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Key Takeaways:
- A lifecycle approach ensures surface cleanliness through design, qualification and monitoring.
- FTIR and in-line UV spectroscopy can reduce or replace swabbing in routine cleaning validation.
- Studies show UV and FTIR effectively detect and quantify API residues on stainless steel.
- API solubility and structure affect cleaning, requiring tailored chemistries and conditions.
- In-line monitoring and portable FTIR tools enable real-time, risk-based cleaning validation.
Cleaning validation is a critical component in the manufacturing of pharmaceutical ingredients (APIs) and drug products. This article illustrates new and traditional techniques in designing a cleaning process, ensuring the surfaces are clean and developing rinse solution analysis to continuously monitor cleaning performance.
The article is published in Pharmaceutical Technology (Pages 42 - 54) in both the United States and Europe.
