surface sampling.
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.
