Analytical testing, coupled with a robust sampling method with high recovery, is essential to confirm equipment surfaces have been properly cleaned during cleaning validation or verification. The selection of an appropriate cleaning analytical method is integral to the accuracy of test results generated during cleaning validation or verification. There is, however, limited guidance on the selection of analytical methods. This webinar addresses that shortcoming by providing data driven approaches for the selection of an analytical method based on process soil (analyte) characteristics. It will also include a discussion on how those characteristics impact the accuracy of analytical methods. Empirical results for a study conducted in the Hyde Analytical Laboratory will be presented in the discussion that gives further guidance on the selection of an analytical method based on analyte characteristics and their impact on accuracy.
Key takeaways:
• Differences between specific and non-specific analytical methods for cleaning verification or validation
• Choosing between specific and non-specific methods
• How the maximum allowable carryover limit impacts method selection
• How the analyte solubility affects method selection
• Other analyte characteristics critical for selection and development of cleaning analytical methods
• How analyte characteristics affect the accuracy of a cleaning analytical method
• Different sampling methods for cleaning verification or validation
• How analyte characteristics affect sampling method selection
• Selecting a sampling method
• A flow chart for selecting a cleaning sampling and analytical method
